Friday, 19 September 2014

Biogen v Medeva: historical patent litigation landmark recognised

"Biogen v Medeva 20 years on" is the title of a seminar organised by Rouse for Thursday 16 October in the Crisis Skylight London Café (64 Commercial Street London, E1 6LT). You can check out the details here.  According to the rubric:
"Biogen v Medeva occupied the English patent courts for much of the early 1990s and the ‘Biogen insufficiency’ principle is still applied today [for a view of some applications of that decision in recent years, noted by the IPKat, click here]. Twenty years later, Rouse is bringing the protagonists of this landmark case together again...

We would be delighted if you would join us to hear about the impact this case had on the commercial, legal and scientific arenas as well as the personal recollections of the individuals involved. Our distinguished panellists include one of the expert witnesses in the case: Professor Jeffrey Almond; members of the parties’ in-house teams: Peter Cozens, Marcus Dalton and Bill Tyrrell; as well as a number of the external solicitors, barristers and US lawyers who acted in the litigation: Jim Haley, Mark Hodgson, John Ilett, Professor Sir Robin Jacob, Leslie McDonell, Adrian Speck QC and Diana Sternfeld".
This blogger is delighted to see an event that records the significance of a decision which, over the years, has remained centre stage and has fostered so much debate and sometimes fierce argument.

You can read the October 1996 decision of the House of Lords here

Cautionary Tale: CAFC Rules That Delay Resulting From Reexamination Can Trigger Litigation Laches

Defendants accused of patent infringement sometimes raise the equitable doctrines of laches and estoppel as affirmative defenses. Although the defenses often appear to be linked, they are actually quite separate. As the Supreme Court explained last term, laches arises from an unreasonable delay in commencing suit that resulted in prejudice to the defendant, while equitable estoppel requires some action by the patentee, combined with reasonable reliance on that action by the defendant. See Petrella v. Metro-Goldwyn-Mayer, Inc., ___ U.S. ___, 134 S. Ct. 1962 (2014)

This week, the U.S. Court of Appeals for the Federal Circuit applied laches to bar a patentee’s infringement suit. SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC, No. 2013-1564 (Fed. Cir. Sept. 17, 2014). The patentee, SCA Hygiene Products, owns a patent for adult incontinence products. On October 31, 2003, it notified First Quality Baby Products, LLC that First Quality appeared to be infringing the patent. SCA and First Quality exchanged letters for eight months. Then SCA requested ex parte reexamination of the patent based on a reference identified by First Quality. SCA did not notify First Quality of the reexamination proceedings. The U.S. Patent and Trademark Office issued a reexam certificate confirming the original claims and adding additional claims on March 27, 2007. SCA immediately began preparing to sue, but did not actually file suit until August 2, 2010 – six years and nine months after SCA’s first letter. During the pendency of the reexam, First Quality made substantial investments relating to the accused products, including purchasing a division from another diaper manufacturer and spending $10 million to expand production.

First Quality raised both laches and estoppel as defenses to SCA’s action. The Federal Circuit reviewed the elements of laches, as laid out in A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc):
Laches is an equitable defense to patent infringement that may arise only when an accused infringer proves by a preponderance of evidence that a patentee (1) unreasonably and inexcusably delayed filing an infringement suit (2) to the material prejudice of the accused infringer. If these prerequisite elements are present, a court must then balance “all pertinent facts and equities,” including “the length of delay, the seriousness of prejudice, the reasonableness of excuses, and the defendant’s conduct or culpability” before granting relief. . . Delays exceeding six years give rise to a presumption that the delay is unreasonable, inexcusable, and prejudicial. Under this presumption, the burden of evidentiary production shifts from the accused infringer to the patentee. Both of these presumptions disappear if the patentee can identify evidence sufficient for a reasonable jury to conclude either that the delay was excusable or not unreasonable, or that it was not materially prejudicial. If the patentee meets this burden of production, the accused infringer must prove both elements of laches by a preponderance of evidence.
SCA, Slip op. at 5-6 (citations omitted).  

