Source: https://www.patentdocs.org/international_ip/page/3/
Timestamp: 2020-07-05 23:42:58
Document Index: 299784341

Matched Legal Cases: ['§ 141', '§ 145', '§ 145', '§ 42', '§ 42', 'CJEU ', 'arty11', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'EWCA ', 'Art 53']

Top Stories of 2017: #15 to #19
After reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories. For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants. Today, we count down stories #19 to #15, and then in the coming week, we will work our way towards the top stories of 2017. As with our other lists (2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2017" on January 17, 2018 from 10:00 am to 11:15 am (CT). Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.
19. PTAB Finds No CRISPR Interference
CRISPR (an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats), which is part of a system for altering chromosomal sequences in situ in a cell in combination with a bacterially derived protein called Cas9, was hailed as a "Breakthrough of the Year" for 2015. CRISPR provides a mechanism for inserting or deleting specific DNA sequences using CRISPR-associate targeting RNAs and the Cas9 RNA-guided DNA endonuclease enzyme. Given the commercial potential of this method, patenting is an obvious concern and, as it turned out, more than one group of inventors filed patent applications on the reagents, methods, and cells produced or used to produce CRISPR modifications. Because these applications were filed prior to March 16, 2013, the dispute regarding who was the first to invent had to be resolved via an interference. In 2016, the USPTO declared Interference No. 106,048, naming Feng Zhang and his colleagues, the named inventor of the Broad Institute/MIT's patents, as the Junior Party, and Jennifer Doudna and her colleagues at UC/Berkeley as Senior Party. In February of 2017, the Patent Trial and Appeal Board (PTAB) handed down its decision, finding no interference-in-fact between several patents and patent applications owned by The Broad Institute and applications owned by the Regents of the University of California, Berkeley. The decision ended the interference without any prejudice to any of the claims corresponding to the interference count, allowing both parties to license (and assert) their patents to (or against) any third party. The basis for the decision was that UC's claims would not anticipate the Broad's claims-in-interference because all of Broad's claims contained the affirmative limitation that the CRISPR technology be operative in eukaryotic cells, and the UC's claims were devoid of any limitation regarding the context in which CRISPR was applied. In April, the University of California, Berkeley filed a Notice of Appeal at the Federal Circuit, challenging the decision, so the dispute could make a third straight trip to our list of top stories next year -- the CRISPR patent dispute was #18 on last year's list.
• "Berkeley Files Opening Brief in CRISPR Appeal," July 31, 2017
• "University of California/Berkeley Appeals Adverse CRISPR Decision by PTAB," April 13, 2017
18. Unitary Patent and Unified Patent Court Timetable Revised
After making it onto our 2012 and 2013 lists, the unitary patent and Unified Patent Court (UPC) initiatives took a three-year sabbatical from our top stories list. In 2013, the Council of the European Union announced that twenty-four member states had signed the international agreement that would establish a Unified Patent Court (UPC), a specialized court having exclusive jurisdiction over infringement and validity questions related to unitary patents. The signing of the Unified Patent Court Agreement (UPCA) initiated the process of ratification by national parliaments, with ratification requiring at least thirteen member states (including France, Germany, and the United Kingdom). Ratification of the UPC agreement would then result in implementation of two EU regulations on the unitary patent. Back in 2013, it was thought that ratification might not take place until 2015 or 2016, or perhaps even later in 2017 or 2018. In January of 2017, the Preparatory Committee of the UPC released a revised timetable indicating that the Sunrise Period during which existing European Patents can be opted out of the jurisdiction of the UPC could start in September 2017 and the UPC could start accepting cases in December 2017 -- provided that the UK and Germany ratified the UPCA, permitting it to come into effect. While the UK announced its intention to proceed with ratification, the German Constitutional Court asked the German Federal President in June not to ratify the UPCA for the time being. The Preparatory Committee confirmed at the time that the preliminary timetable set out earlier in the year was no longer achievable, and that the UPC would not begin to operate before the end of 2017. This latest setback will likely delay the UPCA from coming into force until at least the spring of 2018.
• "UK Progress on Unitary Patent (UP) and Unified Patent Court (UPC)," July 12, 2017
• "German Constitutional Court Holds up German Ratification of Unitary Patent Court Agreement," June 13, 2017
• "Revised Provisional Timetable for the Unitary Patent and Unified Patent Court," January 23, 2017
17. Federal Circuit to Hear Attorneys' Fees Case En Banc
Patent applicants dissatisfied with final outcome of patent prosecution proceedings have long had two options for court review of a decision made by the U.S. Patent and Trademark Office's Patent and Trademark Appeal Board (PTAB): an appeal to the Federal Circuit under 35 U.S.C. § 141 or a civil action in the Eastern District of Virginia under 35 U.S.C. § 145. For over 175 years, applicants faced the same risk of paying the USPTO's fees in either proceeding. But in June, a divided panel of the Federal Circuit affirmed in Nantkwest, Inc. v. Matal that the USPTO was entitled to recover attorneys' fees (and other expenses) regardless of the outcome of the case. In August, however, the Federal Circuit issued a per curiam, sua sponte order that the question be heard en banc. The order requested that the parties submit briefs addressing the following question:
Did the panel in NantKwest, Inc. v. Matal, 860 F.3d 1352 (Fed. Cir. 2017) correctly determine that 35 U.S.C. § 145's "[a]ll the expenses of the proceedings" provision authorizes an award of the United States Patent and Trademark Office's attorneys' fees?
