We are pleased to bring to our readers another guest piece by Sooraj K. Abraham, on the learning of the Mayo v. Prometheus case. The post is a critique of the oral arguments in the ongoing case of Mayo v. Prometheus in the Supreme Court of the United States. The author seeks to analyze the dynamic approach with which the Judges are in the process of tackling the concept of preemption with regard to patenting of life science inventions. Warning: Long post follows.
Issue: Whether Section 101 of US Patent Act is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally-occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve transformations of body chemistry or whether the correlation between blood test results and patient health is patentable.
The impugned invention of Prometheus was patented. Mayo comes up with their own technique to replicate that invention and offered the same at a substantially cheaper cost. Consequently, Prometheus laboratories filed a suit for infringement. This case has multifarious issues, and I will only be analyzing its patent eligibility. One of the important aspects in this case is the invention of Prometheus which, as argued by the counsel for Mayo, is a principle of natural law and preempts the patentability of the invention. The principles of natural law remain in the public domain in almost all jurisdictions. The classic example since e=mc2 is a law of nature, and the same is not eligible for patent.
Before dwelling more into the issue in hand, I would like to discuss LabCorp v. Metabolite, Inc. The issue in LabCorp was similar to the issue in Prometheus. To state simply, “The claims of Metabolite’s patent include the correlation between levels of homocysteine and vitamins B6 and B12. They sued LabCorp for infringement as they used similar drug administration techniques.” LabCorp claimed that Metabolite’s claims were not patentable because they postulate a principle of nature, which is not a subject matter of patent. However, a majority upheld the validity of patent and held LabCorp liable for infringement.
Against preemption, an consequential argument can be raised. Personal life science is an prominent field in biotechnology. It is a field of science that has been developed over a period of time. It is used to administer drugs according to the statistical analysis of various bio markers of the patient. The amount of drugs administered varies from individual to individual since each of them has different reading. At this juncture, one cannot simply state that it is a law of nature, and that it cannot be patented. This can be easily analyzed from following example.
Suppose, for this article, stomach problem A is caused by loss in a biomarker B. the discovery of a biomarker B per se is not patentable because it is a law of nature. On the other hand, a machine which facilitates the measuring of that biomarker would be patentable as an invention. These are a simple example but modern medical science (as argued by Prometheus), especially with regard to stomach diseases, requires the analysis of several bio markers to procure a clear statistical evaluation. The drugs are administered according to this statistical result and consequently, the decision as to the patentability of this cannot be rejected by merely saying that it is a law of nature.
As far as US precedence is concerned Prometheus’s claims articulates a valid claim. The decision of Supreme Court is due. Oral submissions are over, and it will be in favor of Prometheus; I think. When I was hovering through related precedence and articles, I felt that irrespective of interpretation of law just like Diamond v Chakraborty courts recognized the patent claims in LabCorp to facilitate growth of biotechnology due to the statement of the attorney general. He said that “A decision overturning PTO’s approach could call into a substantial number of patent claims and undermine the settled expectation of numerous participants in technology-based industries.” This, in my opinion, directly influenced the decision of US Supreme Court. Even so, Justice Breyer gave a minority opinion holding that the patent was invalid due to natural law. The lawyer of Mayo will have a good chance of foreclosure of a number of patent applications only if he convinces Justice Breyer. I am pretty sure that this decision will have an implication on the ongoing battle for patentable subject matter.
Indian IP regime, in my opinion, is more vibrant. It has (at least theoretically) a strong demarcation between public domain and private domain. Section 3 of the patent Act 1971, formidably protects the interest of public at large. In US, there is a strong dilution of patentable subject matter, which is totally anti-competitive and against the principles of law. I categorized it as anti-competitive because the whole idea of exemption of principles of natural law from patentability is to facilitate furtherance of innovation. If one tries to monopolize free thinking, it will obstruct the growth of innovation. It is curious to look into the above-mentioned decisions, especially LabCorp. Sections 3 (a) and (g) exempt the patent claims of LabCorp and Prometheus. The former prohibits the patentability of natural law and later treatments or methods of treatment.
Section 101 of the Leahy-Smith America Invents Act (AIA) is not defined properly. It is not capable of demarcating between public domain and private domain. As I stated in the opinion of the attorney general, which is against law, directly influenced the judgment. Similarly, in Eli Lilly v Human Genome Science, a UKSC decision, Bio Industry Association (BIA) intervened and submitted following facts.
“As the BioIndustry Association has pointed out in its written intervention, patent portfolios are often the most valuable asset of companies in the bioscience industry. So assessments of the value of a bioscience company’s patent portfolio are likely to be a key consideration in deciding whether to acquire or invest in such a company. This in turn affects the funding that is made available for research and development, without which effective progress in putting a patented invention to practical use is likely to be very limited. The evaluation of a patent specification for this purpose will depend on whether it discloses an invention that is reasonably capable of industrial application (para 141)”.
This directly influenced the judgment and ruled that “The standard set by the Judge for susceptibility to industrial application was a more exacting one than that used by the Board. He was looking for a description that showed a particular use for the product had actually been demonstrated, rather than that the product had plausibly been shown to be usable for the purposes of research work [para. 151] and [para. 154], which the Board must be taken to have regarded as an industrial activity in itself [paras. 155-156].”
Instead of laws, the market directly influenced the decision of judges.