Source: https://www.patentdocs.org/international_ip/
Timestamp: 2019-04-19 10:29:19+00:00

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The long-awaited UK Supreme Court decision concerning Warner-Lambert's Lyrica® patent was handed down in December. In summary, the Supreme Court dismissed Warner-Lambert's appeal and upheld that the patent did not sufficiently disclose the claimed medical uses, i.e., all pain including peripheral and neuropathic pain. They also found that the claims were not even sufficient in respect of neuropathic pain in dependent claim 3. They also found that even if the claims had been found valid, they would not have been infringed by Actavis and Mylan's activities, and that the post-trial amendment to try to limit the claims to the treatment of peripheral neuropathic pain was an abuse of process.
The Supreme Court is known for being pro-patentee, but this decision was a departure from that and appears, at first glance, to set the bar higher for medical use claims. This decision provides important guidance on the role of plausibility in the test for sufficiency and how infringement of European Swiss-type claims (the old medical use claim format) is assessed in the UK.
Claim 1 of the patent is directed towards pregabalin for the treatment of pain using a European Swiss-type claim. Dependent claim 3 was limited to the treatment of neuropathic pain.
It was known that neuropathic pain can be categorised into peripheral and central neuropathic pain. The patent only exemplified the use of pregabalin in a rat model, which the Court of Appeal viewed only to be linked to peripheral neuropathic pain. It was later confirmed (after the filing date) that pregabalin is effective in treating both peripheral and central neuropathic pain. Actavis manufactures Lecaent, a pregabalin generic and brought proceedings for revocation along with Mylan in the UK.
Warner-Lambert then brought UK infringement proceedings against Actavis later that year. The High Court at first instance ruled that claims 1 and 3 were insufficient, and even if valid, were not infringed. The Court of Appeal upheld these findings and also found that a post-trial amendment filed by Warner-Lambert after the High Court decision to limit the claim 3 to the treatment of peripheral neuropathic pain was an abuse of process.
1. Enablement -- the patent must enable the skilled person to carry out the invention. This aspect of sufficiency was recently dealt with by the UK Court of Appeal in Regeneron v Kymab where they found that the patent was enabled and sufficiently disclosed despite the methods provided in the application being unworkable at the time of the invention. The Court of Appeal afforded the skilled person with considerable time and expertise to find a workable method in that case. Thus, an unworkable method is not an immediate bar to patentability in respect of the enablement aspect of sufficiency.
2. Entire scope -- the patent must also enable the skilled person to work the invention across its entire scope without an undue burden. It must also be plausible to a skilled person for the data provided in the application, that the invention would work across its entire scope, e.g., in the case of a broad medical use claim to a class of diseases, if the drug's mechanism of action is applicable to that broad class of diseases. The Warner-Lambert case dealt with this aspect of sufficiency.
In recent years, the EPO has raised an increasing number of plausibility objections to the claims concerning this second aspect of sufficiency with some decisions seemingly raising the threshold for plausibility (e.g., the Dasatinib decision – T0488/16).
In the Warner-Lambert case, the Court of Appeal found that it was implausible that pregabalin would be effective at treating any type of pain (claim 1) or central neuropathic pain (in respect of claim 3) based on the data in the application showing a mouse model of inflammatory pain. The treatment of peripheral neuropathic pain was found plausible because there was a sufficient unifying mechanistic link between inflammatory pain and peripheral neuropathic pain because both types of pain have a central sensitisation component. The Court noted that while the data was not predictive, it at least rendered its efficacy in treating that type of claim as plausible.
The Supreme Court paid close attention to the EPO Board of Appeal decision T609/02 (Salk Institute) and held by a slim majority that the disclosure supported claims so far as they extend to inflammatory pain but not to any kind of neuropathic pain. Interestingly, dependent claim 2 was directed to the treatment of inflammatory pain, but does not appear to have been asserted. In T609/02, the EPO Board of Appeal held that the specification must disclose the suitability of the drug for the claimed therapeutic application. Clinical trials were not deemed necessary but a mere assertion of efficacy was not enough. In vitro data that provides a direct link to the disease in question is also sufficient.
Warner-Lambert argued that it is necessary to disclose reasons why the claimed effect is plausible only when the skilled person reading the patent would be sceptical about it in the absence of such a disclosure (so-called negative plausibility). Lord Sumption in the Supreme Court disagreed because it would mean that if nothing was known either for or against the claimed therapeutic effect, no disclosure need be made in support of it. Thus, the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true (so-called positive plausibility). However, not all the Supreme Court judges agreed with this approach.
On the aspect of plausibility across the whole scope of the claim, Lord Sumption in the Supreme Court viewed that where a feature of a claim is an assertion of therapeutic efficacy for a given condition, a monopoly is being claimed for the process of manufacturing the compound for the treatment of that condition. This does not mean that it must work for all patients suffering from that condition, or work on every occasion when it is applied by way of treatment. But, it does mean that where the condition identified embraces a number of different pathologies, and the claim is construed as asserting efficacy of the product for each of them, the assertion must be plausible in relation to them all. While this appears a straightforward test, it has difficulties particularly for diseases having potentially many distinct (and as yet potentially unknown) underlying mechanisms of pathology.
It is important to note that the Warner Lambert case involved a second medical use claim and the Supreme Court appeared to restrict the plausibility test to second medical use claims. Thus, it remains to be seen how a first medical use claim might fare before the Supreme Court.
In assessing the plausibility of the Warner-Lambert claims, the Supreme Court disagreed with the Court of Appeal that the specification sufficiently disclosed the use of pregabalin for the treatment of peripheral neuropathic pain. Thus, while the Court of Appeal had found that the use of pregabalin for the treatment of peripheral neuropathic pain (but not central neuropathic pain) was sufficiently disclosed, the Supreme Court disagreed and found that the use of pregabalin for any type (peripheral or central) of neuropathic pain was not sufficiently disclosed.
The Supreme Court reasoned that the rat models used to obtain the data provided in the specification were only relevant to inflammatory pain. Inflammatory pain is an immune-pathology resulting from an activation and dysregulation of the immune system, whereas neuropathic pain occurs following dysfunction or injury of nerve fibres and is characterised by the lack of conversion of nociceptive stimuli into electrical impulses, which can be caused by an altered sensitivity of the peripheral and central nervous system or by damage of the peripheral nerve tissue.
The patentee argued that peripheral neuropathic pain and inflammation are unified by "central sensitisation", which is the process by which chronic pain signals in the periphery (from inflammatory or neurological causes) sensitize the CNS to pain, leading to pain hypersensitivity. Thus, the data in the application using models of inflammatory pain was relevant to peripheral neuropathic pain via this unifying principle.
However, the Lord Sumption argued that just because central sensitisation may be involved in both peripheral neuropathic pain and inflammatory pain, does not prove that they have a common metabolic mechanism. Lord Sumption further reasoned that the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true. They reasoned that the specification said nothing about neuropathic pain of any kind. Also, the specification did not refer to central sensitisation as a mechanism of action of the drug, so there was nothing to suggest, even as a hypothesis, that pregabalin works with peripheral neuropathic pain by blocking central sensitisation. Also, while the specification provided mouse models that could be used to test for efficacy of the drug in peripheral neuropathic pain, it did not directly suggest doing so.
This test seems to go beyond that applied by the EPO in requiring there to be an explicit disclosure of a mechanism of action of a claimed therapeutic effect that is predictive across the claim scope. The EPO would likely view that if it was known that the mouse models in the specification could be used to test for efficacy of the drug in peripheral neuropathic pain, then the therapeutic effect is derivable from the specification and sufficiently disclosed. The patentee should, however, be careful about any claim amendment to a disease category for which there is little mention in the specification.
It is also worth noting that Lord Hodge and Lord Mance also of the Supreme Court disagreed with the approach taken by Lord Sumption, viewing it as imposing too high a threshold and imposing a burden on the patentee which the EPO Board of Appeal case law does not justify. Therefore, despite the negative decision, the test for sufficiency in the UK appears far from settled since it is difficult to reconcile the differing views of the Judges in the Supreme Court.
The Supreme Court also agreed with the lower courts that Warner-Lambert's post-trial amendment limiting claim 3 to peripheral neuropathic pain was an abuse of process. Therefore, it is important that any claim amendments are put forward as early in the proceedings as possible to avoid them being disallowed for an abuse of process. In any case, it is unlikely that this amendment would have saved their case in this instance in view of the Supreme Court's position on sufficiency.
The action for infringement was brought on the basis of claim 1 and 3. The Court of Appeal found these claims to both lack sufficiency, but Lord Justice Floyd still considered the issue of infringement in obiter, particularly the proper interpretation of Swiss-form medical use claims. Lord Justice Floyd particularly provided a clear test by which infringement of Swiss-type claims by a generic could be assessed. The court should assess whether the alleged infringer knew or could foresee that at least some of the prescriptions written generically for the claimed drug for the claimed indication would in fact be fulfilled with the generic. The absence of the claimed indication from the label ("skinny label") could not "conceivably be sufficient to negative the intention" and so would result in infringement. Instead, where the manufacturer has "taken all reasonable steps within his power to prevent the consequences occurring", this would be sufficient to negative the intention and not result in infringement.
Warner-Lambert also appealed this point to the Supreme Court. The Supreme Court dismissed by majority Warner-Lambert's appeal on this point. Particularly, Lord Sumption, together with Lord Reed, Lord Hodge and Lord Briggs, found that if claims 1 and 3 had been valid, they would not have been infringed, but differed in their reasons. Lord Sumption and Lord Reed agreed that the intention of the alleged infringer is irrelevant and that the sole criterion of infringement is whether the product as it emerges from the manufacturing process, including any labelling or accompanying leaflet, is presented as suitable for the uses which enjoy patent protection. Lord Hodge and Lord Briggs preferred the view of Mr Justice Arnold at first instance that the test is whether the alleged infringer subjectively intended to target the patent-protected market.
Therefore, the Court of Appeal's test was not followed. As with the issue of sufficiency, despite the negative decision, the test for infringement of Swiss-type medial use claims in the UK appears far from settled since it is difficult to reconcile the differing views of the Judges in the Supreme Court.
In summary, Warner-Lambert's patent claims 1 and 3 were found invalid for lack of sufficiency, and even if they were valid, were found not infringed. This is despite pregabalin being confirmed to be effective in treating both central and peripheral neuropathic pain, and becoming a blockbuster drug.
It will remain to be seen in future case law how the UK-IPO and UK Courts interpret and follow this decision. Since the Judges in the Supreme Court could not reach agreement on the test for sufficiency and infringement in respect of Swiss-type claims, this will not be an easy job. However, it does mean that there is scope for arguing that the test of Lord Sumption, particularly in respect of sufficiency is too strict and not in line with EPO Board of Appeal case law.
This article was reprinted with permission from Forresters.
The following article was reprinted with permission from Sargent & Krahn.
Recently, the Chilean Government submitted to Congress a Law Bill modifying the Industrial Property Law, the National Institute of Industrial Property Law as well as minor modifications to the Criminal Procedure Law.
