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In a remarkable judgment delivered on July 20, 2021, a Division Bench of the Delhi High Court has held that a pharmaceutical product which is covered by a patent claim of a "genus" patent cannot be claimed again in a “species" patent since that would amount to securing two patents over the same product without proof of any additional efficacy. The Court has dismissed a batch of nine appeals preferred by AstraZeneca AB, Sweden and AstraZeneca Pharma India Ltd. against two judgments of two different Single Judges of the High Court, both of whom had rejected Astrazeneca’s prayer for interim injunctions against generic Pharma companies such as Torrent, USV, Micro Labs, Zydus & five others for manufacturing and selling the anti-diabetes drug 'Dapagliflozin'. Both Single Judges had held that Astrazeneca’s species patent was prima facie vulnerable to revocation in view of the same product being covered by the claims of Astrazeneca’s own genus patent which had expired earlier.

The Division bench comprising Justices Rajiv Sahai Endlaw & Justice Amit Bansal while dismissing the appeals filed by the pharma giant AstraZeneca imposed a cumulative cost of INR 45 lacs
at
INR 5 Lakhs to be awarded to each Defendant. This is the first time costs of such magnitude have been imposed on a pharmaceutical company at the interim stage.

The Court made strong observations against the patentee for indulging in forum shopping before two Single Judges of the same Court, noting that it was 'inexplicable' as to why the applications for interim injunctions were argued separately, when the same could have been clubbed and argued before one Single Judge of the Hon'ble Court. 

"It is inexplicable, why the appellants/plaintiffs, who have argued all these nine appeals as one and not separately, did not have the two sets of suits clubbed before the same Commercial Division and which would have saved the judicial time spent in the adjudication undertaken by one of the Judges. It appears that the appellants/plaintiffs were taking a chance, of arguing on the same subject and controversy, before two Courts. However the appellants/plaintiffs failed before both," the Court stated.
 

Mr. Pravin Anand appeared for the appellants.
Mr. C.S. Vaidyanathan, Mr. S. Majumdar, Mr. J. Sai Deepak, Mr. Adarsh Ramanujan, Ms. Rajeshwari H. appeared for the respondents.

Factual Matrix:

Appellants AstraZeneca AB, Sweden and AstraZeneca Pharma India Ltd. filed a total of nine appeals before Delhi High Court.

The Pharma giants had impugned two orders/judgments which were pronounced within a span of 16 days, both denying them interim relief & concluding that the appellants, during the pendency of the suits for permanent injunction to restrain infringement of patent, are not entitled to any interim injunction restraining respondents from manufacturing and selling the pharmaceutical products which are alleged to be in breach of the patent of the appellants.

The appeals were thus filed under Section 13(1A) of the Commercial Courts Act, 2015 read with Order XLIII Rule 1(r) of the Code of Civil Procedure, 1908 (CPC) before the Delhi High Court.

[Vol. note: According to the patent laws, the Patents Act, though protects the rights and interests of inventors, but for a limited period, whereafter the monopoly of the patentee ceases and comes to an end and the invention with respect to which patent was granted, falls in public domain i.e. open for all to practice and reap benefit of]

Arguments: 

In the present appeal(s), the appellants contended before court that the product comprising the compound 'Dapagliflozin' (DAPA) which is used to treat people suffering from type-II diabetes mellitus, is the subject matter of two patents granted in the name of the appellants. They argued that though first patent has expired in October, 2020, the second patent is valid till May, 2023.

The appellant further stated that the patent IN 147 (first patent) is the genus patent and IN 625 was the species patent. 

In this light, it was argued that the other species of DAPA was not disclosed yet, as DAPA was being further researched and developed by the appellant companies. It was disclosed for the first time in IN 625 (second patent), which is still valid. Therefore, the use of DAPA by the respondent companies after lapse of IN 147, is infringement of the patent IN 625, it was contended.

Essentially, the Appellants' contention was that the first patent can be granted for a "core structure" (genus) and a second on a product, detailing each and every molecule (species).

