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Reasons for the PTAB’s Priority Determination in Broad’s Favor (Perhaps)

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

PTAB (Again) Awards Priority of Invention to Broad in Interference No. 106,115

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

Judicial Conduct and Disability Committee Has Its Say, Denies Judge Newman’s Latest Request for Review – Patent Docs

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

Parties File Supplemental Priority Statements in CRISPR Interference

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

Meanwhile, Back at the PTAB with CRISPR – Update

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

Judge Newman Seeks Recourse from Supreme Court

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

Quo Vadis mRNA Vaccine Technology? The State of the IP Lawsuits

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

Moderna Settles Patent Litigation with Arbutus et al.

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

BioNTech Sues Moderna over mRNA Vaccine Technology

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

REGENEXBIO Inc. v. Sarepta Therapeutics, Inc. (Fed. Cir. 2026)

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

Bayer Files Suit Against Trio of COVID-19 Vaccine Makers

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

Allen v. Cooper (4th Cir. 2026)

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

Supreme Court to Resolve Dispute Over Marketing of “Skinny Labeled” Generics

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

Solicitor General Proves Persuasive; Supreme Court Grants Hikma’s Certiorari Petition

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

Ethanol Boosting Systems, LLC v. Ford Motor Co. (Fed. Cir. 2025)

The preclusive scope of 35 U.S.C. § 314(d) regarding decisions on instituting post grant review proceedings (specifically, inter partes review or IPR) has been decided several times by the Supreme Court since enactment of the...more

Judge Newman’s Petition for Rehearing En Banc Denied

The D.C. Circuit Court today denied Judge Pauline Newman’s request for rehearing en banc of the panel decision handed down by the Court on August 22, 2025 (see “Judge Newman’s Challenge Fails at D.C. Circuit“). That decision...more

Teva Capitulates to Federal Trade Commission Coercion

Over several years and two administrations (see “FTC Announces Efforts to Police Pharmaceutical Companies’ Patent Behavior“; “FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy“; “Federal Trade...more

USPTO Issues Notice Regarding Improper Small and Micro Entity Status

The new Director of the Patent and Trademark Office, Undersecretary of Commerce for Intellectual Property John A. Squires has spent the last few weeks making serious policy changes in the Office (see “New Director Overturns...more

Aortic Innovations LLC v. Edwards Lifesciences Corp. (Fed. Cir. 2025)

In a seemingly otherwise run-of-the-mill, albeit precedential, decision, the Federal Circuit affirmed a stipulated judgment of non-infringement in Aortic Innovations LLC v. Edwards Lifesciences Corp....more

FDA Releases Draft Guidance Reducing Stringency for Biosimilar Approval

It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general inclination is true of the Department of Health and Human Services and the agencies...more

New Director Overturns PTAB Procedural Precedents: Part I

The advent of a new administration always carries with it changes in how the laws are executed and applied, and patent law is both no exception and tends (at least in recent years) to appear to be fraught with dramatic...more

Judge Newman's Challenge Fails at D.C. Circuit

Congress in writing laws is faced with a dilemma. On the one hand the laws must be sufficiently clear and specific to enable enforcement, but on the other, the myriad of circumstances that can arise make it impossible to...more

DexCom, Inc. v. Stewart (Fed. Cir. 2025)

The Federal Circuit affirmed a decision by the U.S. Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB) in an inter partes review prompted by an infringement allegation in DexCom, Inc. v....more

In re BAC IP B.V. (Fed. Cir. 2025)

A patent applicant dissatisfied by an patent examiner's rejection of that applicant's claims in ex parte prosecution has recourse by appeal to the Patent Trial and Appeal Board (PTAB) under 35 U.S.C. § 134, and to the Federal...more

American Science and Engineering, Inc. v. Stewart (Fed. Cir. 2025)

Under Dickinson v. Zurko courts (specifically, the Federal Circuit) should defer to factual determinations by administrative agencies like the U.S. Patent and Trademark Office unless they are not supported by substantial...more

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