The Proposed Bill intends to update the corresponding legislation of trademarks, patents, industrial designs and drawings, trade secrets, geographical indications and appellations of origin, among other matters.
The Bill is currently before Congress and it is expected to be approved in a relatively expedient manner.
• Non-use and genericide trademark cancelation action.
• Three dimensional and scent trademarks will be allowed.
• Limitation to the rights conferred to trademark holders when said trademarks are names, pseudonyms or geographical locations.
• Commercial and industrial establishment trademarks will now be registered in classes 35 and 40 respectively.
• Graphic representation of trademarks will not be required for registration.
• Set of comprehensive regulation of collective and certification trademarks.
• Enhances the description of trademark counterfeit.
• Allows for provisional patent applications.
• New exceptions to patent holder's exclusive rights.
• Modifications to Term Adjustment and Term Extensions.
• Trade secret definition now mirrors that of the TRIPS agreement.
• Allows for the National Institute of Industrial Property (INAPI) to become a party in proceedings before higher Courts.
• Industrial design and drawing deposit system as well as extending their validity term.
• Modifies regulation for geographical indications and appellations of origin.
If the Bill is approved as proposed then trademarks in Chile will be subject to non-use cancelation actions for the first time. The grounds for this action will be if the trademark has not been used in a real and effective manner within the national territory within five years of the registration date or if the use was suspended for 5 years. The transition rule establishes that for trademarks registered prior to the enactment of the law; the use requirement will start upon its renewal.
Additionally, the Bill establishes the cancelation of a trademark if the holder has provoked or allowed for said trademark to become the usual designation of the product or service it distinguishes (genericide). The trademark holder can prevent this from occurring by using the corresponding indications that it is a registered trademark on the products or services.
These cancelations do not operate ex officio and must be filed by a third party. Also, a third party will be able to a file non-use cancelation action when filing a defense writ against a third party opposition.
The Bill allows for three dimensional and scent trademarks.
Trademark holders cannot exclude a person from using their name or pseudonym or that of their predecessors in commerce, unless said name, pseudonym or that of their predecessor induces consumers into error or confusion.
The Bill also establishes that trademarks that include geographical names or expressions related to the genre, nature, origin, nationality, weight, quality, value, or other descriptive expressions cannot prevent the use of said expressions when they are used to identify or inform consumers precisely about said genre, nature, origin, nationality, weight, quality, value, etc, unless they induce consumers into error or confusion.
The Bill establishes amendments that eliminate the Chilean categories of trademarks to distinguish commercial and industrial establishments. Current trademarks that distinguish commercial establishments will have to be renewed in class 35 while trademarks that distinguish industrial establishments will have to be renewed in class 40. This will simplify the registration and will reduce the official fees that currently apply for the registration and renewal of the referred trademarks.
In line with the TRIPS agreement the Bill eliminates the requirement of graphic representation for registration and states that trademarks that cannot be represented in the registration must allow the authorities and the public to clearly and precisely determine the protection granted to the holders.
The current regulation for these trademarks has proven to be deficient and the Bill thus introduces a new definition of certification trademarks and that the holders of said trademarks must authorize its use to anybody whose products or services comply with the conditions set out in the certifications trademarks by-laws. Additionally, the Bill clarifies its authority to object the By-Laws of collective and certifications trademarks.
The Bill establishes sanctions against trademark counterfeits (they were previously regulated in the criminal code in a somewhat erratic manner), elevating the monetary fines in comparison with normal criminal trademark infringement cases as well as not requiring that the infringer act with "willful intent". Additionally, in the case that a trademark counterfeit is proven, the plaintiff will have the option to request a lump sum of damages to be determined by the judge and that cannot be higher than around 140.000 USD.
The Bill will allow for the possibility of filing a provisional patent application without complying with the filing of all the required documents before INAPI. The provisional application does have to pay the corresponding government filing fees and will be in place for 12 months, at which time the applicant must file all the corresponding documents (claims, specifications, drawings, technical sheet). The provisional patent will have to include a written document in Spanish or English that describes the invention in a clear and complete manner in such a way that it allows for an expert to reproduce the invention. The priority date of the final application will be the date of the provisional application.
The Bill reduces the deadline to request a reinstatement of a patent application from 120 working days to 60 working days.
• Private and non-commercial acts.
• Preparation of medicines under medical prescription for individual cases.
• The use, on board of ships of other countries, of means constituting the object of the patent in the hull of the ship, in the machines, rigs, apparatus and other accessories, when said ships temporarily or accidentally enter the waters of Chilean territory, with the reservation that said means are used exclusively for the needs of the ship.
• The use of means constituting the subject matter of the patent in the construction or operation of air or land locomotion apparatus of other countries or of accessories to such apparatus, when these temporarily or accidentally enter Chilean territory.
The Bill allows for the legitimate inventor to request the assignment of a patent and the corresponding damages from the non-legitimate patent holder. This action has to be filed within five years from the registration date and will follow the procedural rules of a summary trial before a civil judge. This amendment solves a current problem in Chile which is that the legitimate inventor only has the ability to file a cancelation action (and thus eventually end up canceling the corresponding patent).
The Bill reduces the deadline to file for a term adjustment and a term extension request from 6 months to sixty working days. Additionally, the Bill establishes a 5 year cap on the amount of time that can be adjusted or extended by the Industrial Property Court. The Bill also defines that when the Examiner accepts the appointment is when the examination is requested in order to trigger the option to request a term adjustment after only three years of prosecution from said date.
The Bill establishes that inventions in service cases will be of the competence of ordinary justice courts and the summary procedure will be applied.
The Bill will allow to file a patent application even if the corresponding government fees have not been paid. The applicant will have to proceed with this payment within 30 days or the application will be declared abandoned.
Additionally, the Bill establishes that if a patent application dossier exceeds 50 pages, the corresponding government fee will be raised by approximately 100 USD for every additional 20 pages.
The Bill also allows that the applicant of a patent, industrial design, utility model, choose the government fee payment deadline for the second half of the corresponding privilege, permitting the payment on an annual basis after the first 5 or 10 year fractions have lapsed.
This amendment resembles the European Design system and allows for the applicant of an industrial design or drawing to request an abbreviated deposit procedure for the application. This procedure eliminates the Substantive Examination Reports, but the holder will have to request said Report if he wants to file criminal infringement actions.
The Bill extends the duration of the validity term of industrial designs and drawings to 15 years (currently 10 years).
The Bill modifies the definition of geographical indications as well as that of appellations of origin. In the case of geographical indications, it allows for this recognition to exist if at least one of the stages of protection or manufacture of the product is executed in the corresponding country, region or locality. In the case of the appellations of origin, it allows for the recognition to be granted if some of the raw materials come from other geographical territories complying with certain specific additional requirements.
• Graphic, phonetic and conceptual similarities that may cause consumer confusion with a previously applied for or registered distinctive sign.
• Graphic, phonetic or conceptual similarities that can cause confusion with a non-registered distinctive sign that is being used in a real and effective manner within the national territory for the same or related goods.
• That constitute the complete or partial reproduction, imitation, or translation of a trademark, appellation of origin, or geographical indication that is well known in Chile in the corresponding consuming public, as long as said use will cause consumer confusion.
The Bill allows for a cancelation action to be filed when the product is no longer manufactured in the protected zone or when the product no longer complies with the conditions that allowed for its recognition. There is no statute of limitation for these actions.
The Bill introduces modifications regarding the manner in which certain resolutions of INAPI are served to the interested parties. For example, oppositions will be served to the applicant in an electronic manner (as well as office actions if there was an opposition).
The Bill introduces an amendment that the government fees for the second half of the validity term can either be paid upfront in total or on an annual basis. Additionally, the Bill establishes that the government fees for a trademark renewal must be paid together with the filing of the renewal request as well as allowing a trademark to be renewed within six months of the end of its validity term (currently 30 days).
INAPI will be able to become a party in recourses filed against their decisions, i.e., before the Industrial Property Court and eventually the Supreme Court.
On December 1, 2018, the Canadian government released its proposed new Patent Rules in the Canada Gazette, Part I. This is one of the last steps necessary for implementing significant changes to Canada's patent law, which are expected to come into force in 2019.
There will be many changes to Canadian patent law and practice. In this article, we discuss the most notable changes expected, and some tips for safe and effective practice under the new rules.
Currently, in order to make a valid priority claim in Canada, the Canadian patent application must be filed no more than 12 months after the filing date of the priority application.
The new system will allow for the 12-month priority period to be extended to 14 months if the failure to meet the 12-month deadline was unintentional. This change will bring Canadian practice into line with the right of restoration of priority provided for in Rule 49ter of the Regulations under the PCT.
However, the Federal Court of Canada can reverse the restoration of priority and declare the priority claim invalid if it is later determined that the failure to meet the 12-month deadline was intentional.
Tip: The "unintentional" standard for restoration of priority in Canada will likely be easier to meet than a "due care" standard applied by some other patent offices. Consider Canada as a favourable choice for situations in which restoration of priority must be relied upon.
Under the current system, in order to obtain a filing date in Canada, the patent application must be in English or French, and a filing fee must be paid.
The new system will relax this requirement for direct filings not entering through the PCT: if the filing fee is not paid, or if the patent application is not in English or French, then the Canadian Patent Office will still grant a filing date.
It will also be possible to obtain a filing date on a day the Canadian Patent Office is closed, e.g., on a weekend or holiday, by filing the application electronically. It will even be possible to defer filing a specification and drawings by instead making reference to a previously regularly filed application.
However, most of these relaxed filing requirements will not apply to PCT national phase applications. For example, it will remain necessary to pay the filing fee at the time of national entry and, if the international application is not in English or French, a translation into English or French must be submitted at the time of national entry.
Tip: As discussed in greater detail below, restrictions will be placed on amendments after a translation is filed. Care should be taken to ensure that all translations submitted to the Canadian Patent Office are free of errors.
A patent application occasionally is filed missing content, e.g., due to a clerical error when preparing the application.
Under the new system, the applicant may add the missing content, without loss of the original filing date, if the addition is wholly contained in a priority document, and the addition is made within two months from filing or, if the Commissioner of Patents sends a notice indicating that a part of the application appears to be missing, within the earlier of two months from the notice or six months from filing. The addition cannot add to the claims of the application.
Tip: This procedure is only applicable to direct filings not entering through the PCT. Advise immediately if missing content is discovered because the deadline to add the missing content may expire as soon as two months from filing.
Currently, only very limited amendments are permitted after an application is allowed. In order to re-open prosecution, it is necessary to allow the issue fee deadline to pass such that the application becomes abandoned, and then reinstate the application. This is complex and time-consuming.
Under the new system, the procedure will be streamlined such that the notice of allowance can be withdrawn and prosecution re-opened simply upon payment of a fee within four months of the date of allowance (and before the issue fee is paid).
Tip: Use the new simplified amendment after allowance procedure to add claims instead of filing a "voluntary" divisional application that could be rejected for obviousness double patenting.
