When the Supreme Court hands down a decision bearing on a hotly contested area of law, it means the work has just begun for any agency tasked with administering its consequences. Last term, the Court rendered such a decision in Association for Molecular Pathology v. Myriad Genetics, adding a new wrinkle to the already confounding question of patentable subject matter under §101 of the Patent Act.
As companies consider current cases related to patents before the Supreme Court, they would be wise to learn from the challenges the USPTO faced in implementing the Myriad decision. And for the reasons set forth below, we believe that the USPTO and the entire business community are well served by engaging in rigorous public debate about the guidelines that should be established to implement the decision from the Supreme Court.
Washington– The U.S. Department of Commerce’s United States Patent and Trademark Office (USPTO) will host a public forum on May 9, 2014 at the USPTO headquarters in Alexandria, Virginia, to solicit feedback from organizations and individuals on its recent guidance memorandum for determining subject matter eligibility of claims reciting or involving laws of nature, natural phenomena, and natural products (Laws of Nature/Natural Products Guidance). The Laws of Nature/Natural Products Guidance implemented a new procedure to address changes in the law relating to subject matter eligibility in view of recent Supreme Court precedent.
“We are always interested in receiving feedback from the public and this forum will provide an opportunity for participants to present their interpretation of the impact of Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analyses during patent examination.” said Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the USPTO Michelle K. Lee.
The Myriad/Mayo guidelines include an example that discusses the patent eligibility of a purified amazonic acid. The USPTO guidelines read as follows:
“The Amazonian cherry tree is a naturally occurring tree that grows wild in the Amazon basin region of Brazil. The leaves of the Amazonian cherry tree contain a chemical that is useful in treating breast cancer. However, to be effective, a patient must eat 30 pounds of the leaves per day for at least four weeks. Many have tried and failed to isolate the cancer-fighting chemical from the leaves. Applicant has successfully purified the cancer-fighting chemical from the leaves and has named it amazonic acid. The purified amazonic acid is structurally identical to the amazonic acid in the leaves, but a patient only needs to eat one teaspoon of the purified acid to get the same effects as 30 pounds of the leaves…”
The view of the USPTO now is that a claim to purified amazonic acid is not patent-eligible because there is no structural difference between the purified acid in the claim and the acid in the leaves, and the claim does not include features that demonstrate that the recited product is markedly different from what exists in nature. However the proposition that only a structural difference suffices and that differences e.g. in purity and utility do not suffice is derivable neither from the opinion in Prometheus nor from the opinion in Myriad. It is abundantly clear from study of the opinion in Myriad that the reasons why the BRCA1 gene claim did not survive were that the gene had been defined in terms of its informational content rather than its chemical structure, and that no new utility for the isolated full-length gene had been disclosed. Such an interpretation is wholly consistent with the concession made on behalf of the Petitioners in oral argument.
James Madison, father of the Constitution and proponent of strong patent rights.
As the end of 2013 approaches and I look back on what has transpired I am saddened to see that through the year patent rights have continued to erode. It is difficult to comprehend just how far the pendulum has swung. At one time strong patent rights were viewed by our Founding Fathers as obviously necessary. Now any patent rights are ridiculed as a relic of the past that simply stands in the way of innovation. The reality, however, is that patents don’t stand in the way of innovation; patents foster innovation. But so many won’t even take the time to inform themselves. Rather they equate “innovation” with a new consumer product. But to innovate is to do something new. Innovation has nothing in and of itself to do with a new products or services.
What those urging a weaker patent system want is the ability to release products and establish services regardless of whether they are infringing others. But those who infringe are not innovators, at least not in the most broad sense. Sure, they may have improved something, but if they are infringing then what they have done is copy an innovator. How and why that isn’t self-evident is a mystery. Copying is not innovating!
And if patents were getting in the way of innovation then why aren’t we seeing a standstill in the smartphone industry? The arguments made by the anti-patent crowd are ridiculous on their face, yet decision makers just nod their head in agreement as if they speak the gospel. The truth is the smartphone industry started with the iPhone in late 2007. It is just 6 years old! The phones from 2007 look and function nothing like the smartphones do today, and every new version has new improvements, better battery life, stronger structural integrity, glass that is harder to break, operates faster, has better cameras, etc. etc. For an area that is allegedly being suffocated by patents there sure is a lot of readily apparent improvement.
What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of September 2013.
Mark Lemley’s firm files DJ Action against Myriad
On September 20, 2013, Counsyl, Inc. filed a declaratory judgment complaintin the United States District Court for the Northern District of California against Myriad Genetics, Inc. Counsyl seeks a declaration that claims from 8 Myriad patents are invalid and not infringed. Further, Counsyl seeks their attorneys fees because they assert that this is an exceptional case given that Myriad is pursuing enforcing its patent portfolio despite losing on “certain claims” in the patents at issue at the Supreme Court in Association for Molecular Pathology v. Myriad Genetics.
The problem with the Counsyl declaratory judgment action is that there does not seem to be any contact with Myriad, so they claim that “[t]here is a definite, concrete, real and substantial controversy between Counsyl and Myriad of sufficient immediacy to warrant the issuance of a declaratory judgment…” However, there are no facts in the filing that show anything other than suspicion that Myriad may at some time sue Counsyl because Myriad has stated that they aggressively intend on asserting rights to the patents they own. Of course, Myriad has a right to seek to enforce their patents and this type of nebulous, generalized fear has never been sufficient to support declaratory judgment jurisdiction.
Senate Judiciary Committee Chairman Patrick Leahy (D-VT) asked NIH in a July 12 letter to force compulsory licensing of Myriad’s BRCA breast and ovarian cancer genetic test under the “march-in rights” provision of the Bayh-Dole Act. “Testimony presented to the U.S. Patent and Trademark Office made clear that many women are not able to afford the testing provided by Myriad.” Senator Leahy also charged that the Myriad test “was developed with federally-funded research.” See Leahy Urges Action.
Myriad received an exclusive license to develop the test from universities operating under Bayh-Dole Act. The law allows nonprofit institutions receiving federal R&D funds to own and license resulting inventions so they can be commercialized for use by the public.
Critics of Bayh-Dole have long sought to reinterpret its statutory standards under which the government can compel universities to issue compulsory licenses as a weapon to control prices. This was not the intent of the law.
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 willactually 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.