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
Turns Out, Early Humans Not the Cause of Woolly Rhinoceros Extinction -
Paleogenomics (the use of genetic analysis of DNA contained in ancient remains) has developed rapidly since Svante Pääbo first showed that DNA could...more
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
Ninth Circuit Overturns District Court Judge Lucy Koh's Decision That Qualcomm's Licensing and Chip Sales Practices Are Antitrust Violations -
The Federal Trade Commission has a history of taking positions and aggressively...more
8/14/2020
/ Anticompetitive Behavior ,
Antitrust Violations ,
Appeals ,
Cell Phones ,
Federal Trade Commission (FTC) ,
FTC Act ,
IP License ,
Microchip Technology ,
Monopolization ,
OEM ,
Patents ,
Preliminary Injunctions ,
Qualcomm ,
Restraint of Trade ,
Reversal ,
Section 5 ,
Sherman Act ,
Vacated
Federal Circuit (Again) Hands Down Revised Opinion in Response to Petition for Rehearing -
Recently the Federal Circuit has begun a practice of withdrawing an original opinion and handing down a substitute opinion in...more
8/11/2020
/ Abstract Ideas ,
Appeals ,
CLS Bank v Alice Corp ,
En Banc Review ,
Mayo v. Prometheus ,
Partial Reversal ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
Product of Nature Doctrine ,
Reaffirmation ,
Remand ,
Section 101 ,
Summary Judgment ,
Vacated
Chemotherapeutic drug resistance is one reason cancer remains an unsolved clinical problem despite the efforts ever since President Nixon declared his "War on Cancer" in 1971. Cancer cells, due in part to the genetic...more
Federal Circuit Hands Down Modified Opinion in Illumina, Inc. v. Ariosa Diagnostics, Inc.
Earlier this year, the Federal Circuit (somewhat surprisingly) found claims of two Sequenom patents directed to methods for...more
8/6/2020
/ Appeals ,
Diagnostic Method ,
DNA ,
Life Sciences ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
Product of Nature Doctrine ,
Reversal ,
Section 101 ,
Treatment Method Patents
Last week, the Federal Circuit took the opportunity presented in an appeal from judgment on the pleadings in XY, LLC v. Trans Ova Genetics, LC to distinguish claims directed toward a patent-eligible invention from...more
8/4/2020
/ Abstract Ideas ,
Appeals ,
CLS Bank v Alice Corp ,
Judgment on the Pleadings ,
Patent Invalidity ,
Patent-Eligible Subject Matter ,
Patents ,
Popular ,
Remand ,
Reversal ,
Section 101
One of the signal public health achievements/victories of the 20th Century is the eradication of smallpox (variola virus, VARV) announced by the World Health Organization (WHO) in 1980; it has been estimated that smallpox...more
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
As the COVID-19 pandemic has disrupted life throughout the world this spring, bats have been a prominent feature in news stories and recriminations about how the pandemic started (and being blamed even more than happenings in...more
Arthrex recently filed a(nother) certiorari petition with the Supreme Court, this time in Arthrex, Inc. v. Smith & Nephew, Inc., which has also been the subject of petitions from the U.S. government and Smith & Nephew. (This...more
7/20/2020
/ Administrative Patent Judges ,
America Invents Act ,
Appointments Clause ,
Arthrex Inc v Smith & Nephew Inc ,
Congressional Intent ,
Constitutional Challenges ,
Due Process ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patents ,
Petition for Writ of Certiorari ,
SCOTUS ,
Severability Doctrine
Last fall, the Federal Circuit decided in Arthrex, Inc. v. Smith & Nephew, Inc. that Administrative Patent Judges (APJs) serving on the Patent Trial and Appeal Board (PTAB) were principal officers and thus had been improperly...more
7/16/2020
/ Administrative Patent Judges ,
Appeals ,
Appointments Clause ,
Arthrex Inc v Smith & Nephew Inc ,
Director of the USPTO ,
En Banc Review ,
Inter Partes Review (IPR) Proceeding ,
Patent Trial and Appeal Board ,
Petition for Writ of Certiorari ,
Principle Officers ,
SCOTUS ,
Split of Authority ,
USPTO
Arthrex recently filed a certiorari petition with the Supreme Court in Arthrex v. Smith & Nephew Inc. (a case related to Arthrex, Inc. v. Smith & Nephew, Inc., which has also the subject of petitions from the U.S. government...more
7/16/2020
/ Administrative Patent Judges ,
America Invents Act ,
Appeals ,
Application of Intervening Laws ,
Appointments Clause ,
Arthrex Inc v Smith & Nephew Inc ,
Constitutional Challenges ,
Effective Filing Date ,
Fifth Amendment ,
Forfeiture ,
Inter Partes Review (IPR) Proceeding ,
Petition for Writ of Certiorari ,
Retroactive Application ,
SCOTUS ,
Split of Authority ,
Takings Clause
While the Federal Circuit's decision last fall in Arthrex, Inc. v. Smith & Nephew, Inc. raised issues about the appointment of Administrative Patent Judges (APJs) serving on the Patent Trial and Appeal Board (PTAB), it should...more
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 domesticated chicken, Gallus gallus domesticus, is the most numerous domestic animal and a preferred source of animal protein. Chicken domestication has been thought (based on traditional measures) to have arisen in the...more
Genetic instability has long been recognized as a hallmark of oncogenesis and tumor progression. The phenomenon was first identified cytogenetically, most famously by the Philadelphia chromosome in chronic myelogenous...more
There is little rhyme nor reason in the cases the Supreme Court decides to review. But the Court has patterns in its case selection that do (to some degree) probe what the Justices think are important questions. One pattern...more
6/25/2020
/ America Invents Act ,
Constitutional Challenges ,
Denial of Certiorari ,
Fifth Amendment ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Post-Grant Review ,
Retroactive Application ,
SCOTUS ,
Takings Clause
On June 10th, Judge Manish S. Shah, U.S. District Court Judge for the Northern District of Illinois, dismissed (without prejudice) a class action lawsuit against AbbVie and AbbVie Biotechnology Ltd. by consumer groups, drug...more
6/23/2020
/ AbbVie ,
Antitrust Litigation ,
Antitrust Violations ,
Biosimilars ,
Biotechnology ,
Class Action ,
Competition ,
Generic Drugs ,
Patent Applications ,
Patent Dance ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Sherman Act
The written description requirement has had a twenty-five year renaissance, particularly in the chemical and biotechnology arts as a way of restricting claim scope to what an inventor has actually invented (see Regents of the...more
6/22/2020
/ Abbreviated New Drug Application (ANDA) ,
Collateral Estoppel ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
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
Measured by global dispersal alone, the common house mouse (Mus musculus ssp.) is the most successful invasive mammalian species. Perhaps surprisingly, the origin and history of this dispersal in the Western world has not be...more
The inherent, ineluctable unpredictability of biology can be the basis for biological patent claims being non-obvious (lacking the requisite "reasonable expectation of success"; see, e.g., OSI Pharmaceuticals v. Apotex) and...more