At a recent European Commission hearing on Future Patent Policy In Europe, stakeholders’ views on the patent system in Europe were examined. Participants called for more centralization in terms of a single patent system or a common litigation system but there was plenty of dissent. This was the second step of the public consultation with […]

After the Medicines Company, based in Massachusetts, missed a non-extendable deadline for filing for a patent term extension by a single day, Rep William Jenkins [TN] introduced H.R. 5120 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. Known as the “Dog […]

After the Supreme Court refused to hear the Federal Trade Commission v. Schering-Plough case, Senators Herb Kohl (D-WI), Patrick Leahy (D-VT), Chuck Grassley (R-IA) and Charles Schumer (D-NY) have introduced legislation to explicitly prohibit brand-name drug manufacturers from using pay-off agreements to keep cheaper generic equivalents off the market. In 2005, two appellate court decisions […]

I have written extensively about the ethical issues that can arise during patent prosecution and litigation. This summer, I’m tackling two topics which, stated simply, are: what patent agents can and can’t do, and subject matter conflicts during patent prosecution. This post relates to one issue concerning the former. First, some definitions: nonlawyers are people […]

The San Francisco Business Times ran an article reiterating what patent practitioners already know. That is, the increasing backlog at the U.S. Patent & Trademark Office is bad, it’s getting worse and the new set of proposals meant to reduce the waiting time will not provide relief. The backlogs are an increasingly serious issue for […]

Rep. Jenkins introduced a bill, H.R. 5120, to amend title 35, United States Code, to change the provisions for patent term extensions for drup patents. Specifically, the bill would amend 35 USC 156, which extends the term for a patent where the product has been subject to a regulatory review period before its commercial marketing […]

The Federal Trade Commission (FTC) is considering conducting a study to analyze the use and likely short- and long-run competitive effects of authorized generic drugs in the prescription drug marketplace. An authorized generic is chemically identical to a particular brand-name drug, but the brand-name manufacturer authorizes it to be marketed in a generic version. In […]

The U.S. Court of Appeals for the DC Circuit, in Teva Pharmaceuticals v. FDA and Apotex (05-5401 & 05-5460), held that in a suit challenging agency action, the courts are not to choose between competing meanings of an ambiguous statute when the agency hasn’t weighed in first. The Food, Drug, and Cosmetic Act grants a […]