The PTAB held an Oral Hearing between Junior Party the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") and Senior Party ToolGen on September 12th, bringing to a close...more
The Patent Trial and Appeal Board held an Oral Hearing between Junior Party the Broad Institute, Harvard University and MIT (collectively, "Broad") and Senior Party ToolGen on September 12th, bringing to a close proceedings...more
President Biden announced his signing of an Executive Order launching a major effort to enhance U.S. capabilities in biotechnology and biomanufacturing last week (see "President Biden Signs Executive Order on Biotechnology...more
On Monday, September 12th, President Biden signed an Executive Order entitled "Advancing Biotechnology and Biomanufacturing Innovation for Sustainable, Safe and Secure American Bioeconomy."
The Executive Order (in Section...more
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
On Friday, August 26th, Moderna Tx, Inc. and Moderna US, Inc. filed a complaint for patent infringement in Federal district court for the District of Massachusetts against Pfizer, Inc., BioNTech SE, BioNTech Manufacturing...more
On August 16th, the Patent Trial and Appeal Board rescheduled back-to-back oral hearings for interferences between ToolGen Inc. (Senior Party) and Junior Party The Broad Institute, Massachusetts Institute of Technology...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
For most of the past decade, the Supreme Court has been marking out the metes and bounds of the Patent Trial and Appeal Board's execution of the post-grant review provisions of the Leahy-Smith America Invents Act,...more
The consequences of expressly recited claim limitations and how patentees can be held to these limitations was illustrated in the Federal Circuit's recent decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. ...more
Last year, the Supreme Court declined an invitation to abrogate the doctrine of assignor estoppel by an assignor sued for patent infringement in Minerva Surgical v. Hologic. Nevertheless, the Court followed its proclivities...more
A little more than three years ago, the Federal Circuit rejected the University of Minnesota's contention that LSI was barred from bringing (and the Patent Trial and Appeal Board barred from hearing) an inter partes review of...more
As promised in our earlier post (see "Professor Sarnoff Provides His Perspective on Tillis Bill"), here we turn to Professor Joshua Sarnoff's thoughts on the portions of Senator Thom Tillis' (R-NC) bill regarding diagnostic...more
Patent Docs has always ascribed to the notion that respectful debate is good for most issues, and with the adage that if you are dumb, it's best to surround yourself with smart people and if you are smart surround yourself...more
Senator Thom Tillis (R-NC) introduced S. 4734, entitled "A Bill to amend Title 35, U.S. Code, to address matters relating to patent subject matter eligibility, and for other purposes" last night, as was discussed in an...more
A little over two years ago, U.S. District Court Judge Manish Shah sitting in the Northern District of Illinois held that AbbVie did not violate Sections 1 or 2 of the Sherman Antitrust Act by amassing a large number (132) of...more
Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (at right) released a blog post on the USPTO's Director's Blog on Monday addressing the fraught subject...more
The Federal Circuit today appealed determinations by the Patent Trial and Appeal Board (PTAB) in an inter partes review in American National Manufacturing v. Sleep Number Corp., in an opinion by Judge Cunningham. The opinion...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
Plus ça change, plus c'est la même chose -
Judge Moore, in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC stated the obvious when she said in her dissent: My colleagues' refusal deflates the Amici's hopeful...more
Almost four years ago, in a relatively rare occurrence based on there being an insufficient factual record to permit proper appellate review, the Federal Circuit vacated a District Court decision rendering invalid the claims...more
The Federal Circuit today affirmed a decision by the District Court denying defendant Thales DIS AIS Deutschland USA's motion for preliminary injunction to prevent patentee plaintiff Koninklijke Philips N.V. from obtaining an...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
In a month where the Supreme Court's conservative majority has exercised its judicial muscle by striking down several well-established precedents, one portion of their jurisprudence is as fixed a constant as the Northern...more