Since SCA’s delay in filing suit was more than six years, the delay was presumed to be unreasonable, inexcusable, and prejudicial. SCA attempted to rebut the presumption by pointing out that three years of the delay was due to the reexam, which was a public proceeding. The Federal Circuit was not impressed. First, it rejected SCA’s argument that the time spent in reexam should not count toward the six year presumption trigger. Second, it ruled that SCA’s overall conduct , including its delay in filing suit after the reexam, could not rebut the presumption:
Under such circumstances, SCA was not required to provide notice of the reexamination to First Quality. But even though SCA’s delay may have been excusable when viewed in isolation, we must examine whether SCA’s delay, viewed as a whole, was excusable. The district court found that “SCA admitted that it has continuously tracked First Quality’s activity since 2003 and has an entire department dedicated solely to competitive intelligence.” SCA then continued to evaluate First Quality’s products during the reexamination period. SCA was also represented by U.S. patent counsel when it sent letters to First Quality in 2003 and 2004 and during the reexamination proceedings between 2004 and 2007. No evidence suggests that SCA was unable to find counsel or reinitiate contact with First Quality shortly after the reexamination ended. Moreover, “personal lack of familiarity with the patent system . . . does not excuse . . . failure to file suit.” Given the circumstances, SCA should have been prepared to reassert its rights against First Quality shortly after the ’646 patent emerged from reexamination. [Cites] But SCA remained silent for more than three years after the patent came out of reexamination. Accordingly, SCA has failed to raise a genuine issue of material fact regarding the reasonability of its delay. Viewing all of the facts in the light most favorable to SCA, no reasonable fact-finder could conclude that SCA’s delay, viewed as a whole, was reasonable. 
Slip op. at 11-12. Since First Quality was able to establish prejudice due to the delay, laches barred SCA’s claim. 

One fascinating aspect of the SCA decision is the Federal Circuit’s treatment of SCA’s argument that the entire laches defense, as well as the Aukerman case on which it rests, was severely undermined by the Supreme Court last term in Petrella, a copyright case. In Petrella, the Supreme Court ruled 9-0 that although laches sometimes is adopted as a “gap filling” doctrine when a federal statute omits any limitations period, it has a limited role when Congress provides a statutory limitation period. “[L]aches is a defense developed by courts of equity; its principal application was, and remains, to claims of an equitable cast for which the Legislature has provided no fixed time limitation.” 134 S. Ct. at 1973. The Court noted that laches’s role is “gap-filling, not legislation-overriding,” and the Court has “never applied laches to bar in their entirety claims for discrete wrongs occurring within a federally prescribed limitations period.” Id. at 1774-75. This view of laches is squarely contrary to the Federal Circuit’s reasoning in Aukerman. Since SCA's claim was timely under the Patent Act's limitations provision, 35 U.S.C. § 286, laches would appear to be unavailable as a defense.

Nonetheless, the Federal Circuit in SCA considered itself bound by Aukerman, wounded though it may be:
But Petrella notably left Aukerman intact. See 134 S. Ct. at 1974 n.15 (“We have not had occasion to review the Federal Circuit’s position.”). Because Aukerman may only be overruled by the Supreme Court or an en banc panel of this court, Aukerman remains controlling precedent.
Slip op. at 8. 

The Federal Circuit reversed the district court’s ruling that SCA’s conduct also created an estoppel, since there was no affirmative act, or failure to act, that First Quality could reasonably have relied upon.  The full decision is available HERE.

Thursday, 18 September 2014

UPC Roadmap updated

Anglo-German law firm Taylor Wessing has just published an updated version of its Roadmap for the UPC is published. According to the rubric on the firm's website:
The Preparatory Committee of the Unified Patent Court has published a September 2014 update on the progress of its work towards the opening of the court. The key milestones in the update are:
The Committee will continue to work on the basis that "the Court will not be ready before the end of 2015", although it acknowledges that this is "ambitious";

Following a hearing of user organisations in November 2014 and then further review, the Committee expects there to be agreement on the Rules of Procedure in May 2015;

A draft schedule of court fees – fixed fee, and calculation method for value based fees in matters above the defined ceiling of the fixed fee – is being considered by the Finance Group. A second draft is expected to be discussed at the beginning of 2015;

