The Federal Circuit has issued a landmark venue decision setting forth the standard for determining what constitutes a “regular and established place of business” under 28 U.S.C. § 1400(b). Section 1400(b) limits venue in...more
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 ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Life Sciences ,
Patent Dance ,
Patent Litigation ,
Pharmaceutical Patents ,
Popular ,
Sandoz v Amgen
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 ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice of Intent ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Sandoz v Amgen
This week in Cuozzo Speed Technologies, LLC v. Lee, the United States Supreme Court decided two important questions related to the power of the Patent Trial and Appeal Board (PTAB) over inter partes review proceedings. First,...more
6/27/2016
/ Administrative Procedure Act ,
America Invents Act ,
Appeals ,
Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Cuozzo Speed Technologies v Lee ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Non-Appealable Decisions ,
Patent Trial and Appeal Board ,
Patents ,
Phillips Standard ,
SCOTUS ,
Standard of Review ,
USPTO
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 ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
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
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
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
28 U.S.C. § 1782: A Powerful Tool in Global Disputes -
As the number and complexity of cross-border and multi-jurisdictional disputes increase, companies can use 28 U.S.C. § 1782 to obtain evidence from U.S.-based...more
10/1/2015
/ 28 U.S.C. § 1782 ,
America Invents Act ,
Claim Construction ,
Copyright ,
Cross-Border ,
Defend Trade Secrets Act (DTSA) ,
Discovery ,
Evidence ,
Foreign Jurisdictions ,
Global Disputes ,
Google ,
Intellectual Property Litigation ,
Kimble v Marvel Enterprises ,
Likelihood of Confusion ,
Multi-Jurisdictional Litigation ,
Patent Royalties ,
Patents ,
POM Wonderful ,
Preliminary Injunctions ,
Rule 11 ,
Testimony ,
Trade Secrets ,
USPTO
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
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 ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
License Agreements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen
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
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
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
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
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 ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Mootness ,
Nike ,
Pharmaceutical Industry ,
Public Performance Rights ,
Safe Harbors ,
SCOTUS ,
Standing ,
Trade Secrets ,
Trademarks ,
Transfer of Venue
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