Currently, the issue fee is CAD $300 plus $6 for each page of specification and drawings in excess of 100.
The fee schedule will be updated to clarify that the excess page fee does not apply to pages of a sequence listing submitted in electronic form. This will come as welcome news to biotechnology patentees who have in some instances been stuck with exorbitant issue fees due to long electronic sequence listings.
Tip: Consider deferring allowance of applications having very long sequence listings until after the new Rules come into force, in order to avoid excess page fees.
The current system allows for the correction of "clerical" errors, ultimately at the discretion of the Commissioner of Patents. This has led to a complicated body of law concerning whether an error truly is "clerical" and, if it is, what if anything the Commissioner ought to do about it.
The new system does remove the ability to request correction of "clerical" errors, but it introduces more certainty by establishing clear deadlines for correcting common types of errors. For example, specific deadlines are set in relation to correcting errors in priority claims, correcting errors in the inventor and applicant, and correcting obvious errors found in the patent.
Tip: Check filing documents and granted patents promptly, and advise immediately if an error is discovered. In some cases, the window in which to correct an error is small.
Under the current system, a PCT application can enter the Canadian national phase as late as 42 months from the priority date, although a late fee must be paid if the applicant enters the national phase more than 30 months from the priority date.
Under the new system, the option to enter late by right is removed. If the applicant fails to enter the national phase by the 30-month deadline, it is still possible to enter national phase within 42 months of the priority date, but only upon submitting a statement that the failure to enter the national phase by the 30-month deadline was unintentional.
Tip: This change affects PCT applications having a filing date on or after the coming-into-force date of the new Rules. For such applications, plan ahead for Canadian national phase entry no later than 30 months from the priority date.
To maintain a Canadian application or patent, a maintenance fee is due each year beginning on the second anniversary of the filing date. Under the current system, a missed maintenance fee may be paid up to 12 months late as a matter of right. In the case of a pending application, this requires a request for reinstatement and reinstatement fee, whereas only a late fee is required in the case of a missed maintenance fee on a patent.
The new system will have a benefit in that it will require the Canadian Patent Office to issue a late notice if a maintenance fee is missed. Also, anyone will be able to pay a maintenance fee on a pending application.
However, the new system adds complexity and uncertainty: if the maintenance fee deadline is missed, the deadline for late payment of the maintenance fee is not immediately known and therefore cannot be immediately docketed. Instead, the deadline for late payment is dependent upon when the Canadian Patent Office issues the late notice. If the deadline for late payment is also missed, then in order to restore rights, a submission showing "due care" must be filed within a prescribed period. What constitutes "due care" is currently unknown, and restoring rights under the due care standard may be subsequently challenged in Federal Court. Also, an exemption from infringement ("third party rights") may apply beginning six months after a missed maintenance fee payment, which is also a concept new to Canadian law. Furthermore, because anyone will be able to pay a maintenance fee on a pending application, it will be more difficult to know with certainty whether a maintenance fee payment deadline has been met.
Tip: Do not miss a maintenance fee deadline. Take steps now to put in place robust procedures for the payment of maintenance fees on Canadian patent applications and patents. Consider providing instructions to pay maintenance fees as they come due, absent positive abandonment instructions. Additionally, consider providing instructions to pay the maintenance fee in the event that the Canadian Patent Office issues a notice indicating that the maintenance fee payment was missed (we anticipate the notice will be sent to the Canadian patent agent of record), and absent positive abandonment instructions.
Before a Canadian patent application is examined, examination must be requested and an examination fee paid.
Under the current system, the deadline to request examination is five years from the filing date of the patent application. If the deadline is missed, the application is abandoned, but may be reinstated as of right within 12 months.
Under the new system, the deadline for requesting examination is reduced to four years from the filing date of the patent application. The term for requesting examination in a divisional application filed after the original examination request deadline is reduced from six months to three months from the presentation date of the divisional application. Also, complexities similar to those described above in relation to maintenance fees are introduced if the deadline for requesting examination is missed. For example, missing the deadline to request examination could ultimately result in a situation in which third party rights and due care reinstatement applies.
Tip: It may be advantageous to delay the examination request until close to the deadline so that examination can proceed on the basis of claims allowed in a corresponding application filed in another country. However, do not miss the deadline for requesting examination. Consider having standing instructions to request examination close to the deadline, absent positive abandonment instructions.
An amendment to a Canadian patent application must be reasonably inferred from the application as originally filed, assuming the amended subject matter is not admitted prior art.
However, an additional requirement will be imposed under the new system: if a translation into English or French is filed, then any future amendment to the Canadian patent application must be reasonably inferred from both the application as originally filed (in the foreign language) and the filed translation.
Tip: Take extra caution to ensure that the translation of your patent application is accurate and complete.
Under the new system, it will be necessary to submit a certified copy of each priority application to the Canadian Patent Office, unless a certified copy is otherwise made available through prescribed means.
Submission of a certified copy to WIPO during the international phase of a PCT application will avoid the need for a certified copy during the Canadian national phase. So this change will primarily impact direct filings, not entering through the PCT, in which a claim to priority is being made under the Paris Convention. The deadline to submit the certified copy of each priority application in such a situation will be the later of four months from the filing date of the Canadian patent application and sixteen months from the date of the earliest priority application.
The proposed Rules permit making a priority application available to the Canadian Patent Office in a digital library specified by the Commissioner of Patents, but details are still forthcoming.
Tip: For direct filings not entering through the PCT, or if a certified copy was not filed in the international phase of a PCT application, provide a certified copy of each priority application with your original filing instructions.
The new system reduces the time the applicant will have to meet certain deadlines and to respond to certain requisitions. The term for requesting examination will be reduced from five years to four years from the filing date. Examiner's Reports will have a standard term for response of four months rather than six months. The final fee will be due four months rather than six months from the notice of allowance.
Tip: It may be possible to extend the time to respond to Examiner's Reports by an additional two months (i.e., six months from the date of the Report). However, if such an extension of time is obtained, it will not be possible to request or continue accelerated examination under the "special order" procedure.
There is a 30-day public consultation on the proposed new Rules, ending on December 31, 2018. Subsequently, the final Rules will be published in the Canada Gazette, Part II. We presently anticipate that the new Rules may come into force later in 2019. If you have any questions or would like further information, then please contact a member of our firm's Patent group.
* David Schwartz is a partner in Smart & Biggar's Ottawa office.
** Jeff Leuschner is a senior associate in Smart & Biggar's Ottawa office.
This article was reprinted with permission from Smart & Biggar.
Artificial intelligence (AI) and machine learning (ML) are specifically addressed in new draft Guidelines for Examination (Guidance) released earlier this month from the European Patent Office (EPO). The Guidance includes two new patentability-related subsections directed to 1) AI/ML; and 2) simulation, design or modeling.
The Guidance first defines AI and ML as being "computational models and algorithms for classification, clustering, regression, and dimensionality reduction, [and which may include] neural networks, genetic algorithms, support vector machines, k-means, kernel regression, and discriminant analysis." Additionally, the Guidance states that such computation models and algorithms relating to AI and ML are "per se of an abstract mathematical nature," indicating that the EPO will likely treat such algorithms as unpatentable by default. This is further reinforced by the organizational structure of the new subsection, which appears as G(II)3.3.1 (AI and ML), falling under the mathematical methods exclusion G(II)3.3.
Generally, under examination by the EPO, applications involving mathematical methods are excluded from patentability unless they are determined to have technical character under Art. 52(1). In assessing whether a mathematical method possesses such technical character, a determination is made whether the invention produces a technical effect that serves a technical purpose. A generic purpose such as "controlling a technical system" is not sufficient to confer technical character to the mathematical method.
The Guidance specifically notes that "artificial intelligence and machine learning find applications in various fields of technology," and highlights examples of a "neural network in a heart-monitoring apparatus" and "classification of digital images, videos, audio or speech signals based on low-level features" as both possessing technical character.
In contrast, the EPO identified the classification of text documents solely based on their textual content and classification of abstract data records without any indication of a particular technical use as not having technical purpose. Furthermore, the EPO treats expressions such as "support vector machine", reasoning engine", or "neural network" as merely referring to abstract models that are "devoid of technical character." Furthermore, the Guidance states that "even if [a] classification algorithm may be considered to have valuable mathematical properties," that alone is not per se a technical purpose.
The new EPO Guidelines for Examination will go into effect on November 1, 2018, and are believed to represent the first official patent examination guidance to specifically address the eligibility of subject matter relating to AI and ML. Going forward, it appears that such applications filed in the EPO should specifically highlight how a specific field of technology is improved by the AI-ML-related mathematical methods in order to best demonstrate technical character.
The following article was reprinted with permission from J A Kemp.
The European Patent Office (EPO) applies the same basic patentability criteria to antibodies as to other inventions, but it can sometimes appear that antibodies are treated as a special case. For an explanation of the basic approach adopted by the EPO, please see our related briefing "Antibodies in the European Patent Office – Basic Principles" (an updated version of this report can be found here). The present briefing is intended to develop those Basic Principles into a guide to the drafting and prosecution of patent applications for antibody inventions.
The briefing focuses on the most common type of antibody invention at the present time -- namely monoclonal antibody products for which the target and any associated disease indications are already known. We also provide guidance on ensuring your antibody claims are appropriate to support future applications for Supplementary Protection Certificates (SPCs).
Where is the Case Law?
This Advanced Guide is drawn primarily from our experience prosecuting large numbers of antibody cases before the EPO and our discussions with EPO examiners. This may raise the question: Why is there so little supporting case law?
The main reason is that antibody case law at the EPO has been relatively slow to develop in recent years. In our opinion this is because the most common pending antibody applications during this period have focused narrowly on a lead molecule or molecules of the applicant.
As a consequence, an innovator competitor is unlikely to have freedom to operate concerns for their own molecule, and could even prefer that a patent is granted and in force since this may reduce the likelihood of generic competition. On the other hand, the 9 month opposition term after grant of European patents may come too early in product development for a generic / biosimilar competitor, or they may take the view that their primary barrier for market entry will be regulatory data exclusivity rather than the patent. Again, they may therefore prefer the patent to be granted and maintained in force in the meantime.
The net effect is that there are comparatively few oppositions filed against this type of invention, and thus comparatively few cases reach the Boards of Appeal. The EPO Examining Divisions have therefore developed their approach from the principles outlined in earlier decisions, adapted by their exposure to high volumes of cases.
As is explained in more detail in our Basic Principles briefing, where the target and its relevance to a disease indication are known, the EPO generally assumes that any antibody with a unique amino acid sequence will be novel over prior art antibodies to the same target, but a demonstration of an unexpected (surprising) technical effect will be required to establish an inventive step. It must be at least plausible that the unexpected technical effect, usually a functional characteristic, is shared by substantially all antibodies falling within the scope of the claim.
The following sections provide our suggestions for how best to prepare a patent application to meet these requirements.
• Functional data to show that the antibody has an unexpected technical effect / functional characteristic that can be relied on for inventive step.