• "My Health, Inc. v. ALR Technologies, Inc. (E.D. Tex. 2017)," December 26, 2017
• "Federal Circuit Orders Rehearing En Banc in Nantkwest v. Matal," August 31, 2017
• "Nantkwest, Inc. v. Matal (Fed. Cir. 2017)," June 27, 2017
16. Federal Circuit Again Limits Scope of CBM Review
The Leahy-Smith America Invents Act (AIA) defines a covered business method (CBM) patent as "a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions." For the purpose of determining whether a CBM review is to be instituted, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) considers "whether the patent claims activities that are financial in nature, incidental to a financial activity, or complementary to a financial activity." In 2016, in Unwired Planet, LLC v. Google Inc., the Federal Circuit resolved the issue, determining that the PTAB's "reliance on whether the patent claims activities incidental to or complementary to a financial activity as the legal standard to determine whether a patent is a CBM patent was not in accordance with law." In February of 2017, in Secure Axcess, LLC v. PNC Bank National Association, the Federal Circuit again overturned a decision by the PTAB that a patent was eligible for CBM review. In Secure Axcess, the Court determined that the statute requires that it is the claims, in the traditional patent law sense, properly understood in light of the written description, that identifies a CBM patent. The Federal Circuit therefore determined that the Board had erred in deciding this case under its overly-broad statutory definition of a CBM patent, and thus vacated the Board's other determinations, including claim constructions and the Board's finding of obviousness.
• "Securus Technologies, Inc. vs. Global Tel*Link Corp. (PTAB 2017)," September 5, 2017
• "Cloud9 Technologies LLC v. IPC Systems, Inc. (PTAB 2017)," July 30, 2017
• "Secure Axcess, LLC v. PNC Bank National Association (Fed. Cir. 2017)," February 28, 2017
15. Federal Circuit & PTAB "Loosen" Reins on Amendments in IPR Proceedings
In March, the U.S. Patent and Trademark Office's Patent Trial and Appeals Board (PTAB) granted a motion to amend claims in Amerigen Pharmaceuticals Ltd. v. Shire LLC (IPR2015-02009). As those in the patent community are well aware, this was an uncommon event. As of 2016, the PTAB had reported in its Motion to Amend Study that only 6 motions to amend had been granted (or granted-in-part) -- out of a total of 118 motions filed in 1539 instituted and completed AIA proceedings, which amounted to a positive outcome for the patent owner in 5% of the cases in which a motion was filed. In October of 2017, in Aqua Products, Inc. v. Matal, a highly fractured en banc Federal Circuit determined that the PTAB can no longer place the burden of establishing the patentability of amended claims on the patent owner in IPR proceedings. There are those in the patent community that believe Aqua Products should result in more claim amendments surviving IPR proceedings, and that the decision may increase the possibility that more motions to amend will be filed. In November, PTAB Chief Judge David P. Ruschke issued a memorandum entitled "Guidance on Motions to Amend in view of Aqua Products," in which Judge Ruschke noted that patent owners must still meet the requirements for amending the claims as found in 37 C.F.R. § 42.121 (or § 42.211 for PGR proceedings), including only proposing a reasonable number of substitute claims, not enlarging the claim scope or introducing new matter, and making the claim amendments responsive to a ground of unpatentability involved in the trial.
• "PTAB Motions to Amend Post-Aqua Products -- Chief Judge Ruschke Issues Guidance," December 28, 2017
• "Aqua Products, Inc. v. Matal (Fed. Cir. 2017)," October 4, 2017
• "PTAB Update -- Shire Has Rare Motion to Amend Granted," April 10, 2017
Posted at 11:46 PM in Damages, Federal Circuit, International IP, Patent Trial and Appeal Board, Post-Grant Proceedings | Permalink | Comments (0)
News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry – Recommendations on Changes to Public Policy -- Part IV
In the first three installments of this series, we've explained the general purpose of the study, and gone through the sections of patents, marketing authorizations and strategic behavior of the study published on August 9, 2017 by the Federal Commission for Economic Competition[1]. For this fourth installment, we'll go through the first eight recommendations that COFECE issues to provide better conditions for generic drug competitions.
For the purposes of this series, we'll refer to Mexican authorities by their acronyms; COFECE for the antitrust body, COFEPRIS for the regulatory authority, and IMPI for the patent office.
Let's review the main contents of each recommendation by COFECE.
"1. COFEPRIS should specify, in the list of reference drugs, the specific patents covering the drug and their expiry date, in order to provide transparency to the linkage and patent protection system. COFEPRIS can create this list with information on patents to be provided by IMPI through a government offices inquiry."
I consider that the idea here is correct, but it's missing a) the involvement by the patent holder, to tell the government precisely which patents are relevant to an approved reference drug, and b) a possibility for both the patent holder and the generic drug applicant to be heard on the possible invasion/invalidity of patent rights during the marketing authorization proceeding.
An analysis could also be made on whether our Country should provide an incentive to the generic applicant to initiate an invalidity action, such as the 6-month period granted in the U.S.
"2. IMPI and the Ministry of health should jointly evaluate the convenience of including in the Industrial Property Law regulations a limitation on the granting of secondary patents, as has been done in other countries.
This recommendation substitutes those which are meant to provide transparency to the linkage system, and it may end up being redundant if the linkage system is improved".
This recommendation seems to need a lot more work in order to be duly supported; whereas it is correct that some countries have indeed limited the patentability of some inventions, this should be done not just as an isolated decision, but as a full policy analysis on incentives to innovate versus generic drug competition.
In addition, I do not agree with the argument of this recommendation being "substitute" of transparency in a linkage system. Said transparency is necessary regardless of patentability standards, and the recommendation to limit certain patents would have a bigger impact on entry times for competing products, for obvious reasons.
"3. Establish explicit restrictions to the linkage system in order for patents registered (sic) after the marketing authorization for a reference product is granted will not be considered for linkage analysis for the same reference product.
This does not limit laboratories from using their patents - granted after the reference product marketing authorization has been approved - to develop second generation, or other types of drugs."
The proposed restrictions have some sense to them, when one considers that drugs in the reference product list are the benchmark for generics to imitate. It would be necessary however, to determine the situation with patent applications filed before the reference product designation, but granted afterwards.
"4. COFEPRIS should grant a new marketing authorization when a laboratory requests the modification of an authorization for a reference drug, based on a marginal improvement which is associated with a new patent, that will expire after those patents granted when the initial authorization was issued.
The registration of the original reference product would stay in force after patent expiration, in order for generic products to use it as reference.
The purpose of this proposal is to prevent marginal innovations over a reference drug with a patent close to expiration to create an obstacle to the entry of generic products which reference the original drug, as said innovations are commonly associated to the registration (sic) of new patents".
The main problem with this recommendation is the term "marginal innovations", which is not defined, and will certainly be seen as negative by patent holders. Otherwise, the idea of having more than one reference product makes sense as patent infringement situations would be avoided.
"5. COFEPRIS should promote the use of the Bolar exception through the publication of rules and criteria under which it can be requested, and periodically publish the list of innovative drugs for which patents will expire in the following 3 years."
This is a clear reference to the orange book rules, which allow a generic drug applicant to request "paragraph III certifications" for marketing authorizations to be issued right after patent expiration. This seems to be a positive policy recommendation.
"6. COFEPRIS should finish completing the database of marketing authorizations and make it available online, to the public, with information beyond five years, and to keep said database updated. The database must include public information on consultations to IMPI and response times by COFEPRIS.
This information will provide transparency to the process of market entry, and will remove discretional spaces which may provide incentives for unnecessary entry obstacles."
This is a welcome recommendation, which has been expressed before COFEPRIS by both innovator and generic drug companies. The database has not been updated in years, and the current situation forces companies to go through transparency requirements which can take 2 months before a response is issued.
"7. COFEPRIS should guarantee and communicate that the process of marketing authorization is done in a first in – first out basis, and not accumulate the issuance of the authorizations in packages or batches.
This mechanism looks to benefit the laboratory that filed an earlier application, which constitutes an incentive to take advantage by having market presence. The current strategy by COFEPRIS is the announcement of release of marketing authorizations in "package" forms, which does not generate adequate incentives for generic manufacturers to take a lead over competitors upon filing."
This recommendation makes a lot of sense. The marketing authorizations should be issued as soon as they are ready, and the current practice could be substituted with announcement of those authorizations issued in the previous semester/year.
"8. COFEPRIS should issue technical criteria for the consideration that the generation of clinical data by an applicant represents "considerable effort."
This measure seeks to close the door on litigation generated on alleged violations to clinical data protection.
This recommendation appears to oversimplify a complex issue, which derives from international treaty obligations and which is not properly regulated in our laws.
Currently, as mentioned in the study, clinical data protection is established as an obligation in NAFTA and TRIPS. COFEPRIS issued an internal memorandum in 2012 which refers to this form of protection, but that document does not constitute a mandate and is certainly not the proper way to regulate a granted right.
On the "considerable effort" side, there are varying positions in other countries: In broad terms, the U.S., Canada and Europe consider that simply by obtaining a new drug product registration considerable effort was present in the clinical trials process. In contrast, countries such as Colombia have tried to establish criteria (such as the amount of money spent) to determine if the effort was indeed considerable and thus if it merits protection.
I think that the study addresses the problem from the wrong angle. If the intention is to avert litigation proceedings, transparency on specific periods of protection for all interested parties will do more than a high or low bar on what is considerable effort.
In Parts V and VI of the series on the COFECE study, we will analyze the sections on "insufficient response from the demand side" which refers to information available to physicians and patients and "Entry of generic drugs to public procurement processes".
By Adrian M Trioli* & Noelene Treloar** --
The Australian Full Federal Court's recent decision in Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 confirms that an extension of patent term for pharmaceutical substances does not extend to Swiss type claims.
The decision highlights that Swiss type claims do not fall within the relevant legislative provisions for patent term extensions under (i) section 70 (2)(a) for a pharmaceutical substance per se, or (ii) section 70 (2)(b) for a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology.
Section 70(2)(b) of the Patents Act 1990 (Cth) (the Patents Act) allows for the term of a standard patent to be extended in circumstances where one or more pharmaceutical substances, when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.
AbbVie Biotechnology Ltd (AbbVie) is the patentee of three (3) Australian patents directed to use of its blockbuster drug adalimumab, marketed under the brand name Humira™. The drug has been successful in the treatment of diseases including rheumatoid arthritis, rheumatoid spondylitis, Chrone's disease and ulcerative colitis.
