Setback to AstraZeneca: Delhi HC rejects plea against 9 pharma firms over Dapagliflozin
New Delhi: In a major setback to AstraZeneca and its Indian subsidiary ,the Delhi High Court has dismissed AstraZeneca's plea against nine generic pharma firms seeking a permanent injunction restraining infringement of the patent for the popular anti-diabetes drug Dapagliflozin.
These nine pharma firms included Intas, Alkem, Torrent Pharmaceuticals, Micro Labs, Zydus Healthcare Ltd. and Zydus Medica, Eris LifeSciences, USV, MSN, and Ajanta.
This came in response to the nine appeals filed by AstraZeneca and its Indian subsidiary challenging the previous two court orders which were pronounced within a span of 16 days, with both, independently of each other, on the same facts, concluding that AstraZeneca and its Indian subsidiary, during the pendency of the suits for permanent injunction to restrain infringement of the patent, were not entitled to any interim injunction restraining the above mentioned companies from manufacturing and selling pharmaceutical products which are alleged to be in breach of the patent of the AstraZeneca.
Firstly, suits were filed by AstraZeneca against Intas, Alkem, Torrent, Micro, and Ajanta to prevent the companies from manufacturing, selling, or otherwise dealing in the compound 'Dapagliflozin' ('DAPA'), which was the subject of Indian Patent No.205147 ('IN 147') and Indian Patent No.235625 ('IN 625'), as well as other ancillary relief.
Following the foregoing, when the validity of IN 147 expired, AstraZeneca sued Zydus, Eris, USV, and MSN to prevent them from producing, marketing, or otherwise dealing in any way with a product containing the chemical DAPA, which it claimed would be an infringement of IN 625.
AstraZeneca and its Indian subsidiary argued, DAPA, being the subject matter of the two patents, is used worldwide, to treat people suffering from type-II diabetes mellitus.
AstraZeneca claimed it possessed two patents, Indian Patent No. 205147 (IN 147) and Indian Patent No. 235625 (IN 625), and both IN 147 and IN 625 were awarded to Bristol Myers Squibb Company, which then assigned the rights to AstraZeneca AB, Sweden, in February 2014. IN 147 is the genus patent and IN 625 is the species patent.
Further, as per AstraZeneca's statement, IN 147 is a Markush structure, i.e. a patent covering a group of compounds, which discloses the possibility of individual permutations and combinations running into several million structurally diverse compounds. It argued that IN 147, bearing a Markush structure, covered DAPA, though it did not disclose the same.
In respect of this, AstraZeneca highlighted the dates of grant and expiry of IN 147 are 15th March, 2007 and 2nd October, 2020, and also the dates of grant and expiry of IN 625 are 9th July, 2009 and 15th May, 2023.
According to AstraZeneca and its Indian subsidiary, the above-mentioned firms began infringing on IN 147 and IN 625 in the year 2020, and some of the respondent(s) /defendant(s) also commenced post-grant objections, revocation procedures, or counter-claims against IN 625.
A single product, according to AstraZeneca, may cover hundreds of patents. As a result, the claimed invention in IN 147 differs from the claimed invention in IN 625. It was argued that IN 147 claims a class of Markush structure compounds, but IN 625 claims only one specific molecule, DAPA; hence, IN 147 can not be stated to claim DAPA.
However, the generic drug makers (listed as respondent(s)/defendant(s))contended,
"The manufacture and sale of DAPA was in infringement of IN 147; AstraZeneca and its Indian subsidiary are deemed to have admitted that DAPA stood fully and particularly described in IN 147. Further, as IN 147 expired on 2nd October, 2020, there could thus be no interim injunction qua IN 147. "
While mentioning the price difference of the drug, it further added,
"The difference in the prices of drugs of the appellants/plaintiffs and the respondent(s)/defendant(s) ranged between 250% to 350%; thus if the respondent(s)/defendant(s) continued to manufacture and market the impugned drugs, the same would be available to the public at large at a much cheaper rate than those being marketed by the appellants/plaintiffs or their licensees; thus public interest was also in favour of non-grant of injunction."
Accordingly, the previous judgment dated November 2, 2020, stated, "the interim injunction claimed by the appellants/plaintiffs was declined but the respondent(s)/defendant(s) were directed to place on record the details, quantum and value of the drug manufactured and sold as also indirect and direct taxes paid in that behalf as well as their assets, from which the damages, if any awarded against them, could be recovered."
After thoroughly evaluating the circumstances, the bench of Justice Rajiv Sahai Endlaw and Justice Amit Bansal expressed concerns about how the plaintiffs in the suits from which these appeals arise could allege infringement of IN 147 by the defendant (s) by manufacturing DAPA, if the patent IN 147 was/is not for DAPA.
It was also inquired whether, based on the factum of the appellants/plaintiffs in the suits from which these appeals arise, the appellants/plaintiffs are deemed to have admitted DAPA as the subject matter of both IN 147 and IN 625, having claimed infringement by the respondent(s)/defendant(s) of both IN 147 and IN 625.
In light of the aforementioned considerations, the court stated,
"In our opinion, with respect to one invention, there can be only one patent. The appellants/plaintiffs herein however, while claiming one invention only, i.e. DAPA, are claiming two patents with respect thereto, with infringement of both, by the respondent(s)/defendant(s). The same alone, in our view, strikes at the very root of the claim of the appellants/plaintiffs and disentitles the appellants/plaintiffs from any interim relief."
"In our opinion, a single formulation, such as DAPA, is incapable of protection under two separate patents having separate validity periods. The appellants/plaintiffs, in their pleadings, are not found to have pleaded the difference, save for pleading that DAPA was discovered by further research. From the field of the invention subject matter of the two patents being verbatim the 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."
Finally, dismissing AstraZeneca and its Indian subsidiary's appeal, the court held,
"We are also of the opinion that the mere fact that there is a difference in the reasoning in the two impugned orders/judgments, would not entitle the appellants/plaintiffs to an interim injunction. We have already hereinabove commented on the appellants/plaintiffs having wasted the time of two Hon'ble Judges of this Court by pursuing the same subject matter separately, and the appellants/plaintiffs, on appeal, can not be permitted to reap any benefit thereof. It is not as if, one impugned order/judgment grants interim relief to the appellants/plaintiffs and the other denies it. Though for different reasons, both the impugned orders/judgments find the appellants/plaintiffs to be not entitled to interim relief. "
In addition to this, the court concluded,
"There is thus no merit in the appeals, which are dismissed, with costs assessed at Rs.5,00,000/-to the respondent(s)/defendant(s) in each of the suits."
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