By Vikrant Rana and Priya Adlakha
In a Commercial Suit titled as the Ferring B.V. & Ors. Vs Precise Bio Pharma Pvt. Ltd. & Ors.[1], Hon’ble Ms. Justice Jyoti Singh of the Intellectual Property Division of the Delhi High Court, while adjudicating upon the suit for permanent injunction under Section 48 read with Sections 108 and 11A (7) of the Patents Act, 1970 (hereinafter, referred to as the ‘Act’), discussed the maintainability of an infringement suit, for the acts done by the Defendants, between the duration of grant of patent and the date of order setting aside such grant.
Brief Facts of the case
The Plaintiffs filed a Patent Cooperation Treaty (PCT) Application on March 20, 2013, for an RTS Carbetocin (when administered prevents excessive bleeding after child birth) claiming priority from September 30, 2010, which was eventually granted by the Assistant Controller of Patents vide an order dated January 27, 2022, dismissing pre-grant opposition filed by Precise Bio Pharma Pvt. Ltd. i.e. the Defendant No. 1 in this suit. The Certificate for the grant of patent was issued on January 27, 2022, and the grant of patent was published on February 04, 2022.
The Defendant No. 1 challenged the order granting a patent in a Writ Petition[2], before the Hon’ble Delhi High Court, on the sole ground that the order dated January 27, 2022, was a non-speaking order.
Hon’ble Mr. Justice Sanjeev Narula of the Delhi High Court, hearing the aforesaid writ petition vide order dated March 03, 2022, set aside the impugned order dated January 27, 2022, on the ground that it was bereft of any reason, and was a non-speaking order, thereby remanding the matter to the Assistant Controller of Patents and Designs, to pass a reasoned order within four weeks, justifying the rejection of the pre-grant opposition. The said order was later modified on March 22, 2022, to the extent that the direction issued to Assistant Controller of Patents and Designs to pass a reasoned order, does not necessarily have to result in a rejection of a pre-grant opposition and he shall be free to adjudicate the pre-grant opposition in any manner as deem appropriate in facts and circumstances of the case, in accordance with law, within the extended period of four weeks.
Plaintiff’s submissions
The Plaintiffs, in their suit for permanent injunction inter-alia sought damages, delivery up and recall of infringing products, disclosure, and deposit of sale proceeds alleging infringement of the patent IN 387567 for the period 31.10.2014 i.e. the date of publication to 03.03.2022 i.e. the date of setting aside the order of grant.
The Plaintiffs contented that the Defendant No. 1 had started the manufacturing of the generic RTS Carbetocin 100 mcg/ml that is the subject matter of the suit patent, which would eventually be sold and marketed by the Defendant Nos. 2 and 3. Therefore, since the patent had been granted in favour of the Plaintiffs on January 27, 2022, and was valid and subsisting for the month of February, 2022, before the order of grant was set aside on March 03, 2022 in the writ petition, any act of manufacturing, using, selling or offering for sale of the infringing product in the said duration, would amount to infringement of the suit patent under Section 48 of the Act.
The Plaintiffs placed reliance on Astra Zeneca AB and Anr. Vs Natco Pharma Ltd.[3] and Sotefin SA vs Indraprastha Cancer Society and Research Center and Ors.[4] to contend that if the infringement had occurred during the lifetime of the patent, the infringing good would not become genuine on the expiry of the patent, and the Plaintiffs therefore would be entitled to seek restraint with respect to the infringing products, which had either been made or imported at the time of the suit patent being valid or subsisting.
Defendants’ submissions
The Defendants drew the attention of the Court to Section 48 of the Act, contending that the exclusive right of a patentee to prevent third parties from the act of making, using, offering for sale, or importing a product or a process, would arise only from the grant of the patent. Furthermore, under Section 11A (7) of the Act on and from the date of publication of the application for the patent and until the date of grant of a patent, the applicant would have privileges and rights as if the patent for the invention had been granted on the date of the application, however, the Proviso clearly states that the applicant shall not be entitled to institute proceedings for infringement until the patent has been granted.
Therefore, the Defendants contended that once the order granting the patent has been set aside, the order will relate back to the date of grant therefore, no valid patent subsists which would entitle the Plaintiffs to file the present suit.
Court’s Observations and Orders
The Hon’ble Court, finding merit in the contentions raised by the Defendants, observed that a plain reading of Section 48 shows that the exclusive right of a patentee to prevent third parties from manufacturing, selling, etc. the products or using the process, as the case may be, being the subject matter of the patent, shall only arise once the patent has been granted. Furthermore, the first proviso of Section 11A (7) is clear that an infringement action could not lie until the grant of the patent. The order granting the patent in favour of the Plaintiffs stands set aside in a writ petition, and such setting aside the order of the Court would relate back to the date of grant of the patent.
The Hon’ble Court noted that the inevitable consequence of setting aside of the order granting the patent is that there is no valid patent in favour of the Plaintiffs and they are not entitled to file the present suit for infringement and the judgements relied upon by the Plaintiffs were distinguishable as the issue in those cases was the right of patentee in a suit during validity of the patents, which were about to be expired/lapsed.
Therefore, on April 07, 2022, the suit was withdrawn upon instructions from the Plaintiffs, and the Court granted liberty to the Plaintiffs to file a fresh suit, after the decision of the Assistant Controller of Patents and Design in the patent application. The Hon’ble Court clarified that the order is not on the merits of the case.
The Full Story!
Eventually, the Patent IN 387567 was granted in favour of the patentee vide a reasoned order dated April 19, 2022 by the Assistant Controller of Patents and Design, dismissing the pre-grant opposition and the Plaintiffs filed a fresh suit CS(COMM) 351/2022 against the Defendants in the Delhi High Court.
It was submitted on behalf of the Defendants, that they have never manufactured or sold an aqueous composition comprising carbetocin or a pharmaceutically active salt thereof with the pH value ranging from 5.2 to 5.65 and do not intend to manufacture/sell such a composition. It was also submitted that the Defendants shall not, in any manner, use or make any reference to the ‘CHAMPION (Carbetocin Haemorrhage Prevention) Trial’ on their product; product packaging; promotional material/advertisements; and/or online listings and the products manufactured by the Defendants have a pH value ranging from 4.31 to 4.84, which do not violate the patent of the Plaintiffs.
The Defendants were made bound by the said statement and the suit was accordingly disposed off as not pressed.
[1] CS (COMM) 211/2022
[2] W.P. (C) IPD 3/2022
[3] CS (COMM) 117/2020
[4] CS(COMM) 327/2021
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Shilpi Sinha, Associate at S.S. Rana & Co. has assisted in the research of this article.