Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have...more
8/31/2015
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen
The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision...more
8/26/2015
/ Abuse of Process ,
Generic Drugs ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Real Party in Interest ,
USPTO
In an en banc, per curiam decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., on remand from the Supreme Court, the Federal Circuit broadened the circumstances under which a party can be liable for direct...more
8/21/2015
/ Akamai Technologies ,
Biotechnology ,
Direct Infringement ,
Divided Infringement ,
En Banc Review ,
Limelight v Akamai ,
Method Claims ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Remand ,
SCOTUS
In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops. This decision shows that it is still...more
8/13/2015
/ Allergan Inc ,
Allergan v Sandoz ,
Enablement Inquiries ,
Inherency ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Ownership ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Written Descriptions
In The Medicines Company v. Hospira, Inc., the Federal Circuit held that a transaction with a contract manufacturer gave rise to an on sale bar that invalidated The Medicines Company’s Angiomax® patents. Are the facts of this...more
7/14/2015
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Disclosure ,
Generic Drugs ,
Manufacturers ,
On-Sale Bar ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Transfer of Title
In 2008, the Federal Circuit determined that claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 were invalid for obviousness-type double patenting (OTDP) over a related parent patent, in part because the ‘068 patent was filed...more
6/27/2015
/ Divisional Applications ,
Double Patent ,
OTDP ,
Patent Applications ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reissue Patents ,
Safe Harbors ,
USPTO
In a June 15, 2015 Federal Register Notice, the USPTO announced the Expedited Patent Appeal Pilot program, which will run until 2,000 ex parte patent appeals are expedited under the program, or until June 20, 2016, whichever...more
On June 3, 2015, the Federal Circuit heard oral arguments in Amgen v. Sandoz regarding the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). As reflected in Judge Lourie’s...more
On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more
In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for...more
In the few weeks since I first wrote about Kyle Bass and the Coalition for Affordable Drugs he formed to challenge Orange Book-listed patents that he believes “have little value other than to drive up prescription drug...more
Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more
Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more
Judge Seeborg of the U.S. District Court for the Northern District of California issued an order in Amgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and...more
On January 26, 2015, the Supreme Court granted certiorari, vacated, and remanded Shire Development LLC v. Watson Pharmaceuticals, Inc., to the Federal Circuit “for further consideration in light of Teva Pharmaceuticals USA,...more
1/30/2015
/ Certiorari ,
Claim Construction ,
Clear Error Standard ,
De Novo Standard of Review ,
Federal Rules of Civil Procedure ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Remand ,
SCOTUS ,
Shire Development v Watson ,
Teva v Sandoz ,
Vacated
On January 20, 2015, the Supreme Court issued its decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., finding that the Federal Rules of Civil Procedure call for some deference in the claim construction standard of...more
Less than a month after their case was argued at the Federal Circuit, Illumina Inc. and Sequenom Inc. have announced a deal to settle their patent infringement litigation. While I haven’t seen an order dismissing the case,...more
In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating...more
In Par Pharmaceutical Inc. v. Twi Pharmaceuticals, Inc., the Federal Circuit vacated and remanded the district court decision holding the Par claims at issue obvious. The district court decision rested in part on the doctrine...more
On October 20, 2014, the Federal Circuit issued an order denying the petition for rehearing or rehearing en banc filed in Bristol-Meyers Squibb Co. v. Teva Pharmaceuticals, USA, Inc. While the order itself may not be...more
In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more
In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more
In AbbVie Deutschland Gmbh v. Janssen Biotech, Inc., the Federal Circuit affirmed the district court decision that found AbbVie’s patents directed to anti-IL-12 antibodies invalid for lack of adequate written description. As...more
The USPTO’s ”Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural Products” has been criticized for requiring a product to be markedly different in...more
In Bristol-Myers Squibb Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed the district court’s finding that BMS’s Baraclude® patent is invalid as obvious. In so doing, the court gave little weight to...more