As the dust begins to settle on the Supreme Court’s recently issued opinion in AMP v. Myriad, and hopefully as the misguided “gloating” by the media and the ACLU settles down to a dull “roar,” what does the Myriad decision really mean?

The ruling that was handed down by the Supreme Court in Myriad was pretty much as I expected, and could have been far, far worse.  Again, let’s not get lost in the mistaken (and misrepresentative) hype and hyperbole of the media and the ACLU, i.e., the “patenting of human genes has been blocked by the Supreme Court” which the Myriad case was never about in the first place. Frankly, the “doom and gloom” I’m seeing and hearing from the patent law world (including a depressing and mind-boggling statement I saw from the AIPLA about the potential impact of the Myriad decision on biotechnology) isn’t warranted in my opinion.

And please also note that Myriad’s stock initially shot upwards in price significantly Thursday after the Myriad decision came out (although it also fell back again Friday) which suggests investors are not necessarily as “bearish” about the financial impact of this decision compared to the media, and at least some in the patent law world.

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!

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.

Yesterday the United States Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. While the Association for Molecular Pathology (AMP) is the named party in the case, it is really a case brought and forwarded by the American Civil Liberties Union (ACLU).

Myriad Genetics is the patent holder on various innovations relating to isolated DNA comprising an altered BRCA1 DNA and various methods of screening for cancer built upon various observations of the altered BRCA1 DNA. Essentially, AMP and the ACLU, along with researchers, competitors of Myriad Genetics and consumers filed a lawsuit challenging the constitutionality of a number of gene patents owned by Myriad and argued that gene patents should not be granted because patenting a gene is the same as patenting something that exists in nature.

This argument succeeded at the district court, but has twice failed at the Federal Circuit. The Federal Circuit initially reversed the district court, but appeal was made to the Supreme Court by AMP/ACLU. See As Predicted, Federal Circuit Rules Isolated DNA Patentable. In the meantime the Supreme Court issued a decision in Mayo v. Prometheus and remanded this case to the Federal Circuit for further consideration in light of the Court’s decision in Mayo v. Prometheus. The Federal Circuit again sided with Myriad Genetics. See AMP v. USPTO Remand Déjà Vu. Appeal was taken to the Supreme Court, which accepted certiorari. See Supreme Court Grants Cert in Amp v. Myriad. The only issue accepted by the Supreme Court was the broadest issue: are human genes patent eligible?

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.

As the patent community waits to see whether the United States Supreme Court will deal a significant, perhaps fatal blow, to the patenting of many genetic related innovations in Association of Molecular Pathology v. Myriad Genetics, announcement came this morning of a newly issued U.S. patent. This patent — U.S. Patent No. 8,399,645 — was issued to St. Jude Children’s Research Hospital. The invention relates to compositions for genetically modifying human immune cells so they can destroy some of the most common forms of cancer in children and adults.

It seems unthinkable that the Supreme Court could issue a ruling that would call into question the patent eligibility of an innovation that has the potential for curing cancer, but that is what is at stake. The Supreme Court will hear oral arguments in AMP v. Myriad on April 15, 2013, and the issue they will consider only a single question: Are human genes patentable?

While this St. Jude invention is not likely to be directly impacted by any ruling the Supreme Court makes, if the Supreme Court says that human genes are not patentable then what is to stop the march toward a ruling that says genetic modifications are likewise not patentable? Additionally, the Myriad claims relate to isolated DNA sequences, not DNA as it exists in a person or in nature. Some of St. Jude claims to this cure for cancer would seem to fall if the Myriad claims fall because they cover isolated host cells. Indeed, there is a lot at stake.

On February 20, the UC Hastings Constitutional Law Quarterly held a symposium titled, Patent Pending: Corporations, the Constitution, and the Human Gene. See Event Program. The 3-hour event featured Alex Kozinski, Chief Judge of the US Court of Appeals for the Ninth Circuit, as well as Professor David Winickoff of UC Berkeley, Dr. Megan Allyse of Stanford University, Vern Norviel of Wilson Sonsini Goodrich & Rosati, and James Mullen and Wes Overson of Morrison & Foerster. I was the moderator for the symposium, and what follows is a summary of the discussion.