A revised draft of the rules on the litigation certificate for patent attorneys is expected in early 2015;

The procurement process for the electronic filing and case management system of the UPC is expected to take place in autumn 2014. Development and testing of this system is expected to be finalised by the last quarter of 2015;

Work on the number and qualifications of local staff is due to be finalised in March 2015;
A provisional list of legally and technically qualified judges has been approved by the Preparatory Committee. The first training programmes for those judges deemed to require training will begin in December 2014. The Committee aims to appoint a sufficient number of part-time and full-time judges before the entry into operation of the UPC and to create a reserve list of judges who could be appointed should the case law increase more than expected.
The six-page document, which you can read here, has a handy list of 13 tasks completed by the Regulatory Committee over the past 12 months. Some of these tasks are not particularly onerous or significant, but there is a certain pleasure in placing little ticks next to activities that have been dealt with.

Our good friend and occasional contributor both to this blog and to the IPKat, Paul England, is the person to contact if you want any further information.

Hijacked book-launch? Or two for one ...

This blogger attended a very pleasant event at London's Oxford and Cambridge Club yesterday afternoon, this being the launch of Angela Fox's new tome, Intellectual Property Enterprise Court: Practice and Procedure (already noted here on PatLit and soon to be reviewed on the IPKat).  To his delight he was able to exchange some amicable words not only with the excellent Angela herself but also with that court's Enterprise Judge, Richard Hacon, plus a brace of more senior judges who creditably support numerous IP events in their own spare time and make themselves generally visible, demonstrating the fact that they are not remote from society but an active component of it.

To his surprise, though, this blogger discovered that Angela's was not the only new book on the block, as it were.  On display, indeed on the same table as Angela's book, were copies of the second edition European Unitary Patent and Unified Patent Court, an agreeably short softback by Angela's fellow Jenkins partner Hugh Dunlop that apparently had rolled off the presses earlier in the day.  This text is the second edition, a year later than its predecessor, and it includes a brief commentary on the structure, the legislation and the draft 16th revision of the Rules of Procedure of the Unified Court.  You can get a bit more information from this book, plus an order form and, if further temptation were needed, a review of the 2013 edition, from the website of publishers CIPA here.

Oktoberfest and Patented Technology

While Munich is pleasantly anticipating the forthcoming Oktoberfest season, the EPO has produced really fancy movie on patented technology at the Oktoberfest.

Have a look! This blogger really appreciates the efforts of the EPO to create positive headlines (other than ones involving mutant tomatoes) in relation to patents.

Wednesday, 17 September 2014

Enablement to USE drugs vs. enablement to PRODUCE drugs

The decision T 1616/09 deals with an application including both claims directed to pharmaceutical compositions and claims directed to the medical use of such compositions. The application had been rejected based on lack of enabling disclosure. The arguments of the examining division were based on an alleged lack of evidence in the application showing that the technical problem as stated in the application - synergistic improvement of the effectiveness of antineoplastic agents - had indeed been solved, especially in view of all possible anti-neoplastic agents encompassed in the claims.

The decision contains interesting notes on the level of disclosure required for the different categories of claims. Here are the headnotes:
For the purposes of Article 83 EPC, the level of disclosure in the application which is required for claims directed to pharmaceutical compositions or kits is not the same as that which is required for medical-use claims. For claims directed to pharmaceutical compositions or kits it is in principle sufficient that the application provides information which allows the skilled person to produce the composition or kit, and that there are no substantiated doubts that it could indeed be used in therapy. For second-medical-use claims on the other hand it is required not only that the composition itself is disclosed in an enabling way but also that its suitability for the claimed treatment is plausibly disclosed in the application (Reasons 6).

In the case of a claim directed to a pharmaceutical composition comprising two classes of compounds which have both already been used in therapy in the prior art, there is a priori no reason to doubt that such a pharmaceutical composition can be produced; no specific functional effect has to be demonstrated (Reasons 6.1.1 and 6.1.2).

In the case of second-medical-use claims, if the claimed therapeutic effect was already known to the skilled person at the priority date, it is not necessary to demonstrate it in the application (Reasons 6.2.2).

