By Andrew Williams --
On June 29, a panel at the 2011 BIO International Conference discussed the topic of "IP Challenges for Personalized Medicine: Navigating Bilski, Myriad, and Prometheus." This session addressed one of the most prevalent issues at this year's conference -- are the courts going to alter the intellectual property landscape for biomarkers and personalized medicine? As moderator, Jennifer Gordon of Baker Botts L.L.P. began the session by providing a definition for personalized medicine -- a definition that included at its core the ability to "classify individuals into sub-populations." And how is this accomplished? By identifying biomarkers (compositions of matter), and building diagnostics around them (methods). As a result, Dr. Gordon identified three IP challenges: (1) potential limitations on meaningful claim coverage for composition of matter claims; (2) potential limitations on meaningful claim coverage for companion diagnostic claims; (3) and the proliferation of patent thickets that results when many patents cover a particular diagnostic.
Hans Sauer, Associate General Counsel of BIO, addressed the first of these challenges by introducing and discussing the Myriad case (Association for Molecular Pathology v. USPTO). Dr. Sauer pointed out the differences of this case as compared to other patent cases, specifically noting that the plaintiffs brought this suit on behalf of breast cancer survivors by attempting to reach the patent holder of a diagnostic test related to the risk of developing breast and ovarian cancer. This is distinct from the typical patent case in which both of the parties are commercial actors. In his general observations of the case, Dr. Sauer noted that there are two types of claims at issue, broad method claims and composition-of-matter claims, otherwise referred to here as "gene patents." And gene patents, because they are claimed as isolated DNA, are legally indistinguishable from other biological chemicals such as proteins and antibodies. Dr. Sauer opined that what the courts are being asked to decide is what does it take to go from a discovery to an invention? In other words, how much human intervention is enough? Of course, merely isolating and purifying a composition of matter has never been enough to obtain a patent, because a patentee still needs to meet the requirements that the invention be new, useful, and non-obvious, for example. The Patent Office does not simply give away gene patents. Therefore, as Dr. Sauer concluded, patent eligibility might not be the best tool to address these issues.
Mark Seka, Global Head of IP for Novartis Molecular Diagnostics, addressed the second identified challenge, the limitation on meaningful claim coverage for companion diagnostic claims, by specifically discussing the Prometheus case (Prometheus Laboratories, Inc. v. Mayo Collaborative Services). At the outset, Mr. Seka noted that personalized medicine is basically a spin-off technology from the human genome project, and that the original mapping was just the beginning. Because it is very costly to bring such a diagnostic invention to market, the cases currently making their way through the court system are threatening the ability of commercial enterprises to recoup their investments through the protection of their intellectual property. Mr. Seka noted that the Prometheus case involved two types of claims, those that test a patient's blood to determine the presence of an analyte with a therapeutic administrative step, and those that just contain the testing step. The Federal Circuit reversed a summary judgment ruling that the claims are patent ineligible because they recite a natural phenomenon. The Federal Circuit used the machine or transformation test, and found that because both types of claims involved a transformation, they were both patent eligible. However, in the wake of the Supreme Court's Bilski ruling, in which it held that the machine or transformation test was not the only test to determine patent eligibility, the Court remanded the case to the Federal Circuit to render a decision consistent with the Bilski ruling. Mr. Seka noted that the Supreme Court did not dispense with the machine or transformation test, and so the Federal Circuit was able to reach the same result. Of course, just recently, four Justices voted to take up the Prometheus in the next term, so the uncertainty continues.
Dr. Sauer played devil's advocate by asking Mr. Seka whether the patentees in Prometheus were just using old knowledge, and therefore asked if they were really entitled to patent protection. After all, weren't the drugs old, and didn't the patentees just discover that the drug was metabolized -- is that enough for patent protection? Mr. Seka responded two-fold. First, the issue being decided is not whether the methods are novel, but rather whether you can even get in the door of the Patent Office with such claims. Second, it is the correlation that is the silver bullet -- the invention converted an ineffective treatment to an effective one. Dr. Sauer followed up by questioning Mayo's motivation in bringing such a suit, and asking why Mayo finds such claims so objectionable. A possible answer was supplied by the final panelist -- because access to treatment is being blocked.
Kristin Neuman, on behalf of MPEG LA, LLC, addressed the final challenge -- that of patent thickets, or multiple patents covering a diagnostic method owned by multiple parties (Ms. Neuman's presentation can be found here). She started out noting that there is something different about diagnostic claims, because the market would like these tests to be freely available. In fact, she believes that the Myriad case is actually about the business model of exclusivity. As an alternative, she suggested that the proper model might be that of the non-exclusive license. MPEG LA was involved in pioneering modern patent pool licensing with the MPEG-2 standard, allowing multiple users to acquire patent rights from multiple patent holder. Such licensees account for most MPEG-2 products in the market, including TVs, DVD players, set-top boxes, etc. Ms. Neuman noted that a similar issue exists in for personalized medicine, citing a study looking at Lynch Syndrome, which is a predisposition to various cancers. They found that ten institutions, including both universities and companies, owned patents related to this syndrome. The problem is that one patent holder can hold back access to the technology. Ms. Neuman explained that the goal of MPEG LA was to help clear patent rights to make the technology widely available to the public. As a result, they are developing LibrassayTM, which is a web-based store of molecular diagnostic patent rights. The vision of Librassay is larger than any single disease or test, and is not limited to gene patents. With this system, the patents are grouped in meaningful categories to help customize a particular license while maintaining reasonable fees. Dr. Sauer asked if there were any other services included, such as enforcement. Ms. Neuman explained that the pool wouldn't enforce the patent rights, but it could help the owners coordinate their resources. However, MPEG LA's experience has been that there are very few enforcement actions because it is easier to join the pool than hold out.
Overall, the panel thoughtfully addressed the challenges that were identified at the outset, and provided interesting and thought-provoking perspectives from individuals that deal with these issues, sometimes on a daily basis. In addition, the panel provided plenty of interaction for the speakers, both from within the panel, and from the audience. Clearly, those in attendance, as well as just about every other member of the patent bar, will be paying close attention to how these issues play out in the upcoming year.