Fordham 32 (Report 1): Patents in Pharma

http://ipkitten.blogspot.com/2025/04/fordham-32-report-1-patents-in-pharma.html

The tulips are saluting in Broadway, the trees are blossoming in Central Park and the chattering of IP lawyers, judges, policy makers and commentators can be heard around Fordham Law School where Fordham University’s 32^nd Annual
Intellectual Property Law and Policy Conference got off to an early, engaging
and exciting start with a breakfast-time panel on Patents in Pharma. 

Over to long-time Kat friend, Dr Justin Watts (WilmerHale) who reports on the first session:

“Nina Bayerl of Freshfields, Munich took the chair, introducing speakers Professor Coenraad Visser of the University of South Africa in Pretoria, Brian Cordery of Bristows in London, Judge Jiyoung Yi, judge of the Korean IP High Court in Daejeon, and Anne-Charlotte Le Bihan of Bird & Bird’s Paris office, and panellists Bindu Donovan of Morrison Foerster in New York and Mr Justice Peter Charleton of the Supreme Court of Ireland. As ever, Fordham packed a huge scope and depth of thought-provoking content into a surprisingly short session.

Professor Visser spoke on the WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge, which, he said, has proven to be Much Ado About Almost Nothing. Despite the many years in gestation, the end result was a treaty that was in his view largely toothless. He drew attention to shortcomings in the terms of the treaty and in its likely uptake, the former, in particular, including no substantial IP remedy for a breach of the requirements of the treaty, and the latter including the fact that the 30 signatories of the treaty to date are all from the global south and in particular did not include the US, Europe, China or Japan.

Brian Cordery turned to developments in SPCs, covering a great deal of ground in just seven minutes. He generally welcomed the CJEU’s decision in Merck v Clonmel C-149/22 / Merck v Teva C-119/22, explaining that it has clarified the approach to SPCs for combination pharmaceuticals. Mr Cordery noted, however, that the judgment opened the door to further uncertainty by introducing a new synergy requirement in paragraph 70, and predicted substantial further litigation to clarify what this would mean in practice. He then turned to the reform of the SPC in Europe, welcoming the simplification that a single-regulator SPC would bring. He noted, however, that the process currently proposed in the draft legislation would be complex, time-consuming, and open to considerable game-playing by interested parties.

Panellist Mr Justice Peter Charlton responded to the comments on Merck, noting that he had himself written the referral to the CJEU and echoing Mr Cordery’s concerns at the need for predictability and practicality in the legal tests for the availability of SPCs.

Judge Jiyoung Yi spoke on Second Medical Use Inventions and Specification Requirements, comparing the Korean Standards with those in Europe and the United States. She explained that there were disclosure and enablement requirements in South Korea, and that the development of Korean case law had set a high threshold in the case of second medical use. By way of example, the Korean cases on aripiprazole (Abilify) and sildenafil (Viagra) had both resulted in patent revocation on the basis of insufficient disclosure in the specification specific to the second medical use for which protection was claimed. The judge noted that the requirement in Korea for data or other quantitative support specific to the claimed condition went further than the plausibility threshold in Europe, and that this led to difficult questions for innovators over when to file.

Panellist Bindu Donovan contrasted the Korean position with that in the US, particularly following the 2023 Supreme Court decision in Amgen v Sanofi, summarized in the quote from that case: “The more one claims, the more one must enable.”

Finally, Anne-Charlotte Le Bihan spoke on the Bolar exemption. She observed that the EU Bolar exemption in Directive 2001/83 did not harmonise the position and there were many serious differences in the application of the exemption across EU jurisdictions. She observed that this gave rise to a complex interaction between national and UPC systems, including the possibility that the UPC may apply differing national regimes, and UPC case law, in cases dealing with infringements spanning the UPC commencement date. Turning to the EU reform package, Anne-Charlotte highlighted how the proposed reforms would very substantially broaden the application of Bolar exemptions, and questioned whether this was overly broad and whether it would be compatible with TRIPS.

From the audience, a question from Judge Edger Brinkman, judge of The Hague local division of the UPC, who observed that the complexities Anne-Charlotte referred to for the UPC would also potentially apply in national litigation as the applicable law should not be dependent on forum.

Bindu contrasted the position with that for Bolar exemptions in the US, referring in particular to the 2024 CAFC Edwards Lifesciences v Meril Life Sciences decision. The majority of the court held the US Bolar exemption, 35 U.S.C. §271(e)(1), applied to protect Meril from allegations of infringement arising from the importation of two demonstration samples of its transcatheter heart valves to a medical conference, related to recruiting investigators for a clinical trial to support FDA approval. Judge Lourie dissented, holding that a correct interpretation of the law, particularly of the word “solely,” led to the opposite conclusion because the importations occurred, at least partially, for commercial reasons.”

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