Monday, 15 September 2014

Broad Claims with narrow support – Vorrichtung zur Schwingungserzeugung

The decision 4 Ni 16/11 of the 4th senate of the Bundespatentgericht (BPatG) is worthwhile noting because it approaches the jurisdiction of the BPatG with a jurisdiction of the Technical Boards of Appeal of the EPO.

The patent subject to the nullity action had claimed a direct power transmission of power created by reaction torques (reactive power) using servo motors in a very general way. The claim was much broader than the specific solution described in the documents as a whole, which described a hydraulic solution without overlapping drive.

The Court finds that the generalized solution of the claim is no longer represented by the disclosed way of solving the problem and that, as a consequence, the patent protection extended beyond the contribution of the invention to the prior art. As a consequence, the requirement of the enabling disclosure is not met (§ 21, paragraph 1, number 2 and § 22, paragraph 1 PatG).

BPatG notes that the balancing assessment (wertende Betrachtung) should account for the facts that the electronic solution - which was covered by the claim but not disclosed in an enabling way - does not only require an autonomous technical development starting from the prior art but further that this embodiment has considerable economic importance and that the patentee had explicitly noted the existence of such an embodiment engrafting the application and claimed this alternative embodiment in a dependent claim without, however, being able to disclose a way to reproduce the embodiment.

After “Okklusionsvorrichtung” and “Diglycidverbindung”, this is a further example of the case where the abstract mentioning of possible embodiments without detailed support is detrimental rather than helpful for the scope of protection.
The full text (in German) can be found here, the headnote here.

Posted by. M. Thesen

Do people know that patents exist? A judge opines

OOO Abbott & Another v Design & Display Ltd & Another [2014] EWHC 2924 (IPEC) is a 4 September 2014 ruling of Judge Hacon in the Intellectual Property Enterprise Court, England and Wales, on the subject of calculation of an account of profits after a patent has been held infringed.

This blog post focuses on just one small issue arising in this case: the availability of the remedies of damages and an account of profits against an ostensibly innocent infringer.
  1. Section 62(1) of the Patents Act 1977 states:
  2. "In proceedings for infringement of a patent damages shall not be awarded, and no order shall be made for an account of profits, against a defendant or defender who proves that at the date of the infringement he was not aware, and had no reasonable grounds for supposing, that the patent existed; and a person shall not be taken to have been so aware or to have had reasonable grounds for so supposing by reason only of the application to a product of the word "patent" or "patented", or any word or words expressing or implying that a patent has been obtained for the product, unless the number of the patent accompanied the word or words in question."
So, to what extent is a person said to be unaware, and of having no reasonable grounds for supposing, that an infringed patent existed?  Judge Hacon had this to say:
  1. ... I am not satisfied that Design & Display has established the necessary lack of knowledge or reasonable grounds for supposing that the Patent existed. In cross-examination Mr Lloyd [managing director of Design & Display] said that he had only heard of patents because he was a local historian and he did not know whether his colleagues knew what a patent was. While it is easy for those whose working lives are concerned with patents to over-assume how much the general public know about patents, I think most individuals, such as Mr Lloyd and presumably his colleagues, will have heard of the concept of patents and will have on board the basic notion that you can get one to protect your idea. It seems to me unlikely that an interest in local history is needed to know that much".
Duly noted!

Friday, 12 September 2014

NPEs in the US: who's doing the suing?

Which non-practising entities (NPEs) are filing patent infringement suits in the United States? We have found a great table depicting new NPE litigation over the past eight months thanks to Article One Partners, whose crowd-sourcing of devastating prior art to blast unpopular patents off the face of the Earth looks must seem particularly attractive if one of these businesses comes knocking at your door:

This information comes from PatentFreedom, whose chairman and founder is Daniel McCurdy, whose patent risk management company RPX Corporation acquired it earlier this year.

Thursday, 11 September 2014

Disclosure without disruption? Finding the least bad option

Vringo Infrastructure Inc v ZTE (UK) Ltd is a Patents Court, England and Wales, ruling of Mr Justice Birss which is unlikely to reach BAILII since it's a fairly small procedural matter -- but it's still interesting enough to note here, this blogger having spotted it on the Lawtel subscription-only service.

