New Gene Patent Rules - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

New Gene Patent Rules
The US Supreme Court's Myriad decision satisfied both patient groups and patent holders. Includes bonus online coverage.

Pharmaceutical Technology
Volume 37, Issue 8, pp. 14-16

On the Road to the Supreme Court
The ACLU filed suit in the US District Court for the Southern District of New York (SDNY) in May 2009 asking the court to invalidate Myriad's patents for failing to satisfy 35 U.S.C. 101. The ACLU also challenged the diagnostic method claims but these were not appealed to the Supreme Court (8). The ACLU also argued that the USPTO's policy of granting patents on isolated human genes violated the First Amendment of the US Constitution.

Myriad sought to dismiss the suit, arguing that the patent claims were valid because the difference in the structural and functional properties of isolated DNA rendered its claims patent-eligible. Additionally, the USPTO had been granting similar patents on this technology for decades, and the biotechnology industry had relied on patents to support research and investment.

The ACLU prevailed (9). Judge Sweet of the SDNY held that Myriad's challenged patent claims were invalid. Judge Sweet opined that DNA represents the physical embodiment of biological information and that Myriad's focus on the chemical nature of DNA failed to acknowledge the unique characteristics of DNA that differentiate it from other chemical compounds. Judge Sweet concluded that the preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition of matter claims are directed to unpatentable products of nature (9).

Myriad appealed to the US Court of Appeals for the Federal Circuit, where the judges twice reversed Judge Sweet's ruling. The first appeal was returned to the district court after the Supreme Court granted ACLU's petition for certiorari, vacated the Federal Circuit's prior decision, and remanded the case to the Federal Circuit for further consideration in light of its decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. __, 132 S.Ct. 1289 (2012) (10).

A three-judge panel, led by Judge Lourie, held that all claims were valid but the opinions of the other judges on the panel varied with the claims. Judge Lourie opined that all appealed claims were patentable and Judge Moore agreed, but on different grounds. Judge Lourie reasoned that: "[t]he isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decompositions, are made from natural materials" (11). Judge Lourie also cautioned that Congress, not the courts have the appropriate mandate to categorically exclude subject matter such as isolated genes from patenting. Congress, he noted, was aware of the controversial issue when it recently enacted the comprehensive patent reform act, and it is ultimately for Congress to act if it wishes to overturn case law and the long practice of the USPTO to determine that isolated DNA must be treated differently from other compositions of matter.

Judge Bryson opined that only the synthetic man-made "cDNA genes" were patent-eligible and agreed with Judge Sweet that claims to isolated naturally occurring genes and fragments are invalid. The ACLU appealed to the Supreme Court.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here