ILNews

SCOTUS: isolated, naturally occurring DNA segment can't be patented

Back to TopCommentsE-mailPrintBookmark and Share

A naturally occurring DNA segment is not eligible for a patent simply because it has been isolated, the Supreme Court of the United States ruled June 13. DNA that is not a product of nature may be patent eligible, however.

The ruling came in Association for Molecular Pathology, et al. v. Myriad Genetics Inc., et al., 12-398, in which Myriad Genetics Inc. filed several patents after discovering the precise location and sequence of what are known as BRCA1 and BRCA2 genes. Mutations in these genes can significantly increase a person’s risk of developing breast and ovarian cancer.

Other organizations offered BRCA testing after Myriad discovered the genes, but the company asserted that testing infringed on its patents.
 

janis-mark-mug.jpg Janis

The United States Court of Appeals for the Federal Circuit held both isolated DNA and cDNA – which is an exons-only molecule that is created in a lab – are patent eligible. Two of the three judges on the panel held that the act of isolating DNA allows a company to obtain a patent.

The question in this case is whether Myriad’s discovery of the location and genetic sequences of the genes render it patentable under 35 U.S.C. Section 101. “In this case … Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention,” the opinion states, delivered by Associate Justice Clarence Thomas. All of the justices joined, with Associate Justice Antonin Scalia joining in part.

“The court said that you can’t get a patent on a DNA sequence that has been isolated from its surrounding material because it’s a ‘product of nature,’ but you can potentially get a patent on a DNA sequence that has been altered in the lab,” explained Mark D. Janis, director of the Center for Intellectual Property Research at Indiana University Maurer School of Law.

Thomas noted what was not implicated by this decision. There are no method claims before the court; the processes used by Myriad to isolate the DNA were well understood and widely used. The case doesn’t involve patents on new applications of knowledge about these genes. And the court did not consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.

“We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”

In a statement issued after the decision, Peter D. Meldrum, president and CEO of Myriad Genetics Inc. said, “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward. More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall healthcare costs.”

Janis believes the impact of the decision will be modest.

“There are many alternative ways to claim biotechnology inventions, and the court’s decision is directed only to one of those strategies,” he said. “In the long term, I think it will be viewed largely as a symbolic gesture by the court – a reminder that at least some subject matter does lie in the zone of ineligible products of nature. I do not think it will be regarded as a particularly memorable exposition of patent law principles.”•

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in Indiana Lawyer editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT
Subscribe to Indiana Lawyer
  1. Mr. Levin says that the BMV engaged in misconduct--that the BMV (or, rather, someone in the BMV) knew Indiana motorists were being overcharged fees but did nothing to correct the situation. Such misconduct, whether engaged in by one individual or by a group, is called theft (defined as knowingly or intentionally exerting unauthorized control over the property of another person with the intent to deprive the other person of the property's value or use). Theft is a crime in Indiana (as it still is in most of the civilized world). One wonders, then, why there have been no criminal prosecutions of BMV officials for this theft? Government misconduct doesn't occur in a vacuum. An individual who works for or oversees a government agency is responsible for the misconduct. In this instance, somebody (or somebodies) with the BMV, at some time, knew Indiana motorists were being overcharged. What's more, this person (or these people), even after having the error of their ways pointed out to them, did nothing to fix the problem. Instead, the overcharges continued. Thus, the taxpayers of Indiana are also on the hook for the millions of dollars in attorneys fees (for both sides; the BMV didn't see fit to avail itself of the services of a lawyer employed by the state government) that had to be spent in order to finally convince the BMV that stealing money from Indiana motorists was a bad thing. Given that the BMV official(s) responsible for this crime continued their misconduct, covered it up, and never did anything until the agency reached an agreeable settlement, it seems the statute of limitations for prosecuting these folks has not yet run. I hope our Attorney General is paying attention to this fiasco and is seriously considering prosecution. Indiana, the state that works . . . for thieves.