In short, Vringo sued ZTE for patent infringement [on which see Annsley Merelle Ward's earlier Katposts here, and here on whether the trial of patent infringement issues should take place ahead of the trial of FRAND issues, or vice versa]. In the proceedings noted here, Vringo applied for disclosure in its infringement claim. Vringo produced a mobile handset, the standard for which stated that it supported a certain multimedia handover technology. If this were so, argued Vringo, that meant that ZTE's product had to infringed its patent, which covered that technology. ZTE had provided a product description which stated that the relevant infrastructure and handsets did not in fact have that function.

According to Vringo, although that function was initially switched off, it would be open to ZTE to switch it on later and make the multimedia handover function available. ZTE however denied that its product could be reconfigured so as to support the function. Vringo then sought clarity as to how that was the case when it had been stated as a feature in ZTE's standard, seeking an order for disclosure on that point in order to support its claim that ZTE was committing a "secondary infringement" by supplying means of infringement under the Patents Act 1977 section 60(2) which states:
" ... a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom".
The disclosure application was made approximately six weeks before the date of the trial of the matter. This trial looked like being a big one, since it also involved three other infringement claims, not to mention the predictable challenge by ZTE to the validity of the patent.

On Tuesday Birss J agreed to let Vringo obtain disclosure. In his view:

* It was plain that, if the court acceded to Vringo's application, it would not be possible to try the multimedia handover technology point at the listed trial date. While the court could determine that Vringo had not properly pleaded its case and simply dismiss the point, that gave rise to a possible grave injustice if Vringo was correct and if there had been a properly pleaded case.

* Another option was to adjourn the trial altogether, including the other matters.

* On balance, the least bad option was to permit Vringo to amend its pleadings and to ensure that there was proper disclosure by ZTE so as to deal with this issue. That meant that the multimedia handover point could not be dealt with at the listed trial -- but all the other matters could still be determined.

* There was no need to hear ZTE's section 60(2) defence at the same time as the validity challenge.

Birss J added that an advantage of his chosen course of action was that the multimedia handover point would be left to one side until the trial was resolved: three different patent infringement claims in one trial was already quite enough.

Wednesday, 10 September 2014

Brits go Bolar, with some helpful guidelines

"Changes to the patents research exceptions" is the title of a media release issued by the UK Intellectual Property Office which has some cheery news for researchers who lose sleep over the prospect of their laboratory work leading them into the uncomfortable position of being defendants in patent infringement proceedings.   The good news reads thus:
Guidance on changes to patent law made by the Legislative Reform (Patents) Order 2014 which will come into force on 1 October 2014.

The Legislative Reform (Patents) Order 2014 No.1997 was approved by Parliament in July 2014 and will come into force on 1 October 2014. The Order clarifies that activities relating to medicinal product assessments are within scope of the experimental use exception (also known as the research exception).

The changes will allow companies to use a patented product, when carrying out medicinal product assessments, either to provide information to the regulatory authorities or for health technology assessment.

The changes meet a government commitment to ensure the IP system supports the life sciences sector.

Changes to patent law

The Legislative Reform (Patents) Order introduces changes to the Patents Act which clarifies that medicinal product assessments are exempt from patent infringement by virtue of the existing research exception.

