Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims
Late on the afternoon of Monday, March 29, 2010, Judge Robert W. Sweet of the United States District Court for the Southern District of New York issued a jaw-dropping summary judgment ruling (pdf) in Association for Molecular Pathology v. USPTO that invalidates certain of Myriad Genetics’ patents related to the BRCA 1 and 2 breast and ovarian cancer susceptibility genes. In a post written immediately after the release of the opinion, Dan gave a thorough summary of the ruling. Our objective here is to offer a bit more depth on what the ruling means—and what it doesn’t mean. On the one hand, Judge Sweet’s order is radical and astonishing in its sweep. On the other, it will be some time before we have any idea what impact it will ultimately have.
We should first disclose that one of us (John) has a dog in this fight, albeit a small one. In 2003, (along with biologist and patent lawyer Roberte Makowski), John published an article in the Journal of the Patent and Trademark Office Society entitled Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents (pdf). In that article, Roberte and John laid out an argument for challenging Myriad-style patents on “isolated” genes as claiming products that are only trivially different from the naturally-occurring versions. Judge Sweet cited this article and, in several parts of his opinion, followed the roadmap it created. So, if you oppose the Myriad patents, you’re welcome; if you like them, we’re sorry.
What Summary Judgment Means. As Dan noted, and John first wrote last fall, it is rare for plaintiffs to win on summary judgment. For either side to receive summary judgment, it must show that there are no disputed issues of fact that require a trial to resolve, and that, on the undisputed facts, the law mandates judgment in its favor. This standard is especially hard for a plaintiff to meet, since it bears the burden of proof at trial. At the summary judgment stage, a defendant can usually create an issue of fact and thereby avoid summary judgment just by saying “they have the burden of proof at trial, and a jury might not believe them.” Although this is an unusual case in that the basic facts—most notably Myriad’s patent claims and the fundamental biology and genetics that makes possible those claims—really are not in dispute, a summary judgment ruling for the plaintiffs nonetheless sends a clear message about how strong this particular judge thought their case was—and how weak he thought Myriad’s was.
The Road to Invalidation. The court broke Myriad’s patent claims into two major groups: (i) those claiming isolated DNA sequences and (ii) those claiming methods for comparing or analyzing gene sequences to identify the presence of mutations corresponding to a predisposition to breast or ovarian cancer (p. 2). Both sets of patents were rejected under Section 101 of the Patent Act, which enumerates the permissible categories of patentable subject matter: processes, machines, manufactures, and compositions of matter. As the judge noted, a long history of cases forbids claims on laws of nature, abstract ideas, and natural phenomena, which include products of nature.
SACGHS Gene Patent Recommendations Still Controversial
The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) for the Department of Health and Human Services (HHS) convened again on Friday for a snow-shortened session. One of several items on the Committee’s agenda was a report that the GLR has covered several times (see here and here): Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. With the threat of a blizzard looming, the meeting was unexpectedly short, with only a pair of public comments followed by the Committee’s vote to approve the report.
The report itself will not be available for several weeks, but the six recommendations on gene patenting and licensing approved by the Committee this past October continue to provoke a heated response. The Biotechnology Industry Organization (BIO), along with former Senator Birch Bayh (of Bayh-Dole Act fame) and others, held a Friday press conference to denounce – again – the report’s recommendations.
The SACGHS Recommendations. Most of the recommendations are uncontroversial, urging the Secretary of HHS to convene stakeholders to “explore” and “encourage” strategies to improve access to genetic testing, enhance patent licensing and ensure that the USPTO is “kept current with the latest scientific and technological developments related to genetic testing and technology.”
So what prompted Bayh’s charge that the recommendations represent “an attempt to send us back to a time when it appeared that American innovation was on its last legs and our economy was in deep distress”?
Read the rest of this entry »
Final Words from the Sidelines as Courtroom Arguments Begin in Gene Patent Litigation
Yesterday, on the eve of summary judgment arguments in the Myriad case, The Boston Globe editorialized—strongly—against patenting isolated genes. This is an issue in which the Globe has a natural interest, given the concentration of biotech companies in and around Boston. The Globe’s editorialists may or may not be right on the merits, but they are surely too glib.
