What "hot" patent topics have the English courts grappled with in 2018?
If I could pick just three buzzwords, it would be these: “plausibility,” “FRAND” and “equivalents.”
The U.K. Supreme Court has been particularly active, having opined on equivalents in 2017 and on plausibility in 2018. FRAND (fair, reasonable and nondiscriminatory) issues have yet to make its way to the highest court in the land, but it’s probably just a matter of time.
2019 promises to be another exciting year as English patent lawyers eagerly await another decision from the Supreme Court, this time on obviousness, and possibly two further hearings on insufficiency and employee inventor compensation respectively.
Sufficiency/Plausibility and Infringement of Second Medical Use Claims
The U.K.’s most anticipated decision of 2018 is the Supreme Court case of Warner-Lambert Company LLC v. Generics (UK) Ltd. t/a Mylan, which dealt with how the concepts of sufficiency/plausibility and infringement are to be applied to a “Swiss-form” patent relating to a specified medical use of a known pharmaceutical compound.
The Supreme Court was divided on the issues.
On sufficiency/plausibility, the majority’s approach required patentees to demonstrate that the specification discloses some scientific reason for supposing that the implied assertion of efficacy in the patent claim is true. Put another way, there must be something in the specification that would cause the skilled person to think there was a reasonable prospect that the assertion would prove to be true, such reasonable prospect being based on a direct effect on a metabolic mechanism specifically involved in the disease, this mechanism being either known from the prior art or demonstrated in the patent per se. The minority proposed an alternative approach to sufficiency, preferring a lower standard of plausibility.
On infringement, the majority favored the “outward presentation” test, which is not dependent on any subjective or objective intention of the alleged infringer, but whether the product as it emerges from the manufacturing process, including any labeling or accompanying patient information leaflet, is presented as suitable for the patented use. One of the justices left open the possibility (1) that in rare cases the context may make it obvious that the objective appearance and characteristics of the product as it is prepared, presented and put on the market are not to be taken at face value, and (2) that there may be circumstances in which the generic manufacturer should positively exclude use for the patent-protected purpose. The minority preferred a test of whether the alleged infringer subjectively intended to target the patent-protected market.
Applying the Principle of Equivalents
Icescape Ltd. v. Ice-World International BV is a case concerning a system for cooling mobile ice rinks. It is the first occasion in which the Court of Appeal has had the chance to consider in any depth the effect of the ground-breaking Supreme Court decision in Actavis UK Ltd. v. Eli Lilly. The Court of Appeal applied the Supreme Court’s decision to consider whether there was infringement (1) as a matter of normal interpretation (which it confirmed involves purposive interpretation), and (2) as a matter of equivalents (by asking what it termed the “Actavis questions”).
The emergence of a principle of equivalents in English law is welcomed by patentees as it extends the scope of protection to cover an infringing variant which may not necessarily have been caught by just construing patent claims as a matter of normal, purposive interpretation. This is a significant shift in the state of English patent law as, prior to Actavis v. Lilly, it was thought that purposive construction was the be all and end all when considering infringement. On whether reference can be made to the contents of the prosecution file, English courts continue to adopt a skeptical (but not absolutist) attitude.
Following the Court of Appeal decision in Unwired Planet International Ltd. v. Huawei Technologies Ltd., the U.K. is now arguably the most attractive forum globally for holders of standard essential patents, or SEPs, looking for assistance in settling long-running licensing negotiations with implementers, not least because the rates determined by the English court in this case were higher than has been seen in other jurisdictions. The Court of Appeal upheld Judge Colin Birss’ imposition of a global FRAND license on Unwired Planet’s SEPs. Judge Birss initially found that there is only one set of FRAND terms and one FRAND rate for any given set of circumstances, but the appellate court held that multiple rates and sets of terms may all be fair and reasonable.
The Court of Appeal further held (1) that the nondiscrimination obligation is general, rather than hard-edged, and (2) that the conditions set out by the Court of Justice of the European Union in Huawei v. ZTE are not mandatory, but rather provide a safe harbor by ensuring that, if satisfied, the commencement of proceedings does not amount to an abuse of a dominant position under Article 102 of the Treaty of the Functioning of the European Union.
English courts continue to demonstrate flexibility in imposing final injunctions on infringers.
