On June 20, 2016, instead of deciding whether to grant certiorari in the biosimilar patent dance dispute between Amgen and Sandoz, the Supreme Court invited the Solicitor General “to file a brief in this case expressing the...more
6/21/2016
/ Amgen ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Litigation ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
Solicitor General
As we wait for the Supreme Court decision in Cuozzo Speed Technologies, LLC v. Lee, where the Court has been asked to decide whether the USPTO Patent Trial and Appeal Board (PTAB) should apply the “broadest reasonable...more
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
The USPTO Patent Trial and Appeal Board has instituted Post Grant Review (PGR) proceedings against a patent directed to a process for treating contaminated media. The petition for PGR challenged that patent on written...more
In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate...more
5/31/2016
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Confidentiality Agreements ,
Generic Drugs ,
Joint Venture ,
Merck ,
Non-Compete Agreements ,
On-Sale Bar ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Patents ,
Reversal ,
Watson Pharmaceuticals
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 patent eligibility examples published by the USPTO on May 5, 2016 include two new examples relating to diagnostic methods and two new examples relating to “nature-based” products. This article will consider the diagnostic...more
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
While I do not usually write about non-precedential decisions, In re: Brown caught my eye as an interesting patent eligibility case. It does not relate to diagnostics or computer programs, but rather to the art of cutting...more
On April 5, 2016, the Federal Circuit heard oral arguments in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., where the U.S. District Court for the Northern District of Illinois held invalid claims directed to a “method of...more
The USPTO Patent Trial and Appeal Board (PTAB) decided not to institute inter partes review (IPR) of key claims of Jazz’s U.S. Patent 8,772,306, which is listed in the Orange Book for Xyrem®. Although the PTAB did institute...more
In Singhal v. Lee, the U.S. District Court for the Eastern District of Virginia dismissed a complaint that challenged the Patent Term Adjustment (PTA) awarded to two patents, because the complaint failed to state a claim upon...more
Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35...more
4/12/2016
/ Biotechnology ,
CLS Bank v Alice Corp ,
Corporate Counsel ,
Diagnostic Method ,
DNA ,
Federal Rule 12(b)(6) ,
Genetic Technologies Ltd. ,
Machine-or-Transformation Test ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
SCOTUS
Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more
4/12/2016
/ Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Injunctive Relief ,
Notice Requirements ,
Patent Litigation ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
The Federal Circuit is set to hear oral arguments in Immersion Corp. v. HTC Corp. on May 6, 2016. According to the amicus brief filed on behalf of the United States, if the court affirms the district court decision “over...more
The USPTO Patent Trial and Appeal Board (PTAB) has decided to institute inter partes review (IPR) proceedings against the Ampyra patents based on the second set of petitions filed by Kyle Bass and the Coalition for Affordable...more
It comes as no surprise that Sequenom has filed a petition for certiorari to the Supreme Court, asking the Court to review the Federal Circuit decision that upheld the district court decision that held its diagnostic method...more
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
The USPTO Patent Trial and Appeal Board (PTAB) decided to institute inter partes review (IPR) proceedings filed by Kyle Bass against two of the five Juxtapid patents listed in the Orange Book. Two of the cited references may...more
In In re Queen’s University At Kingston, a divided panel of the Federal Circuit recognized a limited “attorney”-client privilege for patent agents. The majority’s decision to recognize a patent agent privilege is based...more
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
Judge Gaughan of the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss after finding three Cleveland Clinic Foundation diagnostic patents invalid under 35 USC § 101. While the...more
In Magna Electronics, Inc. v. TRW Automotive Holdings Corp., No. 1:12-cv-654; 1:13-cv-324 (Dec. 10, 2015), Judge Maloney of the U.S. District Court for the Western District of Michigan granted TRW’s motion for partial summary...more
On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price...more
2/19/2016
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Injunctive Relief ,
Patent Dance ,
Patent Litigation ,
Petition for Writ of Certiorari ,
Pre-Market Notification ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS