On December 7, the White House announced “New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition,” which included “a proposed framework for agencies on the exercise of march-in rights on...more
Last week, a federal judge in Boston answered a question of first impression arising under the patent dispute resolution provisions of the Biological Price Competition and Innovation Act (“BPCIA”), a process commonly known as...more
On July 11, 2016, the Federal Circuit, sitting en banc in The Medicines Company v. Hospira, held that a contract manufacturer’s sale of manufacturing services to an inventor did not constitute a sale of the patented invention...more
In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more
7/7/2016
/ Amgen ,
Apotex ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
In Cuozzo Speed Technologies, LLC v. Lee, the Supreme Court handed a victory to the Patent Office, affirming its broad discretion in the institution and management of post-issuance proceedings created by the Leahy-Smith...more
6/22/2016
/ Administrative Proceedings ,
America Invents Act ,
Appeals ,
Broadest Reasonable Interpretation Standard ,
Chevron Deference ,
Claim Construction ,
Cuozzo Speed Technologies v Lee ,
Final Judgment ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Patent Trial and Appeal Board ,
Patents ,
SCOTUS ,
Standard of Review ,
USPTO
The Federal Circuit, sitting en banc in Akamai Technologies, Inc. v. Limelight Networks, Inc., this week adopted a new standard governing divided infringement under 35 U.S.C. § 271(a). The new standard is likely to enhance...more
8/18/2015
/ 35 U.S.C. § 271(e)(1) ,
Covered Business Method Patents ,
Direct Infringement ,
Divided Infringement ,
En Banc Review ,
Induced Infringement ,
Joint Tortfeasors ,
Limelight v Akamai ,
Patent Infringement ,
Patents ,
Reversal
On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more
7/24/2015
/ Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Opt-Outs ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Preliminary Injunctions ,
Prescription Drugs
The Supreme Court’s Kimble Decision Reminds Licensors and Licensees to Evaluate Post-Expiration Royalties with Care -
On June 22, 2015, the Supreme Court, in Kimble v. Marvel Entertainment, LLC, declined to overrule–on...more
In a 2-1 decision in In re Cuozzo Speed Technologies LLC, No. 14-1301 (Fed. Cir. Feb. 4, 2015), the Federal Circuit recently held that the Patent Office may apply the “broadest reasonable interpretation” standard to construe...more
This week, in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Supreme Court held that the Federal Circuit must apply a deferential “clear error” standard of review to any finding of fact underlying a district court’s...more
On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more
On Monday, in Nautilus Inc. v. Biosig Instruments, the United States Supreme Court unanimously set aside the Federal Circuit’s indefiniteness standard, potentially easing the way for defendants to invalidate ambiguous patent...more