First, they wrongly blame the Patent Office for what they see as bad policy: “The US patent office assumes that granting one firm the exclusive right to profit off of a gene is the best way to encourage further research.” No, the Patent Office doesn’t “assume” this—it’s in the U.S. Constitution (Art. I, sec. 8, cl. 8), which allows Congress to grant exclusive rights to inventors to promote the progress of science and the useful arts. That is, the Constitution states an economic rationale for patents: the Framers believed that the promise of monopoly returns was the best way to motivate inventors to invent and then to disclose their technology (which you have to do to get a patent). So even if you disagree with this policy, you shouldn’t say that the Patent Office dreamed it up or has any authority to change it.
Myriad Genetics, USPTO File Summary Judgment Motions in Gene Patent Case
Two of the defendants in Association for Molecular Pathology v. U.S. Patent and Trademark Office, the frontal attack on Myriad Genetics’ breast cancer gene patents organized by the American Civil Liberties Union, have now filed their own summary judgment motions. (Click through to read the memorandum in support of Myriad Genetics’ motion (pdf) filed on December 23 and the memorandum in support of the PTO’s motion (pdf) filed on December 24). As we explained in an earlier post, a summary judgment motion seeks to convince the trial judge that the facts are so clear-cut that there is no reason to go ahead with the trial—in legal jargon, that there is “no issue of material fact” that needs to be tried. This is the rare case in which both sides have asked for summary judgment (the plaintiffs filed their motion and supporting memorandum (pdf) back on August 26). The filings by both sides are not a surprise here, however, since the facts surrounding the challenged patents are largely undisputed and the real question is how to apply patent law to those facts.
Protecting the Name
A great invention deserves a great name. When the time comes to market your game-changer, you can be sure of two marketing realities: copiers will race to build similar products, and purchasers will reward the product they remember. These two truths lie behind the adoption of the trademark iPhone® to identify Apple Inc.’s unique combination of music player and smart telephone and to distinguish it from other, similar products that now are marketed by Palm, RIM and other competitors. Because consumers know to ask for an iPhone® device by name, iPhone symbolizes and sustains the considerable goodwill that attaches to this category-creating product. The inner electronics of the device have changed repeatedly since it was first introduced, but consumers still associate today’s product with the original and its goodwill because of the consistent use of this trademark.
Provisional Patents: A (Temporary) First Step
Any entrepreneur is likely to be euphoric when her company discovers a novel and potentially valuable genomic invention that may be protectable by a patent. But when the celebrations start to fade, difficult decisions will remain about how to protect and exploit the intellectual property rights associated with the invention. A company may protect its rights by carefully avoiding disclosure until it has reduced its invention to practice (that is, made it work) and filed a patent application. But our entrepreneur may not have that option. Reducing the invention to practice requires money, which may be in short supply.
For the purpose of this post, we assume that the entrepreneur has already taken the required steps to be sure the company owns all necessary rights in the invention. (See our earlier Bench to Market articles: “What Happens When Professors Have Valuable Inventions?” and “Don’t Overlook Agreements with the Inventors.”) How can she now have the discussions with outside parties (such as venture capital firms) that may be necessary to commercialize the invention, without risking the loss of important intellectual property rights?
A Court Ruling in the ACLU v. Myriad Gene Patent Litigation, But We’re Still A Long Way From A Gene Patent Resolution
For nearly six months the Genomics Law Report has been covering the developments in the ACLU-instigated lawsuit against Myriad Genetics, the University of Utah and the U.S. Patent and Trademark Office (USPTO). In late July, Myriad and its co-defendants filed motions to dismiss the lawsuit. Yesterday, Judge Robert W. Sweet of the Southern District of New York finally denied those motions.
