The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act...more
When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim? This is a question that comes readily to mind...more
While the Federal Circuit has patent law as its principal focus, as a U.S. Circuit Court of Appeals, questions come before the Court on more mundane, procedural matters (which, sometimes being dispositive, does not reduce...more
Following a telephone conference held on August 16th (a transcript of which can be found here) between the Board and representatives of Junior Party the University of California/Berkeley, the University of Vienna, and...more
Following a telephone conference held on August 16th between the Board and representatives of Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) and Senior Party Sigma-Aldrich, the Board...more
There are some cases where the Federal Circuit makes its decision based on the eternal verities of patent law (insofar as there are any eternal verities in patent law). One such decision arose earlier this month when the...more
The issue of standing can be outcome-determinative: without it, no matter how worthy a party's position or arguments, a court will not consider them without standing. The vagaries of standing and its importance were...more
The parties in Interference No. 106,132, namely Senior Party Sigma-Aldrich and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC"), filed their...more
The parties in Interference No. 106,133, namely Senior Party Sigma-Aldrich and Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad"), filed their respective lists of proposed preliminary...more
On June 21st,* the Patent Trial and Appeal Board declared two new interferences involving CRISPR technology. The first, Interference No. 106,132, named Sigma-Aldrich as Senior Party and the University of California/Berkeley,...more
The domestic cat has been the subject of much study, recently involving its genetic structure, genomic DNA sequence, and comparisons with other felines. The first such study was published in 2014, when an international...more
An enduring and persistent (albeit until now unresolved) issue in the patent interferences involving the Broad Institute, Harvard University, and MIT (collectively, "Broad") as Senior Party and the University of...more
It is well to recall that the battle over inventorship and thus ownership of CRISPR technology is not limited to the parties in the various interferences surrounding the Doudna and Zhang patents and applications (see "CRISPR...more
As is well-known, Congress established the Federal Circuit as a circuit court of appeals to harmonize U.S. patent law in an environment where regional Circuit Courts had developed their own judicial interpretations of the...more
The Leahy-Smith America Invents Act prescribed two very different post-grant review proceedings in U.S. patent law. The first, post-grant review (PGR), had some analogies with European opposition practice, in that petitions...more
On October 1st, Senior Party ToolGen Inc. filed its Motion to Exclude certain evidence presented by Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") in Interference No. 106,126. Broad...more
In its turn, on September 17th, Senior Party ToolGen Inc. filed its Motion to Exclude certain evidence presented by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier...more
11/22/2021
/ CRISPR ,
Hearsay ,
Hearsay Exceptions ,
Inadmissible Evidence ,
Interference Claims ,
Life Sciences ,
Motion to Exclude ,
Objections ,
Patent Litigation ,
Patents ,
Prior Art ,
Rule of Evidence 702
On September 17th, Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") filed its Motion to Exclude certain evidence presented by Senior Party ToolGen...more
Joint inventorship has been called "one of the muddiest concepts in the muddy metaphysics of patent law" because the "exact parameters of what constitutes joint inventorship are quite difficult to define." Mueller Brass Co....more
11/18/2021
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Joint Inventors ,
Obviousness ,
Patent Applications ,
Patent Infringement ,
Patent Ownership ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Patents ,
Prior Art
The Federal Circuit continued its stringent (if misguided) application of the scope of subject matter eligibility by invalidating claims asserted in CardioNet, LLC v. InfoBionic, Inc....more
The inter partes review (IPR) provisions of the Leahy-Smith America Invents Act have been castigated by many for the propensity of the Patent Trial and Appeal Board (PTAB) to find claims challenged in these proceedings to be...more
11/12/2021
/ America Invents Act ,
Claim Construction ,
Expert Testimony ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Preponderance of the Evidence ,
Printed Publications
It being the holiday season in America, it is perhaps appropriate that patent traditionalists get something more than coal in their stocking from Representatives Massie (R-KY), Gohmert (R-TX), Gosar (R-AZ), and McClintock...more
11/11/2021
/ America Invents Act ,
Board of Patent Appeals ,
Inter Partes Review (IPR) Proceeding ,
Patent Applications ,
Patent Litigation ,
Patent Reform ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Post-Grant Review ,
Section 101
The question of the proper court for a branded pharmaceutical maker to bring suit against an Abbreviated New Drug Application filer under the Hatch-Waxman Act is surprisingly unsettled seeing as the Act was enacted in 1984. ...more
11/10/2021
/ Abbreviated New Drug Application (ANDA) ,
Hatch-Waxman ,
Leave to Amend ,
Motion to Dismiss ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Principal Place of Business ,
Venue
In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft...more
On May 28th, Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") filed its Substantive Preliminary Motion No. 1 in CRISPR Interference No. 106,126, where ToolGen is the Senior Party. On...more