Posts Tagged: "Hatch-Waxman Act"

Delisting Counterclaims in Hatch-Waxman Cases: An Ineffective Weapon to Address Improper Patent Listing

The Hatch-Waxman Act (“the Act”) was designed to strike a delicate balance between pharmaceutical innovation and faster access to affordable drugs. However, one aspect of the Act, the patent listing process, when used improperly, can knock this balance out of whack. Unfortunately, in the present environment, the potential for improper patent listing is high, and current remedies are insufficient.

U.S. Government Sides with Teva in Skinny Label SCOTUS Fight

The U.S. Solicitor General on Wednesday filed an amicus brief with the United States Supreme Court advising it to grant Teva Pharmaceuticals’ petition for writ of certiorari relating to generic manufacturers’ liability for infringement through the use of “skinny labels” on generic drugs. The SG’s brief said that the U.S. Court of Appeals for the Federal Circuit (CAFC) got it wrong, and that the decision could upend the careful balance contemplated by the Hatch-Waxman Amendments between incentivizing new brand name drugs and allowing cheaper generics into the market.

In Memoriam: Senator Orrin Hatch

Funeral services will be held in Salt Lake City, Utah,  on Friday, May 6, for Senator Orrin Hatch, who died on Saturday, April 23, 2022, at the age of 88. Hatch was Utah’s longest-serving senator, first sworn in by Vice President Nelson Rockefeller as a member of the 95th Congress in 1977, and co-author of one of the most significant IP bills ever passed, the 1984 Hatch-Waxman Act.

Two Pharma and Biotech Cases to Watch in 2022

As we enter the second month of 2022, the old saying, “If at first you don’t succeed, try, try again” and the famous line, “I’m not dead,” from Monty Python and the Holy Grail, come to mind to describe two issues we’ll be watching closely this year relating to litigation involving small and large molecule therapies. In the first instance, Amgen recently petitioned the Supreme Court to review the Federal Circuit’s affirmance invalidating several patent claims based on the lack of enablement for genus claims. This case comes on the heels of the Supreme Court’s denial of cert. in Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019) on similar issues. Amgen now hopes for a better result.

Use of Research Tools May Expose Companies to Patent Infringement Claims

The safe harbor provision set forth in 35 U.S.C. § 271(e)(1) immunizes many types of activities in pursuit of a Food and Drug Administration (FDA) submission from patent infringement claims. Research tools are frequently used in pursuit of an FDA submission, such as drug development, testing and screening. But research tools themselves generally are not subject to FDA or other regulatory approval. Depending on the circumstances, using research tools to submit data to the FDA may not be protected by the safe harbor provision and thus may expose companies to patent infringement claims.