Source: http://patlit.blogspot.com/2013/11/
Timestamp: 2019-04-23 18:48:16+00:00

Document:
Please be kindly informed that the Hungarian Ministry of Public Administration and Justice and the Hungarian Intellectual Property Office, in cooperation with the European Patent Office, jointly organise a conference on the training of the Unified Patent Court’s judges. The conference will take place in conjunction with the inauguration of the building of the Training Centre in Budapest.
Please save these dates in your calendar of next year.
We will keep you updated on the programme and further details of the event.
The second was a link to Miguel Montana's post on the Kluwer Patent Blog to the effect that, of the 1,300 applicants for consideration as judges for the new Unified Patent Court, not a single soul was eligible.
As reported in the past months (see here and here, as well as PatLit posts here, here and here), the US Congress is currently examining several legislative proposals addressing 'patent trolling'. Patent assertion entities (PAEs) do not make or sell products, nor engage in R&D activities. Rather, they are created with the primary aim of enforcing a portfolio of patents acquired from (or assigned by) other companies. According to several studies, PAEs filed between 40% (here) and 61% (here) of all the patent lawsuits initiated in the United States in 2012. Essentially, the debate focuses on the risk that the prospect of high litigation costs might force any third party sued by PAEs for infringement to settle the lawsuit, even if the accused infringer believes that the asserted patents are invalid or the infringement allegations unfounded.
Among the legislative proposals which purport to address the issue, Congressman Goodlatte's 'Innovation Act' provides a comprehensive stack of measures, aimed at increasing transparency, limiting discovery costs, shifting fees, and protecting end users strategically targeted by PAEs in lieu of the manufacturer. The House Judiciary Committee, on 20 November, approved the bill, which thus advanced to the House floor. Other proposals include the Patent Transparency and Improvements Act, Patent Quality Improvement Act, Patent Abuse Reduction Act, Patent Litigation Integrity Act, Patent Litigation and Innovation Act, SHIELD Act, STOP Act. The recently introduced Demand Letter Transparency Act would subject PAE's demand letters to strict requisites, creating a publicly accessible database; any violation of the Act would be treated as an unfair or deceptive practice under sec. 18(a)(1)(B) of the Federal Trade Commission Act.
On Monday, 60 professors of IP law from 26 states wrote to the US Congress, supporting the ongoing efforts to pass legislation addressing patent trolling. The scholars highlighted that defendants in patent infringement actions face high and rising costs, which are primarily related to the discovery phase of litigation. A study by the American Intellectual Property Law Association, cited in the letter, estimated that the median cost of litigating a moderately-sized patent suit increased over 70% in the past decade, reaching $ 2.6 million, while the expense of defending even a low-stake patent suit is normally in excess of $ 600,000. According to the signatories, '[t]he magnitude and front-loaded nature of patent litigation expenses creates an opportunity for abuse', as '[p]atentholders can file suit and quickly impose large discovery costs on their opponents regardless of the validity of their patent rights and the merits of their infringement allegations'. As outlined above, this situation creates a strong incentive to settle, even when the accused infringer believes that the claims are meritless.
The professors observed that, in suits between product-producing technology companies, counterclaims serve as a way to correct the issues arising from high litigation costs, as counterclaims render them symmetrical. When a PAE is involved in patent litigation, instead, the accused infringer cannot rely on a counterclaim for infringement to impose an equal amount of discovery costs on the plaintiff. Thus, defendants are caught in the situation described above, where high litigation costs primarily borne by a single party act as a powerful incentive to settle.
Patent assertion entities appear to favor targeting small businesses (earning less than $ 10 million in annual revenues) downstream in the supply chain. This strategy, according to the scholars, allows PAEs to sue a large number of sellers or users of an allegedly infringing product, increasing litigation costs 'to induce a larger total settlement amount'. At the same time, smaller companies are generally less familiar with patent law, and less likely to engage in costly litigation outside of their areas of expertise. In this perspective, the vague prospect of a lawsuit may be sufficient to persuade these companies to settle, even before an actual lawsuit is filed.