The claims will typically need to incorporate a structural definition of the antibody, at least for the target-binding region. It can be assumed that a minimum of six CDRs will be required unless there is compelling data to show that target binding and other key characteristics are shared by antibodies defined less precisely. It is now relatively common for complete variable region sequences to be required.
Where there are multiple candidate antibodies in an application, it should be ensured that each molecule is defined by reference to as complete a set of structural information as possible, ideally all six CDRs and both complete variable region sequences. The use of "mix and match" language, which typically seeks to encompass any combination of CDRs and variable region sequences from multiple candidates should not be relied on. Instead, the specific combinations of target-binding region sequences that make up each of the candidates should be disclosed.
It is increasingly common for EPO examiners to object that references to CDRs in the claims are unclear unless the identification method used is also recited. Under strict EPO disclosure requirements, it may only be possible to comply with a request to insert a definition of the identification method into a claim if there is an explicit reference to it in the application as filed.
The application as filed should therefore disclose how the structural information was determined. In particular, the numbering scheme and definitions used to identify CDRs should be specified (Kabat, Chothia, AbM etc). It is acceptable to list alternative CDR sequences for a given molecule based on the different available definitions, provided that each alternative is clearly identified alongside the definition used.
Sequence information for the variable region is routinely included in applications, but there is often no indication of the constant region either by reference to an isotype class or a specific sequence. Desirably, at least one preferred isotype class should be recited, and ideally at least one exemplary constant region sequence should also be included. This information should be presented together with the target-binding region information, such that there is an explicit disclosure of the structure of the combined target-binding region and constant region for each complete antibody molecule.
It may be helpful to recite the sequence of a complete heavy chain and a complete light chain for each molecule, with an explicit statement that each heavy chain / light chain pair is combined to produce a complete molecule of the invention. Once again, "mix and match" language should not be relied upon.
In some cases it may be necessary to specify the isotype / constant region sequence in the claims, particularly if this is relevant to the unexpected characteristic relied upon for inventive step. Under strict EPO disclosure requirements, this will likely only be possible if there is an explicit reference to the constant region in the application as filed.
A demonstration that an antibody binds to a target should not be difficult to provide, since any antibody development plan will likely include a significant quantity of data demonstrating target specificity and affinity/avidity.
There is no single preferred technique for measuring target binding for patent purposes, although surface plasmon resonance is increasingly regarded as the standard. Whichever technique is used, the patent application should ideally describe this in general terms (optionally by reference to standard texts) but should also include the specific experimental conditions that apply to the determinations of binding that were actually conducted for the exemplary antibodies of the application: temperature, ionic strength, nature of target etc. At least one individual experiment should be described in full in the Examples and the corresponding data provided in the application.
If a required level of affinity/avidity is recited in the claims, typically the EPO will now require that the claims also include an indication of the technique used to determine this parameter. Under strict EPO disclosure requirements, it may only be possible to comply with a request to insert the technique if there is an explicit reference to it in the application as filed.
The type of functional data available will, of course, be highly dependent upon the nature of a given antibody project. However, the EPO will be looking for evidence of a functional property of the claimed antibodies in the application. Therefore, although additional data in support of an inventive step may be filed during prosecution, it is important to at least include a description of the functional characteristics of the antibodies. The techniques used to demonstrate the functional characteristics should be described both in general and in more specific terms, and at least one individual experiment should be described in full in the Examples alongside the corresponding data.
If it is necessary or desirable to limit the claimed antibodies by reference to a functional feature in the claims, an EPO examiner may request that claims also include an indication of the technique used to determine the feature for the exemplary antibodies disclosed in the application. It may only be possible to comply with such a request if there is an explicit disclosure of the technique in the application as filed.
EPO examiners often look for comparative data with prior art antibodies as evidence of an unexpected technical effect. A patent application does not necessarily need to include comparative data, and indeed it may not be possible to include comparisons to particular prior art antibodies -- not least because these may only be identified in later Patent Office searches. However, if the applicant wishes to rely upon comparative data generated after filing to prove that a functional characteristic of the claimed antibodies represents an improvement over the prior art, the comparative data must relate to information about the claimed antibodies that is disclosed in the application as filed. It must be at least plausible from the application that the claimed antibodies possess the property relied upon.
As a consequence, the more information that is included in the application regarding the antibody of interest, the easier it is likely to be to rely upon comparative data that is only generated later in response to an objection based on a particular prior art antibody.
It can, in particular, be helpful to include comparative data from related antibodies produced in the course of the antibody development project which do not share the same characteristics as the lead antibody, or lead antibodies.
This may seem counter-intuitive, since such data may limit the extent to which the structural definition in the claims can be broadened to a class of molecules. However, comparative data of this type may help to illustrate or emphasise the unexpected nature of a characteristic relied upon for inventive step, since it can help to establish that anti-target antibodies (and hence prior art antibodies) cannot be assumed to share that characteristic.
Another situation where including data relating to a number of different anti-target antibodies can be helpful is where a panel of antibodies have been developed in an attempt to identify candidates which have one specific improved property -- such as improved solubility, reduced isomerisation etc. Comparative data for antibodies for which such attempts were unsuccessful will help to show that the successful attempts were not predictable in advance, and thus are unexpected.
Although the EPO have historically allowed claims which define antibodies in terms of their epitope binding, such claims are coming under increasing scrutiny. Our understanding is that the EPO now require more detailed information concerning how the epitope was identified and how binding to it is to be assessed. The EPO may also require detailed information regarding any novel / inventive characteristics that are asserted as being conferred on an antibody by virtue of binding to a particular epitope, as well as evidence that prior art antibodies do not bind to the same epitope. This need not necessarily take the form of epitope-binding data for prior art antibodies. The EPO may accept a technical explanation as to why a prior art antibody would not bind to the same epitope.
Where an epitope is identified in an application, it should be considered whether it represents a sequence bound by an antibody only when present in the context of the target molecule as a whole, or whether it can also be bound as a short peptide fragment in isolated form. Care should be taken when drafting the specification so that it is clear exactly what properties are intended when referring to epitope binding. There are a variety of different methods can be used in establishing epitope binding, including analysis of binding to short fragments, mutagenesis studies, and crystallography analysis. It is desirable to include detailed information regarding the technique that has been used for the antibodies that are disclosed.
When drafting an application, consideration should be given to the techniques employed both for epitope determination and for assessment of the resulting characteristics. Sufficient information should be provided to ensure that the particular epitope is clearly defined, and that one of skill in the art could produce antibodies which can be identified as binding to it. The EPO may also require evidence to establish that it is at least plausible that all antibodies binding to the particular epitope can be expected to share the resulting properties.
The SPC Regulation pre-dates the development of biological pharmaceuticals such as antibodies, and thus does not take into account the particular complexities of such molecules as compared to traditional small molecule pharmaceuticals. As a consequence, the basic requirements to obtain a valid SPC are the same for all types of pharmaceutical. One of these requirements is that the active ingredient of an authorised medicinal product must be "protected by the basic patent" (Article 3(a) of the SPC Regulation).
This requirement is not satisfied merely because the active ingredient is encompassed within a claim of the patent for the purposes of infringement. Rather, the cumulative effect of multiple CJEU decisions is that the active ingredient must be "specified" in the claims at some higher degree of precision. For more detailed information, see our separate SPC briefing.
The key point to bear in mind is that it is desirable to include a claim (or language to support a claim) that defines the expected active ingredient of any medicinal product with as high a degree of precision as possible. Where possible, this should include as much structural information as is available regarding both target-binding and constant regions of an antibody.
On April 28th, Ambassador Robert Lighthizer, U.S. Trade Representative (USTR), issued the 2018 Special 301 Report. According to the USTR website, "[t]he ideas and creativity of American entrepreneurs fuel economic growth and employ millions of hardworking Americans" and "[t]his report sends a clear signal to our trading partners that the protection of Americans' intellectual property rights is a top priority of the Trump Administration," language reiterating last year's Report and consistent with much of the trade-related rhetoric emanating from the White House this year. The press release accompanying the report again recites statistics as the basis for these views, citing government estimates that 45.5 million American jobs that depend (directly or indirectly) on IP-intensive industries, representing 30% of all employment. The Report "calls on U.S. trading partners to address IP-related challenges" and "draws attention to IP-related trade barriers and the steps foreign countries can take to open their markets to IP-intensive goods—steps that help to protect U.S. jobs, create opportunities for job growth, and promote free and fair trade that benefits all Americans."
As it has done for the past several years over very different administrations, the Report highlights China as a country in which both "[l]ongstanding and new IP concerns merit attention," including with respect to "coercive technology transfer requirements, range of impediments to effective IP enforcement, and widespread infringing activity" (enumerated as "trade secret theft, rampant online piracy and counterfeit manufacturing"). It is the 14th consecutive year that China has been placed on the Priority Watch List, which as it sounds reflects greater concern and greater scrutiny.
The USTR also cites India for what he calls "longstanding challenges in its IP framework and lack of sufficient measurable improvements, particularly with respect to patents, copyrights, trade secrets, and enforcement, as well as for new issues that have negatively affected U.S. right holders over the past year."
Canada once again is singled out, being "downgrade[d]" from the Watch List to the Priority Watch List, for "for failing to make progress on overcoming important IP enforcement challenges." These include "key concerns" related to "poor border enforcement generally and, in particular, lack of customs authority to inspect or detain suspected counterfeit or pirated goods shipped through Canada, concerns about IP protections and procedures related to pharmaceuticals, deficient copyright protection, and inadequate transparency and due process regarding the protection of geographical indications."
The Report also announces that the USTR has closed "Out-of-Cycle" reviews of Kuwait albeit "without a change in status", because, inter alia, the country "has not yet brought its copyright regime in line with its international commitments and still needs to make necessary improvements to the regulations implementing its 2016 Copyright and Related Rights Law." Closure of OCR of Tajikistan resulted in that country being downgraded to the Priority Watch List, for "fail[ing] to address unlicensed software use by government agencies during the OCR." The USTR also announced that he will begin an OCR Colombia, Kuwait, and Malaysia.
The USTR reviewed "more than 100" of this country's trading partners and identified twelve countries on a "Priority Watch List" (increased by one from last year) and another 24 countries on the "Watch List" (also increasing by one from last year), all relating to deficiencies in intellectual property protection in these countries. The Priority Watch List in the 2018 Report adds Canada to those countries cited in the 2017 Report (Algeria, Argentina, Chile, China, India, Indonesia, Kuwait, Russia, Thailand, Ukraine, and Venezuela). Countries on this list "present the most significant concerns this year regarding insufficient IP protection or enforcement or actions that otherwise limited market access for persons relying on intellectual property protection." On the Watch List this year are Barbados, Bolivia, Brazil, Costa Rica, Dominican Republic, Ecuador, Egypt, Greece, Guatemala, Jamaica, Lebanon, Mexico, Pakistan, Peru, Romania, Switzerland, Turkey, Turkmenistan, Uzbekistan, and Vietnam. Saudi Arabia, Tajikstan, Thailand, and the United Arab Emirates were added, Bulgaria was removed, and Canada and Columbia moved to the Priority Watch List this year.
