More Myriad: Moving Beyond Single Gene Patents

Unless you have been living under a rock – or, if you hail from the Northeast, living under water – Monday’s decision in Association for Molecular Pathology v. USPTO is no longer new news. Previous coverage from the Genomics Law Report (here and here) reviews Judge Sweet’s opinion and its implications.

Moving Beyond Single Gene Patents. Much of the discussion following the decision has centered on what effect the invalidation of Myriad’s gene patents – should that decision be affirmed by a higher court and extended to other similar patents – will have on scientific and commercial innovation.

In many ways, that issue is at the center of the policy debate surrounding Sweet’s opinion and, more generally, the appropriateness of certain biotechnology patents. It’s a question that’s difficult to answer prospectively, but Andrew Pollack’s piece in The New York Times succinctly makes an important point about an emerging reality in the biotechnology industry.

…[T]he [biotechnology] industry is already moving to a period of somewhat less dependence on DNA patents for its sustenance. Diagnostic laboratories, for instance, are shifting from testing individual genes to testing multiple genes or even a person’s entire genome. When hundreds or thousands of genes are being tested at once, patents on each individual gene can become a hindrance to innovation rather than a spur.


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Filed under Badges, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims

Late on the afternoon of Monday, March 29, 2010, Judge Robert W. Sweet of the United States District Court for the Southern District of New York issued a jaw-dropping summary judgment ruling (pdf) in Association for Molecular Pathology v. USPTO that invalidates certain of Myriad Genetics’ patents related to the BRCA 1 and 2 breast and ovarian cancer susceptibility genes. In a post written immediately after the release of the opinion, Dan gave a thorough summary of the ruling. Our objective here is to offer a bit more depth on what the ruling means—and what it doesn’t mean. On the one hand, Judge Sweet’s order is radical and astonishing in its sweep. On the other, it will be some time before we have any idea what impact it will ultimately have.

We should first disclose that one of us (John) has a dog in this fight, albeit a small one. In 2003, (along with biologist and patent lawyer Roberte Makowski), John published an article in the Journal of the Patent and Trademark Office Society entitled Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents (pdf). In that article, Roberte and John laid out an argument for challenging Myriad-style patents on “isolated” genes as claiming products that are only trivially different from the naturally-occurring versions. Judge Sweet cited this article and, in several parts of his opinion, followed the roadmap it created. So, if you oppose the Myriad patents, you’re welcome; if you like them, we’re sorry.

What Summary Judgment Means. As Dan noted, and John first wrote last fall, it is rare for plaintiffs to win on summary judgment. For either side to receive summary judgment, it must show that there are no disputed issues of fact that require a trial to resolve, and that, on the undisputed facts, the law mandates judgment in its favor. This standard is especially hard for a plaintiff to meet, since it bears the burden of proof at trial. At the summary judgment stage, a defendant can usually create an issue of fact and thereby avoid summary judgment just by saying “they have the burden of proof at trial, and a jury might not believe them.” Although this is an unusual case in that the basic facts—most notably Myriad’s patent claims and the fundamental biology and genetics that makes possible those claims—really are not in dispute, a summary judgment ruling for the plaintiffs nonetheless sends a clear message about how strong this particular judge thought their case was—and how weak he thought Myriad’s was.

The Road to Invalidation. The court broke Myriad’s patent claims into two major groups: (i) those claiming isolated DNA sequences and (ii) those claiming methods for comparing or analyzing gene sequences to identify the presence of mutations corresponding to a predisposition to breast or ovarian cancer (p. 2). Both sets of patents were rejected under Section 101 of the Patent Act, which enumerates the permissible categories of patentable subject matter: processes, machines, manufactures, and compositions of matter. As the judge noted, a long history of cases forbids claims on laws of nature, abstract ideas, and natural phenomena, which include products of nature.


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Filed under Badges, Bioinformatics/IT, Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation

Breaking: District Court Rules Myriad Breast Cancer Patents Invalid

The highly anticipated decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office, the frontal attack on Myriad Genetics’ breast cancer gene patents, was handed down today. A copy of the opinion, from Judge Robert Sweet of the Southern District of New York is available here.

The opinion was released late this afternoon and it weighs in at 156 pages, so a more complete analysis will be forthcoming. [Edit 3/30: John Conley and I have published a more detailed review and analysis of the decision here: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims. For just the highlights, continue reading below.] However, there are a few crucial points that deserve an initial reaction.