Finally, the signatories underlined how the lack of reliable information about patent rights fuels patent trolling phenomena. Example of lawsuits which exploit the lack of transparency include cases where the plaintiff asserts patents it does not own, or where it seeks double recovery by suing sellers or users of a product for which the manufacturer already obtained a license to the asserted patent.
1. To discourage weak claims of patent infringement brought at least in part for nuisance value, we recommend an increase in the frequency of attorneys’ fee awards to accused patent infringers who choose to fight, rather than settle, and ultimately defeat the infringement allegations levelled against them.
2. To reduce the size and front-loaded nature of patent litigation costs, we recommend limitations on the scope of discovery in patent cases prior to the issuance of a claim construction order, particularly with respect to the discovery of electronic materials like software source code, emails, and other electronic communications.
3. To further protect innocent retailers and end-users that are particularly vulnerable to litigation cost hold-up, we recommend that courts begin to stay suits filed against parties that simply sell or use allegedly infringing technology until after the conclusion of parallel litigation between the patentee and the technology’s manufacturer.
4. To facilitate the early adjudication of patent infringement suits, we recommend that patentees be required to plead their infringement allegations with greater specificity.
6. that Congress consider additional legislation designed to deter fraudulent, misleading, or otherwise abusive patent licensing demands made outside of court.
The most recent version of the Innovation Act appears to address each of these elements. Goodlatte's proposal also includes provisions requiring specific studies on patent transactions, quality and examination, as well as on the effects of the rules and procedures adopted to reduce discovery costs.
Manvers Engineering Limited and another v Lubetech Industries Limited and others  EWHC 3393 (IPEC) is on the whole a fairly unexciting, unremarkable ruling that the claimant's patent was valid (good news for him) but not infringed (oh, bother ...) The Court was the Intellectual Property Enterprise Court, England and Wales, and the judge a surprisingly senior Mr Justice Mann, who has been a member of the Chancery Division of the High Court for nearly ten years, and a Patents Court judge for most of that time too.
"29. In his "faint" (his word) argument in favour of infringement for this product Mr Wilson relied on a picture in the defendants' brochure which suggested that part of the long side of the liner would ride partly up the wall of the collector, and he suggested that he had a case for secondary infringement by selling the product with some sort of guidance as to its use in an infringing way. This argument is hopeless. ... There is no question of this configuration infringing.
30. I would go further in relation to this argument. This court (IPEC, as it now is) exists to provide quicker and cheaper determination of IP disputes. Speed and economy of hearings are at the heart of the procedure. That objective is frustrated if "faint" points, in which there is obviously no real hope, let alone any real prospect, of success take up the time of the court. Parties to proceedings in this court really should bring to it only the main points that are capable of making a difference. Judgment must be exercised as to which points it is worth putting before the court".
This blogger hopes that parties will take these words to heart. So many people complain about patent litigation being expensive and cumbersome, but without appreciating that this consequence is of their own doing.
A single patent for the European single market has been a policy goal for over four decades. In December 2012, Member States and the European Parliament agreed on a new package of legislation in the form of two Regulations for a Unitary Patent and an international Agreement for a Unified Patent Court, thereby laying the ground for enhanced cooperation in unitary patent protection between all but a few of the EU Member States.
Once the Agreement and the Regulations enter into force, it will be possible to obtain a European patent with unitary effect - a legal title ensuring uniform protection for an invention across Member States on a one-stop shop basis, providing huge cost advantages and reducing administrative burdens.
• Paris - everything else.
This volume includes a brief commentary on the structure, the legislation and the draft Rules of Procedure of the Court, in their 15th revision. Simple charts guide the reader through the procedures. The Regulations, Agreement and draft Rules are set out in their entirety and indexed, to provide a complete reference source.
This reviewer expects that there will be a flurry of books on this title and that, given both the importance of the subject matter and the monumental uncertainties that occupy centre stage in the minds of so many of us, it will be some time before any of these books fails to sell well.
Teva Pharma BV and Teva UK Ltd v Amgen Inc and Amgen Manufacturing Ltd  EWHC 3711 (Pat), a Patents Court, England and Wales, ruling of Mr Justice Arnold this morning, is not yet available on BAILII but can be accessed here.
