On February 18th, Sigma-Aldrich filed its Opposition to Junior Party's (the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC") Substantive Preliminary Motion No. 1...more
Inventorship determinations have been called, in some of their incarnations, "one of the muddiest concepts in the muddy metaphysics of patent law." Mueller Brass Co. v. Reading Indus., 352 F. Supp. 1357, 1372 (E.D. Pa....more
In an 82-page decision, the Patent Trial and Appeal Board granted priority for eukaryotic CRISPR to the Broad Institute, Harvard University, and MIT (collectively, "Broad") as Senior Party and against Junior Party the...more
In a crowded pharmaceutical art, the deficiencies thereof being so patent that the FDA encouraged industry to address and correct them, concerning a formulation developed to address the opioid crisis raging earlier in this...more
On December 3rd, Senior Party Sigma-Aldrich filed its Substantive Preliminary Motion No. 2 in Interference No. 106,133 (which names the Broad Institute, Harvard University, and MIT (collectively, Broad) as Junior Party),...more
On December 3rd, Senior Party Sigma-Aldrich filed its Substantive Preliminary Motion No. 1 in Interference No. 106,133 (which names the Broad Institute, Harvard University, and MIT (collectively, Broad) as Junior Party),...more
The 2020 decision by a divided Federal Circuit panel in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA regarding the extent to which an ANDA applicant who obtained regulatory approval under the Section viii carve-out...more
On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Contingent Preliminary Motion No. 3 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...more
On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Contingent Preliminary Motion No. 2 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...more
The Patent Trial and Appeal Board heard oral argument under 37 C.F.R. § 41.124(c) on February 4th in the Priority Phase of Interference No. 106,115 between the Broad Institute, Harvard University, and MIT (collectively,...more
On Wednesday, the U.S. Food and Drug Administration announced approval to Mylan Pharmaceuticals for a generic form of Allergan's RESTASIS® (Cyclosporine Ophthalmic Emulsion 0.05%) product for treatment of chronic dry eye. ...more
On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Substantive Preliminary Motion No. 1 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...more
Pursuant to the Patent Trial and Appeal Board Order issued November 29, 2021, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") on December 17,...more
The Patent Trial and Appeal Board has set February 4th at 1:00 pm EST for the Oral Hearing in the Priority Phase of Interference No. 106,115 between the Broad Institute, Harvard University, and MIT (collectively, "Broad") as...more
On November 19th, Senior Party Sigma-Aldrich filed its Substantive Preliminary Motion No. 1 in CRISPR Interference No. 106,132 (where the Broad Institute, Harvard University and MIT, collectively, "Broad" is the Junior Party)...more
On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Miscellaneous Motion No. 4 in Interference No. 106,132...more
On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Preliminary Motion No. 3 in Interference No. 106,132...more
On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Preliminary Motion No. 1 in Interference No. 106,132...more
On January 6, 2022, the U.S. Patent and Trademark Office announced a new program with the goal of increasing examiner efficiency. The Deferred Subject Matter Eligibility Response (DSMER) Pilot Program will launch on February...more
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