Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more
3/10/2017
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Dismissals ,
Genentech ,
Information Sharing ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Subject Matter Jurisdiction
In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more
2/24/2017
/ aBLA ,
Biologics ,
Biosimilars ,
BPCIA ,
Confidential Information ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Injunctive Relief ,
Motion to Compel ,
Patent Dance ,
Patent Infringement ,
Pharmaceutical Patents
The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so...more
The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more
1/19/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Certiorari ,
Commercial Marketing ,
Declaratory Judgments ,
License Applications ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Remedies ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
Solicitor General
The Solicitor General of the United States has filed an amicus brief in Sandoz Inc. v. Amgen Inc., asking the Supreme Court to grant certiorari and reverse the Federal Circuit’s interpretation of one of the “patent dance”...more
The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more
In LifeNet Health v. LifeCell Corporation, one of the many issues the Federal Circuit decided was that functional claim language did not create a divided infringement situation, even though an independent actor could impact...more
In what may be the first decision on the merits in a patent infringement suit brought under the Biologics Price Competition and Innovation Act (BPCIA), the U.S. District Court for Southern District of Florida has found that...more
In Vanda Pharmaceuticals Inc. v. Roxane Labs., Inc., Judge Stark of the U.S. District Court for the District of Delaware upheld the patent eligibility of personalized medicine method claims related to Vanda’s FANAPT®...more
On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more
8/10/2016
/ Abbreviated New Drug Application (ANDA) ,
AbbVie ,
Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents
3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....more
8/1/2016
/ 3D Printing ,
Bilski ,
CLS Bank v Alice Corp ,
Contributory Infringement ,
Food and Drug Administration (FDA) ,
Induced Infringement ,
Intellectual Property Protection ,
Manufacturers ,
Medical Devices ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Professional Conferences ,
USPTO
In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more
7/15/2016
/ Actual Damages ,
Biosimilars ,
Confidentiality Agreements ,
Direct Infringement ,
Hospira ,
Induced Infringement ,
Injunctive Relief ,
Janssen Pharmaceuticals ,
On-Sale Bar ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Treble Damages
In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more
7/8/2016
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz v Amgen
In Halo Electronics, Inc. v. Pulse Electronics, Inc., the Supreme Court rejected the Federal Circuit’s two-part Seagate test for awarding enhanced damages under 35 USC § 284, finding that both the substantive requirement for...more
6/15/2016
/ 35 U.S.C. § 284 ,
Enhanced Damages ,
Halo v Pulse ,
Judicial Discretion ,
Octane Fitness v. ICON ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Preponderance of the Evidence ,
SCOTUS ,
Seagate ,
Willful Infringement
In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more
5/24/2016
/ Abbreviated New Drug Application (ANDA) ,
CAFC ,
De Novo Standard of Review ,
Doctrine of Equivalents ,
Estoppel ,
FDA Approval ,
Generic Drugs ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Prior Art
Amgen Inc. has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Sandoz Inc. seeking approval of a biosimilar version of Neulasta® infringes...more
5/17/2016
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Sandoz ,
Sandoz v Amgen
The U.S. District Court for the District of Delaware accepted Merck’s arguments that method of treatment patents asserted by BMS against its Keytruda product “touch[] upon a natural phenomenon” such that they should be...more
5/5/2016
/ Bristol-Myers Squibb ,
CLS Bank v Alice Corp ,
Federal Rule 12(b)(6) ,
Mayo v. Prometheus ,
Merck ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Presumption of Validity ,
SCOTUS ,
Treatment Method Patents
In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the...more
3/25/2016
/ Abbreviated New Drug Application (ANDA) ,
AstraZeneca ,
Forum Shopping ,
General Jurisdiction ,
Generic Drugs ,
Minimum Contacts ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Personal Jurisdiction ,
Pharmaceutical Patents ,
Proposed Legislation ,
Specific Jurisdiction
Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act...more
3/4/2016
/ Amgen ,
Biosimilars ,
BPCIA ,
Inter Partes Review (IPR) Proceeding ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product cleared a significant regulatory hurdle on February 9, 2016, when the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee voted 21-3...more
In Akzo Nobel Coatings, Inc. v. Dow Chemical Co., the Federal Circuit upheld the district court’s grant of summary judgment of no infringement under the doctrine of equivalents because the patent holder had failed to...more
In a single decision issued for companion cases Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. and Momenta Pharmaceuticals, Inc. v Amphastar Pharmaceuticals, Inc., the Federal Circuit interpreted two important...more
In Dynamic Drinkware, LLC v. National Graphics, Inc., the Federal Circuit held that in order for a patent to qualify as prior art as of its provisional application filing date, the provisional application must support the...more
The Federal Circuit denied the petitions for rehearing en banc filed in Amgen Inc. v. Sandoz Inc., which was the court’s first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA). Perhaps the...more
10/20/2015
/ Amgen ,
Amicus Briefs ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition For Rehearing ,
Sandoz ,
Sandoz v Amgen
After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more
10/13/2015
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Generic Drugs ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Likelihood of Success ,
Obviousness ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Real Party in Interest ,
USPTO