The Respondent(s) on the other hand, inter alia contended that IN 147 being a Markush Structure, i.e. a patent covering a group of compounds, which disclosed the possibility of individual permutations and combinations running into several million structurally diverse compounds, included DAPA. In this context, they stated that as patent laws require the patentee to give complete specification of the product before the grant of the patent, IN 147 included as well as disclosed DAPA.
Therefore, after the lapse of the patent IN 147, drugs using DAPA could be manufactured and sold by the respondents and there was no question of a second patent being granted as there was no new invention and such, no infringement, it was contended.

Held:

After hearing both sides and after scrutinising minutely, the material placed on record, the Division Bench concluded that no case for grant of injunction against the respondent(s) manufacturers was made out during the pendency of the suit and ordered that the Pharma Giants (AstraZeneca's) pay a total whooping cost of Rs. 45,00,000/- to the Respondent(s).

Important observations:

1. There can be only one patent for one invention - no ever greening permissible under the Patents Act
Court has clarified that the denial of interim relief to the appellant stems from the root of two patent claims by the Appellant(s) for only one invention (DAPA). While elaborating further, the Court has said that the Rights of a patentee, unlike that of a proprietor of a trademark are not natural or common law rights but are a creation of law (statutory rights). In this light, to enjoy protection, a patentee's rights have to be within the 4 corners of the statute (Patents Act) which clearly stipulates that the grant of a patent requires:
a. a new product 
b. technical advancement
c. capability of industrial application
d. it is not obvious to a person skilled in the art
e. it was had not been anticipated by any publication
f. it had not been used at any time before the date of filing of patent application with complete specification
g. it was not a mere discovery of a scientific principle or formulation of an abstract theory
h. it was not a mere discovery of a new form of a known substance which did not result in enhancement of known efficacy of that substance; and,
i. it was not a presentation of information.

In light of the aforementioned, Court dissected the inventions claimed in each of the patents and found that the claim of the second patent did not suffice in terms of the Act.

2. Monopoly of the patentee ceases after patent expires
Court noted that though the Act protects the rights and interests of inventors, it only does so for a limited period, following which the monopoly of the patentee ceases and comes to an end and the invention with respect to which patent was granted, falls in public domain i.e. open for all to practice and reap benefit of. Court said that in granting successive patents for the same invention, legislative intent of limiting the life of a patent will stand negated.

"It is obvious therefrom that the appellants/plaintiffs have no legs to stand on, by claiming infringement of IN 625 only, without also claiming infringement of IN 147. However, as held in the impugned judgment/order dated 2nd November, 2020, the question of the respondent(s)/defendant(s), by working DAPA, infringing IN 147 could arise only if DAPA was disclosed in IN 147. If DAPA was disclosed in IN 147, even if better disclosed in IN 625, cannot enjoy two rounds of 20 years of protection, when the legislative policy is to grant protection for a period of one term of 20 years only," Court said.

3. A single formulation is incapable of protection under two separate patents having separate validity period
Court observed that the Appellants have pleaded that IN 625 was discovered by further research. "From the field of the invention subject matter of the two patents being verbatim same, at this stage, it also appears that there is no enhancement of the known efficacy, within the meaning of Section 3(d) of the Act, between the product subject matter of IN 147 and the product subject matter of IN 625," the court said.

4. An inventor cannot restrain others from researching the same field merely on the basis of his work, research and prior art, Court said, adding that this would be non-conducive to research and development and would violate the fundamental duties of the citizens of this country, enshrined in Article 51A. 

"The same will enable busy bodies to, by walking only part of the mile, prevent others also from completing the mile"
- Delhi HC
 

Case Title: Batch Plea's
AstraZeneca AB & Anr. Vs. Intas Pharmaceuticals Ltd.
AstraZeneca AB & Anr. Vs. Alkem Laboratories Ltd.
AstraZeneca AB & Anr. Vs. Zydus Healthcare Limited & Anr.
AstraZeneca AB & Anr. Vs. Eris Lifesciences Ltd.
AstraZeneca AB & Anr. Vs. USV Pvt. Ltd.
AstraZeneca AB & Anr. Vs. Torrent Pharmaceuticals Ltd.
AstraZeneca AB & Anr. Vs. MSN Laboratories Pvt. Ltd.
AstraZeneca AB & Anr. Vs. Microlabs Ltd.
AstraZeneca AB & Anr. Vs. Ajanta Pharma Ltd.