Category Archives: 35 U.S.C. 101

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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

"Human Genes" and Patents

At 10:00 A.M. on April 15th, the U.S. Supreme Court will entertain oral arguments in the dispute now known as the human “gene patenting” case. The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013) is likely the highest profile patent dispute before the Supreme Court in recent history, arguably because it touches on issues concerning invention, innovation, investment, … 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

More on Myriad -- "Gene Patenting" Debate Continues

As promised in my earlier post, today our firm issued its review of the much anticipated decision regarding the “gene patenting” case (formally known as The Association For Molecular Pathology. et al. v. USPTO et al.) The case was before the Federal Circuit on remand from the U.S. Supreme Court’s March 20, 2012 decision in Mayo Collaborative Services … 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

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

Dissecting Prometheus – My Wish List

In his March 23rd Patently-O blog, Dennis Crouch posted a U.S. Patent and Trademark Office memorandum to examiners setting forth the Office’s current thinking on application of the U.S. Supreme Court’s recent Mayo v. Prometheus holding to patent examination. The memorandum preliminarily advises examiners to reject a patent claim under 35 U.S.C. § 101 if the … Continue reading this entry

U.K. Supreme Court in HGS v. Eli Lilly Determines “Gene Patent” Meets European “Industrial Application” Requirement

On November 2, 2011, England’s highest court issued an important decision, Human Genome Sciences v. Eli Lilly, relating to biotechnology and claims directed to genes in particular, and consequently personalized medicine. Interestingly, claims at issue in this U.K. case are very similar to the type of compositions claims at issue in the U.S. Myriad “gene … Continue reading this entry

Patent-Eligibility Trilogy: One of Three Reaches U.S. Supreme Court

As the U.S. Supreme Court starts its next term on Oct. 3, 2011, the biotechnology industry is awaiting resolution of at least one of three pending disputes addressing the extent to which diagnostic medical methods are patent-eligible. Per colleague Hal Wegner, respondent’s U.S. Supreme Court brief in Mayo Collaborative Services v. Prometheus Laboratories, Inc. is due Oct. 31, 2011 … Continue reading this entry

Federal Circuit Denies ACLU's Petition for Panel Rehearing in Myriad "Gene Patenting" Case

For those of you closely following Assn. Molec. Path. et al. v. USPTO et al., otherwise known as the Myriad “gene patenting” case, you already know that both sides petitioned the Federal Circuit for a rehearing by the three-judge panel (not en banc), albeit for different reasons. Specifically, on August 25, 2011, on behalf of … Continue reading this entry

U.S. Patent Reform - What Does It Mean To Personalized Medicine?

Yesterday, September 8, 2011, the Senate passed by a vote of 89-9 the House version of the patent reform bill H.R. 1249, also known as the Leahy-Smith America Invents Act, without amendment. Consequently, after many years of discussion, debate and hand-wringing, significant patent reform is imminent. In fact, at this point, the legislation only requires action … Continue reading this entry

In Classen, the Federal Circuit Determines That Certain Method Claims Satisfy 35 USC § 101

On August 31, 2011, the Federal Circuit issued a precedential decision in Classen Immunotherapies, Inc. v. Biogen Idec (App. 2006-1643, -1649), a patent case of significant interest to the personalized medicine industry. As with the Prometheus case, this case addresses patent-eligibility of certain types of method claims. The Federal Circuit decided Classen on remand from … Continue reading this entry

ACLU and Myriad Both Petition for Panel Rehearing In Myriad "Gene Patenting" Case

On August 25, 2011, on behalf of Plaintiffs, the ACLU filed a Petition for Panel Rehearing with the Federal Circuit in Assn. Molec. Path. et al. v. USPTO et al., known as the Myriad “gene patenting” case. Four days later, on August 29, 2011, Myriad likewise filed its own Petition for Panel Rehearing. Both parties … Continue reading this entry

Top Twelve Practice Tips Following Myriad and Prometheus

*  Written by Kristel Schorr and Jackie Wright Bonilla, both partners in the Washington, DC office of Foley & Lardner LLP As most in the biotech industry know by now, the Federal Circuit recently issued its decision in Assn. Molec. Path. et al. v. USPTO et al., a case otherwise known as Myriad or the … Continue reading this entry

Myriad's Gene Patenting Debate Continues

Late last week the Federal Circuit issued its much anticipated opinion – Assn. Molec. Path. et al. v. USPTO et al. – which addressed, inter alia, the issue of whether and to what extent is genetic material patent-eligible. Judge Lourie, writing for the majority, held that isolated genetic material is patent-eligible. Judge Moore concurred-in-part that isolated … Continue reading this entry

Highly Anticipated "ACLU/Myriad" Gene Patenting Case Decided by Federal Circuit

Subject Matter Patent-Eligibility of Isolated DNA and Diagnostic Methods Addressed Head-on On Friday, July 29, 2011, in one of the most controversial and publicized biotech patent cases in recent years, the Federal Circuit decided the “ACLU/Myriad” gene patenting case, formally known as Assn. Molec. Path. et al. v. USPTO et al. In a majority opinion … Continue reading this entry

Diagnostic Method Claims and Patent Eligibility - Supreme Court Has Something to Say In Prometheus v. Mayo

Today, in a short but sweet statement, the Supreme Court granted the petition for certiorari in Prometheus v. Mayo, 628 F.3d 1347 (Fed. Cir. 2010) (finding method claims relevant to personalized medicine patent eligible) (petition for cert. filed March 2011). As discussed in our previous Personalized Medicine Bulletin post, parties once again petitioned for certiorari in the … Continue reading this entry

Patent Eligibility of Diagnostic Method Claims - What Have Courts Considered So Far?

Even for patent attorneys who specialize in personalized medicine, confusion still exists as to the best way to pursue and enforce diagnostic method patent claims in light of patent eligibility considerations under 35 U.S.C. §101.  While the Supreme Court and Federal Circuit have provided some guidance regarding patent eligibility of certain method claims, details of … Continue reading this entry