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USPTO Provides Guidance on Standards for Enablement Requirement

On January 10th, the U.S. Patent and Trademark Office published a Notice in the Federal Register (89 Fed. Reg. 1563) regarding proposed Guidance on how the Office will apply the enablement requirement under 35 U.S.C. § 112(a)...more

PureCircle USA Inc. v. SweeGen, Inc. (Fed. Cir. 2024)

Not surprisingly, the Federal Circuit visited upon Plaintiff/Appellant PureCircle two of the Four Horsemen of the Biotech Patent Apocalypse* in a decision affirming the District Court's invalidation of the claims asserted...more

In re Institut Pasteur (Fed. Cir. 2023)

In the shadow of its recent, precedent-challenging In re Cellect decision, the Federal Circuit illustrated the pedestrian application of its obviousness-type double patenting jurisprudence in affirming the Patent Trial and...more

Jager Pro, Inc. v. W-W Manufacturing Co. (Fed. Cir. 2023)

Although merely exemplifying the burden imposed on an appellant by the Federal Circuit's substantial evidence standard of review over decisions by the U.S. Patent and Trademark Office regarding the facts underlying legal...more

Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

Proper construction of claim limitations reciting the chemical property of pH (which denotes the concentration of hydrogen ions in a solution as an indication of acidity) has arisen several times in district court and Federal...more

Medtronic, Inc. v. Teleflex Life Sciences Ltd. (Fed. Cir. 2023)

In what was an otherwise run-of-the-mill affirmance of a decision by the Patent Trial and Appeal Board (PTAB) (albeit somewhat noteworthy in affirming the Board's determination that the challenged claims were not invalid),...more

Overcoming the Consequences of In re Cellect

In view of the unprecedented uncertainty in patent law generated by counter-doctrinal Supreme Court decisions over the past decade or so and a cowed Federal Circuit relegated to complaining that their hands are tied on most...more

In the Wake of the Supreme Court's Amgen v. Sanofi decision: What’s Next for Biotechnology Claims?

Section 112 of the patent statute, which in earlier years was something of a backwater in patent law, has had a tumultuous quarter century beginning with the Federal Circuit decision in Regents of the University of California...more

Patent Luminaries Try to Set Congress Straight on Drug Price Controls

Over the past few years the drumbeat regarding the cost of healthcare in general and drugs in particular has steadily mounted (see "Faux-Populist Patent Fantasies from The New York Times"). Patents are often (and quite...more

Baxalta Inc. v. Genentech, Inc. (Fed. Cir. 2023)

There has been, since the turn of the century, a steady, seemingly inexorable trend towards limiting patent rights and focusing the application of U.S. patent law towards an emphasis on preventing innovators from obtaining...more

USPTO Shares Data on Multiple IPR Challenges

One of the many criticisms of the post-grant review proceedings instituted by the Leahy-Smith America Invents Act, both post-grant review (PGR) available within 9 months of patent grant based on all provisions of the Patent...more

Rembrandt Diagnostics LP v. Alere, Inc. (Fed. Cir. 2023)

The Federal Circuit reviewed the latest decision from the Patent Trial and Appeal Board (PTAB) in an inter partes review that claims 3-6 and 10 of U.S. Patent No. 6,548,019 are obvious, in Rembrandt Diagnostics LP v. Alere,...more

In re Theripion (Fed. Cir. 2023)

The Patent Trial and Appeal Board (PTAB) has benefited, particularly after enactment of the Leahy-Smith America Invents Act, from the deference to its factual findings mandated by the Supreme Court's interpretation in...more

United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)

In earlier times, the Federal Circuit, responding to efforts by the U.S. Patent and Trademark Office to reject patent applications directed to biotechnology-related inventions, held (In re Brana) that utility of such...more

Amici Support Reversal of PTAB Decision in CRISPR Interference

Two amici have filed briefs in support of the appeal by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") of the decision by the Patent Trial and...more

Broad Files Opening Brief and Cross-Appeal in CRISPR Interference

The decision by the Patent Trial and Appeal Board (PTAB) in favor of Senior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") and against Junior Party the University of California/Berkeley, the...more

Drugs May Cost Too Much, But Patents Are Not the Cause

For at least a decade, Congress has been concerned (not to say obsessed) with drug costs (understandably so, no matter how ineffective; see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived...more

SNIPR Technologies Ltd. v. Rockefeller University (Fed. Cir. 2023)

One of the wonderful (as in, it makes one wonder) and frustrating (which needs no explanation) aspects of patent law is that just when you think a question is settled it either isn't or the conventional interpretation is...more

CVC Appeals PTAB Decision in CRISPR Interference

The decision by the Patent Trial and Appeal Board (PTAB) in favor of Senior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") and against Junior Party the University of California/Berkeley, the...more

Medytox, Inc. v. Galderma S.A. (Fed. Cir. 2023)

It is not surprising that the Federal Circuit has taken the opportunity to apply the Supreme Court's recent precedent in Amgen v. Sanofi regarding the sufficiency of disclosure needed to satisfy the statutory enablement...more

Senator Coons And Co-Sponsors Introduce the PREVAIL Act

In addition to his efforts regarding patent subject matter eligibility law (see "Senate Bill Proposed to Provide Subject Matter Eligibility Solution", co-sponsored with Senator Tillis), Senator Coons, joined by Senators...more

In re Couvaras (Fed. Cir. 2023)

The Federal Circuit provided a reminder last week that merely identifying an unappreciated consequence of a prior art method cannot confer non-obviousness on practice of methods that did not acknowledge that consequence, in...more

Congress’ latest attempt to address subject matter eligibility

Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting to provide a legislative solution. They chaired a series of Congressional hearings in...more

Senate Bill Proposed to Provide Subject Matter Eligibility Solution

Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting to provide a legislative solution.  They chaired a series of Congressional hearings...more

Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing

Responsive to the letter from Judge Pauline Newman's counsel sent June 15th (see "Judge Newman Matter Continues"), the Special Committee directing the Federal Circuit's inquiry regarding Judge Newman's fitness for continued...more

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