Drug Regulation Patent

Mayo v. Prometheus: Natural law ++ Significant application ~ Patent


The United States (US) Supreme Court recently invalidated an extremely broad patent, allowed by the Federal Circuit (CAFC), covering a method for determining the proper dose of a drug used to treat autoimmune disorders.  We had previously, in a guest post by Sooraj Abraham, briefly discussed about the case, Mayo Medical  Labs. v. Prometheus Labs., Inc.  This post provides a briefly discusses the judgment   in Mayo, and its implications upon Indian patent law.  
In Mayo, a unanimous Court held that an individualized patient dosing strategy is not eligible for patent protection because the process is effectively an unpatentable law of nature.  The CAFC had earlier held that the claims were patentable because they included substantial physical limitations.
In reaching the conclusion, the Court discussed Einstein’s theory of relativity, and Newton’s laws and stated that neither would have been patentable.  Similarly, an individualized patient dosing strategy could not be patented merely because the discovery that the blood level of a compound in a human correlated with   dosage of a drug.  In the court’s opinion, Justice Breyer wrote that the patent “simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field.”
Two distinct conclusions may be made from this decision.  (1) Law of nature (even if newly discovered) is itself unpatentable- (as before); and (2) An application of that law of nature (even if newly discovered) must not merely rely upon the application of the law, but add to the law.  Although “laws of nature, natural phenomena, and abstract ideas” are not patentable subject matter under §101 of the Patent Act, Diamond v. Diehr, 450 U. S. 175, 185, “an application of a law of nature . . . to a known structure or process may [deserve] patent protection,” id., at 187.  But to transform an unpatentable law of nature into a patenteligible application of such a law, a patent must do more than simply state the law of nature while adding the words “apply it.”  See, e.g., Gottschalk v. Benson, 409 U. S. 63, 71–72. It must limit its reach to a particular, inventive application of the law. 
“…[A]n application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”  On the other hand, the “application” must be “significant,” not “too broadly preempt” use of the law, and include other elements that constitute an “inventive concept” that is significant and separate from the natural law itself. “

Justice Breyer in this decision wrote, that the Supreme Court had, “….the cases have endorsed a bright-line prohibition against patenting laws of nature, mathematical formulas and the like.”  However, the Court did not rule out other highly debated patents (software patents?).  Hence this judgment in my opinion, is totally focused on the issue at hand (that no patents for correlating metabolite level and drug dosages) and does not provide guidance on these other areas, leaving them for another case.

Implications upon Indian law:  This decision provides enough guidelines (standard paragraphs) to examiners to refuse applications on the grounds that it is merely an application of law of nature without any additional elements that constitute an inventive step.  
As a side note, the subject line indicates that, an applicant must significantly to a natural law to maybe obtain a patent.

Rajiv Kr. Choudhry

Rajiv Kr. Choudhry

Rajiv did his engineering from Nagpur University in 2000 in electronics design technology. He has completed his LL.B. from Delhi University, Law Center II in 2006, while working as an engineer at ST Microelectronics in NOIDA. After his LL.B., he went on to The George Washington Univeristy, Washington DC to do his LL.M. in 2007. After his LL.M., he has worked in the US at a prestigious IP law firm based out of Philadelphia. Till 2014, he was Of-Counsel to a Noida based IP law firm where he specialized in advising clients on wireless, telecommunication, and high technology. Rajiv is the founder of Tech Law Associates, a New Delhi based law firm specializing in IP law, with a focus on high - technology, and patent law. His core IP interest areas are the intersection of technology and IP, Indian IP policy, innovation, and telecommunications patents. He is also an inventor with pending applications in machine-to-machine communications domain (WO2015029061).

One comment.

  1. AvatarNatasha

    From a competition- IP interface perspective, the judgement is a positive step too. It brings home the point of the trade off between ex ante and ex post efficiency in promoting competition without hindering innovation. Ex ante efficiency ensures that firms receive rewards for investments and innovations and ex post ensures that the fruits of the innovation reach rival firms and consumers in the economy. The design of the length and breadth of a patent is where this balance is hinged. Judgements such as these are a positive step in optimising the balance.

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