The Report also notes the USTR's continued efforts to enhance public engagement. In addition to written comments (from 62 interested parties, including 23 trading partner governments), there was a public hearing on March 8, 2018 that heard testimony from "representatives of foreign governments, industry, and non-governmental organizations" (where the comments and a transcript of the hearing are available on the USTR website).
The Report reflects the resolve of this Administration to call out foreign countries and expose the laws, policies, and practices that fail to provide adequate and effective IP protection and enforcement for U.S. inventors, creators, brands, manufacturers, and service providers. The identification of the countries and IP-related market access barriers in this Report and of steps necessary to address those barriers are a critical component of the Administration's aggressive efforts to defend Americans from harmful IP-related trade barriers.
The Report notes that "[i]n virtually all countries mentioned in the Report, IP enforcement is lacking," based on (a) "[in]adequate or [in]effective border enforcement against counterfeit and pirated goods" (Canada, Egypt, Indonesia, Mexico, Turkey, Turkmenistan, UAE, and Uzbekistan); (b) copyright piracy in China, Mexico, Russia, Ukraine and Vietnam, with particular emphasis on use of unlicensed software by government agencies in Argentina, Greece, Tajikistan, Turkmenistan, Uzbekistan, and Venezuela; (c) online piracy in Canada, China, India, the Netherlands, Romania, Russia, Switzerland, Taiwan, Ukraine, "and elsewhere"; (d) restrictive patentability criteria in Argentina, China, India, Indonesia Saudi Arabia, Thailand, and Russia, including "a lack of adequate and effective protection for regulatory test or other data submitted by pharmaceutical and agricultural chemical producers"; (e) inadequate trade secret protection in China and India, which "U.S. trade secrets at unnecessary risk"; and (f) negative market access effects on regulatory agencies in the European Union."
IP infringement undermines U.S. competitive advantages in innovation and creativity, to the detriment of American businesses and workers. In its most pernicious forms, IP infringement endangers the public, such as through exposure to health and safety risks from counterfeit products like semiconductors, automobile parts, apparel and footwear, toys, and medicines. In addition, trade in counterfeit and pirated products often fuels cross-border organized criminal networks and hinders sustainable economic development in many countries. Fostering innovation and creativity is essential to U.S. economic growth, competitiveness, and an estimated 45 million American jobs that directly or indirectly rely on IP-intensive industries. USTR continues to work to protect American innovation and creativity in foreign markets with all the tools of U.S. trade policy, including through the annual Special 301 Report.
It then reviews "initiatives for strengthen IP protection and enforcement," which includes "examples of initiatives to strengthen IP protection and enforcement; illustrative best practices demonstrated by the United States and our trading partners; [and] U.S.-led initiatives in multilateral organizations; and bilateral and regional developments." It also highlights areas of continued concern, including "counterfeits, online piracy, forced technology transfer, innovative pharmaceutical products and medical devices, and geographical indications (GIs)." As in earlier years, it mentions how important IP protection is to innovations in the environmental sector. Finally, Section I includes a discussion relating to "the importance of full implementation of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and developments on the U.S. use of WTO dispute settlement procedures to resolve IP concerns."
• United Arab Emirates (UAE): seeking reassurance that UAE will provide protection for pharmaceuticals through, inter alia, the Gulf Cooperation Council (GCC) patent system.
Compulsory licensing poses particular concerns with regard to pharmaceuticals and medical devices, according to the Report, because "[s]uch actions can undermine a patent holder's IP, reduce incentives to invest in research and development for new treatments and cures, unfairly shift the burden for funding such research and development to American patients and those in other markets that properly respect IP, and discourage the introduction of important new medicines into affected markets." Even when compulsory licenses are justified they should be used in only "limited circumstances" and only after attempting to negotiate with the rights holder; the Report cited these concerns particularly with Chile, Colombia, El Salvador, India, and Malaysia. More generally, the Report points to "non-transparent" and discriminatory practices and "unreasonable regulatory delay" as being of concern to the USTR and administration. In contrast, national systems that accelerate approval based on regulatory in other countries is praised in the Report. The Report notes that stakeholders have identified industries have expressed concerns regarding the policies of several trading partners, including Algeria, Australia, Canada, China, Colombia, Ecuador, Japan, Korea, New Zealand, and Turkey with regard to these issues, citing specific examples falling within these general categories for each country.
The Report next turns to technology transfer issues, including innovation by indigenous peoples and "localization." In this portion of the Report, compulsory technology transfer is emphasized as causing difficulties for American innovators, particularly in China. The Report identifies the anti-innovation cycle of imposing such measures to incentivize local innovation, which leads to create market entry barriers and thus discourages foreign (i.e., U.S.) investment, which not only hurts domestic industry in those countries but also can produce "non-market distortions" which in turn can lead to "suboptimal outcomes." The Report sets forth a litany of these practices, including requirements for technology transfer as the price for regulatory or other governmental approval; permitting state-owned enterprises to seek "non-commercial terms" for IP licensing or otherwise; providing unfair competitive advantage to local industry (if only passively by permitting U.S. IP-rights infringement); permitting cyber-intrusions; giving preference to local products and services dependent on indigenous IP; "[m]anipulating" processes of standards to prefer local concerns; and conditioning regulatory approval or other governmental approvals on disclosure of confidential business information and then "failing to protect such information appropriately." China, Indonesia, Nigeria, and Turkey are particularly cited for these concerns.
Trade secret protection, or lack of it, is also a concern discussed in the Report. It cites "growing need for trading partners to provide effective protection and enforcement of trade secrets" in "a wide variety of industry sectors, including information and communications technologies, services, pharmaceuticals and medical devices, environmental technologies, and other manufacturing" areas. The Report cites "various sources, including the U.S. Office of the National Counterintelligence Executive (ON- CIX)" for reporting these concerns, which are discussed in the Report with specificity regarding Brazil, China, India, Indonesia, and Nigeria for a wide variety of trade secret related breaches, including permitting (or not stopping) departing employees from taking with them trade secret information-containing electronic storage devices, cyber intrusion and computer hacking, misuse of trade secrets disclosed to government agencies, for example, as part of a regulatory approval process, and others. The Report on a positive note cites efforts by China, the European Union, and Taiwan to address these issues (albeit noting that China's efforts have come up short), and supports he Organization for Economic Co-operation and Development (OECD)'s work on trade secret protection.
The Report next addresses geographical indications (GIs) issues (which is ironic, in view of the Administrations withdrawal from the Trans-Pacific Partnership treaty, which addressed this issue in a U.S-friendly fashion). The Report cites U.S. efforts "through bilateral and multilateral channels" to improve U.S. access to a variety of goods having geographic specificity, as the Report states the issue where the goods identifier includes "place names (or words associated with a place) and identify products as having a particular quality, reputation, or other characteristic essentially attributable to the geographic origin of the product." This is a particular problem with the EU where it poses a significant barrier to entry (for example, for U.S.-sourced parmesan or feta cheeses), and the bases for the issue (including impairment of trademark and trade dress rights and interference with international standards) are discussed in depth. Part of the reason for U.S. concern is frankly admitted to be that "[t]he United States runs a significant deficit in food and agricultural trade with the EU" and "[t]he EU's GI system contributes to this asymmetry in U.S.-EU trade in agricultural products for products subject to the EU's GI regime." The Report also notes that this issue is being addressed in bilateral or multilateral agreement with other nations, including Argentina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Indonesia, Japan, Malaysia, Mexico, Morocco, Paraguay, the Philippines, South Africa, Tunisia, Uruguay, and Vietnam.
The Report next addresses border control and criminal enforcement against counterfeiting; insofar as placement of the issues discussed in the Report indicates the importance the Trump administration places on them this is a change from the prior administration. Counterfeit goods (including "semiconductors and other electronics, chemicals, automotive and aircraft parts, medicines, food and beverages, household consumer products, personal care products, apparel and footwear, toys, and sporting goods") "make their way from China" and other countries, particularly those having an "ineffective or inadequate IP enforcement system." The Report states that such counterfeit goods harm "consumers, legitimate producers, and governments," particularly with regard to medicines, automotive and airplane parts, and food and beverages" because the counterfeit products do not meet the "rigorous good manufacturing practices used for legitimate products." The Report enunciates particular concern for such activities in China, Hong Kong, India, Indonesia, Singapore, Thailand, Turkey, and the United Arab Emirates, and alleges that 90% of all counterfeit drugs entering the U.S. come from China, the Dominican Republic, Hong Kong, and India, with China and India being particularly singled out as a source of counterfeit drugs. The USTR notes the efforts of ICANN to withdraw the Registrar Accreditation Agreement for Nanjing Imperiosus Technology a known Internet-based source of counterfeit medicines. Accordingly, the Report "urges" U.S. trading partners to "undertake more effective criminal and border enforcement against the manufacture, import, export, transit, and distribution of counterfeit goods" and states that the Office engages trading partners bilaterally, through trade agreement and international organizations on this issue.
The Report next turns to online and broadcast piracy of copyrighted works (again, seemingly of less important to this administration than the prior one), citing the "increased availability of broadband Internet connections around the world" as being a "boon" to the U.S economy and foreign trade. But while advances in technology have enabled U.S. creative producers to better distribute copyrighted materials it has also made the Internet "an extremely efficient vehicle for disseminating infringing content, thus competing unfairly with legitimate e-commerce and distribution services that copyright holders and online platforms use to deliver licensed content." A variety of forms of this issue are discussed in the Report, which names China, India, Mexico, Peru, and Vietnam for optical piracy; Canada, China, Cyprus, India, the Netherlands, Russia, Switzerland, and Ukraine for "commercial-scale online piracy; Canada, Mexico, the Netherlands, Saudi Arabia, Sweden, and Switzerland for "stream-ripping" (which is "the unauthorized converting of a file from a licensed streaming site into an unauthorized copy" and is now a "dominant" method for music piracy); and Argentina, Brazil, Chile, China, Hong Kong, Indonesia, Mexico, Peru, Singapore, Taiwan, and Vietnam for the use of illicit streaming devices. Illicit camcording continues to be a particular concern in the Report, with Brazil, Canada, China, Ecuador, India, Japan, Mexico, Peru, the Philippines, Russia, and Taiwan being cited in this regard. Other aspects of copyright enforcement contained in the Report are royalty payment and administration regimes including collective management organizations (CMO), which the Report states are "flawed or non-operational" in many countries (Argentina, India, Korea, the UAE, and Ukraine, specifically).
Trademarks and impediments to obtaining and enforcing them in some countries make up the next topic in the Report, with Brazil, China, India, Malaysia, and the Philippines, having "slow" opposition proceedings and Russia and Panama having no administrative opposition proceedings. Even registering (i.e., making a record of) trademarks is problematic in some countries, with "unnecessary administrative and financial burdens" imposed on owners and there being unnecessary difficulties in maintaining and enforcing trademarks (albeit without naming any countries where these and other difficulties contained in the Report have arisen). There are also issues with cybersquatting and particularly with country code top-level domain names (ccTLDs) for U.S. rights holders. The governments of Argentina, Chile, China, Costa Rica, Greece, Kazakhstan, Korea, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, and Vietnam are named for unlicensed use of software, and the Report cites a commercial value for such illicit use of software at $52 billion worldwide.
