Tag Archives: Patent Eligibility

Australia Upholds Patent Eligibility Of Isolated DNA

Thanks to Adam Denley, Ph.D., Senior Associate at Freehills Patent Attorneys in Australia, for alerting me to the September 5, 2014 decision of the Full Federal Court of Australia upholding the patent eligibility of isolated nucleic acids, and for letting me share his initial summary here.… Continue reading this entry

Comments On Patent Subject Matter Eligibility Guidance Due By July 31

This week brings the July 31, 2014 deadline for submitting written comments on two USPTO patent subject matter eligibility guidance documents: The “Myriad-Mayo” Guidance issued March 4, 2014 (for claims involving laws of nature, natural phenomena, and natural products) and the “Alice Corp. v. CLS Bank” Guidance issued June 24, 2014 (for claims involving abstract … Continue reading this entry

Putting Structure And Function Into Context For USPTO Patent Subject Matter Eligibility Guidance

The USPTO’s ”Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural Products” has been criticized for requiring a product to be markedly different in structure from a product of nature in order to be eligible for patenting, even though the Supreme Court has considered both structure and function when evaluating the … Continue reading this entry

USPTO Asks For Patent Subject Matter Eligibility Comments By July 31, 2014

In a June 30, 2014 Federal Register notice, the USPTO requested public comments by July 31, 2014  on patent subject matter eligibility under the recent Supreme Court decision in Alice Corporation Pty. Ltd. v. CLS Bank International and on the USPTO’s March 4, 2014 “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural … Continue reading this entry

Update From The May 9, 2014 USPTO Patent Eligibility Guidelines Forum

On May 9, 2014, the USPTO hosted a forum to receive public feedback on the patent subject matter eligibility guidance for examiners circulated on March 4, 2014. The USPTO heard formal presentations from ten speakers (including myself) and comments from audience members. Most speakers suggested alternative approaches to applying the Supreme Court’s “product of nature” and “law … Continue reading this entry

The New USPTO Patent Eligibility Rejections Under Section 101

Well, it’s happening. Office Actions with new patent eligibility rejections based on the USPTO’s March 4, 2014 Guidance are being mailed out to patent practitioners across the nation. While some new rejections under §101 were expected, others have been more surprising. The most frustrating ones I have seen relate to pharmaceutical compositions, methods of making pharmaceutical compositions, … Continue reading this entry

The State Of Vaccines Under The USPTO 101 Guidelines

In his State of the Union Address given on January 28, 2014, President Obama recognized the need for continued and increased investment in new technologies, including technologies specific to the biological and pharmaceutical fields. (Original Official White House Photo by Pete Souza, licensed under Creative Commons Attribution License 3.0) How would “vaccines that stay ahead of drug-resistant … Continue reading this entry

A First Look At The USPTO 101 Training Slides

The USPTO has set up a new web page with resources for examining claims for patent subject matter eligibility, including a link to the slides used in training programs for Examiners in Technology Centers 1600 and 1700. While the slides hew closely to the Guidelines, they include additional commentary and examples that illustrate how the … Continue reading this entry

District Court Doubts Patent Eligibility Of Myriad BRCA Claims

In a decision issued March 10, 2014, Judge Shelby of the U.S. District Court for the District of Utah denied Myriad’s motion for a preliminary injunction against Ambry Genetics Corp. While Ambry had challenged the validity of the Myriad BRCA claims on several grounds, the district court ruled on the most interesting one–patent eligibility. In particular, … Continue reading this entry

Five Things You Should Know About The USPTO Patent Subject Matter Eligibility Guidelines

The new USPTO patent subject matter eligibility guidelines set forth a detailed analytical framework for evaluating whether claims satisfy the patent subject matter eligibility requirement of 35 USC § 101. If you are an examiner, patent agent, patent attorney, or applicant overseeing patent portfolios in chemical, biotechnology, or life sciences technologies, you should read and study … Continue reading this entry

Do Pharmaceutical Compositions Have Patent Subject Matter Eligibility Under The New USPTO Guidelines?

