Category: Pharma, Life Sciences & Med Tech Players
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EPO Board of Appeal revokes Novo Nordisk’s cardiovascular semaglutide patent; generics could enter EU as early as 2031
The Board found the claims lacked priority, so a clinical study publication destroyed novelty, leaving Ozempic and Wegovy potentially vulnerable to competition earlier than expected.
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Halozyme wins Dutch injunction against Merck’s Keytruda SC in eight European countries, court holds patent valid
The Hague District Court has upheld Halozyme’s patent and found infringement. Merck’s subcutaneous cancer drug is blocked in eight European countries, but Merck strongly disagrees, alleging the patent is invalid.
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Janssen wins landmark preliminary injunction in District of Delaware
The U.S. District Court has issued a preliminary injunction against Accord BioPharma and Bio- Thera Solutions over the alleged infringement of 17 of Janssen’s patents related to golimumab, a key ingredient in its drugs used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
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Novo Nordisk signs GLP-1 licensing agreement with China’s Hengrui Pharma
Novo Nordisk and Hengrui Pharma’s agreement, subject to antitrust approval, will allow Novo to obtain exclusive rights to develop, manufacture, and commercialize HRS-1596 globally, excluding mainland China, Hong Kong, Macao, and Taiwan.
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Mylan seeks declaratory judgment against Novo Nordisk over newly issued Wegovy patent, aiming to preempt a new Delaware lawsuit
Mylan has asked a Delaware court to declare a newly issued Novo Nordisk Wegovy patent invalid and not infringed, opening a new front in their long-running Hatch-Waxman fight over generic semaglutide.
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Federal court dismisses Entresto antitrust suit against Novartis: patent listing in Orange Book was proper
Judge Liman held that the U.S. Patent No. 8,101,659 claims the active ingredients on Entresto’s FDA label, so its Orange Book listing was proper, ending a payor’s antitrust case with prejudice.
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Daiichi Sankyo loses six CNIPA administrative patent-linkage cases over mirogabalin formulation patentsÂ
Daiichi Sankyo has now lost six Chinese patent-linkage cases over generic mirogabalin after the CNIPA found two dosage strengths outside three formulation patents. The rulings show the growing importance of CNIPA’s administrative route for resolving patent disputes before generic launch.
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Abbott wins another UPC PI against glucose sensor rival Sibio
The UPC’s Milan Local Division has granted Abbott a second UPC-wide preliminary injunction in its patent infringement case against Chinese rival Sibio, despite allowing the latter’s late-presented claim construction arguments to be admitted.
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Accord slapped with injunction in Munich after invalidity losses in EPO, German Federal Patent CourtÂ
The Munich I Regional Court has found that Accord infringed TOWA’s dabigatran etexilate patent, issuing an injunction against the company. Dabigatran etexilate is an oral anticoagulant medicine that stops blood clots from forming, preventing strokes, deep vein thrombosis, and pulmonary embolism, among other things.
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Lupin granted win against Vertex in Delaware over cystic fibrosis drug patents
Lupin’s generic version of Vertex’s cystic fibrosis treatment Kalydeco does not infringe the latter’s patents, Judge Stephanos Bibas of the Third Circuit has ruled.