Finding that the Patent Trial and Appeal Board’s (PTAB) anticipation and obviousness decisions resulted from an erroneous interpretation of the claim language and a misunderstanding of case law, the US Court of Appeals for the Federal Circuit vacated the PTAB’s decision and remanded for further consideration. Technical Consumer Products v. Lighting Science Group Corp., Case No. 19-1361 (Fed. Cir. Apr. 8, 2020) (Stoll, J.).
The US Court of Appeals for the Federal Circuit reversed a Patent Trial and Appeal Board (PTAB) obviousness decision, finding the decision was infected by an erroneous claim construction that failed to consider the purpose of the claimed invention. Kaken Pharmaceutical Co., LTD v. Iancu, Case No. 18-2232 (Fed. Cir. Mar. 13 2020)(Taranto, J.).
Kaken owns a patent claiming a method for topically treating fungal infections in nails. Fungal infections of the nail plate and nail bed are notoriously difficult to treat because topical treatments cannot penetrate the thick keratin in the nail plate. The patent describes an effective topical treatment with an antifungal, KP-103, having good permeability, retention capacity and activity in the nail plate. The patent specification notes that topical treatments known in the prior art were largely ineffective at penetrating the nail plate and treating onychomycosis.
Addressing a jury verdict of invalidity, the US Court of Appeals for the Federal Circuit found that the district court abused its discretion in allowing trial testimony regarding obviousness from a lay witness, and remanded for a new trial. HVLPO2, LLC v. Oxygen Frog, LLC, Case No. 19-1649 (Fed. Cir. Feb. 5, 2020) (Moore, J).
In an appeal from the Patent Trial and Appeal Board (PTAB), the US Court of Appeals for the Federal Circuit held that although the PTAB erred by instituting review based on a ground not advanced in the petition, the PTAB correctly found the patent at issue was invalid and affirmed the final written decision. Koninklijke Philips N.V. v. Google LLC, Case No. 19-1177 (Fed. Cir., Jan. 30, 2020) (Prost, C.J.).
Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that a patent was invalid based on inherency because the claim limitation was necessarily present in the prior art. Hospira, Inc. v. Fresenius Kabi USA, LLC, Case Nos. 19-1329, -1367 (Fed. Cir. Jan. 9, 2020) (Lourie, J).
The patent at-issue is directed to premixed pharmaceutical compositions of dexmedetomidine that do not require reconstitution or dilution prior to administration and remains stable and active after prolonged storage. Hospira makes and sells dexmedetomidine products, including a ready-to-use product called Precedex Premix covered by the patent at-issue. Fresenius filed an Abbreviated New Drug Application (ANDA) seeking approval by the Food and Drug Administration (FDA) to market a generic ready-to-use dexmedetomidine product. Hospira brought suit alleging infringement under the Hatch-Waxman Act.
In a case involving a patented method for purifying antibodies, the US Court of Appeals for the Federal Circuit determined that the process of chilling a composition to below room temperature could be found both obvious and anticipated by a process that purified that composition at room temperature. Genentech, Inc. v. Hospira, Inc., Case No. 18-1933 (Fed. Cir. Jan. 10, 2020) (Chen, J) (Newman, J, dissenting).
Finding that inherency can be used to show the presence of a missing claim limitation, the US Court of Appeals for the Federal Circuit affirmed a district court decision that asserted claims in pain management method patents were invalid as obvious. Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd., Case No. 18-2361 (Fed. Cir., Dec. 27, 2019) (Reyna, J.).
Persion has US Food and Drug Administration (FDA) approval for its extended release hydrocodone product, Zohydro ER, and also owns two patents directed to methods of treating pain with extended release hydrocodone in patients with mild to moderate hepatic impairment. Persion sued Alvogen for infringement of certain claims in these two patents after Alvogen filed an Abbreviated New Drug Application (ANDA) requesting approval from the FDA to market a generic version of Zohydro ER. The asserted claims include: (i) non-adjustment claims directed to administering a dose of hydrocodone to patients with mild to moderate hepatic impairment without adjusting the dose relative to a healthy liver patient, and (ii) pharmacokinetic claims directed to pharmacokinetic parameters achieved after treatment with hydrocodone.
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