The Report sets forth efforts related to initiatives to strengthen IP protection and enforcement in foreign markets, either supported or assisted by the U.S. (in Bosnia and Herzegovina, Bulgaria, China, Greece, India, Jordan, Kuwait, Pakistan, Taiwan, Thailand, and the United Arab Emirates) and sets forth "illustrative best IP practices" in detail for Brazil, India, Jamaica, Malaysia, Spain, and Thailand. The Report also discussed bilaterial, regional, and international agreements.
Section I of the Report ends by mentioning the role of intellectual property and the environment and intellectual property and health as areas of concern raised by stakeholders in their comments. In India, for example, compulsory licensing of "green" technology "will discourage, rather than promote, investment in and dissemination of green technology innovation, including those technologies that contribute to climate change adaptation and mitigation." The Report contains an affirmation of the provisions regarding IP and public health set forth in the Doha Declaration and states that it "recognizes the role of IP protection in the development of new medicines, while being mindful of the effect of IP protection on price" (a change from the pledge not to interfere with Doha provisions permitting compulsory licensing under certain specified conditions contained in earlier Section 301 Reports). And the final portion of the Report discusses efforts at dispute resolution of IP matters under the GATT/TRIPS provisions as they are implemented by the WTO.
Finally, the last portion of Section I of the Report relates to dispute settlement and enforcement. It states that while the U.S. believes that "[t]he most efficient and preferred manner of resolving concerns is through bilateral dialogue," when that doesn't work "the United States will use enforcement tools including those provided under U.S. law, the WTO and other dispute settlement procedures, as appropriate." Specifically cited is the August 14, 2017 Presidential Memorandum regarding an investigation by the USTR of "laws, policies, practices, or actions of the government of China that may be unreasonable or discriminatory and that may be harming American intellectual property rights, innovation, or technology development" (82 FR 39007) and its subsequent institution on August 18, 2017. The Report notes that the investigation reported, in March 22, 2018 that "the investigation supports findings that acts, policies, and practices of the China related to technology transfer, intellectual property, and innovation covered in the investigation are unreasonable or discriminatory and burden or restrict U.S. commerce" and the subsequent actions of the Administration to impose tariffs on Chinese goods. Other enforcement actions, mostly of historical significance, are also discussed.
As it has for the past several years (and across otherwise very different Administrations), the U.S. Trade Representative Special 301 Report provides insights into both the concerns of U.S. IP rights holders and the Administration's intentions to work with, cajole, coerce, or threaten other countries to increase protection for IP rights of U.S. IP rights holders. The substance of the Report is decidedly more aggressive than Reports issued during the Obama Administration, and while the 2017 Report (the Trump administration's first) was less pugnacious than might have been expected, the tone of this Report is much more consistent with its stated policy positions. As with last year's Report, the tone and tenor of this Report is robustly assertive regarding IP rights and America's intention to negotiate international agreements and confront its trading partners in ways that protect American innovation and commercial interests first and foremost regardless of consequences.
The therapeutic methods exclusion is often problematic to navigate. In T 0699/12, the Technical Board of Appeal (TBA) of the European Patent Office (EPO) has provided some useful guidance on its application. In an opposition before the Opposition Division, the division held that the patent in suit (which was for a method for performing in vivo dosimetry) was invalid pursuant to Art 53(c) of the European Patent Convention (EPC).
Art. 53(c) of the EPC states: "European patents shall not be granted in respect of: . . . methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body . . . ."
On appeal the Technical Board of Appeal, considering the effect of this provision, referred to decision G 01/04 and explained that it ". . . clarified that a method claim falls under the prohibition of patenting methods for treatment by therapy or surgery under Art. 53(c) EPC if it comprises or encompasses at least one feature defining a physical activity of action that constitutes a method step for treatment of a human or animal body by surgery or therapy . . . ."
It concluded that Art 53(c), therefore, did not exclude methods from patent protection that are used during a therapeutic or surgical treatment of a human or animal body, but methods that are therapeutic or surgical treatments of a human or animal body.
- using said relationship information during verification of the treatment of the patient.
The patent specification further explained that the "invention is thereby a method to calibrate the detectors to be used in vivo (during treatment) in a time-efficient and accurate way to achieve high quality, reliable dose measurements during treatment".
The Technical Board of Appeal concluded that the wording of claim 1 did not include any step that could be considered as being of surgical or therapeutic nature, since no actual irradiating step was claimed. It reasoned that the "verification" (namely, 'quantification of the dose delivery' of the treatment) had no therapeutic or surgical effects as such. Rather, it only determined (verified) the radiation dose during a treatment.
Expressed another way, the claimed method only concerned the technical operation of a device (the radiation/ treatment source and the information means/detectors) without any functional link to the effects of the device on the body.
This article was reprinted with permission from D Young & Co.
On April 12th, various news outlets ("fake" and otherwise), as well as several Senators present at the White House, announced that the Trump administration had changed its position on the Trans Pacific Partnership (TPP) Agreement. To that end, Mr. Trump has directed National Economic Council Director Larry Kudlow and U.S. Trade Representative Robert Lighthizer to take a "second look" at the TPP, but only if it was a "substantially better" deal (presumably meaning more in favor of the U.S. than the TPP negotiated by the Obama administration). In addition to these traditional avenues of information, Mr. Trump also announced his intentions on Twitter.
The reason for the change of heart and policy is apparently an effort to ameliorate the effects of the China-U.S. trade war expected to harm farmers and other U.S. industries, and to provide political cover in rural (red) America.
Unfortunately for Mr. Trump and U.S. interests, however, the agreement his representatives are assessing is not the previous Administration's TPP. On March 8th, the remaining members of the international group of countries who negotiated the TPP (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam) signed the agreement, now renamed the Comprehensive and Progressive Agreement for Trans-Pacific Partnership, or CPTPP. While mostly the same as the TPP, there have been some changes in the Agreement after U.S. withdrawal (see "Comprehensive and Progressive Agreement for Trans-Pacific Partnership May Differ Significantly from TPP"). Most of these changes have been in provisions relating to its intellectual property provisions, suspending agreement for provisions supported by the U.S. that provided additional protections in areas of American strengths, like pharmaceuticals and biotechnology. It is ironic that deficiencies in China's protection of American intellectual property is one ostensible reason for recent tariffs and other trade-related actions by the Trump Administration. Any rapprochement with the (CP)TPP will require further negotiations to have all signatory nations agree to re-implement these IP-related provisions.
• Expanded protection for new ways of protecting technology and information, such as technological protection measures, rights management information, encrypted satellite and cable signals, and safe harbors for Internet service providers.
Overall the CPTPP remains exceedingly similar to the TPP, there being no changes to chapters 1-4 (definitions, market access for goods, rules of origin, textiles), 6-8 (trade remedies, sanitary and phytosanitary, technical barriers to trade), 12 (temporary movement of business persons), 14 (electronic commerce), 16-17 (competition, state owned enterprises), 19 (labor), 21-25 (cooperation and capacity building, competitiveness and business facilitation, development, SMEs, regulatory coherence), and 28 (dispute settlement), except for changes needed to remove reference to the U.S.
Additional examples of differences between the CPTPP and the TPP include Article 5 that provides that, "[a]fter the date of entry into force of this Agreement, any State or separate customs territory may accede to this Agreement, subject to such terms and conditions as may be agreed between the Parties and that State or separate customs territory," suggesting that the parties have contemplated other countries, such as China, may be interested in acceding to the treaty's terms (and indeed this eventuality may be desired).
The changes are nicely summarized here.
Suspension of these provisions removes many of the benefits for biotechnological and pharmaceutical inventions that were part of, and part of the attractiveness of, the TPP as negotiated by the Obama Administration. While in many ways far less (and in others, for our technological and global age far more) significant than America's withdrawal from the League of Nations after World War I, these alterations of the TPP are the consequence of an abdication of American leadership on intellectual property rights that (despite occasional anomalous decisions by the Supreme Court) have been a consistent part of U.S. innovation policy for over a generation (and arguably throughout our history).
It remains to be seen, of course, whether the signatory countries have any interest in accommodating the U.S. in re-entering the agreement, or any stomach for providing even a fig-leaf basis for any assertion by the Trump Administration that the CPTPP is a "better deal" than the TPP (which was an excellent trade agreement for American interests; see "Why President Trump Is Wrong about Trans-Pacific Partnership Agreement"). Mr. Trump's feckless withdrawal of U.S. participation in the TPP as one of his first acts as President was in fulfillment of an oft-repeated campaign promise. Now that he has apparently made an about-face on this promise (a change he cannot blame on an uncooperative Congress or judiciary) it is not unfair to Mr Trump to expect (if not demand) he exhibit his self-vaunted prowess as a negotiator to improve on an agreement that more than adequately protected American interests in the first place.
The Enlarged Board of Appeal has now released its written decision in respect of G 1/16 (T 0437/14). This decision resolves the question regarding which standard is to be applied to determine whether an "undisclosed disclaimer" in a patent claim introduces added subject-matter (that is, it contravenes Article 123(2) EPC).
In general, patent claims typically define the subject-matter for which protection is sought in terms of "positive" technical features of the claimed invention; meaning those technical features that define the elements and characteristics of the claimed subject-matter.
In contrast, a "disclaimer" was defined in G 1/03 as meaning an amendment to a claim resulting in the incorporation of a "negative" technical feature, typically excluding from a generally defined subject-matter specific embodiments or areas.
"A composition comprising a metal".
An undisclosed disclaimer refers to a disclaimer which is not disclosed in the application as filed, and nor is there any disclosure of the subject-matter excluded by it in the as-filed application; it is a disclaimer that excludes subject-matter that is not specifically mentioned in the application as filed. Using the above example of "metal – tin", this would be an undisclosed disclaimer in the case where there is simply no mention of tin anywhere in the application as filed.
In contrast, a disclosed disclaimer refers to a disclaimer which may not itself have been disclosed in the application as filed, but the subject-matter excluded by it is disclosed in the application as filed; it is a disclaimer that excludes subject-matter that is specifically mentioned (disclosed) in the application as filed, such as in an embodiment or example. Again, using the above example of "metal – tin", a situation in which there is an example in the application as filed of the metal being tin would constitute this disclaimer being a disclosed disclaimer.
3. Disclaim subject-matter that is excluded from patentability for non-technical reasons under Articles 52 to 57 EPC.
It was thus clear that undisclosed disclaimers could only be introduced if the limitation does not contribute to the invention -- it must not become relevant for assessment of inventive step or sufficiency. Furthermore, it was held that a disclaimer may only serve the purpose for which it is intended and nothing more; meaning it cannot disclaim more than is necessary to restore novelty or disclaim the non-technical subject-matter.
