Patent Case Summaries October 7, 2020

Patent Case Summaries | Week Ending October 2, 2020

A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

GlaxoSmithKline LLC, et al. v. Teva Pharmaceuticals USA, Inc., Nos. 2018-1976, -2023 (Fed. Cir. (D. Del.) Oct. 2, 2020). Opinion by Newman, joined by Moore. Dissenting opinion by Prost.

GSK owns a patent covering administering a combination of a drug called “carvedilol” and an ACE inhibitor, a diuretic, and digoxin. Teva applied for FDA approval of its generic carvedilol, certifying that GSK’s patent was invalid, unenforceable, or not infringed. GSK then obtained a reissue patent adding a requirement that the drug combination is administered “to decrease a risk of mortality caused by congestive heart failure.” The FDA required Teva to amend its original carvedilol label (i.e., the “skinny” label) to include indication for treatment of heart failure (i.e., the “full” label).

GSK sued Teva for induced infringement of the reissue patent. At trial, a jury found the patent valid and willfully infringed and awarded damages. The district court, however, granted judgment as a matter of law of non-infringement. The court ruled that GSK failed to prove that “Teva’s alleged inducement, as opposed to other factors, actually caused the physicians to directly infringe.” The court believed that only “non-Teva factors” caused doctors to prescribe generic carvedilol for infringing use, and thus substantial evidence did not support the verdict of induced infringement “during both the skinny label and full label periods.” GSK appealed, and Teva conditionally cross-appealed the damages verdict.

The Federal Circuit ruled that “the district court applied an incorrect legal standard, for precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met.” And under the correct standard, there was substantial evidence to support the jury’s verdict of induced infringement, which included “evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides.”

Turning to the conditional cross-appeal on damages, the Federal Circuit addressed Teva’s challenge to the jury instruction on acceptable substitutes in a lost-profits analysis. But the court concluded that “the jury instructions are in conformity to law,” and thus reinstated the damages verdict of $234,110,000 based on lost profits plus a royalty of $1,400,000.

In a lengthy dissent, Chief Judge Prost explained that Teva had not induced infringement by marketing its generic carvedilol for unpatented uses through a skinny label. “Congress provided for skinny labels for exactly these circumstances, … [a]nd Teva acted exactly as Congress intended.” When GSK’s reissue patent issued—reciting a new indication, congestive heart failure—“Teva’s skinny label did not even suggest using its product according to the patented method.” And “there was still no inducement via the full label” that included the patented method because “[n]othing changed in the market, and doctors’ prescribing decisions were not affected.” Thus, in Chief Judge Prost’s view, “no evidence established that Teva actually caused the doctors’ infringement for either label.”

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Biogen MA, Inc. v. EMD Serono, Inc., et al., No. 2019-1133 (Fed. Cir. (D.N.J.) Sept. 28, 2020). Opinion by Linn, joined by Newman and Hughes.

Biogen sued Serono for contributory and induced infringement of a patent directed to methods of treatment involving administering a recombinant polypeptide related to human interferon-β (IFN-β). As pertinent here, a jury found the claims anticipated by two references teaching the use of native IFN-β to treat viral diseases.

The district court overturned the jury verdict on anticipation, granting judgment as a matter of law of no anticipation and conditionally granting a new trial on the issue. The court held that no reasonable jury could find anticipation under Serono’s reading of the claims “because treatment in the prior art entailed administration of native IFN-β, which was undisputedly not recombinantly produced.” The district court declined to apply a product-by-process analysis, but held in the alternative that no reasonable jury could have found anticipation even applying that analysis. Serono appealed.

The Federal Circuit reversed and remanded with instructions to reinstate the jury verdict of anticipation. The Federal Circuit ruled that two determinations led the district court to an erroneous conclusion on anticipation: the district court erred when it “(1) declined to apply a product-by-process analysis to the claimed recombinant IFN-β source limitation; and (2) in its alternative ground analysis, required identity of three-dimensional structures not specifically recited in the claims rather than the claimed and lexicographically defined ‘polypeptide.’”

Regarding the first point, Serono argued on appeal that the claimed recombinant IFN-β source limitation alone cannot confer novelty unless the product itself is novel. The Federal Circuit agreed, explaining that the “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.’”

Regarding the second point, the Federal Circuit held that the district court erred in determining that, “without a disclosure in the prior art of [the] three-dimensional protein, a showing of the native polypeptide alone would not necessarily produce ‘antiviral activity’ when administered in a ‘therapeutically effective amount’ as recited in the claims.” The Federal Circuit ruled that the jury had sufficient evidence to find that native IFN-β polypeptide is identical to recombinant IFN-β polypeptide, was administered in therapeutically effective amounts, and showed antiviral activity in the prior art.

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