Late yesterday and today the Federal Circuit released one precedential and two nonprecedential opinions. All come in patent cases. The precedential opinion affirms a district court’s decision to delist patents from the Orange Book because the patents “contain no claim for the active ingredient at issue” but instead “are directed to components of a metered inhaler device.” The nonprecedential opinions affirm a judgment of patent infringement and damages by a district court and affirm a judgment of invalidity by the Patent Trial and Appeal Board. The Federal Circuit also released three nonprecedential orders dismissing appeals. Here are the introductions to the opinions and links to the dismissals.
Teva Branded Pharmaceutical Products R&D, Inc. (Precedential)
When a generic drugmaker applies to market a drug using the same active ingredient as a branded drug, the Food and Drug Administration (“FDA”) cannot approve the generic company’s application if the generic company’s drug would infringe the brand-name manufacturer’s patent. The FDA checks for whether the generic company’s drug would infringe by looking at which patents the brandname manufacturer listed in a publication called the Orange Book. If the brand-name manufacturer lists a nonexpired patent that the brand-name manufacturer purports claims its drug, the FDA will not approve the generic company’s application. Instead, simply by listing a patent as claiming a drug, the brand-name manufacturer can make the FDA withhold approval of the generic company’s application for thirty months. The brand-name manufacturer’s decision on which patents to list, then, can make the difference between the FDA granting the generic company’s application and the FDA withholding approval.
In this case, Amneal alleges that Teva improperly listed patents in the Orange Book and delayed the entry of generic products onto the market. The district court agreed with Amneal and ordered Teva to delist its patents from the Orange Book on the ground “that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate,” but instead “are directed to components of a metered inhaler device.” Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 23-20964, — F. Supp. 3d –, 2024 WL 2923018, at *6, *7 (D.N.J. June 10, 2024) (“Delisting Order”). Teva appealed, and we stayed the district court’s order pending our resolution of this case. We now lift the stay and affirm the district court’s delisting order.
Lone Star Technological Innovations, LLC v. ASUS Computer International (Nonprecedential)
Lone Star Technological Innovations, LLC, (Lone Star) sued Asus Computer International and AsusTek Computer, Inc., (collectively, Asus) in the Eastern District of Texas, alleging Asus induced its customers to infringe certain claims of U.S. Patent No. 6,724,435 (’435 patent). A jury found the asserted claims were infringed and not proven to be invalid and awarded damages of $825,000. The district court ordered a new trial on damages, and the jury found that Asus owed $659,106.40. The district court denied Asus’s motions for judgment as a matter of law. Asus appeals, and we have jurisdiction under 28 U.S.C. § 1295(a)(1). We address each of Asus’s arguments in turn, and none is persuasive. We therefore affirm.
Integrated DNA Technologies, Inc. v. Pillar Biosciences, Inc. (Nonprecedential)
Integrated DNA Technologies, Inc. (“IDT”) appeals from a final written decision of the Patent Trial and Appeal Board in an inter partes review, finding claims 1–6 of U.S. Patent No. 10,316,359 unpatentable. Pillar Biosciences, Inc. v. Swift Biosciences, Inc., No. IPR2021-00401, 2022 WL 2308112, at *1 (P.T.A.B. June 27, 2022) (“Decision”). On appeal, IDT challenges the Board’s claim construction, argues that the Board’s factual findings were not supported by substantial evidence, and asserts that the Board erred in ruling that IDT had forfeited certain arguments. For the reasons below, we affirm the Board’s decision.