On the very same day that the U.S. jobs report shows unexpectedly weak growth, the Federal Court of Australia issued a ruling directly opposite to the ruling rendered by the United States Supreme Court relative to gene patents. In Yvonne D’Arcy v. Myriad Genetics, Inc., the Federal Court of Australia ruled that Myriad’s claims to isolated DNA are patentable under the laws of Australia. That is the correct ruling, and it is the ruling the U.S. Supreme Court should have reached in Association of Molecular Pathology v. Myriad Genetics. As the patent eligibility laws of the U.S. become increasingly inhospitable to high-tech innovative businesses we can expect more job losses and worse news for the U.S. economy on the horizon.
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.
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.
The Supreme Court unanimously ruled yesterday that isolated DNA is not patent eligible under 35 U.S.C. §101. SeeAssociation 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!
One of the central policy issues injected into the current case of AMP v. Myriad Genetics is whether the BRCA patents are good for innovation and ultimately for patients. Specifically, ACLU and PubPat allege that the patents have hindered research, blocked innovation, and harmed patient access to BRCA testing. No matter how many times these allegations are repeated, all available evidence shows concerns over research and innovation to be unfounded. More importantly, two natural experiments give us an opportunity to evaluate actual patient access to testing, the ultimate measure of whether the patents are doing their job of incentivizing delivery of new technology to the public. Both of these experiments show that exclusive licensing of strong “gene patents” not only does not harm patient access to quality testing, but is instead vital to it.
In the impassioned words of Linda Bruzzone, a Lynch syndrome mutation carrier and head of Lynch Syndrome International: “Many of us with Lynch Syndrome wish there had been a patent in place for us. It would have protected us and perhaps protected the lives of our loved ones.” L. Bruzzone, Oral Comments at USPTO Public Roundtable on Genetic Diagnostic Testing (January 10, 2013).
Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three significant cases.
The first case argued at the Supreme Court will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. At issue is whether federal law preempts such claims from proceeding in state court and if drugmakers can be held liable if they decline to withdraw their medicines from the marketplace.
Of course, the same concept could be applied to brand-name drugmakers, which is why the entire pharmaceutical industry is on edge. In fact, the Obama administration filed a brief in support of drugmakers over concerns the FDA regulatory review process could be undermine if medicines deemd safe and effective could later by considered ‘unreasonably dangerous.’
The court reviewed an appeal by Mutual Pharmaceutical to overturn a $21 million jury award to a New Hampshire woman who in 2004 had taken a generic painkiller called sulindac, but developed Stevens-Johnson Syndrome and toxic epidermal necrolysis. She’s nearly permnanetly blind and suffered burn-like lesions over most of her body, underwent numerous surgeries, and is now unable to read, drive or work, and must use a feeding tube, her lawsuit says.