GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Appeal No. 2018-1976, -2023 (Fed. Cir. Aug. 5, 2021)

Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific therapeutic use, and the generic manufacturer purported to exclude that indication from its label—what is known in the field as a “skinny label” that indicates only certain uses though the brand name drug has been indicated for other uses. The FDA then required Teva to relabel its product to be identical with GlaxoSmithKline’s product. GlaxoSmithKline (GSK) sued, alleging induced infringement. A jury agreed, but the district court granted JMOL to Teva for noninfringement, finding insufficient evidence to support an inducement ruling. In October 2020, the Federal Circuit reversed and reinstated the jury verdict, finding that the jury had substantial evidence of inducement relating to the patented use during both time periods. We wrote up that decision as our Case of the Week, here.

Following the Federal Circuit opinion, Teva petitioned for reconsideration. That petition was joined by several amici who were concerned that the Federal Circuit opinion would upset a careful balance struck by Congress in the Hatch-Waxman Act concerning the use of labels on generic pharmaceuticals. One amici stated that the balance resulted in the following bright line: a generic can be held liable for inducement if it labels a product indicating a patented use, but cannot be held liable for selling a product with a “skinny” label that omits all patented indications, or for merely noting that the drug is equivalent to a drug that has other uses.

The Federal Circuit panel then granted the petition for rehearing, vacated its October 2020 decision, and withdrew its opinions. This week it issued a new, per curiam opinion by Judges Moore and Newman, agreeing with the summary of the law provided by the amici. However, it further held that GSK had sufficiently proven that Teva induced infringement nonetheless. The panel held that both the “skinny label” and the revised label on Teva’s generic drug “encourage[d] a patented therapeutic use” and “did not omit all patented indications or merely note (without mentioning any infringing uses) that FDA had rated a product as therapeutically equivalent to a brand name drug.”

The patent at issue concerns the drug carvedilol, sold by GSK under the brand name Coreg®. Carvedilol was originally approved by the FDA for treating hypertension. GSK patented it in 1985. That patent expired in 2007.

Scientists continued to study carvedilol, and discovered its efficacy in treating congestive heart failure. In May 1997, the FDA approved Coreg® for this additional use. GSK then obtained a method patent (the “’000 Patent”) for the use of carvedilol in the treatment of congestive heart failure. The FDA later approved the drug for use by patients suffering from left ventricular dysfunction following a myocardial infarction.

In March 2002, Teva applied for FDA approval for a generic version of carvedilol, to be launched in 2007, when the original GSK patent expired. Teva received approval to sell carvedilol for treatment of heart failure and hypertension as of the expiration of the original GSK patent. When the original patent expired, Teva launched its generic product, touting it as the “AB generic equivalent of Coreg®.” On its packaging, Teva included indications and usage stating: “Left Ventricular Dysfunction following Myocardial Infarction” and “Hypertension.” There was no mention of congestive heart failure.

Four years later, in 2011, the FDA required Teva to amend its label to be “identical in content to the approved [GSK Coreg®] labeling.” Teva amended its label to include the indication for treatment of heart failure, as required by the FDA.

GSK thereafter sued Teva for infringement of the ’000 Patent. In particular, GSK alleged that Teva induced infringement by inducing users to use carvedilol to treat congestive heart failure, pursuant to its new labeling of its generic product. The Court reinforced that “when a product is sold with an infringing label or an infringing instruction manual, such a label is evidence of intent to induce infringement.” The Court traced through a litany of testimony and documentary evidence and concluded that Teva’s product labels were enough to support the jury verdict of infringement.

The Court also sustained the jury’s damages verdict of $235.5 million.

Judge Prost dissented, in a 37-page written opinion, dissenting from the finding of infringement, and expressing concerns about the impact on the generic drug industry and the protections afforded in the Hatch-Waxman Act.

A copy of the opinion can be found here.

By Nika Aldrich

ALSO THIS WEEK

Mondis Technology Ltd. v. LG Electronics Inc., Appeal No. 2020-1812 (Fed. Cir. Aug. 3, 2021)

In this interlocutory appeal from a district court’s decision denying LG’s post-trial motions, the Federal Circuit dismissed for lack of jurisdiction due to LG’s untimely notice of appeal. In September 2019, the district court denied LG’s post-trial motions regarding infringement, invalidity and willfulness, but ordered further briefing on damages. In April 2020, the district court granted a new trial on damages. Seven months after the district court’s September order, in May 2020, LG filed notice of interlocutory appeal challenging the district court’s decision denying LG’s post-trial motions on liability issues.

Taken together, 28 U.S.C. §§ 2107(a) and 1292(c)(2) require that notice of interlocutory appeal be filed within 30 days from the date at which the district court’s judgment became “final except for an accounting.” The Federal Circuit held that the district court’s decision was final as to liability at the time of the September order and because LG did not file its notice of appeal within 30 days, its notice of appeal was untimely. Accordingly, the Federal Circuit dismissed for lack of subject matter jurisdiction pursuant to ‎the combined requirements of 28 U.S.C. §§ 2107(a) and 1292(c)(2) .

A copy of the opinion can be found here.

By Annie White

Andra Group, LP v. Victoria’s Secret Stores, LLC, Appeal No. 2020-2009 (Fed. Cir. Aug. 3, 2021)

In an appeal from the United States District Court for the Eastern District of Texas, the Federal Circuit addressed whether the district court properly granted in part Defendants’ motion to dismiss for improper venue. The Defendants included various Victoria’s Secret entities and parent company (the “Non-Store Defendants”), and Victoria’s Secret Stores, LLC (the “Store”). Whether venue was proper as to the Store was not at issue. The Federal Circuit affirmed the district court’s ruling, holding that venue was improper as to the Non-Store Defendants, finding that the Non-Store Defendants did not exercise the degree of control over the Store’s employees required to find an agency relationship, and they further did not ratify the Store’s locations as their own place of business.

A copy of the opinion can be found here.

By Mario Delegato

Omni MedSci, Inc. v. Apple, Inc., Appeal Nos. 2020-1715, -1716 (Fed. Cir. Aug. 2, 2021)

In an interlocutory appeal from a denial of a motion to dismiss for lack of standing, the Federal Circuit affirmed. The case centered on patents that derived from work done by a professor at the University of Michigan, Dr. Islam, while he was on sabbatical. Apple argued that the patents were assigned pursuant to the Bylaws at the University of Michigan, as incorporated into Dr. Islam’s employment agreement. The district court concluded that the Bylaws did not effectuate an assignment, but rather were a “statement of future intention to assign.” Construing the language of the Bylaws, the Court agreed with the district court that the Bylaws constituted neither an assignment nor a promise to assign in the future. Specifically, rather than use language like “are assigned” or “will be assigned,” the Bylaws used the phrase “shall be the property of.” The Court concluded that this language did not assign any inventions.

Judge Newman issued a 15-page dissent. She would have found that the inventions were assigned to the University of Michigan.

A copy of the reissued opinion can be found here.

By Nika Aldrich

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