This decision deals, in short, with whether Amgen Inc. was properly party to patent revocation, SPC invalidity and declaration of non-infringement proceedings in respect of rights which were registered in the name of Amgen Inc but were subsequently assigned to another party. Arnold J refused Amgen Inc's application for an order that it cease to be a party, on several grounds.
It is intended to post further information on this unusual application once PatLit has had a chance to read it.
Earlier today the Court of Appeal for England and Wales gave an important and keenly-awaited ruling in IPCom GmbH & Co Kg v HTC Europe Co Ltd & Others  EWCA Civ 1496, a decision on whether and when to stay national validity proceedings pending the outcome of European Patent Office (EPO) invalidity proceedings. This decision, which was not available online when news of it first broke, is now accessible on the excellent (and free) BAILII database here.
"The Court of Appeal has today given judgment in IPCom v HTC – a case concerning the validity of a European patent due to be heard in December 2013. HTC applied for a stay of the English validity proceedings pending the outcome of proceedings concerning the same European patent at the ...EPO. Roth J at first instance refused HTC's application .... The Court of Appeal has upheld his decision. This is the first time that the Court of Appeal has ruled on such a stay application since the Supreme Court suggested in Virgin Atlantic v Zodiac that the guidelines set out by the Court of Appeal in Glaxo v Genentech should be considered again.
In the light of this decision, it is to be expected that the considerable duration of EPO proceedings will continue to point in favour of refusing a stay of English proceedings in most cases [this blogger thinks that the trend towards refusing a stay will accelerate anyway since, as patent litigation in England and Wales becomes faster and more efficient, and case management becomes more cogent, the likely duration of any stay will be longer. Meanwhile, in the fast-moving ICT technologies in particular, the commercial life of litigated patents is likely to continue to grow shorter].
The European patent system allows proceedings concerning validity to run concurrently in both national Courts and the EPO. The reasons for requesting a stay in these circumstances are plain: there is the possibility of wasted costs and/or conflicting decisions. All else being equal, it might be said to be sensible for the national Courts to wait and see what happens at the EPO where a decision to revoke a patent trumps a finding of validity in a national Court.
However, ... proceedings in the EPO typically last many years. A decision from a national Court may arrive much quicker and still provide the parties with a helpful measure of commercial certainty, despite the fact that it only applies in that particular jurisdiction.
"If the likelihood is that proceedings in the Patents Court would achieve [some certainty] significantly sooner rather than the proceedings in the EPO, it would normally be a proper exercise of the discretion to decline to stay the Patents Court proceedings."
Roth J applied the Glaxo guidelines in dismissing HTC's stay application at first instance. However, he allowed permission to appeal because the Supreme Court had indicated at around the same time in Virgin Atlantic that the Glaxo guidelines should be reconsidered [it's a pity that the parties in a subsequent case should be made to pay for the reconsideration of rules that was identified as being necessary in an earlier case -- but someone has to pay the price of judicial law-making]. Virgin Atlantic concerned the impact of a later revocation of a patent on an earlier award of damages for infringement, .... Their Lordships highlighted that failure to stay national proceedings could lead to injustice to a defendant ordered to pay damages for infringement of a patent later revoked by the EPO. Furthermore, national decisions were only national, whereas a decision of the EPO applied in all designated states and the potential for inconsistency, uncertainty and wasted cost through allowing national proceedings to continue was not desirable.
In upholding Roth J's decision to refuse the stay, the Court of Appeal considered each of these criticisms of the Glaxo guidelines. While recognising that the guidelines required some revision, the Court did not consider that they should be swept away altogether. In recasting the guidelines, the Court paid particular heed to the issue of potential injustice to a defendant ordered to pay damages by a national court, but proposed ways of mitigating this injustice (e.g. by requiring the patentee to undertake to repay the damages if the patent were subsequently revoked). ... [I]nconsistency and wasted cost could only be avoided altogether (or rather potentially avoided) if stays were mandatory, which was not what the Supreme Court had suggested. Rather, these factors were inherent consequences of the European patent system, which the Courts have to take account of and manage as best they can".
