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Chromadex, Inc. v. Elysium Health, Inc. (Fed. Cir. 2023)

Judge Giles Sutherland Rich, famous for many things (including being the principal author of the 1952 Patent Act and in particular Section 103, which cabined at least for a while the Supreme Court’s penchant for invalidating...more

Astellas US LLC v. Hospira, Inc. (Fed. Cir. 2022)

In perhaps one of his most infelicitous lyrics* Bob Dylan inserted the adage that it is unwise to change horses in midstream.  This lesson comes to mind with regard to the Federal Circuit's decision late last year regarding...more

Amgen Files Its Principal Brief in Amgen v. Sanofi

Facing what is likely to be something of an uphill battle in seeking to have the Federal Circuit's decision against it in Amgen v Sanofi overturned before a not always patent-friendly Supreme Court, Amgen in late December...more

Alternative Reasoning for Supreme Court's Life Sciences Subject Matter Eligibility Jurisprudence

Last week, IP Law360 published an erudite and provocative article by Joseph Matal and his colleagues regarding the Supreme Court's recent subject matter jurisprudence in the context of earlier decisions in the 19th and early...more

President Biden's Biotechnology and Biomanufacturing Executive Order: Funding

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

President Biden Signs Executive Order on Biotechnology and Biomanufacturing Innovations

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

Moderna Sues Pfizer and BioNTech over mRNA Vaccine Technology

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

Oral Arguments Rescheduled in CRISPR Interferences

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

Penguin Genetics Suggests Complex History

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

Hologic, Inc. v. Minerva Surgical, Inc. (Fed. Cir. 2022)

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

More on Professor Sarnoff's Perspective on Tillis Patent Eligibility Bill

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

Professor Sarnoff Provides His Perspective on Tillis Bill

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 Tillis' Patent Eligibility Reform Proposal: A Biopharma Perspective

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

USPTO Director's Blog Post Extolling Certainty in § 101 Determinations Paradoxically Increases Uncertainty

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

CareDx, Inc. v. Natera, Inc. (Fed. Cir. 2022)

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

Solicitor General Provides Government Views in American Axle & Mfg. Inc. v. Neapco Holdings Co.

The faintest glimmer of hope crept over the clouded patent law horizon today, when the Solicitor General provided the government's views to the Supreme Court in an amicus brief in American Axle & Manufacturing, Inc.,...more

U.S. Trade Representative Releases 2022 Special 301 Report

On April 27th, apparently without a trace of irony, Ambassador Katherine Tai, U.S. Trade Representative (USTR), issued the 2022 Special 301 Report.  In a press release, the USTR stated that "[i]ntellectual property-intensive...more

BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation (Fed. Cir. 2022)

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

Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC (Fed. Cir. 2022)

U.S. patent law grants patent owners the right to grant licenses to their patents in analogy to landlords granting rents to real property as a license to use without obtaining ownership.  35 U.S.C. §§ 261-262.  But the...more

PTAB Holds for Broad in CRISPR Interference: The Reasoning

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

USPTO Announces Deferred Subject Matter Eligibility Response Pilot Program

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

Alpek Polyester, S.A. v. Polymetrix AG (Fed. Cir. 2021)

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

University of South Florida Research Foundation, Inc. v. Fujifilm Medical Systems U.S.A., Inc. (Fed. Cir. 2021)

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

CardioNet, LLC v. InfoBionic, Inc. (Fed. Cir. 2021)

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

Is This the WTO Waiver End Game?

Pfizer and BioNTech Agree to Vaccine Technology Transfer with South Africa's Biovac Institute - As reported by Reuters* on Wednesday (see "South African firm to help make Pfizer/BioNTech COVID vaccine"), Pfizer and...more

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