GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Appeal No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020)

Our Case of the Week focuses on the question of induced infringement, and particularly induced infringement in the context of prescription pharmaceuticals. The district court concluded that product labeling in and of itself was insufficient to satisfy the causation requirement for inducement, at least where there were other likely reasons why consumers would have used the product besides the product labeling. Ultimately, a panel of the Federal Circuit, in an opinion by Judge Newman, concluded that product labeling and promotional materials are enough to support a jury finding of induced infringement to use a product in an infringing way, even if the market may be aware of infringing uses from other sources.

The patent at issue concerns the drug carvedilol, sold by GlaxoSmithKline (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. A jury found Teva liable, but on JMOL, the district court reversed the jury verdict and entered judgment for Teva. The district court concluded that there was insufficient evidence of a causation between Teva’s product labeling and end user infringement. The district court found that other factors, such as information widely available to doctors through medical journals and publications, likely caused doctors to prescribe carvedilol to users, and there was insufficient evidence that Teva’s labeling actually caused that infringement. In other words, as Teva argued, “cardiologists already knew of carvedilol and its uses, and Teva did not directly ‘cause’ them to infringe.”

The Federal Circuit, in a 20 page opinion by Judge Newman, reversed. Citing Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011) and MGM Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005), among a string of Federal Circuit opinions concerning FDA-regulated products, the Court held that “inducement to infringe is not negated when the direct infringers already knew of the infringing subject matter.” The Court traced through a litany of testimony and documentary evidence and concluded that Teva’s promotional materials and product labels were enough to support the jury verdict of infringement. The Court reinforced “that the content of the product label is evidence of inducement to infringe,” finding parallels to general tort liability.

The Court also considered a contingent appeal by Teva on the issue of damages.

Judge Prost issued a 33 page dissent, including a lengthy policy discussion of why the majority opinion “undermines Congress’s design for efficient generic drug approval.”

The opinion can be found here.

By Nika F. Aldrich


Biogen MA Inc. v. EMD Serono, Inc., Appeal No. 2019-1133 (Fed. Cir. Sept. 28, 2020)

In this appeal, the Court reversed a district court grant of judgement as a matter of law (“JMOL”) of no anticipation in favor of Biogen after a jury verdict finding the patent at issue was anticipated. The patent at issue was “directed to a method of treating a viral condition, a viral disease, cancers or tumors, by administration of a pharmaceutically effective amount of recombinant polypeptide.” “Serono argue[d] that the district court erred by holding that the lack of a recombinantly produced polypeptide in the prior art references compelled a finding of no anticipation.” The Court agreed, finding that “[t]he district court’s refusal to consider the identity of recombinant and native IFN-β runs afoul of the longstanding rule that ‘an old product is not patentable even if it is made by a new process.’” Instead of comparing the source of the IFN-β, the proper analysis requires the comparison of the “claimed recombinant polypeptide and the prior art native polypeptide.” Thus, “the district court erred in concluding that the mere absence of recombinantly produced polypeptide in the prior art was sufficient to grant JMOL of no anticipation.

The Court also addressed the district court’s alternative theory of no anticipation that “no reasonable jury could have found anticipation because the jury lacked sufficient evidence of identity between the claimed recombinant ‘polypeptide’ and the native IFN-β.” The district court reasoned that the “native polypeptide anticipates the ‘recombinant polypeptide’ only if their respective folded three-dimensional proteins share identical structure and function.” Since the prior art did not disclose the folded three-dimensional structure in the claims at issue, the district court found that the prior art did not anticipate the claims. But, the Court again rejected the district court’s reasoning. The Court found that the district court’s reading of the specification was flawed because it required the prior art references to contain structures “not specifically recited in the claims rather than the claimed and lexicographically defined ‘polypeptide.’” So the district court improperly distinguished between structural forms of the polypeptide rather than focusing on the “‘product’ in the claimed method[, which] is the ‘polypeptide.’” Accordingly, the Court reversed and remanded the matter to the district court with instructions to reinstate the jury verdict of anticipation.

The opinion can be found here.

By Bazsi Takacs

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