"This article considers recent patent decisions from the Supreme Courts of the United States of America, India and the United Kingdom, and identifies the common theme that they display surprising lack of appreciation of basic tenets of patent law or, in some cases, of the practical realities of the patent system. The issue appears to be general in nature, irrespective of jurisdiction, and inherent to systems where superior courts are generalist in nature and lack patent specialists.
It is then questioned whether judges who have not trained in this field can plausibly be entrusted with guiding the development of the jurisprudence of patent law. It is proposed that superior courts should be supplemented with judges having patent experience".
"The Court of Appeal of England and Wales has simplified the test relating to privity of interest, enabling litigants to know the circumstances in which a party will be prevented from re-litigating a matter".
The fourth report of the Global Intellectual Property Index (GIPI 4), produced by the Z/Yen Group with support from the City of London Corporation, has just been launched at the London office of sponsoring law firm Taylor Wessing LLP. The Report tabulates and analyses some 14,000 assessments of the performance of the IP laws of 36 jurisdictions (that's 12 more than GIPI 3 reviewed back in 2011), broken down by 74 objective criteria. Some general comments on GIPI 4 can be found on the IPKat weblog.
There has been no change at the top of the tree since 2011, so far as patents are concerned, where Germany leads a tight pack with the United Kingdom just behind in second place. This is no doubt a gratifying result for Taylor Wessing as well as for other IP practices which possess a strong Anglo-German profile. Moving up from fifth to third is the Netherlands, with three first-time entrants -- Sweden, Switzerland and Austria -- occupying the next positions. Argentina languishes down at the bottom, having achieved the difficult task of finishing below serial weak performers India, Indonesia and Brazil. Another serial underachiever, China, actually notches up its best result for patents, coming 26th. The criteria that most motivated respondents to score a country high or low for patents were (i) cost-effectiveness of proceedings, (ii) the internal consistency of its judicial decision-making and (iii) the extent to which it appeared to conform to international standards of patentability and enforcement.
To participate in the GIPI survey by rating those jurisdictions with which you are familiar, click on the Z/Yen Group's GIPI login here.
(e) govern the protection of confidentiality of information sources or the processing of personal data.
On the one hand, it could be argued that the owner of a banking account counts among the information sources of a bank which should be kept confidential. On the other hand, this interpretation would be in conflict with the aim of the directive to ensure effective enforcement.
Balancing the fundamental right to privacy and the right to intellectual property and effective legal action, the BGH tends to answer his question with yes.
In Ariosa Diagnostics Inc. v Sequenom Inc., the US District Court for the Northern District of California held that several claims of a US patent disclosing a method to detect the presence of paternally inherited DNA of fetal origin (cffDNA), through the screening of maternal serum or plasma, do not constitute eligible subject matter and are invalid under 35 USC 101.
In 2011, Ariosa had filed a declaratory judgment action, seeking a declaration that its non-invasive prenatal test 'Harmony' did not infringe US Patent No. 6,258,540, exclusively licensed by Sequenom from Isis Innovation Ltd. Sequenom had filed a counterclaim for infringement, seeking a preliminary injunction against Ariosa. The court had denied the motion for a preliminary injunction, but the Federal Circuit had vacated the court's order, remanding the case for further proceedings and directing the court to examine subject matter eligibility of the asserted claims in light of the Supreme Court’s recent decision in Association for Molecular Pathology v Myriad Genetics Inc. Both Ariosa and Sequenom had filed motions for summary judgment of whether claims 1, 2, 4, 5, 8, 19-22, 24 and 25 of the '540 patent were drawn to patent-eligible subject matter.
subjecting the amplified nucleic acid to a test for the Paternally [sic] inherited fetal nucleic acid.
in Association for Molecular Pathology v Myriad Genetics Inc., concerning claims directed towards the human genes BRCA1 and BRCA2 and related diagnostic tests, the Supreme Court held that 'a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring'.