  2. I'm glad that attorney Carl Hayes, who represented the BMV in this case, is able to say that his client "is pleased to have resolved the issue". Everyone makes mistakes, even bureaucratic behemoths like Indiana's BMV. So to some extent we need to be forgiving of such mistakes. But when those mistakes are going to cost Indiana taxpayers millions of dollars to rectify (because neither plaintiff's counsel nor Mr. Hayes gave freely of their services, and the BMV, being a state-funded agency, relies on taxpayer dollars to pay these attorneys their fees), the agency doesn't have a right to feel "pleased to have resolved the issue". One is left wondering why the BMV feels so pleased with this resolution? The magnitude of the agency's overcharges might suggest to some that, perhaps, these errors were more than mere oversight. Could this be why the agency is so "pleased" with this resolution? Will Indiana motorists ever be assured that the culture of incompetence (if not worse) that the BMV seems to have fostered is no longer the status quo? Or will even more "overcharges" and lawsuits result? It's fairly obvious who is really "pleased to have resolved the issue", and it's not Indiana's taxpayers who are on the hook for the legal fees generated in these cases.

  3. We are a Finance Industry Company professionals with over 15 Years Experience and a focus on providing Bank Guarantee and Standby Letter of Credit from some of the World Top 25 Prime Banks primarily from Barclays, Deutsche Bank, HSBC,Credit Suisse e.t.c. FEATURES: Amounts from $1 million to 5 Billion+ Euro’s or US Dollars Great Attorney Trust Account Protection Delivered via MT760, MT799 and MT103 Swift with Full Bank Responsibility Brokers Always Protected Purchase Instrument of BG/SBLC : 32%+2% Min Face Value cut = EUR/USD 1M-5B Lease Instrument of BG/SBLC : 4%+2% Min Face Value cut = EUR/USD 1M-5B Interested Agents/Brokers, Investors and Individual proposing international project funding should contact us for directives.We will be glad to share our working procedures with you upon request. We Facilitate Bank instruments SBLC for Lease and Purchase. Whether you are a new startup, medium or large establishment that needs a financial solution to fund/get your project off the ground or business looking for extra capital to expand your operation,our company renders credible and trusted bank guarantee provider who are willing to fund and give financing solutions that suits your specific business needs. We help you secure and issue sblc and bank guarantee for your trade, projects and investment from top AA rated world Banks like HSBC, Barclays, Dutch Ing Bank, Llyods e.t.c because that’s the best and safest strategy for our clients.e.t.c DESCRIPTION OF INSTRUMENTS 1. Instrument: Funds backed Bank Guarantee(BG) ICC-600 2. Currency : USD/EURO 3. Age of Issue: Fresh Cut 4. Term: One year and One day 5. Contract Amount: United State Dollars/Euros (Buyers Face Value) 6. Price : Buy:32%+1, Lease: 4%+2 7. Subsequent tranches: To be mutually agreed between both parties 8. Issuing Bank: Top RATED world banks like HSBC, Barclays, ING Dutch Bank, Llyods e.t.c 9. Delivery Term: Pre advise MT199 or MT799 first. Followed By SWIFT MT760 10. Payment Term: MT799 & Settlement via MT103 11. Hard Copy: By Bank Bonded Courier Interested Agents,Brokers, Investors and Individual proposing international project funding should contact us for directives.We will be glad to share our working procedures with you upon request. Name:Richardson McAnthony Contact Mail : intertekfinance@gmail.com

  4. Affordable Loan Offer (ericloanfinance@hotmail.com) NEED A LOAN?Sometime i really wanna help those in a financial problems.i was wondering why some people talks about inability to get a loan from a bank/company. have you guys ever try Eric Benson lending service.it cost dollars to loan from their company. my aunty from USA,just got a home loan from Eric Benson Lending banking card service.and they gave her a loan of 8,000,000 USD. they give out loan from 100,000 USD - 100,000,000 USD. try it yourself and testimony. have a great day as you try.Kiss & Hug. Contact E-mail: ericloanfinance@hotmail.com

  5. From the article's fourth paragraph: "Her work underscores the blurry lines in Russia between the government and businesses . . ." Obviously, the author of this piece doesn't pay much attention to the "blurry lines" between government and businesses that exist in the United States. And I'm not talking only about Trump's alleged conflicts of interest. When lobbyists for major industries (pharmaceutical, petroleum, insurance, etc) have greater access to this country's elected representatives than do everyday individuals (i.e., voters), then I would say that the lines between government and business in the United States are just as blurry, if not more so, than in Russia.

ADVERTISEMENT