Opinion also contains important holdings for labeling and copyright infringement in the context of the Federal Insecticide, Fungicide, and Rodenticide ActIn Syngenta Crop Protection LLC v. Willowood LLC, et al., the US Court of Appeals for the Federal Circuit held in a case of first impression that infringement liability under 35 U.S.C. § 271(g) does not require a single entity to perform all steps of the patented process. See No. 2018-1614 (Fed. Cir. Dec. 18, 2019) ("Syngenta").

Opinion also contains important holdings for labeling and copyright infringement in the context of the Federal Insecticide, Fungicide, and Rodenticide ActIn Syngenta Crop Protection LLC v. Willowood LLC, et al., the US Court of Appeals for the Federal Circuit held in a case of first impression that infringement liability under 35 U.S.C. § 271(g) does not require a single entity to perform all steps of the patented process. See No. 2018-1614 (Fed. Cir. Dec. 18, 2019) ("Syngenta").

On Wednesday, the Federal Circuit held that infringement under 35 U.S.C. § 271(g) does not require a single entity to perform, direct, or control all of the steps of a patented process for infringement liability to arise from the importation or sale of the product made by the patented process in the United States. While the court’s decision in Syngenta Crop Protection LLC v. Willowood, LLCet al. is directed to only one part of 35 U.S.C. § 271, the opinion provides a good overview of the statute as a whole as it decides this issue of first impression.

[co-author: Nile Delso ]*Congress’s protection from patent infringement for drug developers created under the Hatch-Waxman Act of 1984 (Act) has been extensively litigated over the past three+ decades, but the scope of the so-called “safe harbor exemption,” provided in 35 U.S.C. § 271(e)(1), is still unclear and may be narrower than once thought.In 1984, the Federal Circuit held, in Roche v. Bolar, that a generic manufacturer’s intended experimental use of a patented drug was patent infringement and rejected a broad interpretation of the traditional experimental use exception.

S.D. Ind., Judge Hamilton 07-1296 August 19, 2009 Decision, en bancLast Month at the Federal Circuit - September 2009Judges: Newman, Mayer, Lourie (author). Part C.2 was heard en banc before Michel, Newman (dissenting), Mayer, Lourie (author), Rader, Schall, Bryson, Gajarsa, Linn, Dyk, Prost, Moore. [Appealed from: En Banc Court Holds That § 271(f) Does Not Apply to Method Patents] In Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., Nos. 07-1296, -1347 (Fed. Cir. Aug. 19, 2009) (en banc), the Federal Circuit held en banc that 35 U.S.C. § 271(f) cannot apply to method or process patents. Additionally, a panel of the Federal Circuit reversed the district court’s SJ of invalidity, reinstating the jury’s verdict of validity, held that inequitable conduct arguments could not be asserted on remand, affirmed the district court’s limit on damages to only those products that actually performed the patented method, and declined to reassign the case to a different judge on remand.

Since Appellees limited their respective ANDAs to methods of use that were not claimed in a patent by AstraZeneca, Appellees each filed Section viii statements. After commencing an action against Appellees relating to another patent relating to rosuvastatin calcium owned by AstraZeneca, AstraZeneca commenced another action against Appellees alleging infringement of the Patents-in-Suit pursuant to 35 U.S.C. § 271(e)(2). In particular, “AstraZeneca alleged that: (1) Appellees’ ANDAs, as filed, violated § 271(e)(2) as ‘application[s] for a drug the use of which is claimed’ in the ’618 and ’152 patents; (2) if approved by the FDA, Appellees’ proposed activities will induce infringement of the ’618 and ’152 patents; and (3) the FDA will require Appellees to make labeling amendments explicitly incorporating the indications covered by the ’618 and ’152 patents.”

Although the Hatch-Waxman Act was passed by Congress decades ago, it still produces new questions. Despite vigorous argument by the patent owner, a district court dismissed a count alleging that the ANDA-filer infringed under 35 U.S.C. § 271(e)(2)(A), leaving in place the unchallenged count for infringement under § 271(a). Ferring B.V. v. Actavis, Inc., Civil Action No. 15-4222 (D.N.J. May 26, 2016).

ANDA Seeking to Market a Drug for Unpatented Uses Cannot Infringe Method of Use Patents Under 35 U.S.C. § 271(e)(2) 11-1182 February 09, 2012 Decision Last Month at the Federal Circuit - March 2012Judges: Rader, Lourie (author), Moore [Appealed from: D. Del., Judge Kugler] In AstraZeneca Pharmaceuticals LP v. Apotex Corp., Nos. 11-1182, -1183, -1184, -1185, -1186, -1187, -1188, -1189, -1190 (Fed. Cir. Feb. 9, 2012), the Federal Circuit affirmed the district court’s dismissal of AstraZeneca Pharmaceuticals LP, AstraZeneca AB, IPR Pharmaceuticals, Inc., and The Brigham and Women’s Hospital, Inc.’s (collectively “AstraZeneca”) 35 U.S.C. § 271(e)(2) patent infringement claims for infringement of two method of use patents. AstraZeneca markets a cholesterol-lowering drug, rosuvastatin calcium, under the brand name CRESTOR® and holds rights to two method patents, U.S. Patent Nos. 6,858,618 (“the ’618 patent”) and 7,030,152 (“the ’152 patent”), which are at issue in this appeal, and a compound patent which was the subject of a separate ANDA litigation and appeal.

The Federal Circuit had the opportunity to interpret the extent to which the provisions of 35 U.S.C. § 271(g) require the practice of the patented method that produces a product whose importation imposes infringement liability under the statute to be practiced by a single entity (it does not) in rendering its decision recently in Syngenta Crop Protection, LLC v. Willowood, LLC.The case involved accused infringement of U.S. Patent Nos. 5,602,076 (expired February 11, 2014); 5,633,256 (expired February 11, 2014); 5,847,138 (expired December 8, 2015); and 8,124,761 (will not expire until April 15, 2029), directed to fungicides, pesticides, plant growth regulators, comprising pyrimidinyloxy-phenyl acrylates and derivatives, and in particular azoxystrobin. The '076 and '256 patents are directed to compounds, while the '138 and '761 patents are directed to methods for producing these compounds.

By Kurt R. Karst – We were eager to delve into the Federal Circuit’s recent 2-1 decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Docket Nos. 2012-1062, -1103, -1104) concernng the scope of the Hatch-Waxman “safe harbor” provision at 35 U.S.C. § 271(e)(1), particularly in light of the Court’s prior decision in Classen Immunotherapies v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), which is on appeal to the U.S. Supreme Court (Docket No. 11-1078). Although the 2012 London Olympics captured most of our attention over the weekend, we did find some time to look over the decision.