In the case decided by Judge Susan Illston, the parties agreed on the fact that neither cffDNA, nor its discovery in maternal plasma or serum is patentable, because its presence is a natural phenomenon. The court thus identified the key issue: 'whether the steps of the claimed methods in the ’540 patent, applied to that natural phenomenon, are sufficient to render the claims patentable'. Ariosa argued that the limitations embedded in the claims essentially applied well-understood, routine, and conventional activity to the natural phenomenon. The court agreed, noting that Ariosa had proved that the amplification and detection of DNA sequences in plasma or serum was well known by 1997, as confirmed by Sequenom's own expert. Thus, '[b]ecause the claimed processes at issue - apart from the natural phenomenon of paternally inherited cffDNA - involve no more than well-understood, routine, conventional activity, previously engaged in by those in the field, they are not drawn to patent eligible subject matter and are invalid under § 101'.
The judge dismissed Sequenom's arguments aimed at drawing a distinction between patentability of cffDNA, not permitted, and of its use, allegedly allowed. The decision noted that the Supreme Court has never stated that the use of a naturally occurring phenomenon in patentable. To the contrary, it has clarified that only an innovative or inventive use is entitled to patent protection: such use cannot rely on the simple addition of conventional steps to a non-eligible subject matter. Further, citing Flook, the court held that 'use of a newly discovered natural phenomenon, law of nature, or abstract idea will not render a claim patentable if the use of that natural phenomenon, law of nature or abstract idea is the only innovation contained in the patent'. Applying this reasoning to the case, the judge found that paternally inherited cffDNA does not become patentable just because the claims assert that it can be detected using conventional methods.
[E]ven though Myriad involved composition claims rather than method claims, that decision also supports the Court’s conclusion. The claims in Myriad gave the patentees the exclusive right to isolate the BRCA1 and BCRA2 genes. Although the Supreme Court was not presented with method claims, the Court explained "[h]ad Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents". Similarly, had the inventors of the ’540 patent created an innovative method of performing DNA detection while searching for paternally inherited cffDNA, such as a new method of amplification or fractionation, those claims would be patentable. But, the claims presently before the Court simply rely on processes to detect DNA that - as Sequenom concedes - were conventional techniques by those in the field at the time of the invention.
Evaluating the risk that the claims may preempt the underlying natural phenomenon, judge Illston accepted Ariosa's arguments, observing that preemption is not only triggered by the absence of practicable alternative methods, but also by the lack of commercially viable alternatives. In this perspective, although practicable alternatives for detecting cffDNA existed, the court found that Sequenom's failure to provide evidence of the existence of commercially viable alternative methods suggested that 'the claims at issue pose a substantial risk of preempting the natural phenomenon of paternally inherited cffDNA', supporting the court's conclusion on the unpatentability of the asserted claims.
On 5 November, the US Court of Appeals for the Federal Circuit published its judgment in the case of Sanofi-Aventis v Pfizer Inc., ruling on an appeal brought by Sanofi against a decision of the US Patent and Trademark Office Board of Patent Appeals and Interferences, which had awarded priority of invention to Pfizer in Interference No. 105,757. Upholding the appealed decision, the Federal Circuit held that, when the subject-matter is a DNA segment, conception and reduction to practice require isolation, possession, and appreciation of the DNA segment. To this aim, however, the inventor is not required to have knowledge of the complete nucleotide sequence.
Whenever an application is made for a patent which, in the opinion of the Director, would interfere with any pending application, or with any unexpired patent, an interference may be declared and the Director shall give notice of such declaration to the applicants, or applicant and patentee, as the case may be. The Board of Patent Appeals and Interferences shall determine questions of priority of the inventions and may determine questions of patentability.
In order to establish priority, the interference contest focused on two aspects of the act of invention, namely conception and reduction to practice (see Chapter 2300 of the USPTO's Manual of Patent Examining Procedure). The former concerned 'the formation, in the mind of the inventor, of a definite and permanent idea of the complete and operative invention' (Hybritech Inc. v Monoclonal Antibodies Inc.). The latter referred to the verification of that idea, the described and enabled anticipation of the subject matter of the count (which was 'the Board’s description of the interfering subject matter that sets the scope of admissible proofs on priority'). Reduction to practice could be actual (e.g. showing that the claimed invention worked as intended) or constructive (occurring on the filing of the patent). The proceedings were adjudged by the USPTO Board of Patent Appeals and Interferences, with appeals heard by either the US Court of Appeals for the Federal Circuit, or the District Court for the District of Columbia (according to 35 USC 146).
