News & Analysis as of

Do the USPTO 101 Guidelines Violate International Trade Agreements?

One advantage of being a blogger in the relatively small world of patents is that I have gotten to know practitioners in other countries who also have a keen interest in patent law. One such person is Australian Registered...more

USPTO to Apply Myriad Beyond Isolated DNA

Today, the United States Patent and Trademark Office (“USPTO”) issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35...more

The Fraud-Tainted Cloning Patent: Scandalous in Theory, a Storm in a Teacup in Reality

You may have heard that the United States Patent Office (USPTO) has recently issued a patent on cloning human stem cells to Korean researcher Hwang Woo-Suk. About a decade ago, Dr. Hwang claimed to have cloned the world’s...more

Institut Pasteur Obtains Reversal of USPTO Board Decision of Obviousness of Eukaryotic Site-Directed Mutagenesis Methods

In Institut Pasteur v. Focarino, the Federal Circuit found that the obviousness determination by the USPTO Board of Patent Appeals and Interferences was not supported by substantial evidence, and rested on an “erroneous...more

Federal Circuit Holds Full Sequence Not Required for Invention of DNA

In Sanofi-Aventis v. Pfizer, Inc., the Federal Circuit affirmed the USPTO’s determination that Pfizer had proven an earlier date of invention of the DNA sequence at issue, even though it did not have the full, correct...more

Burden of Section 101 following Myriad

The Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics Inc., 2013 DJDAR 7484 (2013), held that Myriad’s claims directed to “a naturally occurring DNA segment is a product of nature and not...more

Ambry Responds to Myriad Lawsuit

Asserts Affirmative Defenses and Antitrust Counterclaims and Asks for Declaratory Judgment - On Monday Ambry filed its Answer to Myriad's complaint for patent infringement, and asserted patent misuse as an affirmative...more

Gene patents and the future of commercialized technology

Medicine is evolving from a global, one-size-fits-all approach to a more individualized approach that tailors treatment specifically for each patient. Originally published in The Journal Record - August 8, 2013....more

The Real Impact for Healthcare and Biotechnology of the Supreme Court's Decision in Myriad Genetics

On June 13, 2013, the Supreme Court issued a decision supposedly resolving the patentability of DNA in Association for Molecular Pathology v. Myriad Genetics. Immediately, all parties on both sides of the case declared...more

Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test

On Friday, Sen. Patrick Leahy (D-VT) sent a letter to Dr. Francis Collins, the Director of the National Institutes of Health (NIH), "to urge [the Director] to consider using march-in rights under the Bayh-Dole Act to ensure...more

Post-Myriad Strategies for Claiming Biotech Inventions in the United States

The United States Supreme Court recently ruled that genes or other naturally-occurring pieces of DNA are patent ineligible subject matter in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. No....more

Intellectual Property Newsletter - June 2013

In This Issue: *News from the Bench - Unanimous Supreme Court Ruling on Gene Patentability: Natural DNA “No”/ cDNA “Yes” - CAFC Reverses Denial of Permanent Injunction Based on Perceived Future...more

The Future Of Patentable DNA: A Myriad Of Possibilities

In This Issue: - Summary - Case Analysis - Implications ..Prokaryotic Nucleic Acid Sequences ..Short Segments of Eukaryotic DNA ..Promoters/Regulatory regions ..Isolated Proteins ...more

IP Update, Vol. 16, No. 6, June 2013

Patents / Patent Eligible Subject Matter - Supreme Court to Myriad: Isolated DNA Sequences Are Not Patent-Eligible Subject Matter -- AMP et al. v. Myriad Genetics, Inc.: In a 9–0 decision the Supreme...more

Supreme Court Rules that Isolated Human Gene is Not Patent Eligible in AMP v. Myriad

On June 13, 2013, the Supreme Court unanimously held in Association for Molecular Pathology v. Myriad Genetics, Inc., that an isolated but otherwise unmodified segment of human DNA was not eligible for patent protection under...more

USPTO Issues Memo on AMP v. Myriad to Examining Corps

On the same day that the Supreme Court handed down its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Patent and Trademark Office issued a one-page memorandum to its Patent Examining Corps...more

The Curious Case Of Human Gene Patents

The U.S. Supreme Court heard oral arguments last month in the matter of Association for Molecular Pathology v. Myriad Genetics, a curious case that does not bode well for America’s biotechnology industry and could overturn 30...more

Supreme Court To Hear Oral Arguments in Landmark Patent Case

April 15 is a big day for biotechnology, pharmaceutical, and medical diagnostic companies at the Supreme Court, as justices begin a new session by hearing oral arguments in a landmark case involving the patentability of...more

Intellectual Property LEGAL NEWS - March 22, 2013 • Volume 1, Number 2

In This Issue: - AMERICA INVENTS ACT FINAL IMPLEMENTATION: FROM FIRST-TO-INVENT TO FIRST-TO-FILE: The America Invents Act (“AIA”), which went into effect September 16, 2011, introduces some of the most...more

Myriad Finally Gets Its Day in (the Supreme) Court

INTRODUCTION - The Supreme Court today granted certiorari in Assoc. for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. (Myriad), to address the issue of whether human genes are patentable. This...more

Myriad Files Responsive Brief Opposing Certiorari

On Halloween, Myriad Genetics filed its brief in opposition to plaintiffs' petition for certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc. (plaintiffs nominally being the Association for Molecular...more

Myriad Responds: ACLU Asks the Wrong Question

On October 31, 2012, Myriad Genetics, Inc. et al. (“Respondent” or “Myriad”) filed its brief in opposition to Petitioners’ (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or...more

Federal Circuit Upholds Board Determination That Biotechnology Invention Was Obvious

In In re Droge, the Federal Circuit upheld the decision of the USPTO Board of Patent Appeals and Interferences that found that claims directed to recombinant biotechnology methods were obvious. At 8 pages, the decision is one...more

Federal Circuit Again Upholds Patent-Eligibility of Myriad's Isolated DNA Claims, Holds Diagnostic “Analyzing” Claims...

On August 16, 2012, in the most recent decision in one of the most controversial and publicized biotech patent cases in many years, the Federal Circuit again decided the “ACLU/Myriad” gene patenting case (formally, The...more

Myriad Oral Arguments: Deja Vu?

On Friday, July 20, 2012, the Federal Circuit heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which is on remand in view of the Supreme Court...more

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