The USPTO’s new patent subject matter eligibility guidelines  (the “Guidelines”) include examples that apply the multi-factored analysis mandated by the Guidelines to compositions that include one or more “natural products” as a component. Do these examples indicate that pharmaceutical compositions with an active ingredient that can be obtained from a natural source no longer can be … Continue reading this entry

USPTO Issues New Patent Subject Matter Eligibility Guidelines

The USPTO has issued new patent subject matter eligibility guidelines to aid examiners in applying the principles of Myriad and Prometheus to any claim “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products.” The guidelines include a general framework for analyzing such claims for patent subject matter eligibility and examples applying the … Continue reading this entry

Federal Circuit Holds Computer-Implemented Method Claims Invalid Under Section 101

Although SmartGene, Inc. v. Advanced Biological Laboratories, SA is a non-precedential Federal Circuit decision, it could be interesting for that very reason, if it is a reflection of what the court sees as settled aspects of patent eligibility jurisprudence. Viewed in that light, this case could reflect the court’s confidence with at least the “abstract … Continue reading this entry

A Look At The Myriad Gene Patent Claims And The USPTO Memo To Examiners On Myriad

Now that the Supreme Court has issued its decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.), people are wondering what the decision means for the Myriad patents and BRCA1/BRCA2 genetic testing. If you missed it, this article provides an overview of the Supreme Court Myriad decision. Here, I review … Continue reading this entry

Federal Circuit Issues Fractured Affirmance In CLS Bank v. Alice Corporation

In a fractured en banc decision, the Federal Circuit affirmed the district court’s holding that the claims at issue in CLS Bank v. Alice Corporation are invalid under 35 USC § 101. The multiple opinions reveal the judge’s fundamental differences as to the meaning and role of the statute, and the difficulty of applying Supreme … Continue reading this entry

Supreme Court Grants Cert In Myriad To Decide If Human Genes Can Be Patented

On November 30, 2012, the Supreme Court granted certiorari in the “ACLU/Myriad” gene patenting case (Association for Molecular Pathology v. Genetics, Inc.), guaranteeing that the debate over the patent-eligibility of human genes will continue for another round. The Court will review the August 16, 2012 Federal Circuit decision that held for the second time that … Continue reading this entry

Myriad Marches Towards The Supreme Court (Again)

The Association for Molecular Pathology (represented by the ACLU) has filed a petition for certiorari to the Supreme Court, seeking review of the Federal Circuit’s August 16, 2012 decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims. The petition raises three questions for Supreme Court review: Are human genes patentable? Did the court of … Continue reading this entry

Deja Vu All Over Again In Federal Circuit's August 16 Myriad Decision

On August 16, 2012, just four weeks after it heard oral arguments, the Federal Circuit issued its second decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which was on remand in view of the Supreme Court’s March 20, 2012 decision in Mayo v. Prometheus. The same three-judge panel heard the … Continue reading this entry

Non-Legal Perspectives On Isolated DNA: The Watson And Holman Amicus Briefs In The Myriad Remand

The most interesting briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case) may be those submitted by James D. Watson and Christopher M. Holman, which each present non-legal perspectives on the issues before the court.… Continue reading this entry

The Myriad And ACLU Supplemental Briefs On Remand To The Federal Circuit

Myriad and the ACLU filed their supplemental briefs in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case), addressing the Federal Circuit’s question as to the applicability of the Supreme Court’s decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. to the patent eligibility of Myriad’s isolated DNA … Continue reading this entry

Smoke Signals or Smokescreen: The Ultramercial GVR

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101, it was not surprising that the Court asked the U.S. Court of Appeals for the Federal Circuit to take a second look … Continue reading this entry

Puzzled By Prometheus

Last Wednesday I attended an excellent roundtable on Prometheus hosted by The George Washington University Law School and The Biotechnology Industry Organization (BIO). The roundtable was moderated by Hans Sauer of BIO and John M. Whealan of GW Law, and the panelists included The Honorable Paul R. Michel, intellectual property law professors, industry representatives, and practitioners (including my … Continue reading this entry