In the case examined by the Federal Circuit, the interference count concerned two claims to a DNA polynucleotide that encodes the protein binding chain of the human interleukin-13 receptor (IL-13bc). Sanofi was awarded the benefit of its priority date (6 December 1995), while Pfizer's filing date was 1 March 1996. Pfizer presented evidence that it had isolated and identified the sequence before Sanofi's benefit date, although, at the time, it did not possess an accurate analysis of the entire nucleotide sequence, due to sequencing errors. Before the Board of Patent Appeals and Interferences, the parties debated whether priority was to be awarded to the party which had first isolated the DNA sequence, and appreciated its IL-13bc function, or to the party which had first known the complete sequence of nucleotides which constitutes the sequence. The Board ruled that, in this case, 'possession and appreciation of the actual isolated DNA is the dispositive question for priority of conception', and subsequently awarded priority to Pfizer.
The Board distinguished Fiers v. Revel and Amgen as holding that conception and reduction to practice did not occur until the gene was isolated, for in those cases neither structure nor definitive properties had been established for the isolated gene. Burroughs Wellcome Co. v Barr Laboratories Inc. did not change these requirements, in holding that conception requires that the claimed DNA is possessed as a physical embodiment. Knowledge of the specific nucleotide sequence was not required in Burroughs Wellcome.
The decision noted that, in Enzo Biochem Inc. v Gen-Probe Inc., the court had upheld claims for DNA probes, even if the nucleotide sequence had not been determined. Similarly, in In re Wallach, it had clarified that the inventor can be said to be in possession of a protein, if he described a partial amino acid sequence in addition to other characteristics sufficient to identify the protein. In light of this case law, as the Board had already highlighted, knowledge of a complete sequence is not the only way to identify a composition precisely: to establish conception, it is sufficient that the party provides a description capable of distinguishing the composition from other materials, and of defining how to obtain it.
[T]he Board correctly based conception and reduction to practice on the possession of the isolated DNA segment that was shown to have the desired properties. When the subject matter is a DNA segment, conception requires possession and appreciation of the DNA segment that is claimed. [Invitrogen Corp. v Clontech Labs Inc.] [...] The Board found that Pfizer had successfully searched for and isolated the IL-13bc DNA segment, and possessed and appreciated the IL-13bc DNA before the Sanofi benefit date. [...] On these findings, the Board held that Pfizer had conceived and reduced to practice the isolated polynucleotide of Count 3 before the Sanofi benefit date. We conclude that the Board applied the correct law.
With a decision of 23 September 2013, the Italian Supreme Court (Corte di Cassazione) examined the 'galenical exception' (also known as 'galenical exemption'), which allows pharmacists to manufacture and sell medicines containing a patented active ingredient, if there is an individual medical need which is not met by the drug marketed by the patent owner. The court clarified that the medical prescription should indicate the specific modifications needed to cater to the specific needs of the patient, which constitute the necessary pre-requisite for the applicability of the exception. Further, the manufacture and sale of personalized drugs by pharmacists, under the 'galenical exception', must have the characteristics of an extemporary, quantitatively limited, artisanal activity.
in 2005, the legislator promulgated the Code of Industrial Property (d.lgs. 30/2005). Article 68 retained the 'galenical exception', but excluded its applicability when the medicines prepared by pharmacists use 'industrially-produced active ingredients'.
Previous judgments of the Supreme Court (e.g. n. 2241/2008, and n. 5573/2012) clarified that the limitation of the statutory rights of patent owners, established by the 'galenical exception', is justified by the necessity of protecting the right to health. The exception is subject to four requisites: (i) the extemporary character, which means that the medicine should be prepared only when needed, (ii) the quantitative restriction, as the production should be carried out on an individual scale, (iii) the presence of a medical prescription catering to specific needs of the patient, and (iv) the use of active ingredients not produced on an industrial scale. The last requisite aims to strengthen the protection afforded by patent rights, preventing the unlawful production and trade of infringing drugs.
