Delhi HC Held: 'In No Country, A Mere Grant of a Patent by the Patent Offices' Guarantees their Validity'

Delhi HC Held: 'In No Country, A Mere Grant of a Patent by the Patent Offices' Guarantees their Validity'

The Delhi High Court by a single judge, Hon'ble Mr. Justice Rajiv Shakdher in the case of Astrazeneca AB & Anr vs. Intas Pharmaceuticals Limited, observed, "In no country, a mere grant of a patent by the patent offices' guarantees their validity." The grant of monopoly to the inventor, which is necessary for her/him to recoup investments and/or derive profits from her/his inventions, comes with a quid pro quo. The court had accordingly dismissed to grant an injunction in favour of the plaintiffs against the defendants.

In the following case, the primarily concern revolved around two patents, (Indian Patent No.) IN 47 & IN 625. The moot point, which arose for consideration for the case was: whether the compound-in-issue i.e. Dapagliflozin ["DAPA"] which, according to the plaintiffs, is covered in IN 147 stands disclosed both, in law as well as on facts?

The plaintiffs were represented by Mr. Kapil Sibal and Mr. Harish Salve along with other senior learned counsels. First, the plaintiff stated that its two distributors i.e. Sun Pharma Laboratories Limited and Abbott Healthcare Private Limited market and sell the very same drug under various brand names. In 2020, some entities have embarked on infringing the aforementioned patents which led to institution of suits including the captioned suits for patent infringement.

It was only in 2020 that some of these entities have initiated post-grant opposition, revocation proceedings or counter-claims against IN 625. The plaintiffs asserted; they have disclosed all material information with the Indian Patent Office. There has been substantial compliance with the provisions of Section 8 of the Patents Act, 1970. In conclusion, the plaintiffs prayed that the defendants should be restrained from infringing plaintiffs' species patent i.e. IN 625 during the pendency of the suit action.

The defendants relied on Section 53(4) of the Act, which was introduced in pursuant to the 2002 amendment sought to protect abuse by the patentee of its monopoly rights by resorting to double patenting. These statutory safeguards were put in place to balance its international commitment under the Agreement on Trade-Related Aspects of Intellectual Property Rights ["TRIPS agreement"] as against India's obligation to protect the health of its citizens.

Further the defendants argued that the, plaintiffs have failed to disclose material particulars of their corresponding US patents which is violative of Section 8(2) of the Act and that plaintiffs have failed to demonstrate irreparable injury.

There is no presumption qua irreparable injury where the 'validity of a patent has not been tested in litigation. 'This principal is important for cases in India as there is no presumption of validity in India as provided in Section 13(4) of the Act.

The court after analysing the facts of the case noted that, the scheme of the Act does not foreclose the right of the defendants in defence to an infringement action to question the validity of the patent. Section 107 of the Act, expressly conferred a right on the defendants to raise, in defence, in an infringement suit, all those grounds on which the patent can be revoked under Section 64 of the very same Act.

The court further noted, that it has not been emasculated right of the defendant to challenge the validity of the patent. The presumption of validity exists only till such time the patent is challenged a challenge which is credible and no further. The court was of the view that, if the plaintiffs' argument was to be accepted, then, it would have to be held that the older the patent, the stronger the firewall. Such an interpretation, would be contrary to the plain words of the Statute.

The next question before the court was, at the stage of preliminary injunction, what is the threshold that the challenger has to meet? In other words, is the challenger required to demonstrate that the patent is invalid or is the challenger required to establish that the patent is vulnerable and that the validity is not vexatious. The court for the present matter was of the view that it was not possible for the defendant to prove valid patent at the juncture and hence that leverage was awarded.

The court further elucidated the ground for revocation taken under Section 64(1)(f) i.e. that IN 625 is vulnerable as it does not involve any "inventive step" which has been defined under Section 2(1)(ja) and observed, "if a patentee is unable to measure up to the ingredients of either of the two parts, the invention claimed is not construed under the Act as an inventive step."

The court stated, if an injunction was granted, the opportunity lost by the defendants to market their products cannot be quantified in monetary terms, hence even from the point of restitution, the balance tilts in favour of the defendants.