Two Patents Cannot Be Granted For One Invention- One for Genus and The Other for Species: Delhi High Court Dismisses Plea By AztraZeneca

The Delhi High Court has held that two patents cannot be granted for one invention- one for genus and the other for species.

A claim of two patents for one invention only strikes at the very root of the appellants' claim and disentitles the appellants from any interim relief. Dismissing the plea by affixing Rs.5,00,000/-  costs, a division bench of Justices Rajiv Sahai Endlaw and Rajiv Bansal observed that the rights of a patentee, unlike that of the proprietor of a trademark, are not natural or common law rights but are a creation of law, i.e., are statutory rights. Thus, for a patentee to enjoy protection, the rights must be within the four corners of the statute, i.e., the Patents Act, and there are no rights independently thereof or inherent or common law rights of an inventor or patentee.

In a batch of nine pleas by AstraZeneca seeking an injunction against the sale of anti-diabetes drug 'Dapagliflozin' by generic Pharma companies- Torrent, USV, Micro Labs, Zydus, and others. It was challenging two separate judgments of single judge benches of Delhi High Court passed on the same facts, dismissing their plea independently of each other.

Given the proximity of the date of pronouncement, the Court apprehended that the hearings were ongoing simultaneously. However, it noted that instead of pleading to club both the proceedings, it went ahead, wasting judicial time, hoping to take a 'chance.' However, they failed in both the courts.

The petitioner's claim for infringement arises after the expiration of the patent for IN 147 (genus patent; expired on October 2020), thus claiming the infringement of IN 625 (species patent; expiring in May 2023), the subject matter of both being DAPA.

Two Patent Claims- One Invention:

The Court studied the relevant statutory provisions and the 'invention' claimed in each of the two patent claims(IN 147 & IN 625) based on one invention, i.e., DAPA. It remarked that on an inquiry of both the claims, it appears completely identity, without any difference whatsoever, between the field of invention. A 'new product' involves an inventive step, i.e., a feature involving a technical advance compared to existing knowledge, including of IN 147 or having economic significance, not anticipated by earlier publication or use. The invention in IN 625 did not describe the technical advancement or the difference in efficacy from IN 147.

The Court also noted that the inventor of both the claims IN 147 & IN 625 was the same. As there is no advancement or difference in efficacy of the new products, the subject matter thereof over the product subject matter of IN 147 is mentioned, nor any economic significance of the new invention claimed. Once the inventor himself, while writing and seeking the patent, has not mentioned so, the subsequent claims of the assignee of the patent, in this regard, at least at the stage of judging prima facie case, cannot be accepted and have to be necessarily put to trial, the Court noted.

It remarked that the standard tests of "obvious to a person skilled in the art" and "anticipation by publication" and "use before the date of filing of patent application with complete specification," in the context of an earlier patent and its specifications, have to be different when the inventor of both is the same.

It laid down the test of "person in the know," to be used when the inventor is the same instead of the test of "person ordinarily skilled in the art." In such a situation, the inquiry has to be guided by whether the inventor, while writing the first patent, knew of the invention claimed in the subsequent patent, the Court noted.

Can Patent Be Granted More Than Once?

The appellants argued that because of delays in obtaining approvals of Drug Regulators in different jurisdictions, for marketing of a new drug/medicine, after obtaining the patent concerning it, results in the inventor not being able to enjoy the exclusivity granted under the Patent Laws for the full term of the patent. However, the Court noted that mere delays are no reason for the Court to give the patent a longer life than provided in the statute. The Legislature can cure the arising issue and not the Courts by allowing more than one patent concerning the same invention.

Discussing the legislative intent behind the limited life of the patent, the Court noted,

"If patents with respect to the same invention can be granted more than once, successively in time, the same will negate the legislative intent of limiting the life of the patent and enable the patentee to prevent others from making, using or offering for sale, the new product invented by the patentee, till the time patentee successively keeps on obtaining patent therefor."

The petitioners argued that DAPA was only covered and not disclosed in IN 147 and disclosed for the first time in IN 625. It also argued that DAPA being not obvious from and capable of being anticipated from IN 147. However, the Court noted that their suit claiming infringement admit DAPA to be the invention subject matter of both IN 147 and IN 625.

"Without DAPA being disclosed in IN 147, there could be no patent with respect to DAPA in IN 147 and which was being infringed by the respondent(s)/defendant(s) by manufacturing drugs/medicines with DAPA as ingredient."

To decide whether the statutory regime allows for a patent being first granted of "a core structure" and/or of a formula, only "generally describing the molecules, rather than detailing each and every molecule covered by the formula" and after that a second patent being granted detailing every molecule.

The statutory provisions do not permit a patent to be granted concerning the important stage in the inventive process. There is no product capable of industrial application, even if having technical advancement compared to the existing knowledge. However, the appellants, on the other hand, claimed patent IN 147 at the "breakthrough" stage, when DAPA was not even known, but even after obtaining patent IN 625 concerning DAPA suing, the respondents have pleaded infringement of IN 147 also. The Court noted that this must be treated as an admission of DAPA being known while obtaining IN 147.

IN147 & IN 625: Same Or Different?

On examination, the Court concluded that from IN 147 and its US equivalent, the invention described herein could be worked by anyone, save for the exclusivity for the term thereof in favor of the appellants. However, the appellants claim that DAPA was not disclosed in the specifications of IN 147, but 80 other compounds were disclosed. However, the allegations were not for manufacturing any of the said 80 compounds but for the manufacture of DAPA.

The Court also observed that the appellants had not pleaded industrial application or sale of any product subject matter of IN 147, other than DAPA.

On a perusal of Section 10(5) of the Patents Act, the Court noted that it permitted the appellants to obtain IN 147 concerning a group of inventions, as many as 80, forming a single inventive step. With the new product of each of the 80 compounds subject matter thereof affecting as claimed in the description of the field of the invention therein. Consequently, it obviated the need for the appellants/plaintiffs to apply for and obtain separate patents concerning each of the said 80 compounds specifically disclosed.

The Court noted that none of the 80 compounds disclosed in the specifications of IN 147 have 'ethoxy.' Still, Section 10(5) would have enabled the appellants to claim that merely from the substitution of 'ethoxy' for 'methoxy' disclosed in one of the 80 compounds, does not make a sound defense for infringement, as it was a part of the single inventive step.

However, the respondents argue that IN 147 was concerning mere discovery of a scientific principle or formulation of an abstract theory or a mere presentation of information and qua under Sections 3(c) and 3(n) respectively patent could be granted. However, the patent obtained and infringement thereof claimed in the suits from which these appeals arise, admitting DAPA to be the new product subject matter of IN 147. The Court observed,

"If IN 147 did not disclose DAPA and specifications thereof did not describe DAPA or the best method of industrially manufacturing DAPA, there could be no infringement of IN 147 from the action of the respondent(s)/defendant(s) making and selling medicines/drugs with DAPA as ingredient thereof."

Cannot Restraint Research:

The Court also observed that an inventor, merely on the basis of his work, research, discovery and prior art, not yielding to any product capable of commercial exploitation, cannot restrain others from researching in the same field as it would not be conducive to research and development and violate the fundamental duties of the citizens of this country. Article 51A of the Constitution of India develops the scientific temper and a spirit of inquiry.

"The same will enable busy bodies to, by walking only part of the mile, prevent others also from completing the mile", the Court concluded.

Title: AstraZeneca AB & Anr v. INTAS Pharmaceuticals Ltd.

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