In Merck & Co. v. Hi-Tech Pharmacal (06-1401) , the Court of Appeals for the Federal Circuit looked at the question of whether a patent term extension under the Hatch-Waxman Act, 35 U.S.C. § 156, may be applied to a patent subject to a terminal disclaimer under 35 U.S.C. § 253, filed to overcome an […]

After Teva Pharmaceuticals appealed the dismissal of its declaratory judgment action in District Court, the United States Court of Appeals for the Federal Circuit has taken a fresh new look at things in light of the Supreme Court’s decision in MedImmune, Inc. v. Genentech, Inc., 127 S. Ct. 764 (2007). Because the district court relied […]

The guys at have announced a new search feature — cleaverly named — that gives you quick and easy access to patent caselaw and commentary. Here’s how it works:A Google-powered search box is provided on the left side of the page. Search results are presented under the box once a search is performed […]

In the reverse payment case Joblove v. Barr Labs (S.Ct. No. 06-830), the Supreme Court has now asked for the government’s views on the antitrust effects of settlement agreements between holders of drug patents and generic drug makers enjoying the 180-day market exclusivity after Food and Drug Administration approval. This case involves the same legal […]

As a follow-up on yesterday’s article on the road to biogenerics, Food and Drug Administration deputy commissioner Janet Woodcock testified before an Oversight Committee held to examine the prospects and need for a pathway that would allow the FDA to approve safe and affordable generic versions of biotech drugs. Witnesses included representatives of FDA, pharmaceutical […]

Dr. Andrew von Eschenbach, the head of the Food and Drug Administration, addressed the issue of biogenerics at the annual meeting of the annual meeting of the Pharmaceutical Research and Manufacturers of America (PhRMA).  Eschenbach basically outlined that biogenerics would be considered only “similar” to brand-name drugs, not interchangeable or able to be substituted. This […]

A reader on Philip Brooks’ Patent Infringement Updates asked about the downstream effects of the CAFC decision invalidating Pfizer’s Norvasc® patent (U.S. Patent No. 4,879,303). In this appeal, the CAFC held that the district court erred in holding that the subject matter of claims 1-3 of the ’303 patent would not have been obvious. Pfizer, […]

Some readers have asked why there is a pediatric exclusivity add-on for FDA approvals. These exclusivity extensions are provided under the Food and Drug Administration Modernization Act of 1997, section 505A of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(a)), which permits certain new drug applications to obtain an additional six months […]