Supporting information

Further information can be found in our guide.on changes to patents legislation made by the Legislative Reform (Patents) Order 2014.
The guide contains, inter alia, the following information:
Is work done to obtain approval for a drug abroad covered by the change? 
Yes. If the purpose of the work is medicinal product assessment, as defined in the Order, it is within scope of the amendment.  
Which activities are covered by the new exception?
Although the exact scope of the new exception to infringement will be a decision for the Courts [this is an important caveat], the following activities are considered to be in its scope:
• Activities carried out to provide data on new medicines to UK or non-UK regulatory
authorities.
• Activities carried out to provide data on new medicines to UK or non-UK bodies carrying out health technology assessments.
• Post approval studies to comply with UK or non-UK regulatory requirements.
• Activities carried out to amend a UK or non-UK authorisation for a medicine.
• Activities done to obtain a UK or non-UK authorisation for a new indication of an existing drug.
• Any tests or studies required by UK or non-UK regulatory bodies.
• Activities carried out for the purposes of obtaining full authorisation in the EU of a generic drug or biosimilar i.e. where the abridged procedure exempted by section 60(5)(i) of the Patents Act (the "Bolar exception" is not used).
• Activities related to health technology assessment of a generic or biosimilar product.
• Activities carried out to provide data for obtaining regulatory approval outside of the EU for a generic or biosimilar product.  
Does the amendment cover commercial use of a patented drug in a product?
The new provisions do not extend to commercial activities, such as sale, commercial supply, or manufacture in preparation for sale or supply. A licence, or other agreement, will be required from the patent holder before a product can be sold or supplied commercially. 
Does the amendment cover the use of a patented medicine as a comparator?
Yes. The use of a patented medicine as a comparator in a medicinal product assessment, as defined in the Order, is covered by the amendment. 
Are combination products covered by the amendment?
Medicinal product assessments on a combination are within the scope of the new provision. This includes instances where a patented drug is part of the combination.  
Can I supply a patented drug to a person for use in a medicinal product assessment without a licence from the patent owner? 
Sections 60(2) and (6) of the Patents Act 1977 have not been amended. The consent of the patent owner would be needed to supply a patented drug to a person for use in a medicinal product assessment.

Specialised IP court for China: what will it mean for patent litigation?

"China establishes specialised intellectual property courts" is the title of the news flash from Rouse, which reached this blogger as an email today but can also be read in full online here. It states, in relevant part:
" ... Following key indications in the last 12 months of the central government’s intention to establish a specialised IP Court, the National People’s Congress Standing Committee issued the draft Decision on Establishing Intellectual Property Rights Courts in Beijing, Shanghai, and Guangzhou (the Decision).

The Decision establishes the IP Courts as of 31 August 2014 [in other words, they are already presumably up and running in one form or other]. The Decision provides some useful insight into the proposed jurisdiction, staffing, and supervision of the IP Courts, which are intended to further the efficiency and consistency of China’s IP enforcement regime.

Jurisdiction

The IP Court sits within the judicial hierarchy in a position equivalent to the local Intermediate People’s Court. It will be a court of first instance with respect to ‘technically complex’ civil matters relating to patents, technical trade secrets, plant varieties, and semiconductor layout designs.

The Decision indicates that this jurisdiction will become cross-territorial within three years. In addition, the IP Court will also have original jurisdiction over administrative appeals and invalidation actions stemming from decisions issued by SIPO [State Intellectual Property Office] and the CTMO [China Trade Mark Office].

The IP Court will also serve as a court of appeal for trade mark and copyright matters originating in the basic level court in its municipality or province. Foreign parties typically initiate civil matters in the Intermediate People’s Court or higher, so it is likely that the IP Court will serve as a court of first instance in most cases where a trade mark or copyright matter involves a foreign party. Decisions of the IP Court will be reviewed by at least one appellate court, the first of which is the high court of the province or municipality where the IP Court is located. The three IP Courts will not be the ultimate appellate courts for IP matters, so their role in harmonising IP jurisprudence will be limited.

Staffing

The Standing Committee of the local People’s Congress will have the power to appoint and dismiss key positions within the IP Courts, including the President, Deputy President, Chief Judge, Judicial Officer, and Judicial Committee.

Supervision

The IP Courts will have a number of interested stakeholders. They will be supervised by the Supreme People’s Court (the SPC), the local High People’s Court, and the procuratorate, although no particular procuratorate is specified. In particular, the SPC will regulate the workload of the IP Courts, including the type and number of cases heard. The Standing Committee of the local People’s Congress in its supervisory role will have significant influence on the functioning of the IP Courts. The IP Courts will also receive operational guidance and trial supervision from the Higher People’s Court of the district where the IP Court is located. ...".
It's clear that, at this early stage, a good deal of detail remains to be hammered out. It will be good to know whether the court will do little more than enable judges to gain greater expertise through hearing a more concentrated diet of patent cases or whether it will evolve IP-specific rules for dealing with evidence, witnesses and so on. PatLit welcomes this development and awaits further news with eager interest.