AbbVie sought an extension of term to its Australian patents in accordance with section 70(2)(b) of the Patents Act. In August 2015, the Deputy Commissioner of Patents denied the extension of term request on the basis that the condition in section 70(2)(b) had not been satisfied as the relevant patent claims were directed to a therapeutic use of adalimumab, and not directed to the pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology.
AbbVie appealed the decision to the Administrative Appeals Tribunal, and the Tribunal set-aside the Deputy Commissioner's decision. The Deputy Commissioner appealed to the Full Federal Court.
Full Federal Court Decision:
The Full Federal Court of Australia held that adalimumab is a pharmaceutical substance produced by recombinant DNA technology. However, the relevant patent claims were Swiss type claims directed to (i) a method or process in which adalimumab is used to produce a medicament, and (ii) a medicament containing adalimumab that is to be used for specific therapeutic purposes. As such, the Swiss type claims were use claims (or characterised as method or process claims) and therefore did not meet the requirements of section 70(2)(b) that require product claims. The extension of patent term from 20 years to 25 years in Australia was thereby denied.
* Adrian M Trioli, Principal, Adrian M Trioli Patent and Trade Mark Attorney
** Noelene Treloar, Of Counsel, Adrian M Trioli Patent and Trade Mark Attorney
Posted at 10:49 PM in International IP, News from Abroad | Permalink | Comments (0)
In the first and second installments of this series, we've explained the general purpose and the patents and marketing authorizations sections of the study published on August 9, 2017 by the Federal Commission for Economic Competition[1]. In this third installment we take a look at the sections on strategic behaviour and the analysis on litigation cases.
The section on Strategic Behavior of the study by COFECE (3.4), is heavy with criticism to the innovative pharmaceutical industry; it starts with references to evegreening practices, and patent clustering as a way to block generic entrances.
Whereas the study does mention the main argument in favor of allowing several patents related to a single drug product (inventive merit on new formulations or uses), it quotes the policy decisions taken in countries such as Argentina and India which have limited this possibility, mentioning that such policies have required countries to strike a balance between national interests and TRIPS. There is also a reference to the practice in Brazil requiring the regulatory authority to provide a green light before a patent is issued.
The angle of the study in favor of the generic side of industry is clear in the section related to product switching (explained as a marketing strategy leading physicians to a new formulation of an existing product to take advantage of a more recent patent); there is a direct reference to the position of ANAFAM (a major association of generic drug manufacturers) on the issue without a counter-argument from the innovator's association.
This section concludes with a reference to pay for delay agreements which have been subject of antitrust analysis and litigation in the U.S. and Europe, but does not indicate whether any such agreement has taken place in Mexico or not. The Mexican legal system does not force companies to automatically report such an agreement, but if one takes place it could be subject of review by COFECE.
Overall, this section leads the reader to think that the current environment in Mexico is slanted in favor of innovator companies, with an underlying message that the authority will start to look at actions that have been found as anticompetitive in other markets to study them here.
Special relevance comes from the fact that the message is issued by a Government office; whereas other factors would certainly be in play before any major policy decision is taken (the position by Congress and the Patent Office, and current NAFTA renegotiations which will include IP related discussions), it seems clear that we should expect additional activity from COFECE on the review of practices which have been sanctioned abroad.
In the section "litigation related to patents and marketing authorizations" (3.5), the study lists some of the major judicial and policy decisions that have shaped the current regulatory environment for generic drug entry in the past 20 years, as follows:
a) The enactment of linkage regulations in 2003, which were initially interpreted by authorities as limited to patents covering active pharmaceutical ingredients;
b) The creation of a specialized IP Court in 2008;
c) The Supreme Court decision of 2010 establishing that linkage should be broadly interpreted to include formulation patents;
d) The addition of an opposition system to patent applications in the IP Law, also in 2010 (which does not extend to granted patents); and
e) The reform to the IP Law ordering the patent office to publish all decisions which modify a granted patent or trademark.
The study then explains that litigation has taken place in the form of patent infringement actions, challenges to applications or authorizations granted to generic drug manufacturers, and judicial petitions of recognition of Regulatory Data Exclusivity.
Two additional shots are fired at patent holders: on page 52, first paragraph, the study states:
"Upon making this study, we had knowledge that some holders of patents related to an active ingredient which are already in the public domain, have intended to cause confusion in authorities in charge of the purchase of drugs for the public sector and Courts, even trying to persuade their competitors by informally warning them of the initiation of and infringement proceed if (said competitor) does not refrain from manufacturing any product with the relevant active ingredient."
This statement refers to acts which could be subject to antitrust or even criminal investigations. Again, this becomes quite relevant when the source is not an independent writer, but a Government office.
The last paragraph of page 52 is also relevant:
"In summary, innovative laboratories can extend product market exclusivity through the abuse of judicial proceedings established in our laws and thus place obstacles to generic drug entry to the market. This calls for a review of the linkage system in order to have a transparent tool between marketing authorizations and industrial property rights and with this reduce possible spaces of litigation which seek to delay generic entry."
Whereas as mentioned in the first entry of this series, I agree with the need for transparency, the blanket reference to judicial proceedings as abusive does seem over the top. I would argue that those judicial proceedings are not necessarily abusive per se but are on many occasions the only resource available to prevent or correct the actual invasion of a granted right.