In the case examined by the Supreme Court in the decision of 23 September, a pharmacist had manufactured and sold a medicine containing the active ingredient Finasteride, a type II 5α-reductase inhibitor, patented by Merck & Co. and marketed for the treatment of male pattern baldness (Propecia) and benign prostatic hyperplasia (Proscar). The medicine contained the same dosage (1 mg) of Finasteride as Merck's Propecia, and was similarly targeted to the treatment of alopecia. The pharmacist was accused, inter alia, of infringing a patented invention through the production of the alternative medicine, under art. 88 of r.d. 1127/1939 (now reproduced, with modifications, in art. 127 d.lgs. 30/2005).
The court observed that the aim of the 'galenical exception' is to allow pharmacists to prepare and sell medicines which cater to specific medical needs that prevent the use of the drug sold by the patent owner. The exception allows the production of personalized medicines, for example, when it is necessary to provide a different dosage of the active ingredient, or the patient is allergic to an excipient used in the marketed drug. Its application should be subject to a restrictive, rigorous interpretation.
Assessing the facts of the case, the court found that the medical prescription required the active ingredient Finasteride 1 mg, while the accused pharmacist employed Finastid 5mg and Proscar 1 mg, and their related excipients, bought from a third party. Further, the prescription did not require any personalized dosage of the active ingredient in light of specific medical needs of the patient. A fundamental requisite of the 'galenical exception' was, therefore, missing.
Upholding the appealed decision, the Supreme Court also clarified that the prohibition of the use of industrially-produced active ingredients, introduced in 2005, highlighted the artisanal character of the 'galenical exception', which was already implicit in the previous legislation. The requisite is necessary to prevent the creation of an unlawful 'parallel market', where patented drugs are produced and sold as galenical preparations for purely economic reasons.
The Call for expressions of interest for candidate judges for the Unified Patent Court closes on the 15th November. The call was launched in September by the Preparatory Committee of the Unified Patent Court, to identify those interested in judicial roles within the Court.
Those interested should submit a submission of a CV and covering letter to the Secretariat of the Preparatory Committee at secretariat@unified-patent-court.org An application is not a guarantee of selection at the formal application stage, but provides an opportunity for applicants to identify their competence and experience in the field of patent litigation. It also allows candidates to recognise that there may be skills gaps where training could be started before the UPC formal appointment procedure is launched.
This could be some lucky reader's big chance!
In the decision X ZR 19/20 “Tretkurbeleinheit” discussed a few days ago here, the German BGH provides a very interesting discussion on the nature and role of pleas and arguments in a patent nullity suit.
Technical judges in the German patent court are usually recrutited among the examiners of the German Patent and Trademark Office (DPMA). From their experience in patent application and opposition procedures, they are used to apply the principle of official investigation, e.g. that the court is entitled to investigate the facts of the case on its own initiative, i.e. without being bound to the submissions of the parties involved.
Though everybody is aware of the fact that the applicability of this principle in the nullity suit is very limited, it is the experience of the author of this not that the judges are sometines unable to resist to the temptation to look into parts of the documents other than those highlighted by the parties or to to assess the inventiveness of subject-matter base on combinations of prior art which had not been proposed by the plaintiff.
According to the BGH, this approach is incorrect.
With reference to the earlier decision X ZR 99/11 “Fahrzeugwechselstromgenerator”, the court judges that the typically unlimited and unmanageable prior art is transformed into a plea by the specific explanations as to which concrete contribution which part of which document shall make towards the alleged lack of patentability.
A document unaccompanied with indications of such concrete contribitions is not a plea or argument, whereas a new argument based on a document already on file is a new plea oar argument and therefore admissible only in the exceptional situatons defined in § 531(2) of the German Civil Procedural Act (ZPO).
