It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs...more
On August 2nd, Coherus Biosciences announced FDA approval for its Cimerli™ (ranibizumab-eqrn) product, as an interchangeable biosimilar to Genentech/Roche's Lucentis® (ranibizumab). This biologic drug is a vascular...more
Penguins are unique among bird species, having lost the ability to fly more than 60 million years ago and adopting a "hyperspecialized marine body plan" consistent with their unique habitat in the higher latitudes of the...more
On July 20th, the FDA released draft Guidance regarding its standards on therapeutic equivalence (TE) between both biologic and small molecule (NCE) drugs. The definition of "therapeutic equivalence" in the Guidance is...more
An international cadre of scientists* from almost 70 institutions worldwide recently reported their findings in the scientific journal Nature that the domesticated dog (Canis familiaris) arose from two populations of...more
Captioned disarmingly as a Notice of Related Proceedings under 37 C.F.R. § 41.8(a)(1) and ¶ 8.2 of the Standing Order, Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier...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
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 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
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
On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed Substantive Preliminary 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 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 Contingent Preliminary Motion No. 3 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...more
The consequences of joint development agreements, particularly under circumstances where later development is pursued independently by the parties, can create, inter alia, allegations of improper ownership and infringement if...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
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 March 16th, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Opposition to Substantive Preliminary Motion No. 1 filed on December 3rd by Senior Party Sigma-Aldrich. To recap,...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
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. 4* from the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively,...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 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