The section closes with a summary of litigation cases, by active ingredient, indicating the parties and patents involved, and those cases where regulatory data exclusivity has been requested by judicial means.
In part IV of the series on the COFECE study, we'll look at the first eight recommendations of policy changes.
Posted at 11:05 PM in International IP, News from Abroad | Permalink | Comments (0)
A Supplementary Protection Certificate (SPC) is an intellectual property right available for active ingredients of human and veterinary medicinal products requiring marketing authorisation1.
The SPC regime was introduced as a mechanism to compensate patent holders for loss in effective patent term resulting from the time taken to receive marketing authorisation for such products2. However, regulatory delay is not of itself sufficient to justify the grant of SPCs.
In particular, the relevant regulation provides that an SPC can be granted only for an "active ingredient". This has been held to exclude substances that may enable or enhance the activity of a therapeutic ingredient, but which have no therapeutic effect of their own on the human or animal body. Despite the clinical testing (and consequent regulatory delay) involved in developing such auxiliary substances, the CJEU has on two occasions3 held that they do not qualify for an SPC. Similarly, it is not currently possible to obtain SPC protection for a medical device, irrespective of whether or not the marketing of such a device has been subject to regulatory delay.
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom4.
SPCs in these countries are governed by EC Regulation 469/2009 ("the SPC Regulation" -- excerpts of which are included as Annex 1).
SPC protection is also available in the following non-EU States:
• Norway and Iceland: these States are members of the European Economic Area (EEA), but not of the EU, and the governing legislation is the EU SPC Regulation.
• Switzerland: Swiss SPCs are governed by legal provisions which are based on the EU SPC Regulation. An SPC issued in Switzerland will also automatically take effect in Liechtenstein5.
• Albania, Bosnia & Herzegovina, Macedonia, and Serbia: These are non-EU/EEA countries which may nonetheless be covered by a European patent application granted by the EPO. SPC protection is available in these countries under national legal provisions.
Similar provisions also exist in neighbouring jurisdictions including Russia and the Ukraine, and in other countries worldwide. Those interested in rights in these jurisdictions can contact J A Kemp for more information.
The scope of an SPC is limited to the product of the relevant marketing authorisation. It protects that product to the same extent as the patent on which the SPC is based ("the basic patent"). For example, if the basic patent covers the product per se, the SPC will also cover the product per se. If the basic patent only covers a method of manufacturing or using the product, then the SPC will be similarly restricted.
The product of the marketing authorisation has long been established to encompass therapeutically equivalent salts and esters of small molecule drugs6, provided of course that they are covered by the basic patent.
The situation is less clear for active ingredients which are biological molecules. A decision of the Norwegian Court of Appeal7 following an advisory opinion of the EFTA court8 recognised that it would be desirable for therapeutically equivalent variants of a biologic product to be covered by an SPC, but provided little guidance as to the extent of such coverage. It is to be expected that this question will be referred to the CJEU.
Also, subject to the scope of the basic patent, an SPC will cover all subsequently authorised combinations of active ingredients containing the product at issue.9
• 15 years from the first Marketing Authorisation in the EU/EEA10
• 5 years from the expiry of the basic patent
It is possible to extend the term of an SPC by a further 6 months by providing clinical results obtained from an agreed paediatric investigation plan. The request for extension may be filed at any time up to 2 years before normal SPC expiry.
Further information is provided in J A Kemp's briefing note on the Paediatric Products Regulation, which is available upon request.
The Applicant for the SPC must own the basic patent, but need not hold the relevant marketing authorisation. Thus, it is possible to secure an SPC based on a marketing authorisation held by a third party11.
• 6 months from the date on which the first authorisation to place the product on the market is granted in that country; or
• 6 months from the date of grant of the basic patent.
If the basic patent expires before marketing authorisation is achieved, it may not be possible to secure an SPC. Under such circumstances, it may be worthwhile filing an application for an SPC before expiry of the patent and following up with the marketing authorisation when it is available. However, the chances of persuading Patent Offices to grant an SPC under such circumstances would at best be uncertain12.
• Article 3(a) requires that the product be "protected" by a basic patent.
• Articles 3(b) and 3(d) require that the SPC be based on the first valid authorisation to place the product on the market as a medicinal product.
• Article 3(c) requires that the product has not already been the subject of an SPC.
What is meant by "protected" by a basic patent?
Perhaps surprisingly, to fulfill this requirement it is not sufficient that the product would hypothetically infringe the claims of the basic patent. Unfortunately it is also not clear precisely what is sufficient. There have been several referrals to the CJEU on this point, and it is expected that more will follow.
The leading CJEU decisions are generally considered to be the "Medeva"13 and "Eli Lilly"14 decisions.
In Medeva, the CJEU held that for the SPC to be granted, the active ingredient must be "specified in the wording of the claims of the basic patent".
This has generally been interpreted to mean that a patent which claims product A and does not mention combination therapies cannot support an SPC for combinations of active ingredients containing A, e.g., an SPC for A+B 15.
A subsequent CJEU decision16 has also confirmed that a patent which claims only a combination of A+B cannot be the basic patent for an SPC for A alone, despite the fact that sale of A may well, under some circumstances, infringe the patent under "contributory infringement" provisions. This remains true even where the marketing authorisation is for a medicine comprising A and includes an indication that A may or should be used together with B.