The important consequence of this clearcut difference between new documents and new pleas is that the court is not entitled to develop its own arguments and indications relating to eventual relevant contributions of documents on file to the alleged lack of paetentability. Considering any such court-generated argument would violate the principles of impartiality and party disposition (Margin no. 36 of the decision, page 19, 3rd line from the bottom).
This does not necessarily mean that each and every possible line of argument based on every available document should be filed from the onset. The case as initially filed could wel focus on the most promising lines of argumentations.
Accounting for the principles established in the decision “Fahrzeugwechselstromgenerator” , the decisive point on time is the preliminary opinion of the patent court under § 83(1) of the German Patent Act. The parties should go “all in” if this opinion is negative to them because failure to do so could result in the foreclosure of new document of new arguments based on old documents on the 2nd instance.
In the matter X ZR 19/12 “Tretkurbeleinheit”, the German BGH had to decide on a new means of attack based on a certain document D7 submitted with the grounds of appeal in the 2nd instance.
As already discussed earlier (see here and here), the party submitting new means of attack in the 2nd instance has to establish that one of the exceptions mentions in § 531(2) 1st sentence of the German Civil Procedural Act (ZPO) applies, e.g. in this case that the reason for the late submission is not negligence in the 1st instance.
In the case at issue, the plaintiff had argued that he came across the document D7 only in the course of a supplementary search carried out when preparing the grounds of appeal. The BGH did not consider this sufficient and established that the party filing the new document in the appeal instance has to establish why the document could not be found using suitably chosen search profile in the search carried out in the course of preparing the nullity action in the first instance (headnote I).
The practical implication is that the plaintiff in the nullity suit should keep records of his search queries (IPC classes and catchwords) in order to eventually establish why the late-filed document could not be found earlier.
Trolls: if the solution is American, does that mean the problem's American too?
"Trolls Better Watch Out This Halloween -- Senator Hatch Introduces Patent Litigation Integrity Act", by Andrew Williams (McDonnell Boehnen Hulbert & Berghoff LLP), was posted on to the Patent Docs weblog yesterday. You can read the piece in full here. Andrew writes:.
" ... Senator Orrin Hatch (R-Utah) has introduced yet another piece of legislation to combat the perceived "patent troll" problem. The Patent Litigation Integrity Act (S. 1612) is aimed at shifting the reasonable fees and other expenses from the prevailing party in patent litigations to the non-prevailing party, absent "substantially justified" conduct, or other circumstances that would make it unjust. The proposed changes to 35 U.S.C. § 285 (Fees and other expenses) are nearly identical to the comparable section of the Goodlatte "Innovation Act," currently being discussed by the House [summarised on IP Watchdog, here]. The only significant difference between the two amendments to § 285 is that the Senate bill specifies that "reasonable fees and expenses" includes attorney fees. As a result, both the House and Senate now currently have bills pending that would make the shifting of fees in patent litigation the default which can only be overcome by showing that conduct was substantially justified. However, neither version provides guidance explaining when such "justifications" rises to the level of "substantial."
(7) whether the party will agree to pay the shifted fees (and has the ability to do so).
The question is sometimes asked whether the patent troll is a universal problem or a purely American one. The proposals here appear to consist of tweaking or fine-tuning the rules of engagement for US patent litigation rather than addressing issues of principle. Where the proposed solution is so closely focused on the mechanism of patent litigation in the US, one is tempted to conclude that trolls are indeed a by-product of the current US system rather than a business model of wider application.
PatLit has now received the following statement from Public Knowledge, a "Washington D.C.- based public interest group working to defend consumer rights in the emerging digital culture".
Today, Senator Orrin Hatch (R-UT) introduced the Patent Litigation Integrity Act. This bill gives judges more opportunities to shift the costs and expenses of litigation. Furthermore, this bill allows defendants to request an up front bond to prove that the party seeking the claim has the resources to compensate the winning party if that party can't successfully defend its claim.
This release is linked here.
A link to a summary of the bill can be found here.

References: EWCA 
 § 101
 v. 
 art. 88
 art. 127
 § 531
 § 83
 § 531
 § 285
 § 285