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.

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.

Litigation always factors into the pharmaceutical world, but the US Supreme Court commanded a special place in recent days. The high court figured in no fewer than four contentious issues that, not surprisingly, play a vital role in how drug makers can and will operate.

Let’s start with a case that is not yet before the court, but many predict will be headed there thanks to one of its earlier rulings. Earlier this month, a three-judge panel of the US Court of Appeals for the Second Circuit overturned the conviction of a former sales representative, who argued that prosecuting him for remarks made about off-label use violated his free speech rights.

In their decision, the 2-to-1 majority cited a US Supreme Court ruling early last year that struck down a highly controversial Vermont law, which restricted the sale of prescription drug data identifying prescribers and patients for commercial marketing purposes. Specifically, the court ruled that “speech in aid of pharmaceutical marketing… is a form of expression protected by… the First Amendment.”

Given the remand of the Federal Circuit’s original panel decision for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., I’m not surprised that the Supreme Court granted the ACLU’s/Pubpat’s petition for certiorari in AMP v. Myriad.  What is somewhat surprising is that the Supreme Court granted certiorari only as to the first question (“Are Human Genes Patentable”) posed by the ACLU/PubPat.  The patent-eligibility under 35 U.S.C. § 101 of Myriad’s claimed method of screening potential cancer therapeutics that was (again) unanimously upheld by the Federal Circuit panel, but will not be before the Supreme Court.  Nor will the issue of “lack of standing” with respect to but one of the plaintiffs be considered.

I’ve been following the various meanderings and wanderings of the Myriad case for almost three years now.  One unfortunate aspect of this case is that, from the beginning, the ACLU/PubPat has manipulated and fabricated what this case is about in terms of the applicable “science,” as well as the applicable “patent law.”  In fact, in distorting what this case is really about (i.e., the patent-eligibility of Myriad’s claimed “isolated” DNA sequences under 35 U.S.C. § 101), the ACLU/PubPat has also tried to hide the fact that the real plaintiffs in the Myriad case are none other than the ACLU/PubPat themselves; that has become readily apparent, given that all but one of the “alleged” plaintiffs have been knocked out of this case on “lack of standing” grounds.

Before the Myriad case becomes further obscured by the “pseudoscientific” nonsense foisted by the “real plaintiffs,” as well as the PR smokescreen of “politics, policy and philosophy” that the ACLU/PubPat has used to manipulate the applicable “patent law,” the Supreme Court needs to understand, to use Judge Lourie’s words, what this case “is not about.”

When the Supreme Court remanded the Federal Circuit’s original panel decision in AMP v. USPTO for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., I said that nothing would change in that remand.  In particular, I predicted that the same two-to-one majority from that Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) would again rule that the claimed isolated DNA sequences were patent-eligible under 35 U.S.C. § 101.  My primary reason for my confidence in that prediction was that the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) would control on that claimed subject matter, not Mayo Collaborative Services.  See Chakrabarty Controls on Isolated DNA Sequences, not Mayo*.

So guess what happened in the AMP remand of?  As I predicted, simply “déjà vu”:  the same two-to-one majority ruling for essentially the same reasons, as well as confirming that Chakrabarty (not Mayo Collaborative Services) controlled on the patent-eligibility of the claimed isolated DNA sequences.  For the full decision see AMP v. USPTO II (August 16, 2012).

On Friday, July 20, the Federal Circuit heard oral arguments in the remand of the AMP et al. v. USPTO et al. appeal – the case better known as the Myriad Genetics “gene patent” case. The supplemental briefing in this case, and the oral argument itself, continue to reveal how those with diverse perspectives on DNA patents misunderstand each other. Scientists are making dubious assumptions about the operation of patent law. Patent lawyers are making inaccurate assumptions about how the science works. And those who are neither patent lawyers nor scientists just go by what they’ve been told. The Department of Justice’s (DOJ) supplemental amicus brief and oral argument in this case are a good example of the widening disconnect.

