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Brad Graveline is a partner in the Intellectual Property and Litigation Practice Groups in the firm's Chicago office.

In H. Lundbeck A/S, et al. v. Lupin Ltd., et al., Nos. 2022-1194, 2022-1208, and 2022-1246 (December 7, 2023), the Federal Circuit held that generic pharmaceutical companies may continue to use skinny labels to avoid infringement of method of treatment claims as long as they do not engage in advertising or promotional activities that encourage infringement of the patents.Continue Reading Federal Circuit Affirms Skinny Label Carve Outs

The Biden administration recently determined that it has the right to seize patents covering certain high-priced medicines, in an apparent effort to take a more aggressive approach to lowering drug prices. See Targeting costly meds, Biden admin asserts authority to seize certain drug patents – POLITICO. Pursuant to this plan, the Commerce Department announced it plans to issue a framework that lists the factors the government should consider in determining whether to seize drug patents. Id. The department will seek public feedback and comment on the framework. Id.Continue Reading Pharmaceutical Companies Have Rights if the Federal Government Seized their Patents

A Sheppard Mullin trial team led by partners Brad Graveline and Laura Burson obtained one of the largest patent infringement damages awards against the United States of America for client SecurityPoint Holdings, Inc (SecurityPoint).  Sheppard Mullin partner Don Pelto and associates Kazim Naqvi, Rebecca Mackin, and Tom Carr were also key members of the trial team.  In addition, the Sheppard Mullin team included trial specialist Stephanie Limbaugh and legal assistants Dori Dellisanti and Ann Castro.
Continue Reading Historic $130m+ Patent Infringement Award Against the United States of America

A Federal Circuit panel on Tuesday vacated its earlier finding that Teva induced infringement of U.S. Patent No. RE40,000, GSK’s patent covering its drug, Coreg®, and set a new round of oral argument for February 23.  Back in October, the Court in a 2-1 decision found Teva liable for induced infringement, even though Teva’s original label did not include the indication covered by the ’000 Patent.  In its ruling, the Court took issue with Teva’s marketing materials stating that its generic product is an AB rated generic of Coreg tablets without specific reference to any indication.  Following the decision, generic drug manufacturers and other interest groups asked the Court to reconsider, arguing that the ruling would impede the availability of low-cost generic drugs to reach the market and would effectively nullify the purpose of the Section viii statement, which allows a generic company to “carve out” any reference to a patented indication from its product’s labeling.
Continue Reading Federal Circuit Agrees to Reconsider Ruling in GSK v. Teva Drug Patent Case

Many life sciences contracts, including intellectual property licensing agreements, development agreements and supply agreements, contain force majeure clauses.  Depending upon the language of these clauses, the COVID-19 pandemic may be an event that triggers these clauses and provides a defense to nonperformance of the contract.  Companies that are experiencing difficulties complying with or enforcing compliance with their contracts should carefully examine their contracts to determine if a force majeure clause may excuse performance.
Continue Reading Defending Against Nonperformance Of Life Science Contracts

On March 4, 2019, the United States Supreme Court held unanimously that “a copyright claimant may commence an infringement suit … when the Copyright Office registers a copyright.” Fourth Estate Public Benefit Corp. v. Wallstreet.com, LLC. (Slip. Op. at p. 1 (syllabus)). The Court also held unanimously that, upon registration of the copyright, “a copyright owner can recover for infringement that occurred both before and after registration.” Id. This decision resolves a long-standing circuit split between the application approach, which allowed a copyright owner to sue for infringement upon submission of a copyright application, and the registration approach, which allows an infringement suit to proceed only after the Copyright Office granted the registration.  
Continue Reading Supreme Court Holds that a Copyright Claimant May Commence an Infringement Suit Only After the Copyright Office Registers the Copyright

A patentee may bring patent infringement claims against the United States government pursuant to 28 U.S.C. § 1498, in which Congress waived the sovereign immunity of the United States against such claims.  Patent infringement actions against the government are similar to those brought against non-governmental entities, but they do have some idiosyncrasies. For example, patent owners can only sue the government for infringement in the United States Court of Federal Claims, as opposed to a district court, and jury trials are not available in the Court of Federal Claims.
Continue Reading Suing The United States Government For Patent Infringement And Defending Against A Claim Of Obviousness

The United States Patent and Trademark Office (“PTO”) recently proposed a patent-agent privilege that would bring needed consistency to the discovery phase of Patent Trial and Appeal Board (“PTAB”) proceedings.

The proposed rule would recognize a privilege for certain communications between clients and non-attorney U.S. patent agents and foreign patent practitioners (“Patent Practitioners”). The proposed privilege would only apply in PTAB proceedings, and then only “where the practitioner performs legal work authorized by the jurisdiction in which the practitioner practices.”[1]  Notably, the proposed privilege would not extend to communications relating to district court litigation.Continue Reading Proposed “Patent Agent Privilege” Promises Protection For Patent Practitioners And Clients

On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation. In FTC v. Actavis, 570 U.S. 756 (2013), the Federal Trade Commission (“FTC”) prevailed when the Supreme Court held in a 5-to-3 decision [1] that reverse payment settlements in Hatch-Waxman cases are subject to antitrust scrutiny, resolving a circuit split and impassioned debate among antitrust lawyers. This is only the second antitrust case in 20 years where the enforcers have prevailed. The Court, however, rejected the FTC’s position that reverse-payment settlements were presumptively illegal, ruling that they are subject to scrutiny under the rule of reason.Continue Reading FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements?