Tag Archives: 35 U.S.C. 101

USPTO Issues Guidance for Examining Process Patents

On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as … Continue reading this entry

USPTO to Apply Myriad Beyond Isolated DNA

On March 4th, 2014, 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 U.S.C. §101, as applied to patent-eligibility. See Assn. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. … Continue reading this entry

Computer-Aided Selection Method Fails Patent-Eligibility

In SmartGene, Inc. v. Advanced Biological Labs., S.A., No. 2013-1186 (Fed. Cir., Jan. 24, 2014), the Federal Circuit held that a patent claiming the use of a computer to implement routine mental information-comparison and rule-application processes to select a treatment for a patient fails patent-eligibility because the claims are directed to an abstract idea. The … Continue reading this entry

U.S. Government and USPTO Urges Federal Circuit to Dismiss Stem Cell Appeal

On January 17, 2014, the United States government and the United States Patent and Trademark Office (collectively “the government”) responded to the Federal Circuit’s December 4, 2013 order inviting them to address whether Consumer Watchdog (“CW”) has Article III standing to pursue its appeal of the USPTO’s affirmation of the patentability of Wisconsin Alumni Research … Continue reading this entry

United States and PTO Invited to Stem Cell Party

Last week Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) squared off at the Federal Circuit over CW’s appeal of the  inter partes reexamination of WARF’s U.S. Patent No.  7,029,913 (the ’913 Patent, entitled “Primate Embryonic Stem Cells”). Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 13-1377 (Fed. Cir. 2013).  CW’s appeal challenges the patent-eligibility of in vitro cultured human embryonic stem cells (hESCs) … Continue reading this entry

WARF Could Avoid Federal Circuit Review

On November 25, 2013, Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) responded to the Federal Circuit’s Order directing each party to brief whether CW, as a third party requester, has standing to appeal the U.S. Patent and Trademark Office’s (“USPTO’s”) decision in the inter partes reexamination of WARF’s U.S. Patent No.  7,029,913 (the ’913 Patent, … Continue reading this entry

California Court Holds Diagnostic Claims Not Patent-Eligible

In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing detection steps do not make the use of a natural phenomenon patent-eligible. See Ariosa Diagnostics, Inc., v. Sequenom, Inc., No. C 11-06391 SI (N.D. … Continue reading this entry

Patent-Eligibility of hESC Challenged

Now that the U.S. Supreme Court has determined that isolated, naturally-occurring genes are not patent-eligible (see, Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013))(“Myriad”), Consumer Watchdog (“CW”, formerly known as The Foundation for Taxpayer and Consumer Rights, a self-described public charity dedicated to provide a voice for taxpayers and consumers) has … Continue reading this entry

Isolated DNA Is Not Patent-Eligible

Today the U.S. Supreme Court in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., __ U.S. __ (2013) (opinion here), held that genes and DNA fragments merely isolated from nature without alteration are not patent-eligible. Justice Thomas, who delivered the opinion of the Court, stated that claims to isolated DNA (in this case, isolated BRCA1 and BRCA2 … Continue reading this entry

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)(“Mayo“)? Intema Ltd. (“Intema”) asserts that yes, the Federal Circuit did err when it determined that Intema’s diagnostic patent claims are invalid for failing to … Continue reading this entry

Video Interview: Discussing the Supreme Court's Oral Arguments in Myriad Gene Patenting Case

Earlier this week, I had the opportunity to speak again with Colin O’Keefe of LXBN regarding last week’s oral arguments in Association for Molecular Pathology v. Myriad Genetics. In the interview, I share some quick observations on the oral arguments and offer my thoughts why I believe the Justices will “split the baby” with their ruling.… Continue reading this entry

Personalized Medicine and the Gene Patenting Debate

The transcript for today’s Supreme Court oral argument in The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013) has been released, and the importance of the gene patenting debate to personalized medicine was discussed. The Court was well briefed on the issues and questioned the parties and U.S. government regarding why isolated genes should or should not be patent-eligible, the … Continue reading this entry

Petitioners File Supreme Court "Gene Patenting" Brief

Petitioners (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or ”Petitioner” or “ACLU”) filed their brief with the U.S. Supreme Court yesterday urging the Court to reverse the Federal Circuit’s decision and the USPTO’s decades long practice of granting patents on isolated DNA. Similar to their arguments in all prior … Continue reading this entry

Personalized Medicine Patenting Update

Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the decision, as set forth in its Guidance Document distributed to patent examiners. Patent examiners are advised to follow the Guidance Document in examining … Continue reading this entry

Video Interview: Discussing Myriad & the Supreme Court with LXBN TV

Following up on my post examining the Myriad gene patenting case, which is heading to the Supreme Court, I had the chance to discuss the subject with Colin O’Keefe of LXBN. In the interview, I discuss the legal and commercial issues at the core of the controversy, and whether or not genes are indeed patented.  … Continue reading this entry

Amici Urge Reversal of “Gene Patenting” Decision

On November 30th, 2012, the U.S. Supreme Court will conference and consider whether to review the patent-eligibility of isolated DNA sequences. Our prior post of September 25, 2012 addressed Petitioners’ brief and request for review of the Federal Circuit’s decision that upheld the patent-eligibility of isolated DNA. On October 31st, 2012, Myriad Genetics, Inc. et al. … Continue reading this entry

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 “ACLU”) quest for U.S. Supreme Court review in the ongoing legal battle over whether isolated DNA is patent-eligible subject matter. Myriad argued that U.S. Supreme Court … Continue reading this entry

ACLU Petitions Supreme Court to Review Gene Patenting Case

The ACLU and PUBPAT issued a press release today announcing that they are petitioning the U.S. Supreme Court to review the U.S. Federal Circuit’s decision upholding the patent-eligibility of isolated DNA . The release announces in part: “The American Civil Liberties Union and the Public Patent Foundation today asked the U.S. Supreme Court to invalidate … Continue reading this entry

Personalized Medicine After the ACLU “Gene Patenting” Decision

The biotechnology industry, including those investing in personalized medicine, have been waiting for the Federal Circuit’s decision that answers the questions whether isolated DNA and use of the isolated material are patent-eligible under 35 U.S.C. § 101. As reported in our August 16th post, the same three judges (Lourie, Bryson and Moore) held that isolated … Continue reading this entry

Federal Circuit - Non-Naturally DNA Patent-Eligible

Today, in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 2010-1406 (Fed. Cir. 2012), the Federal Circuit held that non-naturally occurring DNA is patent eligible as well as the use of a transformed, non-naturally occurring cell for screening drug candidates. Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences were held to be patent-ineligible. A … Continue reading this entry

Patenting Business Methods After Mayo

Advances in information technology, such as high-performance computing, enables the collection, analysis and sharing of information between patients and medical providers. Computer technology makes possible the sequencing and analysis of huge data sets of genomic information. It also connects clinical and genomic information to support personalized health care. As a result, life science companies and … Continue reading this entry

ACLU "Gene Patenting" Case Argued at Federal Circuit

On July 20th, 2012, the parties in the Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 10-1406 (Fed. Cir. 2011)(also known as the “ACLU gene patenting” case) argued (again) before the Federal Circuit. Recall, the U.S. Supreme Court had asked the court to reconsider its prior ruling as to the patent-eligibility of claims to … Continue reading this entry

What's Patentable After Prometheus? USPTO Issues Interim Response

The USPTO has just issued guidelines for its patent examining corps to assist them in determining whether a process claim is patent-eligible in light of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (“Prometheus”) decision. A copy of the guidance document (“Guidance Document”) is attached. [2012_interim_guidance] The examiners are … Continue reading this entry

Lilly Urges “Poison Species” Test for Process Patents

June 15th, 2012 was the deadline for the parties and interested parties to file briefs in the controversial ACLU gene patenting case (see our post of March 26th, 2012), remanded to the Federal Circuit after the U.S. Supreme Court’s recent Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. __, 132 S.Ct. 1289 (2012) (“Prometheus”) … Continue reading this entry