The Federal Trade Commission carried out an (in)famous crusade against reverse payment (more provocatively, "pay for delay") settlements in ANDA litigation for almost a decade before eventually having the Supreme Court see...more
What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement?
The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...more
Novelty is perhaps the principal, most fundamental requirement for patentability, and depriving the public of anything in the prior art must be avoided. The Federal Circuit recently reinforced the primacy of these rubrics in...more
On September 3rd, the Federal Circuit affirmed under Rule 36 the decision by the District Court of Nevada (Du, J.) in March that the claims asserted by Amarin Pharma against West-Ward Pharmaceuticals International Ltd., Hikma...more
9/5/2020
/ Amarin ,
Appeals ,
Generic Drugs ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Reaffirmation ,
Rule 36
One of the banes of any practicing patent attorney's professional existence is counseling clients on licensing agreements where the parties attempt to avoid setting forth definitive terms on contract provisions regarding...more
9/2/2020
/ Agreement To Agree ,
Appeals ,
Breach of Contract ,
Contract Negotiations ,
Contract Terms ,
Exclusive Licenses ,
Extrinsic Evidence ,
Genuine Issue of Material Fact ,
Injunctive Relief ,
IP License ,
Licensing Rights ,
Meeting of the Minds ,
Option Contracts ,
Patent Infringement ,
Patents ,
Plant Patents ,
Removal ,
Risk Management ,
Summary Judgment ,
Trademark Infringement
The Federal Circuit recently vacated a District Court decision by Federal Circuit Judge Dyk, sitting by designation, based on erroneous claim construction in Baxalta Inc. v. Genentech, Inc...more
ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...more
8/24/2020
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Generic Drugs ,
Hatch Act ,
Irreparable Harm ,
Likelihood of Success ,
Marketing Exclusivity Periods ,
Mylan Pharmaceuticals ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Takeda Pharmaceuticals
The Federal Circuit has spent the past few years applying the Supreme Court's most recent precedent, Nautilus, Inc. v. Biosig Instruments, Inc., on the indefiniteness standards in the patent statute. 35 U.S.C. § 112(b). The...more
8/14/2020
/ Appeals ,
Claim Construction ,
Extrinsic Evidence ,
Indefiniteness ,
Nautilus Inc. v. Biosig Instruments ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Reaffirmation
In a conundrum worthy of a law school civil procedure examination, plaintiff Gensetix found itself apparently with no remedy for infringement by Baylor College of Medicine, Diakonos Research Ltd., and William Decker of...more
7/29/2020
/ Appeals ,
Dismissals ,
Eleventh Amendment ,
Federal Rule 12(b)(1) ,
FRCP 19(a) ,
FRCP 19(b) ,
IP License ,
Joinder ,
Motion to Dismiss ,
Partial Reversal ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Reaffirmation ,
Remand ,
Remedies ,
Sovereign Immunity ,
State Universities ,
Treatment Method Patents
In a procedurally unusual decision (but one unsurprising in all other respects), the Federal Circuit on Monday affirmed a district court's denial of a temporary restraining order to keep off the market Amgen's biosimilar...more
The Federal Circuit held recently that the "all substantive rights" test, used heretofore to determine the identity of the "patentee" for purposes of satisfying 35 U.S.C. § 281, should be the standard for determining common...more
7/8/2020
/ Accord and Satisfaction ,
All Substantive Rights Test ,
Appeals ,
BPCIA ,
Common Ownership ,
Contract Terms ,
IP License ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Infringement ,
Patent Litigation ,
Patent Prosecution ,
Patent Royalties ,
Patent Validity ,
Patents ,
Standard of Review ,
Transfer of Rights ,
Written Descriptions
The Federal Circuit during 2019 and 2020 has issued a spate of decisions on the proper application of the Doctrine of Equivalents (see, e.g., UCB, Inc. v. Watson Laboratories Inc. and Galderma Laboratories, L.P. v. Amneal...more
In Amneal Pharmacueticals LLC v. Almirall, LLC, the Federal Circuit professed to address a question it had not considered before: whether attorney's fees and a exceptional case determination was available for fees and costs...more
6/9/2020
/ Appeals ,
Attorney's Fees ,
Counterclaims ,
Exceptional Case ,
Inter Partes Review (IPR) Proceeding ,
Litigation Fees & Costs ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry
By Kevin E. Noonan -- For several years, Sigma Aldrich has been prosecuting several applications (including USSNs 15/188,911; 15/188,924; and 15/456,204) claiming CRISPR technology that (it alleged) would be deserving of an...more
