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
On December 3rd, Senior Party Sigma-Aldrich filed its Preliminary Motion No. 1 that asked the Board to deny the Broad Institute, Harvard University, and MIT (collectively, Broad) benefit of its U.S. Provisional Application...more
On November 19th, Senior Party Sigma-Aldrich filed its Substantive Preliminary Motion No. 1 in CRISPR Interference No. 106,132, asking the Board to substitute the Count pursuant to 37 C.F.R. §§ 41.121(a)(1)(iii) and...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
On a spring Saturday in a year when three major holidays -- Easter, Passover, and Ramadan -- coincided or overlapped, The New York Times Editorial Board decided it was time to announce that the "United States Patent and...more
As posted Monday, BIO (the Biotechnology Innovation Organization) provided a link to the supposed compromise agreement reached recently to permit WTO member states to waive patent protection for "subject matter required for...more
On February 18th, Senior Party Sigma-Aldrich filed its Opposition to Substantive Preliminary Motion No. 3 from the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively,...more
On March 16th, the Federal Circuit denied Biogen's petition for panel rehearing and rehearing en banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc. Judges Cunningham and Stoll did not participate in the decision, which...more
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
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
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 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 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
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
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
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 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
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
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 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
On May 28th, Junior Party the Broad Institute, Harvard University and MIT (collectively, "Broad") filed its Preliminary Motion No. 2 in CRISPR Interference No. 106,126 (where ToolGen is the Senior Party), contingent on the...more
On May 20th, Senior Party ToolGen filed its Substantive Motion No. 1 for benefit of priority to U.S. Provisional Application No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen 5 P3"), or alternatively, International...more
In June, Senior Party ToolGen filed its Substantive Preliminary Motion No. 2 to deny Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") priority...more