There has been much debate over the extent to which the reasoning in Medeva and other "combination" decisions should apply to single active ingredients. Clearly the requirement that the active ingredient is "specified" will be satisfied if the basic patent contains a claim which specifically mentions the product at issue. The situation is much less clear, though, when the claims of the basic patent embrace the product at without mentioning it specifically.
In Eli Lilly, the CJEU explored this question in the specific context of a functionally defined active ingredient ("…an antibody which binds to <target>…"). It was held that a functional definition can in principle support an SPC, provided that the claims when construed in the context of the description relate "implicitly but necessarily and specifically" to the active ingredient.
Although very little guidance was provided as to how to establish whether a claim meets this test, the referring UK Court17 interpreted the CJEU's intention to be that any general claim language which covers a single active agent, including a functional definition, will satisfy the requirements of Article 3(a) for an SPC directed to that active agent. This remains the case even if there is no "individualised description" of the active ingredient elsewhere in the patent. However, claims which embrace active ingredients only by virtue of open-ended language, such as "comprises", would not satisfy Article 3(a).
Perhaps reflecting general frustration with the lack of clarity on this issue, the UK Court has made a further referral to the CJEU18 posing a deliberately open question:
The facts of that particular case again concern a combination product, but it is hoped that the CJEU will take the opportunity to provide guidance on Article 3(a) in general terms. Ideally the CJEU will also clarify other outstanding matters relating to Article 3(a), such as whether the claims of a basic patent can be amended after grant to cure a deficiency under Article 3(a). This question has also been put to the CJEU in a previous referral19 but they declined to answer.
What is meant by "a valid authorisation to place the product on the market as a medicinal product"?
The CJEU has confirmed that an SPC for a given product should be based on the first authorisation for a drug containing the product even if this is a combination therapy which includes the product. Thus, for example, an SPC for product A can be based on a patent claiming A and a marketing authorisation for a medicinal product containing A+B.20 This may be important for vaccine products, where marketing authorisations often relate to combinations of multiple active ingredients. An SPC granted under such circumstances will cover all products containing product A approved before the SPC expires.
In general, it is also possible to have multiple SPCs granted for multiple different products on the basis of the same basic patent, provided that each product is protected by the basic patent21.
An exception to this principle has however been set out by the CJEU in two cases22, both of which relate to a scenario in which an SPC has already been granted for a single active ingredient A, and a later application is filed for an SPC for a combination containing that active ingredient, A+B. The CJEU has held that the later SPC should not be granted in these circumstances.
However, the reasoning of the CJEU in both cases appears to have been influenced by a finding that the single active ingredient was the "sole" or "core" of the invention underlying the basic patent, and so they were reluctant to award a further SPC for the combination. It is unclear whether the exception would also apply if the combination represented a separate inventive advance disclosed within the same patent, or indeed if the combination had been presented in a separate patent.
Historically it had been thought that a patent to a new medical use of a drug could form the basis of an SPC, but that SPC had to be based on the earliest marketing authorisation for that drug, even if the earliest authorisation was for a different disease or condition from that specified in the patent.23 In practice, reference to the earliest marketing authorisation often meant that any resultant SPC would have a zero term, because of the maximum SPC term of 15 years from first marketing authorisation in the EU.
However, in the landmark "Neurim" decision24, the CJEU indicated that under certain circumstances it is possible to base an SPC application on an authorisation which is not the first marketing authorisation to place a particular drug on the market.
The facts in Neurim were that an earlier authorisation had been issued for a veterinary use. The CJEU held that this should not preclude grant of an SPC based on a later authorisation for a completely separate human use. However, the phrasing used by the CJEU was more general, stating that the "first" authorisation for the purposes of Article 3(d) is the "first" authorisation "which comes within the limits of the protection conferred by the basic patent". That is, an earlier authorisation which is outside the scope of the basic patent should not be taken into account.
There has been much debate over how broadly the principles outlined in Neurim should be applied, with the various national patent offices diverging to a significant extent. For example, some offices apply Neurim very narrowly, such that the SPC will only be granted if the earlier authorisation is veterinary and the later authorisation is for a different indication in humans. Many offices apply a broader interpretation, such that the SPC is granted provided the later authorisation is for any different indication. However, some offices apply Neurim very broadly, such that an SPC may be granted if the later authorisation differs from the earlier in any way, including e.g., the formulation of the active ingredient, the administration or dosage regime, or the specific patient population to be treated.
Perhaps unsurprisingly therefore, this point is the subject of yet another CJEU referral25. The UK Court has specifically requested clarification as to whether Neurim may apply if the later authorisation is for a new formulation of a previously authorised active ingredient.
a) a patent to a downstream development of a known drug, for example a patent for a new medical use or a new formulation of a known active ingredient; and
b) a second or subsequent marketing authorisation for a medicinal product containing the active ingredient at issue.
(i) the downstream patent does not cover the medicinal product specified in the original marketing authorisation; and
(ii) the second or subsequent marketing authorisation is the first authorisation for a medicinal product which is protected by the downstream patent.
Further information on SPCs based on patents for downstream developments of a known drug can be found in J A Kemp's briefing on the Neurim decision, which is available upon request.
Even where there is no formal mechanism to do so, most national patent offices will consider observations filed by a third party against an application for an SPC. Such observations may draw the Examiner's attention to deficiencies in the application with respect to compliance with the substantive requirements of the SPC Regulation.
