In a decision that, in retrospect, is not surprising (in view of the haste with which the Court took up the case after granting certiorari; see “Solicitor General Proves Persuasive; Supreme Court Grants Hikma’s...more
The measurement of the hydrogen ion concentration in an aqueous solution is represented (on a logarithmic scale) as the pH, wherein water under ambient conditions (a temperature of 25°C) has a neutral pH of 7 and the solution...more
The United States recently filed a Statement by the Antitrust Division of the Department of Justice under the provisions of 28 U.S.C. § 517 regarding the “Interests of United States in pending suits” in Corteva Agriscience...more
On April 27, the Supreme Court heard oral argument in Hikma v. Amarin, with Charles Klein, representing Hikma, Michael Huston representing Amarin, and Malcolm Stewart addressing the Court on behalf of the Government....more
While the Supreme Court established a rather definitive standard (“reasonable certainty by a person having ordinary skill in the art”) for determining indefiniteness under 35 U.S.C. § 112(b) in Nautilus, Inc. v. Biosig...more
In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf...more
In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf...more
In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf...more
5/5/2026
/ Drug Pricing ,
Generic Drugs ,
Hatch-Waxman ,
Induced Infringement ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Regulatory Requirements ,
SCOTUS
In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label” prescribing for indications not...more
A distinguished groups of retired judges* filed an amicus brief supporting Judge Pauline Newman’s Petition for Certiorari over the unwillingness of the Court of Appeals for the D.C. Circuit to rule on her complaint regarding...more
In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label” prescribing for indications not...more
The Federal Circuit reversed a District Court grant of judgment as a matter of law (JMOL) that overturned a jury verdict that defendant Eli Lilly had not satisfied the clear-and-convincing-evidence standard in challenging on...more
The alacrity with which the Patent Trial and Appeal Board (PTAB) came to the same conclusion in its latest priority determination in favor of the Senior Party in interference No. 106,115 that it had almost eleven months ago...more
On March 26, the Patent Trial and Appeal Board, without holding an oral hearing and despite a rather sharply worded opinion by the Federal Circuit vacating and remanding its earlier priority decision (see “Regents of the...more
The course of the proceedings involving the attempts to remove Judge Pauline Newman from the Federal Circuit is long, and in many senses tragic (see links below). Just when you might think the last Act has begun (see “Judge...more
The Parties – Senior Party Broad Institute, Harvard University, and MIT (collectively, “Broad”) and Junior Party Regents of the University of California, Berkeley; University of Vienna; and Emmanuelle Charpentier...more
Neither the Parties nor the Patent Trial and Appeal Board (PTAB) have been resting in addressing the decision by the Federal Circuit that vacated and remanded the Board’s decision awarding priority in Interference No. 106,115...more
The course of the proceedings involving the attempts to remove Judge Pauline Newman from the Federal Circuit is long and in many senses tragic (see links below). Last week the latest, and likely last, Act of this sad drama...more
One of the beneficial characteristics of the response to the COVID -19 pandemic were pledges from companies involved in developing vaccines (such as Moderna, Pfizer, BioNTech, and others) not to enforce patents on relevant...more
A consequence of the gradual decline in COVID infections worldwide has been a less gradual increase in patent litigation by the many entities having patent rights for the vaccines or components of them. This is particularly...more
3/11/2026
/ Appeals ,
Department of Justice (DOJ) ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Settlement
One of the paradoxically beneficial consequences of the COVID pandemic was that even without the compulsory aspects of the vaccine patent waiver proposed by certain WTO member states (Brazil, India, and South Africa in...more
A consequence of the Supreme Court’s assault on subject matter eligibility a dozen years or so ago was that the patent defense bar presented the judiciary with ever more stringent standards and extreme if not fanciful...more
One of the characteristics of the response to the COVID-19 pandemic were the pledges from companies involved in developing vaccines (such as Moderna, Pfizer, BioNTech, and others) not to enforce patents on relevant technology...more
Dickens’s Bleak House has long stood as an exemplar for the perils of interminable litigation where no one benefits (except, perhaps, the lawyers; see Jarndyce v. Jarndyce). In a case already somewhat notorious for its...more
The Hatch-Waxman Act has always represented a delicate balance between the interests of innovator and generic drugmakers: innovators seek to maintain exclusivity as broadly and long as possible, generics seek to come to...more