Thursday, September 27, 2007
Friday, September 21, 2007
Wednesday, September 19, 2007
OSI Pharmaceuticals Inc. has received a patent term extension for the US Pat. 5,747,498 (the ‘498 patent) covering anticancer drug Tarceva, generically known as erlotinib indicated for second-line advanced Non-Small Cell Lung Cancer (NSCLC) and for combination therapy for first-line advanced pancreatic cancer. The term of the ‘498 patent is extended by 1,251 days under 35 USC § 156, extending expiration date from June 06, 2015 to November 08, 2018. OSI has already received Supplementary Protection Certificates (SPCs) for Tarceva extending exclusivity to March 2020 in 14 Contracting States including France, Germany, Italy, Switzerland and the United Kingdom.
Friday, September 14, 2007
Wednesday, September 12, 2007
Indian-based pharmaceutical manufacturer Lupin Ltd. has finally tasted the success of the knocking down King’s US Pat. 5,061,722 (the ‘722 patent) covering blockbuster drug Altace, generically known as Ramipril. The US Court of Appeals for the Federal Circuit ruled in the favor of Lupin holding that the ‘722 patent is invalid. Earlier, the US District Court for the District of Columbia concluded at summary judgment that claims of the ‘722 patent are valid and infringed by Lupin’s Abbreviated New Drug Application No. under the doctrine of equivalence. Accordingly Lupin appealed to Court of Appeals. The Court of Appeals invalidated the ‘722 patent over obviousness holding that claims 1 and 2 of the ‘722 patent are invalid over the SCH 31925 mixture (referring to work conducted by Dr. Smith), the US Pat. 5,348,944, and the enalapril references in the prior art.
Monday, September 10, 2007
On September 06, 2007 judge Jose L. Linares of the US District Court rejected Wyeth’s request for an injunction order against the generic challenger Teva Pharmaceutical Industries Ltd. that would have barred Teva from selling its generic version until a patent dispute between the companies get resolved. Generically known as pantoprazole, Protonix is Wyeth’s leading pharmaceutical products worth US $ 1.8 billion in sales in 2006 for which Teva had already bagged first-to-file status, giving 180-days market exclusivity for the US market. Pantoprazole is broadly covered within the scope of the US 4,758,579 (the ‘579 patent) for which Teva has filed a Para IV certification challenging its validity and enforceability.