Such observations may slow (or even prevent) grant of the SPC application. After grant, the validity of an SPC may be challenged in the national courts on the same grounds.
1 SPCs are also available for active substances in plant protection products, but these are not the focus of this briefing.
2 The purpose is thus similar to Patent Term Extensions (PTE) available in, e.g., USA and Japan, but unlike those systems an SPC is not an extension of a patent, it is a separate right.
3 C-431/04 MIT (a bioerodible matrix) & C-210/13 Glaxosmithkline (an adjuvant in a vaccine).
4 The UK is expected to implement a corresponding national provision even in the event of a 'hard' Brexit, and thus SPCs should remain available in the UK.
5 Swiss marketing authorisations also automatically take effect in Liechtenstein, which unlike Switzerland is an EEA member. Thus, this must be taken into account when determining the first authorisation in the EU/EEA. See comments on additional term provided by an SPC below.
6 C-392/97 Farmitalia.
7 Pharmaq v Intervet 15-170539ASD-BORG/01.
8 Similar status to the CJEU for matters referred by the national courts of the EEA states: Norway, Iceland, Liechtenstein.
9 C-322/10 Medeva, C-422/10 Georgetown and C442/11 Novartis v. Actavis.
10 The CJEU confirmed in C-471/14 that the relevant date of an EU Marketing Authorisation is the date on which notification of the authorisation is made to the holder (typically a few days later than the Commission Decision granting the authorisation). This may result in extra days of SPC term, although some national patent offices have yet to correct the term of SPCs granted prior to the CJEU decision. A further referral (C-492/169) from the Hungarian Courts asks whether such correction is required. A hearing date has not yet been set.
11 C-181/95 Biogen V SKB explicitly endorsed this view.
12 A pending CJEU referral (C-567/16) asks the specific questions whether an "end of procedure" notice (indicates an MA is imminent) is sufficient to support an SPC and, if not, whether the absence of a full MA can be remedied later. A hearing date has not yet been set.
13 C-322/10.
14 C-493/12.
15 [2012] EWCA Civ 523 Medeva BV v Comptroller General of Patents.
16 C-518/10 Yeda.
17 [2014] EWHC 2404 (Pat) Eli Lilly.
18 C-121/17 Teva v Gilead – hearing date not yet set. Request for expedition was refused in April 2017.
19 C-577/13 Actavis v Boehringer.
20 C-322/10 Medeva and C-422/10 Georgetown.
21 C-484/12 Georgetown.
22 C-443/12 Actavis v Sanofi, C-577/13 Actavis v Boehringer.
23 C-202/05 Yissum.
24 C-130/11 Neurim.
25 C-tbc Abraxis Bioscience – hearing date not yet set.
(b) 'product' means the active ingredient or combination of active ingredients of a medicinal product; […]
Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.
(d) the authorisation referred to in point (b) is the first authorization to place the product on the market as a medicinal
News from Abroad -- EPO Applies Doctrine of Plausibility to Small Molecule Pharmaceuticals
In Decision T 488/16, the Boards of Appeal of the European Patent Office (BoA) have revoked EP 1 169 038, which protected the blockbuster protein tyrosine kinase (PTK) inhibitor dasatinib (Sprycel®). The only request on file -- a single claim directed to dasatinib per se or a salt thereof -- was found to lack inventive step in view of the absence of evidence in the application as filed (and the common general knowledge) which rendered the activity of dasatinib in inhibiting PTK "plausible". A general statement in the application as filed that "Compounds described in the following Examples have been tested in one or more of these assays, and have shown activity" was not by itself considered enough to render it credible to the skilled person that the described compounds were PTK inhibitors. In the absence of a plausible disclosure of activity against PTK in the specification as filed, the objective technical problem was defined by the Board of Appeal as merely "the provision of a further chemical compound". The extensive clinical data which became available after the filing date of the patent evidencing biological activity was not taken into account when determining inventive step.
The Boards of Appeal of the European Patent Office have for many years imposed a requirement that claims for large molecules (e.g., proteins) must be supported by a plausible disclosure of biological activity in the application as filed (see, for example, T 1329/04). A similar requirement for a plausible disclosure of activity in the original specification has also been required to support medical use claims (see, for example, T 0609/02). However, this Decision indicates that the Boards are willing to apply the same strict standards when assessing claims for small molecule drugs per se.
Posted at 10:51 PM in International IP, News from Abroad | Permalink | Comments (1)
Posted at 11:51 PM in International IP | Permalink | Comments (2)
News from Abroad -- EPO Lifts Stays of Proceedings Following Implementation of New Plant Patent-Eligibility Rules
On 3 July, the European Patent Office (EPO) lifted its stays of proceedings on cases that had been held in abeyance pending new rules on the patent-eligibility of plant-related subject matter. Following an intervention by the European Commission in November 2016, as of December 2016 the EPO had stayed the prosecution of a number of plant-related applications pending a possible rule change. The EPO's Administrative Council then decided at the end of June 2017 to enact some new EPC Rules in this area. These became effective almost immediately, as of 1 July 2017 and are applicable to both existing and newly filed applications.