In G 2/10, the Enlarged Board of Appeal held that an amendment to a claim by the introduction of a disclosed disclaimer infringes Article 123(2) EPC if the subject-matter remaining in the claim after the introduction of the disclaimer is not, be it explicitly or implicitly, directly and unambiguously derivable from the application as filed. This therefore confirmed that the application of the "gold standard" for assessing added matter (what the skilled person would directly and unambiguously derive from the application as filed) of disclosed disclaimers. A number of commentators have considered that this was seemingly in conflict with the decision in G 1/03. There followed a divergence in applicability of G 2/10 to undisclosed disclaimers: in a number of decisions, Boards applied the gold standard test of G 2/10 to undisclosed disclaimers in addition to the criteria set out in G 1/03, whilst in some cases the allowability was primarily assessed on the basis of the gold standard alone.
It follows from the above that the choice of the proper test . . . is determined by the fundamental distinction between disclosed and undisclosed disclaimers. That distinction necessitates providing for each of the two classes of disclaimer a single specific test for assessing whether the introduction of a given disclaimer is in compliance with Article 123(2) EPC. For undisclosed disclaimers, the proper test is whether the criteria of G 1/03 are fulfilled, and for disclosed disclaimers the proper test is the gold standard disclosure test of G 2/10.
In the wake of President Trump's decision to withdraw from the Trans-Pacific Partnership (see "Why President Trump Is Wrong about Trans-Pacific Partnership Agreement"), the other countries involved in negotiations (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam) agreed to continue to implement the treaty without U.S. involvement (see "Trans-Pacific Partnership Becoming a Reality").
But while it is likely that the treaty will come into effect among at least some countries, under the name the Comprehensive and Progressive Agreement for Trans-Pacific Partnership or CPTPP, the parties recently released the results of further negotiations that have in significant ways changed the agreement from what it was before the U.S. withdrew. For example, Article 5 provides that, "[a]fter the date of entry into force of this Agreement, any State or separate customs territory may accede to this Agreement, subject to such terms and conditions as may be agreed between the Parties and that State or separate customs territory," suggesting that the parties have contemplated other countries, such as China, may be interested in acceding to the treaties terms (and indeed this eventuality may be desired). And while Article 1 incorporates the terms of the TPP into this agreement, Article 2 provides that certain provisions of the agreement shall be suspended until such time as the signatories agree to end the suspension.
1. In respect of all categories of intellectual property covered in this Chapter 3 each Party shall accord to nationals of another Party treatment no less favourable than it accords to its own nationals with regard to the protection4 of intellectual property rights.
2. With respect to secondary uses of phonograms by means of analog communications and free over-the-air broadcasting, however, a Party may limit the rights of the performers and producers of another Party to the rights its persons are accorded within the jurisdiction of that other Party.
(b) not applied in a manner that would constitute a disguised restriction on trade.
4. Paragraph 1 does not apply to procedures provided in multilateral agreements concluded under the auspices of WIPO relating to the acquisition or maintenance of intellectual property rights.
3 For greater certainty, with respect to copyrights and related rights that are not covered under Section H (Copyright and Related Rights), nothing in this Agreement limits a Party from taking an otherwise permissible derogation from national treatment with respect to those rights.
(b) animals other than microorganisms, and essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes.
30 For the purposes of this Section, a Party may deem the terms "inventive step" and "capable of industrial application" to be synonymous with the terms "non-obvious" and "useful", respectively. In determinations regarding inventive step, or non-obviousness, each Party shall consider whether the claimed invention would have been obvious to a person skilled, or having ordinary skill in the art, having regard to the prior art.
1. Each Party shall make best efforts to process patent applications in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays.
2. A Party may provide procedures for a patent applicant to request to expedite the examination of its patent application.
36 Annex 18-D applies to this paragraph.
37 For the purposes of this paragraph, a Party may interpret processing to mean initial administrative processing and administrative processing at the time of grant.
38 A Party may treat delays "that are not directly attributable to the granting authority" as delays that are outside the direction or control of the granting authority.
39 Notwithstanding Article 18.10 (Application of Chapter to Existing Subject Matter and Prior Acts), this Article shall apply to all patent applications filed after the date of entry into force of this Agreement for that Party, or the date two years after the signing of this Agreement, whichever is later for that Party.
1. Each Party shall make best efforts to process applications for marketing approval of pharmaceutical products in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays.
3. For greater certainty, in implementing the obligations of this Article, each Party may provide for conditions and limitations, provided that the Party continues to give effect to this Article.
46 For greater certainty, a Party may alternatively make available a period of additional sui generis protection to compensate for unreasonable curtailment of the effective patent term as a result of the marketing approval process. The sui generis protection shall confer the rights conferred by the patent, subject to any conditions and limitations pursuant to paragraph 3.
47 Notwithstanding Article 18.10 (Application of Chapter to Existing Subject Matter and Prior Acts), this Article shall apply to all applications for marketing approval filed after the date of entry into force of this Article for that Party.
48 Annex 18-D applies to this paragraph.
(ii) the marketing approval granted to the person that submitted such information, for at least five years53 from the date of marketing approval of the new pharmaceutical product in the territory of the Party.
(c) any amendment of the TRIPS Agreement to implement the Declaration on TRIPS and Public Health that enters into force with respect to the Parties.
50 Annex 18-B and Annex 18-C apply to paragraphs 1 and 2 of this Article.
51 Each Party confirms that the obligations of this Article, and Article 18.52 (Biologics) apply to cases in which the Party requires the submission of undisclosed test or other data concerning: (a) only the safety of the product, (b) only the efficacy of the product or (c) both.
undisclosed test or other data concerning the safety and efficacy of the previously approved pharmaceutical product, or the prior approval of that previously approved product.
53 For greater certainty, a Party may limit the period of protection under paragraph 1 to five years, and the period of protection under Article 18.52.1(a) (Biologics) to eight years.
54 Annex 18-D applies to this subparagraph.
55 A Party that provides a period of at least eight years of protection pursuant to paragraph 1 is not required to apply paragraph 2.
56 For the purposes of Article 18.50.2(b) (Protection of Undisclosed Test or Other Data), a Party may choose to protect only the undisclosed test or other data concerning the safety and efficacy relating to the chemical entity that has not been previously approved.
(iii) recognising that market circumstances also contribute to effective market protection.
2. For the purposes of this Section, each Party shall apply this Article to, at a minimum, a product that is, or, alternatively, contains, a protein produced using biotechnology processes, for use in human beings for the prevention, treatment, or cure of a disease or condition.
3. Recognising that international and domestic regulation of new pharmaceutical products that are or contain a biologic is in a formative stage and that market circumstances may evolve over time, the Parties shall consult after 10 years from the date of entry into force of this Agreement, or as otherwise decided by the Commission, to review the period of exclusivity provided in paragraph 1 and the scope of application provided in paragraph 2, with a view to providing effective incentives for the development of new pharmaceutical products that are or contain a biologic, as well as with a view to facilitating the timely availability of follow-on biosimilars, and to ensuring that the scope of application remains consistent with international developments regarding approval of additional categories of new pharmaceutical products that are or contain a biologic.
59 Annex 18-B, Annex 18-C and Annex 18-D apply to this Article.
61 Each Party may provide that an applicant may request approval of a pharmaceutical product that is or contains a biologic under the procedures set forth in Article 18.50.1(a) and Article 18.50.1(b) (Protection of Undisclosed Test or Other Data) within five years of the date of entry into force of this Agreement for that Party, provided that other pharmaceutical products in the same class of products have been approved by that Party under the procedures set forth in Article 18.50.1(a) and Article 18.50.1(b) before the date of entry into force of this Agreement for that Party.
Suspension of these provisions removes many of the benefits for biotechnological and pharmaceutical inventions that were part of, and part of the attractiveness of, the TPP as negotiated by the Obama administration. While in many ways far less (and in others, for our technological and global age far more) significant than America's withdrawal from the League of Nations after World War I, these alterations of the TPP are the consequence of an abdication of American leadership on intellectual property rights that (despite occasional anomalous decisions by the Supreme Court) have been a consistent part of U.S. innovation policy for over a generation (and arguably throughout our history). Regardless of the current inclination of the present administration to espouse nationalistic rhetoric and policies, U.S. biotechnology and pharmaceutical companies live in the global community and their ability to compete in foreign markets has not been improved by suspension of these provisions of the CPTPP.
When the Australian High Court ruled against the patentability of isolated naturally occurring genes in the Myriad decision, a number of commentators believed that the decision would ultimately invalidate claims directed to methods involving the practical application of genes. A recent Federal Court decision, however, has confirmed that claims directed to methods involving the correlation of gene sequences to a particular trait in cattle are patent eligible subject matter in Australia.
This case concerns an appeal of an unsuccessful Patent Office opposition, by Meat & Livestock Australia Limited (MLA) and Dairy Australia Limited against Australian patent application 20102022253 (the 253 Application), in the name of Branhaven LLC and Cargill, Inc., directed to animal genomics and the genetic improvement of livestock. The claims relate to methods of identifying beneficial traits in cattle using gene sequence analysis, and specifically the identification of single nucleotide polymorphisms (SNPs).
The principal attack on the 253 Application involved arguments and evidence that the claims did not define patent eligible subject matter. At the outset, the Judge, Beach J., made it clear that the case did not merely involve the discovery of a correlation between genotype and phenotype. Rather, the Court considered this to be the starting point for the analysis rather than the finishing point in relation to determining patentability.
The submissions made by MLA relied heavily on the findings of the High Court in the Myriad decision. The Court, however, ultimately found these submissions unpersuasive on the basis that the Myriad decision centred on the patentability of claims defining isolated naturally occurring gene sequences per se rather than methods of using gene sequences. The Court therefore concluded that the reasoning of the Myriad decision did not assist MLA. In support of this conclusion, Beach J. indicated that there was no suggestion in the Myriad decision that claims to methods involving the practical application of gene sequences could be dismissed as being, in substance, patent ineligible naturally occurring genetic information.
Patent eligible subject matter under Australian law is required to be an artificially created state of affairs having economic significance. As the claims of the 253 Application cover practical applications of identifying SNPs from a bovine nucleic acid sample and their association with a trait of interest, the Court found that the claims were directed to artificial subject matter resulting from human action, rather than something that exists in nature per se. The decision also makes it clear that it is inappropriate to focus on individual elements of claims, such as SNPs and their association with a particular trait -- these being naturally occurring phenomena. For these reasons the claims were found to be "within the plain vanilla concept" of patentable subject matter.
MLA further submitted that the claims if granted would have a chilling effect on future research in the livestock industry in Australia contrary to the interests of the Australian public. The "chilling effect" on innovation was one of a number of "other factors" considered by the High Court in the Myriad decision as being important considerations in determining patent eligible subject matter.
In rebutting MLA's arguments, the Judge identified an Australian granted patent, listing MLA's experts as the inventors (the AV/Goddard patent) and stated that "if MLA's chilling effect point was good, then the AV/Goddard patent would be an example par excellence".
