Novartis Pharmaceuticals announced today that it will appeal the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) June decision invalidating its patent for a dosing regimen for its multiple sclerosis drug Gilenya to the U.S. Supreme Court, after the CAFC denied its request to rehear the case. The CAFC in June vacated a different three-judge panel’s January opinion upholding Novartis’ U.S. Patent No. 9,187,405. In the original ruling, Chief Judge Moore had dissented from the majority; in the rehearing, Moore authored the opinion vacating the January decision, with Judge Linn dissenting.
A panel of administrative patent judges (APJs) at the Patent Trial and Appeal Board (PTAB) issued a final written decision ending a series of inter partes review (IPR) proceedings targeting patents covering a popular multiple sclerosis (MS) treatment developed and sold by Ardsley, NY-based Acorda Therapeutics (NASDAQ:ACOR). The decision strengthens the patent portfolio covering Acorda’s Ampyra pharmaceutical even as competition from generic manufacturers has ramped up in recent months. The IPRs, instituted after petitions from the Kyle Bass-backed Coalition for Affordable Drugs (ADORCA), targeted four patents listed in the U.S. Food and Drug Administration’s (FDA) Orange Book.
On Wednesday, August 24th, the Patent Appeal and Trial Board (PTAB) issued decisions in two inter partes review (IPR) filings made against patents owned by private Israeli firm Yeda Research & Development Co. The company is the tech transfer arm of the Weizmann Institute of Science, a public research university located in Rehovot, Israel. The IPRs, which were filed by American pharmaceutical developer Mylan Inc. (NYSE:MYL), resulted in the invalidation of all claims in both Yeda patents. About a week later, on September 1st, PTAB invalidated a third patent owned by Yeda after another IPR challenge was filed by Mylan.
The conjugates covered by this patent could enable less frequent and better tolerated dosing of one of the most widely used treatments worldwide for relapsing-remitting multiple sclerosis, interferon-beta-1b. The invention described in the European Patent relates to methods for the preparation of conjugates of poly(ethylene glycol), and derivatives thereof, with interferon-beta-1b. Compared to the corresponding unconjugated bioactive components, the conjugates of the invention have increased stability (i.e., longer shelf life and longer half-lives in vivo). In addition, compared to conjugates of the same bioactive component prepared with polymer chains that are attached randomly to solvent-accessible sites along the polypeptide chains, the conjugates of the invention have increased receptor-binding activity and increased potency.
Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the…