The 2019 Review of Notorious Markets for Counterfeiting and Piracy provides a list of such markets (the NML), of both physical and virtual (online) varieties. These include...more
5/15/2020
/ Copyright Infringement ,
Counterfeiting ,
Cyber Crimes ,
Digital Marketplace ,
Intellectual Property Protection ,
Malware ,
Notorious Markets List (NML) ,
Patent Infringement ,
Piracy ,
Risk Assessment ,
Risk Mitigation ,
Section 301 ,
Trademark Infringement ,
USTR
Infringement under the doctrine of equivalents (as a basis of a successful cause of action having renewed vigor before the Federal Circuit recently (see, e.g., "Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC") is...more
5/13/2020
/ Abbreviated New Drug Application (ANDA) ,
Declaration ,
Dedication-Disclosure Defense ,
Dismissals ,
Doctrine of Equivalents ,
Expert Witness ,
Judgment As A Matter Of Law ,
Judicial Discretion ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prosecution History Estoppel ,
Reaffirmation
On April 22, 2020, the Federal Circuit "grappled," as the opinion put it, with the equitable doctrine of assignor estoppel in Hologic, Inc. v. Minerva Surgical, Inc., the Federal Circuit "grappled," as the opinion put it,...more
5/12/2020
/ Appeals ,
Apportionment ,
Assignor Estoppel ,
Damages ,
IP License ,
Obviousness ,
Parallel Proceedings ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Unclean Hands
The Federal Circuit continued its explication of the standing issue for unsuccessful petitioners in inter partes review (see "Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp. (Fed. Cir. 2020)") in Pfizer Inc. v....more
5/11/2020
/ Appeals ,
Burden of Proof ,
Dismissals ,
Final Written Decisions ,
Injury-in-Fact ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pfizer ,
Pharmaceutical Patents ,
Standing
On April 20th, the Patent Trial and Appeal Board (PTAB) set oral argument in Interference No. 106,155, between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively,...more
5/5/2020
/ Court Schedules ,
CRISPR ,
DNA ,
Interference Claims ,
Life Sciences ,
Oral Argument ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Public Hearing ,
Teleconferences
In 1984, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) shepherded a grand legislative compromise through Congress that balanced the rights and solved inefficient regulatory consequences for both branded and generic...more
5/4/2020
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Dismissals ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Patents ,
Reaffirmation
On March 23rd Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") filed its Reply to Junior Party the University of California/Berkeley, the University...more
Yesterday, in Thryv, Inc. v. Click-to-Call Technologies, LP, the Supreme Court ruled that the provisions of 35 U.S.C. § 315(b), which preclude a petitioner from filing an inter partes review petition more than one year after...more
4/21/2020
/ § 314(d) ,
§ 315(b) ,
America Invents Act ,
Appeals ,
Cuozzo Speed Technologies v Lee ,
Dissenting Opinions ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Non-Appealable Decisions ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Reversal ,
SCOTUS ,
Thryv Inc v Click-To-Call Technologies LP ,
Time-Barred Claims
Yesterday, in Thryv, Inc. v. Click-to-Call Technologies, LP[i], the Supreme Court ruled that the provisions of 35 U.S.C. § 315(b)[ii], which preclude a petitioner from filing an inter partes review petition more than one year...more
4/21/2020
/ § 314(d) ,
§ 315(b) ,
America Invents Act ,
Appeals ,
Cuozzo Speed Technologies v Lee ,
Dissenting Opinions ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Non-Appealable Decisions ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
SAS Institute Inc. v Iancu ,
SCOTUS ,
Thryv Inc v Click-To-Call Technologies LP ,
Time-Barred Claims ,
Vacated
In what may be simple happenstance, the Federal Circuit issued opinions on the same day reversing a District Court grant of summary judgment in opinions written by Judge Lourie, here in BASF Corp. v. SNF Holding Co....more
4/13/2020
/ Anticipation ,
Appeals ,
Exploitation ,
IP License ,
Obviousness ,
On-Sale Bar ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patents ,
Prior Art ,
Public Use ,
Reversal ,
Section 102 ,
Summary Judgment
Summary judgment, while clearly advantageous, requires that there be no disputed question of material fact and that the moving party is entitled to judgment as a matter of law. When a district court grants judgment...more