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.
Dear Rajiv,
Great elaboration. there is another face of the same argument i have tried to analyze. Please let me know your views on this.
Regards
Vivek Ranjan
IIT Kharagpur
I wondered how MOT test was not discussed in oral arguments. Secondly, with due respect to Court’s dissent in earlier LabCorp’s case, I fail to understand Mayo’s argument. Mayo’s question is if the patentee can have monopoly on basic natural biological correlations? But here, it is clear that patentee is not claiming any natural phenomenon particularly. It is a method of “analyzing” the effectiveness of thiopurine drugs for treating the gastrointestinal disorders. In short, it is offering a blood test where various factors are studied per se metabolites level in patient, symptomatic/biochemical expression of disorder, etc.
Tks,
Swaroopa Chavan
As i guess it is not possible to forward you the link, Please find below the text of my opinion in the matter.
“the ideas to the extent that they are law of nature or well established principles are not patentable subject matter. So Newton Laws, Mass energy equation and thermodynamic principle are not patentable. However, the application of law of nature is patentable. So a bicycle if is novel and has inventive step and has an utility, based on the principle of Newton Laws of Motion is patentable subject matter.
The question to ponder is when the application of law of nature itself would become the law of nature. Where is the thin line difference and what test to apply.
Human intervention is important parameter that is applied in the arguments of Mayo Collaborative case. In my opinion this test holds good for the most of example. If there is human intervention in the law of nature to make something useful, the matter, prima facie should be patentable .
The other question is what should be patentable, the subject matter as such, or the result obtained by the subject matter. Does the patent on the subject matter extends to the results obtained as well. My answer to this question would be NO. So, whereas the bicycle is patentable in the example given above, the motion obtained from the bicycle is not. If similar motion can be obtained by some other means, like skating board, the board will be patentable subject matter, not the motion itself.
Can the result measurement be patentable? Answer is again, in my view, is NO. There can be no patent on the measurement, as the measurement is merely abstract numbers or the tool to measure. Means to measure the number can be patentable, but not the measurement itself.
In the analogy that Supreme Court has taken various time, for the mass energy equation, the equation itself or the energy obtained through the process regulated by the equation is not patentable, however, If there is some means by which energy can be obtained for useful use, that means is patentable.
In the Mayo Case, the patent claim on range seems to defeat the criteria of subject patentability for two reasons.
1. That they are merely measurements
2. That the opinion based on the measurements are mere opinions.
However, if the defendants could prove that the numbers itself is consequence of calibration (Please note that argument like the calibration is itself a ‘mean’ can’t be ruled out) and not mere measurements obtained as such, the Court might end up with serious thoughts on the defendant arguments.
As far as it goes, looks interesting case in days to come.”
Hope to get your views on this aspect as well. 🙂
Thanks
Vivek Ranjan
Dear All,
I only dealt with preemption aspect in this post. If you are interested please also follow Association for molecular pathology v USPTO. issue is simple “is it ethical to patent human gene?”.
USSC is in the process of deciding whether to issue certiorari to the appeal. 🙂
Dear all,
Clarification: I only dealt with preemption aspect involved in mayo. there are multifarious scientific issues involved which is beyond my current knowledge.
Dear Vivek Ranjan,
Mayo will succed its patent claim becuase of a in re bilski and general US precedens suggest that market will prevail over law. India on the other hand is specific becuase of section 3. US patent act section 101 is in my opinion is not specific.
If you are interested try to follow Association for Molecular PAthology v USPTO. this case raises an important issue “is it ethical to patent human gene”
Also read HGS v Eli Lilly
Thank You
I am a medical student and think you are all missing the absurdity of this patent, and the large scale implications it would have on medicine. For one the patent does not apply to the drug itself, it has been on the market for a long time, and it’s patent date has expired. This patent applies to the coordination between administering a drug and measuring the metabolite levels to determine if the dose is correct.
This would be equivalent to patenting the correct level of cholesterol or blood pressure for a patient on a a generic brand of medication.
Doctor’s determining the levels of the metabolite in patients would violate patents, independent publications about a different level or drug interactions would violate the patent.
Just the mere idea that substance a has an effect or turns into substance b is what is being patented. You should be able to patent the drug, but to patent how the body uses it, changes it, or reacts to it should not be as it is inherit to the original patent. If we begin to patent every small detail of every thought, medicine wouldn’t be able to exist and the entire market system would be shattered.