Monday, May 21, 2012

Human Gene Analysis

This post is a critical comment on a recent United Kingdom Supreme Court decision, which conferred an unconventional interpretation to utility.

In, Human Genome Sciences v Eli Lilly, HGS was seeking protection for an isolated nucleic acid molecule comprising a polynucleotide sequence encoding a Neutrokine-á polypeptide. This was identifiable and isolatable. The subject matter of the patent application was a member of TNF ligand super family.  The fundamental defect to the HGS’ patent application was they were a bit in the dark as how to identify precisely the purpose of protein composition. The applicant was sure that it has its own uses but failed to assert exactly what is usage, or they were aware of the budding use of the invention, but they were not entirely sure their predictions would prove to be correct.

Article 52 of the European Patent Convention (EPC) mandated the requirement of “Susceptible to Industrial Application” for patent eligibility. The requirement explained in the UK legislation as capable of industrial or agricultural (S.4 of the Patent Act 1977) application. This case deals with the interpretation of “Susceptible to Industrial Application” (Utility) in terms of Biotechnology.

Their patent claims were silent about the industrial applicability. The inventors were in a dilemma as to the contemporary appliance of their invention. Protein structures are interpreted to tackle diseases. To state precisely this protein structure came before the  diseases being discovered. However, already identified members of TNF ligand family had shown incredible medicinal qualities. Nevertheless, current diseases did not demand the application of this invention. Future discovery of industrial applicability is a possibility. This created the whole problem to their application because “Capable of Industrial Application” means, invention must be capable of mass production and application in the market.

The court pointed out that research field is a wide market on which this invention has an industrial application. They also rejected the US cases postulated the interpretation for the same by saying that the standard of utility in the US is too high. The court said that the invention of HGS is capable of industrial application because all the other members of the family showed excellent result, and this invention may reveal its purpose in the near future. “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 that 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 [pares. 155-156].”

The Implication of the Decision

This decision will facilitate the admission of speculative patent claims in the biotechnology field. Notional claim means the specification will postulate certain capabilities of the invention based on the qualities and known functions of the previous similar class of invention. These specifications may or may not be true. Utility has always been interpreted in relation to contemporary application. However, this decision cast away the conventional interpretation. This decision added the word “Prospective” to “Susceptible to Industrial Application." To quote, "[A]ll known members of the TNF ligand family were expressed on T-cells and were able to co-stimulate T-cell proliferation, and therefore Neutrokine-α would be expected to have a similar function." 

Patent in The USA

This post is a case comment on the much-awaited decision Mayo v Prometheus. Main question posed before the Supreme Court was "Whether the claims of Prometheus preempt patent law?" The Court, in my view delivered a promising judgment disallowing the patenting of natural laws. Personal life science invention is a growing market in US. It is likely that following days will show the positive or negative repercussions of the decision. 

The United States Supreme Court on March 20 decided unanimously that patent of Prometheus claiming methods to administer thiopurine drugs to treat autoimmune diseases is void.

Prometheus was the sole licensor of thiopurine drug “When in­gested, the body metabolizes the drugs, producing metabolites in the bloodstream. Because patients metabolize these drugs differently, doctors have found it difficult to determine whether a particular pa­tient’s dose is too high, risking harmful side effects, or too low, and so likely ineffective. The patent claims here set forth processes embody­ing researchers’ findings that identify correlations between metabo­lite levels and likely harm or ineffectiveness with precision. Each claim recites (1) an “administering” step—instructing a doctor to ad­minister the drug to his patient—(2) a “determining” step—tellingthe doctor to measure the resulting metabolite levels in the patient’s blood—and (3) a “wherein” step—describing the metabolite concen­trations above which there is a likelihood of harmful side-effects and below which it is likely that the drug dosage is ineffective, and in­forming the doctor that metabolite concentrations above or below these thresholds “indicate a need” to decrease or increase (respective­ly) the drug dosage.”

Petitioners Mayo introduced their own method, which according to Prometheus, violated their patent claims. The district court held that patent claims constituted principles of natural law, which preempts the patent law. Federal Circuit Court overturned the decision based on machine or transformation test held in Bliski v Kappos. Now the Supreme Court of the United States has affirmed the decision of the district court and held that patent claims are void.

The Court held that, “The “wherein” clauses simply tell a doctor about the relevant natural laws, adding, at most, a suggestion that they should consider the test results when making their treatment decisions. The “determining “step tells a doctor to measure patients’ metabolite levels, through whatever process the doctor wishes to use. Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conven­tional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.”
Section 101 of US Patent Act has an explicit exemption that “Laws of nature are not patentable.” The same idea was followed in various celebrated precedence like  Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127, 130 (1948), Dia­mond v. Diehr, 450 U. S. 175, 185 (1981); Bilski v. Kappos, 561 U. S (2010); Diamond v. Chakrabarty, 447 U. S. 303, 309 (1980); Le Roy v. Tat­ham, 14 How. 156, 175 (1853); O’Reilly v. Morse, 15 How. 62, 112–120 (1854).

The Court in Chakrabarty held that patentable subject matter includes anything under the sun that is made by man. “Made by man” is an important criterion for patentability because the cardinal patent eligibility criterion for a “principle of natural law” is that it must have undergone substantial human intervention. The decision in Diehr is in direct relation to the facts of the case. In Diehr the claimed invention was a known mathematical formula, the Arrhenius equation, applied to identify the time to open a rubber press. The invention worked on the information about the temperature inside the mold, the time in which the rubber was inside the mold and thickness of the rubber. However, the court identified that invention as a whole had undergone substantial human intervention and hence patent eligible. To quote “installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly re- calculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time” (at p.187 of Diehr)

In the present case, the court identified that the claims only reinstating a process of natural law and there is no substantial human intervention to make the invention patentable.

Biswajit Sarkar