Myriad Case


Gene Patent Expert Discusses "Duty to Universe," Launches Genome Liberty

Guests:

Christopher Mason, PhD, Assistant Professor, Weill Cornell Medical College

Bio and Contact Info

Listen (5:59) ENCODE and the functional genome

Listen (6:00) 59,000 genes in the human genome

Listen (9:00) Huh? Genes can be patented?

Listen (2:36) Did the Supreme Court get the right balance in Myriad case?

Listen (6:26) Genome Liberty - opening up the flood gates for genetic testing

Today we continue our exploration of the recent Myriad gene patent case and what it means for research and the life science industry.

Chris Mason, a professor of genomics at Weill Cornell Medical College, has always greeted the idea of gene patents with disbelief. Working in his lab to "understand the human genome down to every base and every base modification," Chris has been involved with the Myriad/ACLU case from the beginning, serving at times as an expert witness.

In today's interview, Chris discusses his involvement in the case which included some basic scientific training of the lawyers at the ACLU. He also shares his thoughts on the outcome of the big decision. Did SCOTUS strike the right balance? And what practical implications will the decision have?

One of the outcomes is a new company, co-founded by Chris, called Genome Liberty. The company launched last week with the goal of "opening up the flood gates for genetic testing."

Chris is passionate not just about "genomic liberty", but about basic genomic science as well, citing a "duty to the universe" to get it right.

"It's my favorite thing to do," he says in the interview, "to make sure that any new text that is published is obsolete within a year."

Podcast brought to you by: Ingenuity Variant Analysis - Identify causal variants from human sequencing data in just hours.

Gene Patents No More

As most of you know at this point, on Jun 13, 2013 the Supreme Court of the United States ruled essentially that native DNA sequences are not patentable subject matter.  The question ended up with the Supreme Court precisely because there are good arguments on both sides and, as you would expect, there was a lot of highly charged rhetoric exchanged leading up to the decision.  I’m not going to settle those questions here, but I did think it was worth a few moments musing about less technical aspects of patent issues.

"Not about Owning Genes:" Diagnostics in the Wake of Gene Patent Ruling with Charles Mathews

Guests:

Charles Mathews, VP, Boston Healthcare Bio and Contact Info

Listen (3:51) Response to Myriad ruling

Listen (8:20) What is your number one message to your diagnostic clients?

Listen (9:16) Diagnostics model becoming more like pharma model

Listen (6:17) How can diagnostics startups be better focused on reimbursement from the beginning?

Listen (4:21) Are you seeing more whole genome testing?

Continuing our series, Commercializing Diagnostics, we speak with Charles Mathews, VP at Boston Healthcare. Specializing in reimbursement issues, Charles is a consultant for diagnostics companies. Recorded just hours after the Supreme Court handed down its unanimous decision invalidating Myriad's gene patents, the interview begins with a discussion on the case and what it means for the diagnostics industry.

Charles points out that while Myriad really paved the way in the industry, few diagnostics companies have been able to "carve out" such IP. In fact he sees a possible silver lining with the ruling, saying that it really matches the way the the science is headed, where there are fewer and fewer single markers and more next gen sequencing and multiplexing assays. These new tests with complex algorithms will be better in a world without individual gene patents, he argues.

Mathews' biggest message to his clients is that they must focus on reimbursement at the beginning. No longer is it about a single biomarker or new technology, but rather clinical efficacy. Evidence of clinical impact is much more important, he says, than hiring a host of IP lawyers. How can a start-up be better focused on reimbursement? And is he seeing more whole genome testing? These are questions Charles faces each day.

Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.

and by: Roche Molecular Systems,: A proud sponsor of today's podcast.

Moving to an "Outcomes" World with Steve Burrill

Podcast brought to you by: BioConference Live's annual Clinical Diagnostics Conference, May 29-31

Guests:

Steve Burrill, CEO, Burrill and Co Bio and Contact Info

Listen (4:38) Burrill and Buck Conference on Aging

Listen (7:32) Moving to a world in healthcare where we will pay for outcomes

Listen (6:23) Has it not always been about values?

Listen (4:24) Can Pharma create value outside of providing drugs?

Listen (1:08) Thoughts on gene patent case

"This is not your grandfather’s Buick anymore. If you grew up in biotech any time prior to the last five years, you need to reexamine your assumptions about the world of reimbursement." Ron Cohen, CEO, Acorda

This quote is taken from the yearly state of the industry book put out by Burrill and Company. CEO, Steve Burrill joins us today to discuss the newly published book this year subtitled, "Capturing Value." Cohen's quote summarizes the message in the book in which Burrill and his team argue persuasively that things in healthcare are not the way they used to be, that we are moving from a "cost-based" to a "value-based" system. Steve discusses this paradigm shift in today's show and explains why we need new assumptions in the world of pharma and biotech.

