Patent Baristas

Did you know that the number of FDA warning letters issued increased substantially by 78% from 2007 to 2013? One of the industries that accounted for the highest number of warning letters was Pharmaceutical/Biotechnology. Sparta Systems recently released an infographic that provided an analysis of FDA warning letter trends since 2007, and also gave their predictions […]

After the US Patent and Trademark Office denied a patent term extension under 35 U.S.C. §156, to Metvixia® — with an active ingredient methyl aminolevulinate hydrochloride — Photocure ASA sought a do-over in district court under the Administrative Procedure Act, 5 U.S.C. §702. The district court held that the PTO’s ruling was “not in accordance […]

A featured document in the Docket Report recently highlighted an Amended Opinion by Judge Cavanaugh of New Jersey: “The court granted plaintiff’s motion for summary judgment of indirect infringement based on defendants’ use of a label containing “instructions on how to use the product in a manner that encourages acts of infringement” even though “doctors […]

The Biotechnology Industry Organization (BIO) held a press conference today to provide an overview of the federal policy landscape and impact of the current financial market environment on the biotech industry. BIO President and CEO Jim Greenwood addressed the policies expected to be considered by the Obama Administration and the 111th Congress which will impact […]

The 1984 Hatch-Waxman Act created a 180-day period of exclusivity to generic companies as an incentive to challenge patents on brand name drugs. However, there is a concern that some brand pharmaceutical companies have been circumventing the intent of the Act by using delay tactics such as authorized generics (where the brand product is repackaged […]

The Food and Drug Administration (FDA) issued two Warning Letters to Ranbaxy Laboratories and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India. The Warning Letters identify the agency’s concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta […]

Today’s Washington Post features a story on Ismed’s efforts to promote a follow-on biologics approval pathway here in Washington.  The article outlines the campaign by Insmed’s chief exec, Geoffrey Allan, to give Congress a lesson in biotechnology. The sudden outpouring of educational efforts on protein structures and drug pharmacology has to do with the fact […]

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. […]