“Kitschy, Not Catchy”

Readers will recall that this is not the first time DOJ appears in this case. Two years ago when the Myriad case first reached the Federal Circuit, DOJ filed an unsolicited brief, replete with hypothetical examples of elemental lithium, cotton, coal, isolated electrons, and other things having nothing to do with molecular biology, siding in part with the American Civil Liberties Union (ACLU), and arguing that Myriad’s claims to BRCA-encoding DNA molecules are patent-ineligible under Section 101.

In the immortal words of baseball great Yogi Berra, “It’s déjà vu all over again”.  A little more than a year after they previously heard AMP v. USPTO, the CAFC panel of Judges Lourie, Bryson and Moore have once again taken up the question of whether isolated DNA and related methods are patent eligible subject matter under 35 U.S.C. §101.

To recap, last year, the same panel ruled that the composition claims reciting isolated DNA were patent eligible, with Judges Lourie and Moore supporting patent eligibility and Judge Bryson dissenting.  All three Judges also agreed method claims involving “analyzing” or “comparing” DNA were not patent eligible.  Lastly, all three Judges agreed that a screening claim (claim 20 of the ‘282 patent) was patent eligible.  For a full discussion of last year’s decision (in English and Japanese), please click here.  After the decision, AMP appealed to the Supreme Court, who later vacated the CAFC decision and remanded the case to the CAFC for further consideration in view of their Mayo decision (English summary;Japanese summary).

The supplemental briefs for the parties and amicus are now finally in for the remand of the AMP v. USPTO case to the Federal Circuit.  As I’ve previously stated, the Supreme Court’s reasoning in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which caused this remand should not change the fact that Myriad’s isolated DNA sequence claims are patent-eligible under 35 U.S.C. § 101.  That’s based on the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) being the controlling precedent, not Mayo Collaborative Services.  See Chakrabarty Controls on Isolated DNA Sequences, not Mayo*

Not surprisingly, the ACLU and PubPat’s supplemental brief assert that these Myriad’s isolated DNA sequence claims are patent-ineligible in view of Mayo Collaborative Services, arguing that these claims “patent laws of nature and products of nature.”  This further mischaracterization of Myriad’s isolated DNA sequence claims perpetuates the unfortunate “myth” by the ACLU and PubPat that this case “is about the validity of certain patent claims on human genes.”  See page 8 of Brief for Appellees that filed for the original Federal Circuit panel decision.  But what the Federal Circuit panel should especially take note of in the remand of the AMP case is the supplemental amicus brief filed by Professor Christopher Holman of the University of Missouri-Kansas City School of Law.

Not too surprisingly, the Supreme Court granted certiorari in AMP v. USPTO, vacated the Federal Circuit’s panel decision, and remanded for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc.  On remand, the Federal Circuit is unlikely to “resurrect” the claims to the methods of “comparing” or “analyzing” DNA sequences that were deemed unanimously by the Federal Circuit panel to be invalid as being patent-ineligible under 35 U.S.C. § 101, and nothing in Mayo Collaborative Services changes that result, but simply reaffirms it.  But the story should also be no different for the claim directed to the method of screening potential cancer therapeutics that was unanimously upheld by this same panel as being patent-eligible under 35 U.S.C. § 101 because the Supreme Court’s reasoning in Mayo Collaborative Services is distinguishable for reasons given in the original AMP decision, as well as for reasons given in Judge Newman’s opinion in the remand of Classen Immunotherapies, Inc. v. Biogen IDEC.  See The Way Forward from Mayo Collaborative Services is through the Classen Immunotherapies Remand*.

Unfortunately this unspecific remand by the Supreme Court in AMP vacates as well the two-to-one ruling by this same Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) that the claimed isolated DNA sequences were also patent-eligible under 35 U.S.C. § 101.  What, pray tell, does Mayo Collaborative Services change with regard to that ruling in the original AMP decision?  For those, like the plaintiffs in AMP (including the ACLU), who would like to upset this “applecart,” they’re likely to be very disappointed.  I can describe what should be the impact of the ruling (and reasoning) in Mayo Collaborative Services on the claimed isolated DNA sequences in three short monosyllabic words:  NONE AT ALL.  And the Federal Circuit can (and should) say likewise, perhaps in far more words.