Early in the interview, Steve previews the first Burrill and Buck Aging Conference coming up May 20-21 in Novato California. The interview ends with Burrill's thoughts on the Myriad gene patent case.

Court of Appeals Upholds Myriad Gene Patents: Dan Vorhaus and Kevin Noonan

Podcast Sponsor:Laboratory Product Sales

Guests:

Dan Vorhaus, JD, Editor, GenomicsLawReport.com, Bio and Contact Info

Listen (17:14) Interview with Dan Vorhaus

Listen (5:43) Myriad Update 1: Details of the decision

Listen (2:46) Myriad Update 2: Judges disagree on gene patent issue

Listen (0:51) Myriad Update 3: Justice Lourie: Cleavage fundamentally alters the DNA

Listen (3:17) Myriad Update 4: Justice Moore: It takes congress or the Supreme Court

Listen (1:45 Myriad Update 5: Justice Bryson's dissent

Listen (0;38) Myriad Update 6: Most likely to be repealed

Listen (0:38) Myriad Update 7: Patents to expire soon

Listen (0:58) Myriad Update 8: What about whole genome sequencing

Kevin Noonan, Ph D, Editor, PatentDocs.org, Bio and Contact Info

Listen (11:11) Interview with Kevin Noonan

Listen (6:11) Myriad Update 9: Claims all say 'isolated' DNA

Listen (4:03) Myriad Update 10: Won't be settled until Supreme Court weighs in

Our show today is a follow-up on an earlier show about biotechnology and patent law. Last Friday, July 29th, a the Federal Circuit appeals court reversed a lower court’s ruling and upheld the right of Myriad Genetics to patent the BRCA genes. The BRCA1 and 2 genes account for most inherited forms of breast and ovarian cancers. Women who test positive using Myriad's gene test, have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer. The gene patent issue was decided 2 to 1. The court ruled unanimously that Myriad’s method for screening potential therapies was patentable but that their method for analyzing DNA sequences did not involve sufficient transformation, and thus could not be patented.

It is anticipated that the case will be further appealed, either to the full bench of appeals or to the U.S. Supreme Court.

Read Dan Vorhaus' analysis over at www.genomicslawreport.com.

Read an in-depth analysis of Judge Moore's decision written by Kevin Noonan at www.patentdocs.org.

Biotechnology and Patent Law: Looking at Stanford, Myriad, and Patent Reform Legislation

Guests:

Dan Vorhaus, JD, Editor, Genomics Law Report Bio and Contact Info John Conley, PhD,, UNC, Chapel Hill Bio and Contact Info

Listen (23:15) Dan V & John C - Myriad Case

Listen (03:29) Dan V & John C - Stanford v Roche

Listen (03:03) Dan V & John C - America Invents Act

Kevin Noonan, PhD, Bio and Contact Info

Listen (03:11) Kevin N - PatentDocs Blog

Listen (09:40) Kevin N - Myriad Case

Listen (12:55) Kevin N - Patent Reform

Listen (05:46) Kevin N - Stanford v Roche

On June 6, the Supreme Court handed down a decision on Stanford v. Roche. The case is about who owned the patent for a PCR-based HIV detection kit. Dr. Mark Holodniy joined Stanford as a research fellow, and when he did, he signed a Patent Agreement stating that he will assign the right to inventions resulting from his employment at Stanford. In 88, Cetus began to collaborate with scientists at Stanford to test their HIV technology. Because Holodniy was unfamiliar with PCR, his supervisor arranged for him to conduct research at Cetus. The condition for this would be that Holodniy sign a Visitor’s Confidentiality Agreement which stated that he did presently assign to Cetus any right to any invention made as a consequence of his access to Cetus. So which agreement would hold? Stanford sued Roche (who bought out Cetus) for infringing. The Supreme Court, however, decided against Stanford upholding the agreement with Roche/Cetus as the valid one. The case has been somewhat complicated by a piece of legislation called the Baye-Dole Act which gives universities intellectual property control of their inventions that result from federally funded projects.

Today we have two interviews--the first with Dan Vorhaus and John Conley, the second with Kevin Noonan--to discuss the Stanford Roche decision as well as the ongoing Myriad Genetics which deals with the patentability of genes. We also discuss patent reform legislation before congress called the America Invents Act.



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