The Judge also clarified that the breadth of claims per se is not indicative of a lack of patentable subject matter. A complaint about the breadth of claims is something that arises under other grounds of invalidity, such as a lack of clarity or a failure to define the invention. The Court concluded that none of the "other factors", point against patentability -- they all consistently point in one direction, namely patentability.
MLA also submitted that as a matter of coherency with US law, the claims should be held to be invalid based on a lack of patentable subject matter having regard to decisions in the US, which have rejected claims to methods of diagnosis based on discoveries or principles of nature; for example, Mayo Collaborative Services v Prometheus Laboratories, Inc. 566 U.S. 66 (2012), and Ariosa Diagnostics Inc. v Sequenom, Inc. 788 F.3d 1371 (3d Cir. 2015). These submissions were rejected by the Court for three reasons. Firstly, the Judge found that he could not determine coherency with foreign law generally by only considering cherry-picked jurisprudence from one jurisdiction. Thus, consistency with one foreign jurisdiction might produce inconsistency with another foreign jurisdiction. Secondly, the Court found it necessary to apply an evolving concept of patent eligible subject matter in the context of Australian legislation and Australian conditions, not any foreign law approach. Thirdly, the Judge pointed out that the US approach accepts that a method involving the application of a "law of nature" may be patent eligible.
Notable, Beech J said nothing in relation to the US Ariosa Diagnostics Inc. v Sequenom, Inc. decision as the corresponding Australian case has been set down before him for August 2018.
Ultimately, the single ground upon which MLA succeeded was that of lack of clarity. The Judge, however, provided a specific indication as to how claim 1 and analogous claims could be amended to render the claims valid. This strongly suggests that the amendments will be allowed, and the patent application granted.
The significance of this Federal Court decision is twofold. Firstly, given the nature of the claims, the 253 Application, once it is granted, may significantly impact the use of genomic analysis in the Australian livestock breeding industry. Secondly, and perhaps more importantly, the decision provides certainty in relation to the patentability of claims defining practical applications of gene sequences, including methods of genetic screening. In this regard, the decision potentially foreshadows the outcome of the Sequenom and Ariosa case, concerning the patentability of genetic testing methods.
The interference between the Broad Institute and the University of California/Berkeley has been in the spotlight over the past year (see "PTAB Decides CRISPR Interference -- No interference-in-fact"; "PTAB Decides CRISPR Interference in Favor of Broad Institute -- Their Reasoning"; "University of California/Berkeley Appeals Adverse CRISPR Decision by PTAB"; and "Berkeley Files Opening Brief in CRISPR Appeal"). But there have been other skirmishes between the parties, each of which has recently been (for now) resolved.
wherein the tracrRNA sequence is 50 or more nucleotides in length.
wherein components I and II are located on the same or different vectors of the system.
12. Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon for genome engineering, provided that said use is not a method for treatment of the human or animal body by surgery or therapy, and provided that said use is not a process for modifying the germline genetic identity of human beings.
17. Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon, in the production of a non-human transgenic animal or transgenic plant.
The OD has not yet issued its formal opinion (which can be expected in the next month or so), but last year it did issue a preliminary opinion prior to summoning Proprietor Broad Institute and the opponents to oral hearing earlier this month. In that opinion the OD "preliminarily and non-bindingly" set forth its opinions, on novelty, inventive step, sufficiency of disclosure, and entitlement to priority; the latter ground for opposition apparently formed the basis for the OD's decision to revoke.
The preliminary opinion found claims 1 and 2 did not satisfy Article 123(2) EPC, because the claim limitation "one or more of the guide, tracr and tracr mate sequences are modified in order to preserve stability" went beyond the disclosure of the application as filed. Similar deficiencies of disclosure were found for claims 14 and 15 but not for claim 16. In view of the OD's preliminary priority determination (see below), claims 1-6 and 9-17 were invalid on novelty grounds and claims 7 and 8 invalid on inventive step grounds.
In Europe, under Article 87 EPC and Paragraph IV of the Paris Convention, priority to an earlier-filed application can be validly claimed by the prior applicant or by her successor in interest. In either case, the applicant must be someone having the right to claim priority. In the U.S., these provisional applications were filed in the name of the inventor and the EPO requires that there be an assignment of the invention on or before a European or PCT application is filed. (Of course, a PCT can always be filed naming the inventors as applicants.) In this case, proper application of the applicable rules required both the named applicants (The Broad Institute, MIT and Harvard College) and the Rockefeller to have been named as applicants when the application was filed. Rockefeller was not named as an applicant. Accordingly, the OD determined that the named Proprietors could only validly claim priority to the third provisional application, and by the filing date of that application there had published prior art that invalidated the granted claims. In this regard, the preliminary opinion may provide guidance on the OD's thinking, where that opinion states that "In both the EPC and the Paris convention systems the decisive fact for a valid claim of priority is the status of applicant, rather than the substantial requirement  to the subject matter of the first application" (emphasis in opinion). The OD determined (preliminarily) that "neither the requirement of the applicant's identity nor the proof of a valid success in title [had] been fulfilled" for the claimed invention, and stresses that these were requirements to promote legal certainty that would protect third parties' interests, and that these requirements were not subject to the national law of the priority document. Nor, according to the preliminary opinion could the granted European patent properly claim priority to U.S. 61/758,468 because that document failed to disclose the length of the guide sequence as claimed.
The Broad argued that this was a misapplication of Article 87 and the Paris Convention, and that priority should be determined based on the national law of the priority document. Here, the earlier provisional applications (in the Broad's view) disclosed more than one invention, and the invention pursued in the granted European patent was invented by the Harvard, MIT, and Broad inventors, and not by Dr. Marraffini. Accordingly, those inventors through their assignees properly claimed the priority right to what was disclosed in those provisional applications and contained in the granted European patent.
The Broad filed a notice of appeal and in a press release evinced an intention to make some of these arguments before the Technical Boards of Appeal (although many believe that the decision is consistent with how the EPO has administered their law of priority and that the Broad faces a difficult task in seeking to overturn the OD's decision).
Paradoxically, just two days before the OD's decision, the Broad won its arbitration against the Rockefeller and Dr. Maraffini, wherein U.S. patents claiming priority to some of the same provisional applications were determined to properly exclude Dr. Maraffini as an inventor and to quiet title to these patents with the Broad et al. and not the Rockefeller. This occurrence was not considered by the OD (who deemed its submission two days prior to oral proceedings to be untimely) and may not be particularly relevant to the Broad's appeal, insofar as it is another example of the differences between U.S. law and the EPC regarding a priority determination.
One of Donald J. Trump's signature campaign promises was to reject the Trans-Pacific Partnership negotiated by the Obama administration, and true to his word he did just that almost immediately upon being sworn into office (see "Why President Trump Is Wrong about Trans-Pacific Partnership Agreement"). This action raised questions about the fate of the agreement, which had as a trigger for coming into force that the signatories make up 34% of global GDP. Last July, representatives of the "TPP-11" (all of the TPP member states other than the United States, i.e., Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam) met to discuss implementation of the TPP without U.S. involvement. They indicated then that they would continue to meet and negotiate, and expressed hope that they would be able to finalize a trade agreement by the end of the year having only minimal differences from the original text of the TPP agreement.
Today, the Financial Times reported that the TPP-11 have indeed come to an agreement and plan on ratifying the TPP in March, sourcing the information from the Japanese government. The process has resulted in a name change: the agreement is now called the Comprehensive and Progressive Agreement for Trans-Pacific Partnership or CPTPP and, according to FT, "lays down a marker to China by setting high legal standards for trade and opens up the possibility of other Asian countries joining the pact."
As a reminder of opportunities lost, and provided there have been no wholesale changes in the treaty during current negotiations, the IP provisions of the treaty have broad scope, encompassing copyrights, trademarks, patents, and trade secrets. These provisions are aimed at establishing a minimum level of protection among the member states, and to harmonize such protections where possible. The patent provisions define eligible subject matter broadly, for "any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step and is capable of industrial application." Market exclusivity provisions regarding agricultural products are granted for at least 10 years, and regulated pharmaceutical products are entitled to at least five years of market exclusivity. Signatories will provide a legal framework for the pharmaceutical license holder to challenge approval and marketing of any generic version of a patented drug. Biologic drugs are afforded at least eight years of market exclusivity, or at least five years combined with other regulations in a signatory country that would result in at least eight years of exclusivity. All these provisions are subject to further review by the signatories after 10 years, to provide the ability to adapt the exclusivity term based on experience. These exclusivity terms—which are shorter than those available to biologic drug innovators in the United States (12 years) or Europe (10 years)—are longer than the terms (i.e., no exclusivity term) available in many of the signatory states. These provisions provided in signatory countries the prospect that patent protection would be supported by regulatory regimes that encourage investment in creating distribution and professional networks to bring patented pharmaceuticals to these populations that might otherwise be unattractive for such investment. Paradoxically in view of those that believed the treaty would preclude access to lifesaving medicines in developing countries, having this framework might actually have increased the likelihood that such drugs become more generally available in those countries.
The agreement also contains enforcement provisions for protecting IP rights, aimed at "permit[ting] effective action against any act of infringement of intellectual property rights covered by this Chapter, including expeditious remedies to prevent infringements and remedies that constitute a deterrent to future infringements," available in equal measure for patent, copyright, or trademark infringement. In addition to damages and the possibility of an injunction against future infringement, the agreement empowers signatories to destroy infringing articles, particularly counterfeit goods, and there are particular provisions relating to counterfeit articles identified at a signatory's borders. The TPP further provides, for the first time in an international trade agreement, criminal penalties for trade secret theft, as well as criminal enforcement provisions for willful trademark or copyright infringement including counterfeiting, intercepting or transmitting without authorization an encrypted program-carrying cable signal, and provisions relating to Internet service providers with regard to preventing unauthorized use of copyrighted materials.
The good news for U.S. biologic drug companies is that there are now opportunities for the benefits of the pact to accrue to them, provided that they partner with indigenous companies in member countries or resource their biologic drug production to an affiliate in a TPP country in order to reap the 8-year market exclusivity benefits under the treaty. Potential bad news includes the loss of U.S. leadership and cultivation of and protections for U.S. interests amongst the signatories. Potentially worse news is the potential for China to enter the vacuum of leadership created by U.S. withdrawal. China's participation is evidently contemplated by the TPP-11 (or perhaps more accurately, CPTPP-11), and such entry could further exacerbate trade imbalances that paradoxically were a prime motivation for the current administrations "America First" policy proclivities. While such sloganeering may create cheering when broadcast to the American electorate, global realities may be much less accommodating to the outcome desired by this Administration's supporters. One thing is clear: the CPTPP is unlikely to suffer the fate of other American initiatives abandoned by succeeding administrations (like the League of Nations), and we will likely not be happy when we are on the outside looking in.
Image of Membership of the Trans-Pacific Partnership by JayCoop, from the Wikimedia Commons under the Creative Commons Attribution-Share Alike 4.0 International license.

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