Tagged: ANDA

What is “A Regular and Established Place of Business”?: A Case Compendium

Since the TC Heartland decision in which the Supreme Court ruled that the “residence” prong in the patent venue statute, 28 U.S.C. § 1400(b), refers only to the state of incorporation and not the definition conferred in the general venue statute, § 1391, parties and courts have focused attention on interpreting the alternative basis for venue under the statute: “where the defendant has committed acts of infringement and has a regular and established place of business.” TC Heartland v. Kraft Foods Group Brands, 137 S. Ct. 1514, 1516 (2017). Of particular interest is how courts have ruled on what constitutes “a regular and established place of business.” In September 2017, the Federal Circuit clarified that a “regular and established place of business” must meet three general requirements: “(1) there must be a physical place in the district; (2) it must be a regular and established place of business; and (3) it must be the place of the defendant.” In re Cray, 871 F.3d 1355, 1360 (Fed. Cir. 2017). First, there must be a “physical place,” i.e., a “physical, geographical location in the district from which the business of the defendant is carried out.” Id. at 1362. The Court defined a physical place as a “building or part of a building set apart for any purpose.”...

Supreme Court To Review Whether Non-Public Sales Are Invalidating Under Post-AIA Section 102

The Supreme Court recently agreed to review Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., a case with broad implications for the pharmaceutical industry. In the opinion below, the Federal Circuit held that after the America Invents Act (“AIA”), “if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale” for the sale to be invalidating under Section 102. The Court granted Helsinn’s petition for certiorari to answer “[w]hether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.” Before the AIA, § 102(b) barred the patentability of an invention that was “patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent.” By enacting the AIA, Congress amended § 102 to bar the patentability of an “invention [that] was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” In its petition for certiorari, Helsinn argued...

Senator Hatch Proposes Legislation Forcing Challengers to Choose Between Filing a Hatch-Waxman Action or Filing an IPR

On June 13, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (“IPR”) process for pharmaceuticals. The senator published a press release summarizing and explaining the proposed legislation. The amendment, titled the Hatch-Waxman Integrity Act of 2018, intends to “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development” by “prevent[ing] alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design.” The proposed legislation would amend Sections 505(b)(2) and 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 355(b)(2) and 355(j)(2)(A) respectively) to require the applicant to certify to the FDA that “neither the applicant nor any party in privity with the applicant, has filed, or will file, a petition to institute inter partes review” in order to be eligible for abbreviated regulatory approval under the Hatch-Waxman Act. The applicant would further need to certify that it “is not relying in whole or in part on any decision issued by the Patent Trial and Appeal Board in an [IPR]” in making the certification that the relevant listed patent is invalid or will not be infringed. According to Senator Hatch, the impetus for the proposed amendment is that IPRs are “producing unintended consequences in...

NJ District Courts Continue to Enforce the Disclosure Requirements Regarding Contentions Pursuant to New Jersey’s Local Patent Rules

We previously reported in February 2014 and June 2014 that New Jersey District Court Judges will enforce the District of New Jersey’s Local Patent Rules’ contention disclosure requirements and bar parties from making arguments that were not properly disclosed in their contentions. Consistent with those rulings, in a recent opinion, in Impax Labs., Inc. v. Actavis Labs FL, Inc., Judge Chesler barred one of Actavis’s infringement arguments made during summary judgment as untimely because the argument was not sufficiently disclosed in its infringement contentions. In its opposition brief, Impax argued that Actavis raised new non-infringement arguments based on the pharmacokinetic profiles of its proposed generic product. Actavis claimed that its generic product did not meet claim limitations involving a “maximum concentration” limitation or a “40% fluctuation” limitation for two subsets of asserted claims. Upon review of Actavis’s contentions, the court found that Actavis did sufficiently disclose its non-infringement argument in regard to the “maximum concentration” limitation, but that it did not sufficiently disclose its non-infringement argument regarding the “40% fluctuation” limitation. The court found that Actavis’s non-infringement contentions regarding the “40% fluctuation” limitation stated that “there is no evidence that its products ‘result in a levodopa plasma concentration’ meeting the 40% fluctuation limitation.” Yet, in its summary judgment motion, Actavis expanded that argument by providing a...

