Patent Baristas

It’s a well-known fact that drug industries pursue patents with a zeal that few possess – after all, a patent in the hand is worth millions in the bank and a relative monopoly over the pharmaceutical market. They lobby for political support to push these patents through, even if they know that the drugs have […]

AstraZeneca filed an application for a patent term extension (PTE) of the patent term of U.S. Patent No. 5,674,860 under 35 U.S.C. § 156 in the United States Patent and Trademark Office.  They tried to get the extension based the time for FDA review under section 505 of the Federal Food, Drug, and Cosmetic Act […]

The United States Court of Appeals for the Federal Circuit found in favor of Eisai in Aciphex patent infringement suit against Teva Pharmaceuticals and Dr. Reddy’s Laboratories .  Eisai v. Dr. Reddy’s and Teva (07-1397/98) After Eisai filed infringement actions contesting Teva Pharmaceuticals and Dr. Reddy’s Laboratories’ submission of abbreviated new drug applications (ANDAs) to […]

After vigorous debate, H.R. 6344 passed in the U.S. House of Representatives to amend 35 U.S.C. 156, the statute governing patent term extensions based on regulatory review delay. This has been bounced around for several years now, and is intended (very specifically) to help Massachusetts-based The Medicines Company, which submitted its PTE application for U.S. […]

Generic drug maker Mylan got some good news from the U.S. Court of Appeals for the Federal Circuit in a patent litigation related to its heartburn treatment Omeprazole, the generic version of British drug maker AstraZeneca’s Prilosec, when the court affirmed a District Court ruling that Mylan’s 10 mg and 20 mg Omeprazole delayed-release capsules […]

The U.S. Court of Appeals for the Federal Circuit looked at the issue of whether Aventis committed that most horrible of patent sins — inequitable conduct before the United States Patent and Trademark Office (PTO).   Aventis Pharma v. Amphastar and Teva (07-1280) . Earlier, the CAFC held that the dosage of the prior art composition […]

Biovail Corp., Canada’s largest publicly traded drugmaker, announced that it has settled with the United States Department of Justice (DOJ) regarding criminal allegations related to activities surrounding the 2003 commercial launch of Cardizem LA. The DOJ alleges that prior management’s actions in 2002 and 2003 in respect of the Cardizem LA clinical experience program, titled […]

What happens when a brand name drug company asserts that a patent covers its drug and then pulls it out from the Orange Book? You fight to get it back in, that’s what. In August, Teva Pharmaceuticals USA submitted a Citizen Petition pursuant to section 505 of the Food, Drug, and Cosmetic Act (FDCA) asking […]