Friday, June 26, 2020

Weekly Patent Litigation Round-Up


Kymab Wins Supreme Court Case Against Regeneron

Cambridge, UK; 24 June, 2020: Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibody therapeutics, is pleased to announce that the Supreme Court of the United Kingdom has held that all of the claims of two patents (European Patents EP(UK) 1 360 287 and EP(UK) 2 264 163, the ‘Murphy patents’) owned by Regeneron Pharmaceuticals Inc that were asserted against Kymab are invalid. The Court’s decision upholds the February 2016 decision of the High Court trial judge, Mr. Justice Henry Carr to revoke the claims and reverses the Appeal Court’s determination that they were valid. It was held that the relevant claims of the Murphy patents were invalid for insufficiency because they did not enable the ordinary skilled person to work the claimed invention across the breadth of the claims, in line with established jurisprudence of the UK courts and European Patent Office…


Mylan, seeking to market Victoza generic, convinces panel to start up patent review

Mylan, coming off a big patent win against Biogen, aims to launch a copycat version of Novo Nordisk's diabetes drug Victoza. Now, a U.S. patent office panel says there's a "reasonable likelihood" that Mylan could successfully nix a Victoza patent that covers the blockbuster med through early 2026. The U.S. Patent Trial and Appeal Board instituted an inter partes review on patent No. 8,114,833, which covers Victoza's formulation and methods for producing it effectively. Mylan claims the patent is invalid because it covers an obvious invention. After hearing initial arguments over the patent, the board found a “reasonable likelihood” Mylan would win the case. The review process is set to play out through late 2020 and early 2021, according to a scheduling order...


IPAB stays revocation of Pharmacyclics’ patent on anti-cancer drug Ibrutinib

The Intellectual Property Appellate Board (IPAB) has granted an interim stay on an order issued by the Indian Patent Office removing a patent of Pharmacyclics for anti-cancer drug Ibrutinib. Ibrutinib sold by Pharmacyclics Inc, a Silicon Valley-based biopharmaceutical company and part of AbbVie under the brand name ‘Imbruvica’ is used to treat adults with mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic graft versus host disease (cGVHD). NR Meena, Joint Controller of Patents and Designs, in an order issued on March 4, 2020 revoked the patent based on a post-grant opposition filed by Laurus Labs. The patent office observed the claims made by Pharmacyclics are obvious to an ordinary person skilled in the art and that the drug lacks any inventive step that would make it superior to other existing formulations…


Neurim v. Mylan: UK Court of Appeal denies interim injunction in face of a launch-at-risk, but are damages really adequate?

As this Kat was strolling home Wednesday afternoon, he received a call from his old pal Joost Duijm. On the ball as always, Joost told me that the appeal in Neurim Pharmaceuticals v. Mylan had been handed down [first instance decision here, appeal decision here]. The Court of Appeal has upheld the decision by Marcus Smith J. to deny an interim injunction against a generic company that launched at risk. Big news indeed. The UK patent courts are known across Europe, among many other things, for having developed a clear-the-way doctrine: if a generic entrant does not institute invalidity proceedings against the patent well in advance of a product launch, that is a strong argument in favour of granting an interim injunction awaiting trial and the status quo is maintained…


Bayer inks largest settlement in pharma history with $10B Roundup deal

Bayer volunteered for quite a headache with its 2018 pickup of Monsanto and weedkiller Roundup, what with lawsuits piling up and investors chomping at the bit. Now, it's looking to relieve the pain of that multibillion-dollar legal overhang with an enormous deal to escape the Roundup litigation. Bayer will dole out between $10.1 billion and $10.9 billion—the single largest settlement in pharma history—to put an end to thousands of lawsuits tied to its acquisition of Monsanto and glyphosate-based Roundup. As part of its agreement, Bayer will pay between $8.8 billion and $9.1 billion to settle roughly 125,000 Roundup lawsuits combined in a California multi-district litigation and multiple state bellwether trials, Bayer said. The deal will settle roughly 75% of all Roundup suits and includes an allowance to pay out claims that have not been resolved…


Full Fed. Circ. Skips Biogen Fight Over MS Drug Patent

Biogen lost another bid on Wednesday to ward off competition for its blockbuster multiple sclerosis drug Tecfidera, as the full Federal Circuit said it wouldn't reconsider a panel decision that Banner Life Sciences wasn't infringing a patent covering the drug…


Valeant Tells Full Fed. Circ. Relistor Patent Ruling Is 'Alarming'

Valeant Pharmaceuticals has asked the full Federal Circuit to rehear a panel decision that vacated its win against Mylan Pharmaceuticals in a fight over a patent covering the opioid-induced constipation drug Relistor, saying it can't stand because it "upsets settled law of obviousness…"

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