Tagged: ANDA

Federal Circuit Overturned as SCOTUS Creates a New Patent Venue Rule

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 §...

New Jersey Follows Federal Circuit in Finding Jurisdiction Over Hatch-Waxman Defendants 0

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 0

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”? 0

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 0

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.

Heightened Pleading in Patent Complaints to Frustrate Trolls – Exception for Hatch-Waxman/ANDA Cases 0

Heightened Pleading in Patent Complaints to Frustrate Trolls – Exception for Hatch-Waxman/ANDA Cases

All branches of government have worked to decrease frivolous litigation by non-practicing entities (“NPEs”), or patent trolls, in order to both encourage developing technology and allow businesses to utilize that technology without a looming threat of disruptive and costly litigation. In the course of our coverage of these efforts, we have seen state and federal legislative bodies, as well as the United States Patent and Trademark Office (“USPTO”), the executive branch, and the courts, suggesting potential solutions. Congress is currently weighing a revamped version of House Judiciary Committee Chairman Bob Goodlatte’s Innovation Act bill, which seeks to reform patent litigation by focusing on pleading standards.

Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity 0

Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity

In Mylan Pharm., Inc. v. FDA, generic drug manufacturer Mylan Pharmaceuticals, Inc. (“Mylan”) challenged an FDA letter decision describing the agency’s treatment of original and reissue patents as “a single bundle of patent rights” when determining eligibility for 180-day exclusivity under the Hatch Waxman Act (pre-MMA). The United States District Court for the Northern District of West Virginia deferred to the FDA’s interpretation of the statute under step 2 of Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc..

Heartburn Relief:  AstraZeneca Wins Nexium Antitrust Trial 0

Heartburn Relief: AstraZeneca Wins Nexium Antitrust Trial

On December 5, 2014, an 11-person jury decided in favor of defendants AstraZeneca PLC and Ranbaxy Laboratories, Inc. in the first pay-for-delay class action trial since the United States Supreme Court in FTC v. Actavis, Inc. opened the door on antitrust suits based on patent settlements. Teva Pharmaceutical Industries, Ltd. was also defending the suit before reaching a settlement shortly before the trial ended. United States District Court Judge William Young of the District of Massachusetts last year permitted certification for the class members, including union health plans and insurance companies, based on an alleged injury of supracompetitive prices for AstraZeneca’s brand name heartburn drug, Nexium®.

NJ District Courts Bar Defendants’ Indefiniteness Argument During Claim Construction Because Not Alleged in Invalidity Contentions 0

NJ District Courts Bar Defendants’ Indefiniteness Argument During Claim Construction Because Not Alleged in Invalidity Contentions

We previously reported that New Jersey District Court Judges will limit a patent infringement defendant’s discovery to the claims and defenses identified in its Invalidity Contentions served under Local Patent Rule 3.3. For the same reasons, a defendant may be barred from taking certain positions during claim construction. In an opinion issued last week, Judge Jose L. Linares held in Auxilium Pharmaceuticals, Inc. & FCB I LLC v. Watson Laboratories, Inc., No. 12-3084 (JLL) that a defendant that does “not raise an indefiniteness defense in its invalidity contentions . . . cannot seek a determination that the patents-at-issue are invalid for indefiniteness through claim construction.”

It Ain’t that Obvious to Try 0

It Ain’t that Obvious to Try

In Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms Inc., the Federal Circuit followed previous precedent in holding that the combination of compounds is not “obvious to try” if unexpected properties are supported by evidence. The patent-at-issue was directed to an antihypertension drug, Tarka®, which is the combination of an angiotension-converting enzyme inhibitor (such as trandolapril or quinapril, both double-ring compounds) and a calcium channel blocker. The jury found that the patent had not been proven invalid and defendant, on appeal, argued that “if a combination of classes of components is already known, all selections within such classes are obvious to try . . . .” The Federal Circuit found that there was substantial evidence supporting the jury’s verdict that obviousness had not been proved by clear and convincing evidence because of the unpredicted “longer-lasting effectiveness” achieved with the drug.