David Tellekson

David Tellekson

Fenwick & West LLP

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Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

7/21/2016 - Amgen Apotex Biosimilars BPCIA FDA Generic Drugs Life Sciences Patent Dance Patent Litigation Pharmaceutical Patents Popular Sandoz v Amgen

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant...more

7/13/2016 - aBLA Amgen Apotex Biosimilars BPCIA Commercial Marketing Declaratory Judgments FDA Generic Drugs Notice of Intent Patent Dance Patent Infringement Patent Litigation Pharmaceutical Patents Sandoz v Amgen

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

6/24/2016 - Amgen Biologics Biosimilars BPCIA Certiorari FDA Life Sciences Patent Infringement Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents Sandoz Sandoz v Amgen SCOTUS

Lingering in Lexmark's wake, uncertainty about the limits of patent exhaustion

According to ten judges of the Federal Circuit, a patent owner’s right to sue for infringement in the United States is not exhausted by sales of products abroad or by sales subject to valid post-sale contractual restrictions...more

3/8/2016 - Corporate Counsel First Sale Doctrine Foreign Sales Lexmark Patent Exhaustion Patent Infringement Popular Quanta Young Lawyers

Litigation Alert: Federal Circuit’s Ariosa Decision, Good Chance for Rehearing En Banc

In June of this year, the Federal Circuit panel in Ariosa Diagnostics, Inc. v. Sequenom, Inc. invalidated a patent on the grounds of patent-ineligible subject matter. 788 F.3d 1371 (Fed. Cir. 2015). While the case is one of...more

11/5/2015 - Declaratory Rulings DNA En Banc Review Life Sciences Mootness Myriad-Mayo Patent Infringement Patent Invalidity Patent-Eligible Subject Matter Patents Petition For Rehearing Preemption Product of Nature Doctrine Section 101

U.S. Supreme Court Upholds Ban on Post-Patent Expiration Royalties

Fifty years ago, in Brulotte v. Thys Co., the U.S. Supreme Court held that “a patentee’s use of a royalty agreement that projects beyond the expiration date of the patent is unlawful per se.” 379 U.S. 29, 32 (1964). On June...more

10/2/2015 - Breach of Contract Brulotte IP License Kimble v Marvel Enterprises License Agreements Licensing Rights Patent Expiration Patent Infringement Patent Royalties Patents Public Domain SCOTUS Stare Decisis

Litigation Alert: Federal Circuit Expands Liability for Divided Patent Infringement

On August 13, 2015, the Federal Circuit in Akamai Technologies, Inc. v. Limelight Networks, Inc. changed the law regarding liability for direct infringement of a method patent involving more than one actor (divided...more

8/24/2015 - Akamai Technologies Covered Business Method Patents Divided Infringement En Banc Review Limelight Limelight v Akamai Patent Infringement Patent Litigation Patents SCOTUS

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

8/13/2015 - aBLA Amgen Biosimilars BPCIA Commercial Marketing FDA Generic Drugs Hatch-Waxman License Agreements Patent Dance Patent Infringement Patents Pharmaceutical Industry Pharmaceutical Patents Preliminary Injunctions Sandoz Sandoz v Amgen

Litigation Alert: Even Spider-Man Can't Defeat Ban on Post-Patent Expiration Royalties

Fifty years ago, in Brulotte v. Thys Co., the U.S. Supreme Court held that “a patentee’s use of a royalty agreement that projects beyond the expiration date of the patent is unlawful per se.” 379 U.S. 29, 32 (1964). On June...more

6/26/2015 - Brulotte Contract Term IP License Kimble v Marvel Enterprises Patent Royalties Patents SCOTUS Stare Decisis

Litigation Alert: A Good-Faith Belief of Patent Invalidity Is Not a Defense to Inducement of Infringement

Six justices of the Supreme Court agree that an accused indirect infringer’s good faith belief in invalidity of a patent “will not negate the scienter required under §271(b).” Commil USA, LLC v. Cisco Sys., Inc., No. 13-896,...more

6/11/2015 - Cisco Cisco v CommilUSA Good Faith Induced Infringement Patent Infringement Patent Invalidity Patent Litigation Patents SCOTUS

Litigation Alert: Supreme Court Rules on “Reverse Payment” Settlements in Federal Trade Commission v. Actavis, Inc.

Today, the U.S. Supreme Court held in Federal Trade Commission v. Actavis, Inc. that so-called “reverse payment” settlement agreements should be analyzed under a rule-of-reason analysis under which the court assesses any...more

6/18/2013 - ANDA Anti-Competitive Antitrust Litigation FTC FTC v Actavis Hatch-Waxman Patents Pharmaceutical Industry Reverse Payment Settlement Agreements SCOTUS

Intellectual Property Bulletin Winter 2013: Murky Waters: Post-Approval Regulatory Activities and the § 271(e)(1) Safe Harbor

On January 14, 2013, the U.S. Supreme Court refused to consider the U.S. Court of Appeals for the Federal Circuit's exclusion in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), of post-approval...more

4/5/2013 - Biogen Idec Classen Immunotherapies FDA GlaxoSmithKline Infringement Patents Safe Harbors SCOTUS

Intellectual Property Bulletin - Winter 2013

In This Bulletin: - Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case - Murky Waters: Post-Approval Regulatory Activities and the §...more

4/4/2013 - Covenant Not to Sue FDA Generic Drugs Mootness Nike Pharmaceutical Industry Public Performance Rights Safe Harbors SCOTUS Standing Trade Secrets Trademarks Transfer of Venue

Litigation Alert: U.S. Supreme Court to Weigh In on Reverse Payment Deals

On March 25, 2013, the U.S. Supreme Court heard oral argument in FTC v. Actavis, Inc.,1 which is on appeal from the U.S. Court of Appeals for the Eleventh Circuit. This case addresses a type of patent litigation settlement...more

4/3/2013 - FDA FTC v Actavis Generic Drugs Patents Pay-For-Delay Pharmaceutical Industry Pharmaceutical Patents Reverse Payment Settlement Agreements SCOTUS

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