Posts Tagged: "Generics"

Seventh Circuit Throws Out Antitrust Suit Against AbbVie in Welcome Victory for Patent Rights

The U.S. Court of Appeals for the Seventh Circuit agreed with a district court earlier this week that neither a settlement agreement between AbbVie and a number of generic biologics companies, nor the 132 patents owned by Abbvie covering its blockbuster drug, Humira, violate the Sherman Antitrust Act. This holding, which is significant in its own right, also has broader implications for patent-antitrust analysis.

Teva Tells SCOTUS CAFC Decision Could Upend Hatch-Waxman

On July 11, Teva Pharmaceuticals USA filed a Petition for Writ of Certiorari to the U.S. Supreme Court asking it to review a decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) in which the CAFC found that Teva could be held liable for inducement based on sections of a “skinny label” that provided information about unpatented uses. Teva claims that the decision by the CAFC would upend the legal rules governing the modern prescription-drug marketplace. The petition notes that the decision would wreak doctrinal havoc in two equally disturbing ways. First, the court’s decision eliminates the key element of inducement liability requiring plaintiffs to prove that a defendant took active steps to encourage the direct infringement. Secondly, it effectively nullifies a Congressional act that was enacted to bring low-cost generic drugs to market, which is precisely what Teva was doing.

USPTO to Crack Down on ‘Incremental’ Patents in Response to Biden Executive Order’s Drug Pricing Mandate

The U.S. Patent and Trademark Office (USPTO) yesterday announced in a joint blog post with the Food and Drug Administration (FDA) that the Office plans to execute a number of initiatives aimed at lowering drug prices, as directed in July 2021 by President Joe Biden’s “Executive Order on Promoting Competition in the American Economy.” The announcement came via a blog post jointly authored by USPTO Director Kathi Vidal and Food and Drug Administration (FDA) Commissioner Robert M. Califf. Biden’s Executive Order in part encouraged curbing some pharmaceutical companies’ practices, such as so-called pay-for-delay settlement agreements between brand pharmaceutical companies and generics manufacturers. The Order called for the USPTO and the FDA “to leverage [their] collective expertise in promoting innovation, competition, and the approval and regulation of safe and effective drugs to help provide relief to American families at the pharmacy.”

The Hudson Institute Memo Draws the Wrong Conclusions from Discrepancies in I-MAK’s Data

The debate around whether patents are unnecessarily propping up drug prices has been simmering for years. A recent policy memo from the Hudson Institute has thoughtfully raised concerns about the data underlying this debate, and the memo made its way up to the U.S. Senate Judiciary Subcommittee on Intellectual Property. While the memo may have successfully poked holes in some of the data, it draws questionable conclusions regarding what those holes might mean. Unpacking this debate is therefore necessary to guide the correct policy on the intersection of patents and drug prices.

Mossoff Policy Memo for Hudson Institute Calls for Transparency from I-MAK on Data Used in Drug Pricing Debate

A Policy Memo published by the Hudson Institute and authored by Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University has charged that some of the key data relied upon in the heated debate over the effects of pharmaceutical patents on drug pricing and access may be faulty. The memo, titled “Unreliable Data Have Infected the Policy Debates Over Drug Patents,” specifically targets the Initiative for Medicines, Access & Knowledge (I-MAK), an advocacy organization that has become a “principal, go-to source” for data on the number of patents and patent applications covering pharmaceutical innovations.