There are a great many people inside the patent industry that are working hard to convince themselves that the Supreme Court decision in Association of Molecular Pathology v. Myriad Genetics is not so bad. The argument goes that the Supreme Court explicitly stated that cDNA is patent eligible and that Chakrabarty remains good law. The trouble with both rationales is that they are incorrect.

It seems to me that anyone who tries to convince themselves that Myriad is anything other than a disaster is just fooling themselves. It does no good to put our heads in the sand and ignore what the Supreme Court said as if by doing so it will make a difference. Anyone who is honest with themselves knows how the district courts will interpret Myriad, and it will not be in a patentee friendly manner.

But before going to far, let me conclusively demonstrate with the Supreme Court’s own explicit language why those who are trying to convince themselves, and others, that the decision is workable are wrong.

Widely divergent views have formed in the wake of the Supreme Court’s decision in Association of Molecular Pathology v.  Myriad Genetics, Inc., No. 12-398, slip. op. (U.S. Jun. 13, 2013).  Some commentators have reacted with dire predictions for the biotech industry, suggesting that the Court’s holding has unduly narrowed patent protection traditionally granted to DNA technology and has disincentivized researchers in the field, particularly those from small start-ups. Other commentators suggest that the Supreme Court’s decision in Myriad will actually benefit genetic research, particularly researchers at the start-up level.   The authors of this post tend to agree with this latter view.

The Court’s holding with respect to what constitutes unpatentable DNA subject matter was quite limited. Justice Thomas, writing for the Court, explained that “[w]e 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.” Id. at 18. In other words, a naturally occurring DNA segment does not qualify as patentable subject matter merely by virtue of its “isolation from the remainder of the human genome.” Id. at 1.  Despite this limitation, the Court identified and implicated several related areas of technology that would not, as a matter of law, qualify as unpatentable subject matter. Indeed, if read carefully, the opinion actually provides instructions on how to successfully procure patent rights for technologies related to genes that have been identified and isolated.

The Supreme Court unanimously ruled yesterday that isolated DNA is not patent eligible under 35 U.S.C. §101. See  Association of Molecular Pathology v. Myriad Genetics. Or, put more precisely, the Court ruled that Myriad’s isolated DNA claims as written are not patent eligible.  The Court further ruled that similar cDNA claims are for the most part patent eligible, seemingly because the information underlying the claimed molecule omits some content of the information which underlies the full gene.

Spoiler alert: If you are the type of person who enjoys reading about convoluted analogies to baseball bats, plucked leaves, mined gold and surgically removed livers, you are out of luck.  Mercifully, and quite amazingly, the Court managed to avoid that morass.

A pivotal point is the question of whether Myriad was claiming information or a chemical compound.  Of course, the unique thing about DNA is that it is both (i) a chemical compound comprised of carbon, oxygen, nitrogen, phosphorus and hydrogen, and can be bound to cellular proteins, and (ii) an informational blueprint for proteins which form the building blocks of every living thing.

Earlier today the United States Supreme Court issued a decision that fundamentally changed the law of patent eligibility that has existed in the United States for the past 30 years, calling into question at least many tens of thousands of issued patents and many tens of thousands of pending patent applications. See Supremes Rule Isolated DNA and some cDNA Patent Ineligible.

With lightening speed, the United States Patent and Trademark Office has sent a memorandum to patent examiners relating to the aforementioned Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. The 1-page memorandum from Drew Hirshfeld, who is Deputy Commissioner for Patent Examination Policy, is direct. “Examiners should now reject…”

UPDATED June 13, 8:24pm ET (see comment #15 & #19)

Earlier this morning the United States Supreme Court issued its much anticipated ruling in Association of Molecular Pathology v. Myriad Genetics. Justice Thomas wrote for a a nearly unanimous Court, only Justice Scalia wrote separately and he concurred in part and concurred in the judgment. The decision is not long, and approximately half of the decision is background, yet at the end of the day much damage has been done to the biotechnology industry, the medical industry and the patent system. Indeed, the assault on patents continues.

According to Todd Dickinson, Executive Director of the American Intellectual Property Law Association, the outcome was fairly predictable given the oral argument, although 9-0 was a bit surprising. Dickinson told me via telephone earlier today the the decision itself is disappointing because it “keeps framing an anti-patent narrative.” He went on: “Patents are terribly useful to incent innovation and necessary to provide funding. If we undermine the patent system further I think we will be shooting ourselves in the foot.” I couldn’t agree more!

Today the Supreme Court will hear oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. Myriad Genetics was founded in 1991, and licensed, exclusively in the field of diagnostics, and also invented a group of patents associated with the five to ten percent of breast cancers known to have a strong hereditary component. The biomarkers disclosed, discussed, and claimed in these patents are also associated with an increased lifetime risk of ovarian and other cancers. See this U.S. Government website Genetics of Breast and Ovarian Cancer, updated 3/04/2013, and accessed April 14, 2013, for timely information on the significance of these biomarkers.

Social policy concerns have influenced the AMP v Myriad debate.  This article is intended to address certain misstatements of fact and draw attention to other facts not generally considered.

Atmosphere.

Petitioners have cast the case as “patients versus patents”. Petitioners comprise primarily molecular pathologists and women who assert they had to provide, and receive, respectively, inferior medical care because of Respondent’s patents. In part, because the SACGHS found that so called “genetic” diagnostic tests which were covered by patents cost no more than such tests which were not covered by patents, alleged negative impacts on future medical research have been more forcefully added into the mix of policy concerns creating a biased context for the debate.

You may have heard about the “breast cancer gene patent wars.”  Most likely, you have heard from various individuals and popular media asking “how can someone patent my genes?”  One can’t and never could patent your genes as they are in you.

One side in the “gene patent war” has nevertheless convinced the Supreme Court to weigh in on the issue of whether DNA sequences derived from the human genome are patentable, in Association for Molecular Pathology (AMP) v. Myriad Genetics, while disingenuously labeling the patents at issue as “human gene patents.”

Myriad (the “other” side) owns several patents with claims directed to “isolated” nucleic acid molecules (e.g., DNA) and fragments thereof which are referred to as either “probes” or “primers,” based on their function.  Probes anneal, i.e., bind, to a particular part of a DNA and are used to detect the presence of certain genes which indicate abnormalities or disease states.  Primers anneal to particular parts of a DNA and are used to make additional pieces of DNA, e.g., make multiple copies of a single abnormal sequence such that it is readily detectable and/or become capable of being utilized in other useful applications, e.g. forensic science.