Judge Sweet ruled against the defendants in each of several separate motions to dismiss, including lack of subject matter jurisdiction, lack of personal jurisdiction and failure to state a claim. The always-comprehensive Patent Docs blog has a complete summary of yesterday’s ruling—as well as the court’s full opinion (pdf)—but there’s at least one part of the ruling that’s worth highlighting here.
Duke Finds a Second Alzheimer’s Gene—What Does It Mean?
The recent discovery of a gene linked to Alzheimer’s disease provides a timely context for revisiting the significance of gene patents. Researchers at Duke University Medical Center recently announced that they have identified a second gene (called TOMM40) associated with an increased risk of late-onset Alzheimer’s, which affects people over the age of 65. A team of Duke gene hunters originally identified the first Alzheimer’s gene (APOE) in 1993. Although the announcement prompted warnings about the need for further confirmation, the Duke researchers hope that the analysis of which versions, or alleles, of the two genes that people carry will significantly sharpen geneticists’ ability to predict susceptibility to Alzheimer’s. Those predictions might prove especially useful in both diagnosing Alzheimer’s disease and in developing future Alzheimer’s drugs.
One of the first questions on everyone’s mind, particularly in light of the high-profile lawsuit by the ACLU and others against Myriad Genetics, is whether this newly discovered Alzheimer’s gene could be patented. In principle, yes. Going back at least to the early 1980s, the U.S. Patent and Trademark Office (US PTO) and the federal courts have repeatedly taken the position that genes in isolation from their natural environment (that is, outside the body) are patentable subject matter, just like any other chemical compound. Individual cases have turned on such specifics as whether others had previously identified the gene, or whether and when the patent applicant or others had first disclosed the gene. But there is no general prohibition against patenting genes.
Whole-Genome Sequencing and Gene Patents Coexist (For Now)
In a recent post, John Conley analyzed the ACLU’s lawsuit challenging Myriad Genetics’ patents on the BRCA-1 and BRCA-2 “breast and ovarian cancer susceptibility” genes. Several readers responded with the same general inquiry: if an individual undergoes a whole-genome sequence analysis, will the individual (or the company providing the sequence) be required to pay royalties to Myriad because the BRCA-1 and -2 loci will have been sequenced?
Although focused on the BRCA genes, the question is broadly applicable to the entire genome sequencing industry: when sequencing all or a portion (e.g., the exome) of an individual’s genome, are individual gene patents infringed upon by either the company providing the sequence or the individual purchasing or requesting it? The answer is not entirely clear, but, at least in the case of Myriad and the BRCA genes, it appears to be no. Or at least, not yet.
Let’s begin with what is not patented, which includes a majority of genes and the vast majority of the human genome. Genes—those stretches of DNA that encode for proteins—make up approximately 2% of the human genome. The estimate of the exact number of genes ranges from between roughly 20,000 to 30,000 and, of those, a 2005 study in the journal Science found that only 20% of human gene DNA sequences are patented (subscription). Although those numbers are certainly subject to change, the reality is that, today, it is likely that less than 1% of the entire human genome has been patented.
Of course, that very small number belies the fact that the genes which have been patented consist of some of the most important identified genes associated with the prediction or determination of human health and disease. The high-profile BRCA genes are an excellent example and thus make for a good case study.
ACLU v. Myriad Genetics: Defendants Move to Dismiss
The US Patent and Trademark Office, the University of Utah and Myriad Genetics have all filed motions seeking to dismiss the ACLU’s high-profile lawsuit attacking the patentability of genes (pdfs: USPTO Memorandum; Myriad/Utah Memorandum). In alleging that the plaintiffs lack standing to bring the lawsuit — a common procedural tactic in litigation — Myriad does not mince words, opening its argument as follows:
This case is a thinly veiled attempt to challenge the validity of patents where, other than an overall policy disagreement concerning the legitimacy of gene patents, the plaintiffs have no actual dispute with the Defendants over patent infringement. If the plaintiffs in this case have standing, then virtually anyone can challenge any patent at any time.
The ACLU has yet to publicly comment on the motions to dismiss. The court is scheduled to hear the Motion to Dismiss (pdf) on August 26th.