I began by describing the facts of the Myriad case, which is currently before the Supreme Court, and the science behind the issues, as well as introducing the panelists. I then began the discussion by asking the panelists if genetic sequence and cDNA patents interfere with scientific research and with those who provide health care.  Vern Norviel of Wilson Sonsini argued that it does not matter either way with regards to patents and new biotech product innovations.  Mr. Norviel pointed out that the entire human genome was already mapped and the company who mapped it was not sued.  More importantly, he argued, is that human genes are limited and it would be a very small bit of information that could be determined to not be patentable.  He did, however, caution that the Court should try and restrain itself and not go too far such that it destroys what is currently a massive and successful life sciences industry.  The bottom line is that regardless of whether a patent exists, professors and researchers will continue to do the research.  Dr. James Mullen of Morrison & Foerster further argued that patents encourage research and innovation as venture capitalists want to know if (1) the research does what it is claimed to do and (2) if the party owns that research.

The Honorable Alex Kozinski immediately posed the question—by way of an analogy to scientists who stare at the stars—of why should someone be able to get a gene patent just because there was a significant amount of effort put in to discover that gene.  Throughout the event, Judge Kozinski took on the role of the generalist judge, who would need to be convinced that the invention in the lab is anything other than a product of nature. Professor David Winickoff of UC Berkeley followed that question up by discussing James Watson’s amicus brief and the idea that genes are both symbolic in our culture and shared by all humans, thus making them a unique item in our world.

A good old fashioned witch trial can be jolly fun for most participants (save one). They are briefly cathartic, providing accusers a platform to be sanctimonious, while misleading a trusting public. Such efforts are best conducted behind closed doors as they lose credibility in the light of day. Thus, it was a relief to see the Patent and Trademark Office resist this approach in its January 10th Roundtable on Genetic Testing. This openness exposed claims that have driven the debate so far to a rare scrutiny.  Perhaps the bonfires being prepared for the accused are premature.

The PTO is charged under section 27 of the America Invents Act with conducting a study on the influence of patents and exclusive licensing on the availability of confirmatory genetic testing – that is, the ability to obtain an independent confirmation of a genetic test by a second laboratory for patented tests only available from an exclusive provider. The sponsor, Congresswoman Debbie Wasserman-Schultz, is a breast cancer survivor who had to make serious medical decisions based on her own genetic test.  Understandably, anyone in that situation wants to ensure they received the most accurate testing possible.

It is that time of the year when reflections are made on the year that is about to pass, wishes are made for the new year, and a prediction or two start to pop from both amateur and professional prognosticators alike. In years past we have done a Patent Wishes article, which is currently in the works. This year I thought I would add an article that gave some industry insiders an opportunity to reflect upon the biggest moments in intellectual property for 2012.

Whenever I do something like this I keep my fingers crossed. The biggest moments in IP seem rather obvious to me, so will they to others? Will I wind up printing the same thing 5 or 6 times? The answer: Absolutely not! We had a very busy year, from Supreme Court decisions to failed legislation to fight piracy on the Internet, to important Federal Circuit cases and implementation of the America Invents Act.

Indeed, for this inaugural edition of Biggest Moments in IP we have a variety of reflections on a wide array of IP issues. Former Commissioner for Patents Bob Stoll walked through some of the biggest items on the patent docket for the year. Stephen Kunin of Oblon Spivak gives us his Top 10 list in David Letterman style. Former staffer to Senator Leahy (D-VT) and current lobbyist Marla Grossman reflects on Senator Leahy’s decision to refuse the Chairmanship of the Senate Appropriations Committee to stay on as Chair of the Judiciary Committee. IP attorney and frequent feature contributor to IPWatchdog.com Beth Hutchens focuses on several copyright and first amendment issues, and reminds us of the battle that ensued to defeat SOPA.