1. The Plaintiffs Win. The ruling appears to be a nearly complete victory for the plaintiffs and their supporters, including the ACLU. With respect to Myriad’s issued patents on the BRCA1 and BRCA2 genes, Judge Sweet’s ruling invalidates both Myriad’s composition of matter claims (its patents on isolated DNA sequences to all or a portion of the breast cancer genes) and its method claims (those patent claims that relate to analyzing or comparing isolated DNA sequences in order to detect mutations in a patient’s BRCA1/2 genes that might cause breast cancer).

The overall tone of the Court’s ruling is best captured by this passage (from page 135):

The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent.


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Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

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New Tools for Forensic DNA: Keyboards and Cats

Earlier this week James Cass wrote a piece discussing forensic DNA profiling (“The Cost of Making Crime Not Pay: Obama, CODIS and Forensic DNA“). That article prompted GLR readers to write in and point out that, thanks to several recent developments, the next generation of forensic DNA investigations may increasingly involve the use of non-human DNA profiling techniques.

Last week, a paper in the Proceedings of the National Academy of Sciences presented research that every person – even twins whose DNA is practically identical – possesses a unique bacterial signature. It appears that traces of that bacterial signature can be recovered from household surfaces, including a computer keyboard, and potentially used to link a crime scene to a suspected criminal. The researchers’ findings are summarized in ScienceNOW (“CSI’s Latest Clue – Bacteria“).


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Choosing to use genetic testing is an option. Ignorance isn’t.

Last week I posted a response to a column in the Sunday Times by Camilla Long, “Long’s Op-Ed on Personal Genomics Comes Up Short.” Readers of that piece may be interested in a further response (“Choosing to use genetic testing is an option. Ignorance isn’t“), which I wrote with Daniel MacArthur of Genetic Future, published today in the Times.

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The Cost of Making Crime Not Pay: Obama, CODIS and Forensic DNA

Earlier this month President Barack Obama appeared on the television show “America’s Most Wanted” to discuss the creation of a national forensic DNA database. In his interview with AMW host John Walsh, President Obama expressed his strong support for a number of law enforcement initiatives, including a proposal to expand the compulsory DNA sampling of individuals arrested and charged with certain crimes.

In this post we’ll take a look at the current system of forensic DNA profiling, starting with the Combined DNA Index System (CODIS), which is the FBI program that oversees DNA profile databanking in the United States. It comprises databases at the local, state and national levels, with the National DNA Index System (NDIS) the crown jewel. The CODIS program operates as a powerful law enforcement tool but, in the eyes of some – including President Obama – it is not yet powerful enough. But even the existing CODIS collection, with its nearly eight million DNA profiles, poses a number of interesting ethical, legal and social issues.


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The New York Times vs. Personal Genomics: Much Ado About Not Very Much

Earlier this month, there was speculation that The New York Times was preparing a piece “attacking” the “fledgling industry” of personal genomics (see: Linda Avey Versus the New York Times). The article in question, by reporter Andrew Pollack, was published over the weekend and, in retrospect, it’s hard to see what all the hubbub was about.

The title (Consumers Slow to Embrace the Age of Genomics) fairly reflects the tone of the rest of the article, which is a factual assessment of the business of personal genomics. In his piece, Pollack brings forth a standard set of issues confronting 23andMe and its peers (including Navigenics, deCODEme and Pathway Genomics). All are familiar, and most drive at a central challenge for these companies: demonstrating the value of their services and identifying customers willing to pay for them. (In a short, separate article that appears alongside, Pollack raises (but does not attempt to resolve) a much more controversial issue: whether personal genomics products represent medical tests or recreational services.) By and large, Pollack points out these challenges to the business of personal genomics without passing judgment. 


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Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

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Evaluating the NIH’s New Genetic Testing Registry

This morning the NIH announced plans to create a publicly accessible registry of genetic tests.  The Genetic Testing Registry (GTR) is expected to be available in 2011 and will contain information voluntarily submitted by genetic test providers.  The news is significant and carries implications for clinical genetic testing laboratories, personal genomics service providers and individual purchasers of genetic tests.

Many details of the GTR are yet to come, with NIH promising to “engage stakeholders – such as genetic test developers, test kit manufacturers, health care providers, patients and researchers – for their insights on the best way to collect and display test information.”  While the GTR isn’t expected to launch until next year, and there is time to fill in the details, the questions and answers section of the GTR’s new website helpfully addresses several of the most important features of the registry.

This post looks at what we know about the GTR today, and considers what the GTR’s ultimate implementation might mean for the development and regulation of genetic testing.  (Note that the inset orange questions, and the text that immediately follows each question, is taken directly from the GTR question and answer page.)


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