District Court Proceedings

We have previously written about the Patent Trial and Appeal Board’s (“PTAB”) precedential decision in Apple Inc. v. Fintiv, Inc., which set forth six factors the PTAB will consider when assessing whether to discretionarily deny an IPR petition in light of co-pending district court litigation.  Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (March 20, 2020).  The PTAB has been applying the Fintiv factors in subsequent IPRs, many of which involve a stayed district court litigation.  The PTAB has now designated as precedential a decision instituting IPR in Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (Dec. 1, 2020).  In this IPR, although the co-pending district court case was not stayed, Sotera Wireless (“Sotera”) filed a stipulation relinquishing all potentially duplicative arguments.  The PTAB allowed the IPR to proceed, noting that the stipulation avoided duplication and prevented conflicting results, chief components of the Fintiv factors.  More detail on this decision is below.
Continue Reading One More Tool to Avoid Fintiv IPR Denial: File A Stipulation in District Court Relinquishing Potentially Duplicative Arguments

On January 5, 2021, the Orange Book Transparency Act of 2020, H.R. 1503, was signed into law. H.R. 1503 amends provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) related to patent information that new drug applicants must submit to the Food and Drug Administration (“FDA”) and FDA must publish in the “Orange Book.”[1] See H.R. 1503, 116th Cong. § 2(a)–(d) (2021). The amendments require “manufacturers to share complete and timely patent information with the . . . (FDA), ensure that periods of exclusivity listed in the Orange Book are promptly updated, and clarify that patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed from the Orange Book promptly, but not before time for appeal has expired.” H.R. Rep. No. 116-47, at 3–4 (2019). The amendments also require FDA and the Comptroller General to submit reports to Congress about the types of patents that should and should not be listed in the Orange Book. See H.R. 1503 § 2(e)–(f).
Continue Reading Orange Book Transparency Act of 2020 Signed Into Law

In an April 11, 2019 order, Judge Andrews of the District of Delaware ruled that a Hatch-Waxman defendant’s obviousness defenses were precluded under 35 U.S.C. § 315(e)(2) even though the barring PTAB decision issued over a year after the court had held an obviousness trial.  Novartis Pharm. Corp. v. Par Pharm., Inc., No. 14-cv-01289 (D. Del. Apr. 11, 2019), Docket No. 198.  Read on for the details.
Continue Reading Court Applies Post-Trial IPR Estoppel Where Final Judgment Didn’t Address All Obviousness Defenses

On May 15, 2018, the Federal Circuit in In re BigCommerce issued an order in response to writs of mandamus seeking dismissal and transfer.  Nos. 2018-120, 2018-122, 2018 WL 2207265 (Fed. Cir. May 15, 2018).  The panel ruled that for purposes of the patent venue statute (28 U.S.C. § 1400(b)), if a domestic corporation is incorporated in a state having several judicial districts, then it “resides” in only one district.  Id. at *6.  That district is either (1) the district in the state where the corporation maintains its principal place of business or (2) if that does not exist, then the district containing the corporation’s registered office.  Id.  In re BigCommerce follows the Supreme Court’s seminal 2017 TC Heartland LLC v. Kraft Foods Group Brands LLC, 137 S. Ct. 1514 (2017) decision altering the course of where domestic corporations may be sued for patent infringement.

Continue Reading If There Was Any Doubt, Federal Circuit Confirms Its Agreement with Dorothy: “There’s No Place Like Home”

On May 14, 2018, the Federal Circuit (Judge Linn, with Judges Reyna and Hughes) ruled on mandamus to address two important issues related to proper venue in a patent infringement case: 1) whether regional or Federal Circuit law governs the analysis of proper venue under 28 U.S.C. § 1400(b), and 2) which party bears the burden of persuasion on the issue when a defendant challenges proper venue.  The court held that Federal Circuit law applies, and the plaintiff bears the burden of persuasion.  In re: ZTE (USA) Inc., No. 2018-113 (Fed. Cir. May 14, 2018).

Continue Reading Federal Circuit to District Courts: On Venue, Apply Our Law, Not Theirs

On April 13, 2018, the Federal Circuit issued a new decision in its recent line of cases analyzing whether generic drug labels may be evidence of induced infringement of method of treatment claims in Hatch-Waxman cases. In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the Court, in upholding the District Court’s finding of induced infringement, held that proposed instructions to physicians can satisfy the specific-intent element of induced infringement. 887 F.3d 1117 (Fed. Cir. 2018) (Judges Lourie and Hughes, Chief Judge Prost dissenting on other issues). This decision follows and builds upon the Federal Circuit’s 2017 decisions in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) and Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017).

Continue Reading Generic Drug Labels May Establish Specific Intent to Induce Infringement of Method of Use Claims