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
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
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
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
Inexorable, inevitable, and regrettable are three words that come to mind with publication from the Report from Special Committee of the Federal Circuit (composed of Chief Judge Moore and Judges Prost and Taranto)...more
The doctrine of equivalents (DOE), a creation of the Supreme Court in Graver Tank & Mfg. v. Linde Air Products (1950), is balanced by the concept of prosecution history estoppel (PHE), the contours of which were delineated...more
7/23/2025
/ Appeals ,
Doctrine of Equivalents ,
Inventions ,
Medical Devices ,
Medical Technology Companies ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Prosecution History Estoppel ,
Summary Judgment
Received wisdom is that inter partes review proceedings are limited to prior art as defined by patents and printed publications. But in recently decided Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., another prior...more
Patent law in many respects has its own language and idiosyncratic expressions, and one such respect involves so-called "transitional" words or phrases (discussed in greater depth in the Manual of Patent Examination Procedure...more
Almost two decades ago the Supreme Court handed down what has turned out to be one of its most significant patent decisions of this century: eBay v. MercExchange. The eBay case has had the effect of precluding prevailing...more
Almost two decades ago, the Supreme Court handed down what has turned out to be one of its most significant patent decisions of this century: eBay v. MercExchange. The eBay case has had the effect of precluding prevailing...more
As has been noted recently (Agilent Technologies, Inc. v. Synthego Corp.), fact-based decisions from the U.S. Patent and Trademark Office (typically from the Patent Trial and Appeal Board) are reviewed under the substantial...more
One of the assumptions, or promises, or hopes, attendant on the inauguration of post-grant review proceedings (particularly inter partes reviews) under the Leahy-Smith America Invents Act was that, as in European Opposition...more
An argument could be made that one of the most significant Supreme Court decisions in U.S. patent law in the last thirty years was Dickinson v. Zurko. In that case the Court held that the Federal Circuit was bound by the...more
The evolution of subject matter eligibility after the Supreme Court's decisions in Prometheus v. Mayo, Alice v. CLS Bank, and Association for Molecular Pathology v. Myriad Genetics has resulted in a regime of predictable...more
United Therapeutics Corp. (UTC) and Liquidia Technologies Inc. have been battling for close to a decade over their respective inhaled formulations of treprostinil (UTC's Tyvaso®, Liquidia's Yutrepia™) for treatment of...more
In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging...more
Only a few days after the one-year anniversary of hearing oral argument, the Federal Circuit handed down its decision in Regents of the University of California v. Broad Institute, Inc. on Monday. The opinion reviewed the...more
Only a few days after the one-year anniversary of hearing oral argument, the Federal Circuit handed down its decision in Regents of the University of California v. Broad Institute, Inc. In short -- and to be explicated more...more
On April 29th, Ambassador Jamieson Greer, U.S. Trade Representative (USTR), issued the 2025 Special 301 Report. In a press release (being quite different in tone from many over the past decade), the USTR stated that "[o]ur...more
5/7/2025
/ China ,
Copyright Infringement ,
Enforcement Actions ,
Intellectual Property Protection ,
International Trade ,
Mexico ,
Pharmaceutical Industry ,
Popular ,
Trade Secrets ,
Trademarks ,
US Trade Policies
The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange...more
When a prevailing challenger withdraws from an appeal in post-grant proceedings, the Director can intervene under 35 U.S.C. § 143, which is what happened in an appeal in Sage Products, LLC v. Stewart after Challenger Becton...more
The inter partes review provisions of the Leahy-Smith America Invents Act have been criticized for the propensity of the Patent Trial and Appeal Board (PTAB) to find invalid all or at least some of the challenged claims,...more
The dispute between the Judicial Council of the Federal Circuit and The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit has been waging for more than a year (see links below). The...more
Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be...more
Sometimes important contributions to innovation can come from the mundane rather than the extraordinary. One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the...more
3/14/2025
/ Appeals ,
Claim Construction ,
DNA ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Summary Judgment