The main change is the addition of new Rule 28(2) EPC, which reads as follows:
Article 53(b) EPC provides that patents cannot be granted for plant or animal varieties or essentially biological processes for the production of plants or animals. The interpretation of these provisions has been controversial for some two decades. The latest area of dispute has been around whether, in light of the exclusion of essentially biological processes, it is nevertheless possible to patent the products of those processes, e.g., to patent "classically" bred plants even though not the breeding processes by which they are created. Some European countries' national laws already contain provisions to the effect that the products of essentially biological processes are not patentable, even though the EPC refers only to the processes themselves. In its so-called Broccoli/Tomatoes I decisions in 2010, the EPO's Enlarged Board of Appeal held that, in essence, any process claim containing one or more breeding steps was patent-ineligible under Article 53(b) but then in further decisions known as Broccoli/Tomatoes II, it held in 2015 that the products of such processes could be patented. In fact, prosecution of such applications tended to be very difficult for other reasons, so few such patents were granted, but improvements in technology, especially growth in the availability of molecular marker data, that gave applicants more information about their plants and allowed better definition of traits contained in them have recently been beginning to render such filings more realistic. In the meantime, however, political pressure from breeders' groups, non-governmental organisations, and continental European governments opposed to such patents led the EU to lobby the EPO and the EPO to change its Rules.
New Rule 28(2) is prima facie in conflict with the Broccoli/Tomatoes II decision so it remains to be seen how this will be play out when the EPO begins to apply it. In principle, Article 23 EPC means that the EPO's Boards of Appeal have to follow only the EPC itself, not its Rules, so if the Boards feel that the Rules are not in line with the EPC, they can ignore them. However, day-to-day examination will of course be conducted in line with the Rules so it seems likely that applications will be refused and test cases filed with the Boards of Appeal, leading ultimately to a further Enlarged Board of Appeal decision on the topic in the next few years. If the Enlarged Board ultimately re-confirms its existing case law, this will create a conflict in that the EPO will be forced to grant patents that may be unenforceable in litigation in many EPC member states, i.e., all those that are members of the European Union. This situation however exists to an extent already because of the national laws that are drafted differently than the EPC. The position of non-EU states that are members of the EPC is interesting in this regard, as those countries will more easily be able to reach their own decisions and may be more swayed by EPO case law than EU opinion. It is for example possible that UK practice on this issue could diverge when the UK leaves the EU. However, it is equally possible that the UK could enact a rule change similar to the one that introduced Rule 28(2) EPC.
All of this is however for the future. In the meantime, examination of the stayed cases will now resume and the new rules will also be applied to newly filed cases. Exactly how they will be applied will only become clear with time and experience but, from guidance published by the EPO before the changes were made, it appears that practice will remain similar in some ways and toughen in others. The use of the word "exclusively" in new Rule 28(2) suggests that plants and animals that are obtained partly by breeding and partly by technical means such as transformation and mutagenesis (including gene-editing techniques such as CRISPR/Cas) should still be patent-eligible as long as the claims are not confined to individual plant varieties, which are excluded by the other limb of Art 53(b) EPC. Claims to transgenic and mutant plants are thus unlikely to be affected, and new Rule 28(2) also does not change the position on claims in process format, on which the main authority remains Broccoli/Tomatoes I.
However, the rule change is likely problematic for so-called "native trait" claims in which the invention lies in the identification and definition of a beneficial characteristic and its transfer into other genetic backgrounds by breeding because, even when such traits are well-understood and defined in terms of sequences or marker positions, the plants themselves are still obtained by breeding processes. The EPO has in particular opined that claims to plants produced by marker-aided selection processes, in which breeding is accelerated by reliance on molecular markers but still fundamentally composed of crossing and selection steps, should not be patent-eligible under new Rule 28(2) EPC. Such subject matter could already not be claimed in process format because of the Broccoli/Tomatoes I decisions but this is a significant step away from the position in the Broccoli II decision, where the Enlarged Board of Appeal specifically approved claims relating to subject matter of this type in product-by-process format. The growing introduction into national infringement laws (including that relating to the forthcoming EU unitary patent) of so-called breeder's exemptions, which have somewhat differing scopes but in general provide that it is not an infringement to breed a new variety from a patented plant, further tends to weaken patentees' positions in this regard.
Patent applicants in this field therefore continue to face uncertainty but in general may need to recognise that some options previously available to them have been closed down and other strategies will have to be developed for protection of their inventions in Europe.
Posted at 11:22 PM in International IP, News from Abroad, Patentable Subject Matter | Permalink | Comments (0)
News from Abroad -- German Constitutional Court Holds up German Ratification of Unitary Patent Court Agreement
It was reported yesterday that the German Constitutional Court has asked the German Federal President not to ratify the Unified Patent Court Agreement (UPCA) for the time being. The request is the result of a complaint (Az.:2BvR 739/17) made to the Constitutional Court by an unnamed person. Details of the complaint are somewhat unclear at present, but the Court is reported to consider the complaint "not wholly without merit" ("nicht von vorneherein aussichtslos").
In order for the UPCA to come into force, ratification by both Germany and the UK is still required. The preparatory committee of the UPC has already confirmed that the preliminary timetable set out in March is no longer achievable and that the UPC will not begin to operate before the end of 2017. This latest setback will likely delay the coming into force of the UPCA yet further, probably at least until spring 2018.
Image of Bundesverfassungsgericht, Karlsruhe (Federal Constitutional Court in Karlsruhe, Germany) by Tobias Helfrich, from the Wikipedia Commons under the Creative Commons Attribution-Share Alike 3.0 Unported license.
Posted at 11:30 PM in International IP, News from Abroad | Permalink | Comments (0)