In Unwired Planet International Ltd. v. Huawei Technologies Ltd., Judge Birss granted a “FRAND injunction,” i.e. an injunction to restrain infringement of the relevant SEPs but with a proviso that it will cease to have effect if the defendant enters into a FRAND licence.
In Edwards Lifesciences LLC v. Boston Scientific Scimed Inc., notwithstanding that the claimant’s transcatheter heart valve, or THV, had been found to be an infringing device, the court granted an initial stay of the injunction to permit continued implementation of the claimant’s device for a period of 12 months to enable certain clinicians to be retrained to use another THV. Justified by health protection considerations, the court further granted a limited exception to the injunction on the basis of evidence that the claimant’s device is the only suitable THV for a small but growing number of patients.
Although not in the patents space, it is also worth mentioning the case of Cartier International AG v. British Sky Broadcasting Limited, where the English court was prepared to order a never-before-been-made injunction (a website-blocking order) against intermediaries whose websites were being used by third parties to advertise and sell counterfeit goods which infringed the claimants’ trademarks.
An Arrow declaration is, in effect, a declaration that, a given product was obvious as of a particular date, with the consequence that any subsequent patent to it would be invalid. Such declarations are particularly useful when facing pending patent and divisional applications which have yet to grant. Following the recent cases of Fujifilm Kyowa Biologics Co Ltd. v. AbbVie Biotechnology Ltd. concerning adalimumab (AbbVie’s HUMIRA) and Glaxo Group Ltd. v. Vectura Ltd. concerning vilanterol and umeclidinium (GSK’s ELLIPTA), the English court’s grant of Arrow declarations has seen a resurgence.
Earlier in the year, the U.K. ratified the UPC agreement. Notwithstanding Brexit, the U.K. government has stated its intention of exploring options to stay in the UPC and the unified patent system after the U.K. leaves the EU. All that remains for the UPC agreement to enter into force is Germany’s ratification, which is currently held up by a constitutional challenge before the Bundesverfassungsgericht.
Looking Forward to 2019
One area in which a continual rise in litigation can be observed (which won’t be a surprise to many) is in the biologics and biosimilars space. Another is FRAND disputes on the back of the Unwired Planet v. Huawei decision, and related jurisdiction challenges like in Conversant Wireless Licensing SARL v. Huawei Technologies Co Ltd. and Apple Retail UK Ltd. v. Qualcomm (UK) Ltd. The Court of Appeal’s (jurisdiction) decision in Conversant v. Huawei remains pending at the time of writing.
As alluded to earlier, the U.K. Supreme Court is playing an unusually active role granting permission to appeal in patent cases, and it will be interesting to see how the highest court in the land continue to shape the landscape of patent law.
In November 2018, the Supreme Court heard the case of Actavis Group PTC ehf v. ICOS Corporation concerning whether a dosage regime patent for tadalafil (Lilly’s CIALIS) was obvious. The Supreme Court’s decision remains pending.
In early February 2019, the Supreme Court will hear the case of Shanks v. Unilever PLC concerning employee inventor compensation, and whether the relevant patents which resulted from professor Ian Shanks’ invention had been of “outstanding benefit” (including what that means and how it should be calculated).
Permission to appeal was very recently granted in Kymab Ltd. v. Regeneron Pharmaceuticals Inc. on the ground that the Court of Appeal wrongly interpreted and applied the law of insufficiency. The patents are concerned with biotechnology, and in particular the production of human antibodies using transgenic mice. No date has yet been set for a hearing.
I for one (and no doubt many English patent lawyers) will be waiting for the Supreme Court judgments with bated breath.
Jin Ooi is an associate at Kirkland & Ellis LLP.
Disclosure: The author represented Warner-Lambert Company LLC in patent litigation which dealt with sufficiency/plausibility and infringement of second medical use claims
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
 Warner-Lambert Company LLC v. Generics (UK) Ltd t/a Mylan  UKSC 56
 Icescape Ltd v. Ice-World International BV  EWCA Civ 2219
 Actavis UK Ltd v. Eli Lilly  UKSC 48
  EWCA Civ 2344
  EWHC 1304 (Pat)
  EWHC 1256 (Pat)
  EWCA Civ 658
  EWCA 1
  EWHC 3414 (Pat)
  EWHC 808 (Pat)
  EWHC 1188 (Pat)