Prometheus vs Mayo: Threatening patient health with patent litigation
In Greek mythology, Prometheus stole fire from the Gods and gave it to mankind. In the realm of patents and medical technology, Prometheus Laboratories has turned this myth heralding its namesake’s altruism on its head by stealing the metaphorical fire from man and selling it back to him in order to pad the corporate gods’ bank accounts.
In reality, Prometheus Laboratories patented a medical treatment claiming methods for determining the optimal dosage of thiopurine drugs used to treat gastrointestinal autoimmune diseases, such as inflammatory bowel disease and Crohn’s disease, and offered to license this method back to doctors, at a price, for use on patients.
The drugs disclosed in Prometheus’ patents (U.S. Patent Nos. 6,355,623 and 6,680,302) are already widely known and are independently produced, but present issues of non-responsiveness and toxicity. Thus, the patents claim methods to optimize therapeutic efficacy while minimizing toxic side effects. To that end, the patents claim a three-step method of administering the drug, determining levels of the drug’s metabolites in the patient and comparing the measured levels to standard levels to determine whether to increase or decrease the level of the drug administered.
The Mayo Clinic of Rochester, MN, originally purchased a license for Prometheus’ patented test, but after conducting independent research, announced that it intended to begin using and selling its own test measuring the same metabolites as those of the patented test, but using different – and what it believed to be more accurate – levels to determine toxicity. Shortly thereafter, Prometheus sued Mayo for patent infringement in the Southern District of California.
Mayo moved for and was granted summary judgment of patent invalidity under 35 U.S.C. § 101, the court having categorized Prometheus’ claims as natural phenomena and thus unpatentable subject matter. On appeal, the Federal Circuit reversed the district court’s ruling using the then-valid machine-or-transformation test to find that the patents’ administering and determining tests are transformative.
The U.S. Supreme Court, after deciding the pivotal Bilski v. Kappos case on method patents, remanded the case back to the Federal Circuit for reconsideration in light of the Bilski standard. The Court in Bilski explained that, “while a law of nature, natural phenomenon, or abstract idea cannot be patented, an application [thereof] may be deserving of patent protection.” Applying this new legal standard, the Federal Circuit again held the patents valid, explaining that the claims are drawn to a particular application of a natural phenomenon. The Mayo Clinic appealed this decision to the U.S. Supreme Court, which granted certiorari and will hear oral arguments on December 7, 2011.
This impending decision raises two pivotal issues in patent law: patentability of methods of medical treatment and legitimacy of “patent trolls.” How the Supreme Court decides this case will have a significant impact on the landscape of patent law and intellectual property management.
With the exception of Australia and the United States, the developed world at large has reached a consensus that patents directed to medical processes are not patentable. The TRIPS Agreement presents this limitation as optional (“Members may exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals”), but most countries have adopted this guideline as compulsory in an effort to keep medical treatments widely available to the public.
The European Patent Convention, for example, excludes from the scope of patentable subject matter methods of treatment of the human or animal body by surgery, therapy and diagnostic methods. By contrast, the U.S. allows methods of medical treatment to be patented, but nullifies this right by denying a remedy for infringement of such patents. Prometheus circumvented this limitation, however, by directing its patents not to a method of medical treatment, but rather to the scientific observations underlying proper diagnosis and treatment of medical conditions, thereby preserving its right to sue for infringement.
In its briefs, Mayo argues that Prometheus’ claims preempt all practical use of naturally occurring correlations between metabolite levels and drug efficacy. The sole novel element of Prometheus’ claims is that they identify the particular threshold metabolite levels for drug administration. In practice, however, the process of comparing the metabolite levels to the patient’s drug level is a mental process each physician performs in the ordinary course of patient treatment. By patenting this mental comparison, Prometheus effectively monopolizes standard physician practices, and offers them back to the physicians at a price. This is precisely the commercial practice that limits public access to health care that most countries seek to avoid by excluding medical treatments from patentable subject matter.
In addition to this subversive conduct, Prometheus’ intellectual property management practices subject it to characterization as a “patent troll.” This controversial term is used to describe a corporate entity that aggressively buys and enforces patents against infringers with no intention to further develop, manufacture or market the patented invention. A recent study reported that patent trolls have cost companies $500 billion in lost wealth over the past twenty years as a result of diverting funds that could have been used for product development instead to costly infringement litigation.
With regard to each of these issues, Mayo and its supporters have voiced valid concerns that the spirit of invention and public access to new technologies patent law was intended to promote is being compromised by allowing patent troll practices and patents directed to methods of medical treatment. Mayo argues that Prometheus’ patents give it a monopoly on a biological correlation between drug administration and natural changes in blood chemistry.
Mayo fears that if these patents are sustained, health care providers will be unable to improve Prometheus’ disclosed standards to provide more accurate drug monitoring services to patients at lower costs. Furthermore, if the patents are upheld, scientists will be barred from developing similar tests directed to different diseases from those covered by the claims. For example, Prometheus has already threatened an infringement suit against a doctor who conducted research on the appropriate metabolite range for patients suffering from dermatological diseases. Prometheus’ resources are directed solely to managing and protecting this patented method, without improving the existing technology or developing new inventions.
While the punishment imposed on the mythological Prometheus – namely, having his liver pecked out by an eagle every day for eternity – may not be proportional in the present case, at the very least the Supreme Court should invalidate Prometheus Laboratories’ patents, returning the claimed diagnostic methods to the public realm. The practices these two patents represent were not intended to garner the protection a patent provides, and they detract from, rather than contribute to, the proliferation of new and beneficial technologies.