Pharmaceutical patent round-up
patent litigations.
The Federal Patent Court in Munich, Germany, has revoked Pfizer's patent covering Lipitor's active ingredient atorvastatin calcium. Generic manufacturers Ranbaxy Laboratories and Basics GmbH had challenged the patent. The court decision has no immediate commercial impact as neither generics company has received regulatory approval in Germany for their generic versions of the drug, and because Pfizer's basic patent covering atorvastatin remains in force, and expires after the enantiomer patent, which expires in November 2011. The ruling also has no effect on a pending challenge to the basic atorvastatin patent in Germany by the same two companies. Lipitor is sold in Germany under the brand name Sortis. Pfizer has said it will appeal the decision. Dexcel Pharma Technologies and AstraZeneca have settled their patent litigation involving three Orange Book patents relating to omeprazole, the over-the-counter (OTC) drug for the treatment of heartburn which is sold under AstraZeneca's brand name Prilosec OTC. While terms and conditions of the settlement have not been disclosed, the agreement means Dexcel can commercialise its 20mg omeprazole delayed release tablet once it receives final regulatory approval by the US Food and Drug Administration (FDA). Dexcel's partner and marketer for the product expected the product to be launched by the end of the first quarter next year. Dexcel had originally filed a New Drug Application (NDA) with paragraph IV Certification stating that AstraZeneca's patents were invalid, unenforceable or would not be infringed under the NDA. AstraZeneca filed a patent infringement suit in May 2006. Barr Laboratories has initiated a challenge of the patents listed by Novartis in relation to its Ritalin (methylphenidate hydrochloride) extended-release capsules, 10mg, 20mg, 30mg and 40mg, indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). In May this year, Barr filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV Certification for a generic Ritalin product, which was accepted. Last week, Celgene, Novartis Pharmaceuticals and Novartis Pharma filed suit in the US District Court of New Jersey to prevent Barr from proceeding with the commercialisation of the product, thereby formally initiating the patent challenge. Barr has also, in the last fortnight, initiated a patent challenge in relation to Alcon's Patanol (olopatadine hydrochloride ophthalmic solution) 0.1%, indicated for the treatment of the signs and symptoms of allergic conjunctivitis. After Barr filed its ANDA in June, Alcon announced on October 24 it had filed suit in the US District Court - Indiana Southern to prevent Barr from proceeding with commercialisation of the product. Meanwhile, the US District Court for the District of Delaware has rejected Dr Reddy's Laboratories challenges to the validity and enforceability of Bayer's patents over Avelox (moxifloxacin HCL), a fluroquinolone antibiotic for the treatment of respiratory tract and other infections. Another generic company, Teva Pharmaceuticals, has also challenged the validity of the same Bayer patents in a case which is currently pending in the US District Court for the District of Delaware and is scheduled to commence on February 25, 2008. Bayer intends to defend its patents vigorously.