What are “Acts of Infringement” and Where is “A Regular and Established Place of Business” for a Hatch-Waxman Defendant: The District of Delaware Weighs in on the Patent Venue Rule

We previously reported on the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, in which the Supreme Court created a new patent venue rule. The patent venue statute, 28 U.S.C. § 1400(b), provides that patent infringement suits “may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.” In TC Heartland, the Supreme Court held that “[a]s applied to domestic corporations, ‘reside[nce] in § 1400(b) refers only to the State of incorporation.” A Delaware District Court recently considered the provision of the patent venue statute not addressed by TC Heartland – where venue is proper if a “defendant has committed acts of infringement and has a regular and established place of business” in the context of a defendant’s motion to dismiss for improper venue. In Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., a patent infringement matter brought under the Hatch-Waxman statute and filed before the TC Heartland decision, the parties did not dispute that, in light of TC Heartland, the defendant, a West Virginia corporation, could not be said to “reside” in Delaware. Thus, venue would be proper in Delaware only if the defendant committed act of infringement in Delaware and had a...

Federal Circuit Overturned as SCOTUS Creates a New Patent Venue Rule

In TC Heartland LLC v. Kraft Foods Group Brands LLC, the Supreme Court fundamentally changed the national patent litigation landscape when it considered “where proper venue lies for a patent infringement lawsuit brought against a domestic corporation” and held that “[a]s applied to domestic corporations, ‘reside[nce]’ in § 1400(b) refers only to the State of incorporation.” In so holding, the Supreme Court altered the established patent venue rule – that a corporation is deemed to reside anywhere in which it is subject to personal jurisdiction at the time the action is commenced – which was established by the Federal Circuit’s decision in VE Holding Corp. v. Johnson Gas Appliance Co., 917 F.2d 1574 (Fed. Cir. 1990). In VE Holding, the Federal Circuit held that the definition of venue in § 1391(c), the general venue statute, also applied to patent cases. The Supreme Court based the TC Heartland decision on its prior ruling in Fourco Glass Co. v. Transmirra Products Corp., 335 U.S. 222 (1957) in which, as it described in TC Heartland, it “definitively and unambiguously” held that “residence” in § 1400(b) “refers only to the State of incorporation” as well as its reasoning that “[t]he current version of § 1391 [as amended in 2011] does not contain any indication that Congress intended to alter...

New Jersey Follows Federal Circuit in Finding Jurisdiction Over Hatch-Waxman Defendants

We recently reported on the Federal Circuit’s holdings in Acorda Therapeutics, Inc. v. Mylan Pharm. Inc. and AstraZeneca AB v. Mylan Pharm., Inc., where it held that Mylan was subject to jurisdiction in Delaware because “Mylan’s ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs.” Earlier this month, the first decision from the District of New Jersey District applying the Federal Circuits ruling was rendered. In Helsinn Healthcare S.A., et al. v. Hospira, Inc., No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. April 5, 2016), Judge Mary L. Cooper held that sufficient minimum contacts is to find specific jurisdiction is established by the fact that Hospira filed an ANDA seeking to market a generic version of Helsinn’s Aloxi® product that if approved, the marketing of will take place in New Jersey.

Interesting Trends in Establishing Personal Jurisdiction in Hatch-Waxman/ANDA Litigations

Last week the Federal Circuit handed down one of its more anticipated decisions regarding jurisdiction in cases brought under 35 U.S.C. § 271(e)(2) (aka Hatch-Waxman or ANDA litigation). In its holding, the Federal Circuit stated that a “[defendant’s] ANDA filings and its distribution channels” are enough to “establish that [the defendant’s] plans to market its proposed [ANDA product in the forum state]” are enough to meet the minimum-contacts requirement to establish jurisdiction. It further held “there is no substantial argument that considerations of unfairness override the minimum-contacts basis for [the forum state’s] exercise of specific personal jurisdiction over” the defendants. This holding is much broader than the underlying district court rulings and limited the analysis to specific jurisdiction without addressing the underlying general jurisdictional questions.

Need to Construe “Plain and Ordinary Meaning”?

In 2005, the Federal Circuit established the framework for the construction of patent claim terms. In its landmark holding in Philips v. AWH Corp., the Federal Circuit stated that “words of a claim ‘are generally given their ordinary and customary meaning . . . [and] that the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art . . . .”

The Patient Survives: Third Party Challenge to PTO Revival of Patent Application Barred under the Administrative Procedures Act

The Federal Circuit Court of Appeals recently held that a third party may not challenge a decision by the United States Patent and Trademark Office (“PTO”) to revive an application under the Patent Cooperation Treaty and enabling statutes (“PCT”) through the Administrative Procedures Act (“APA”). See Excela Pharma Sciences, LLC v. Lee, No. 13-1206 (Fed. Cir. Mar. 26, 2015). In combination with the Federal Circuit’s prior holding in Aristocrat Technologies Australia Pty Ltd. v. International Game Technology, 543 F.3d 657 (Fed. Cir. 2008), this holding puts such decisions beyond the reach of third parties, whether affirmatively attacked under the APA or defensively raised in a later infringement action.