Astrazeneca AB and Anr vs Torrent Pharmaceuticals Ltd: Refusal of Injunction for non-compliance of Patent Law

In an infringement suit by Astrazeneca AB and Astrazeneca Pharma India Limited the defendants challenged the validity of the patent on the ground that Plaintiff has failed to disclose its patent applications in other countries. The Delhi High Court passed the judgment on 18^th Nov 2020 and refused to grant an interim injunction in favor of the Plaintiff, on the ground that it failed to disclose information to the Indian Patent Office about its patent applications for the same or similar inventions in other countries.

Brief Facts of the Case

The applicants Astrazeneca AB and Astrazeneca Pharma India Limited is a subsidiary of Astrazeneca PLC- a British-Swedish multinational pharmaceutical and Biopharmaceutical Company. The plaintiffs claim to have invented the pharmaceutical composition namely ‘Dapagliflozin’. They further claim that Dapagliflozin has proven to be an effective inhibitor for managing diabetes and diabetic complication. The plaintiffs authorize to make and distribute drugs in India comprising Dapagliflozin to Sun Pharma Laboratories Limited and Abbott Healthcare Private Limited.

The plaintiffs filed the suit against Torrent Pharmaceuticals Ltd., Micro Labs Limited, Zydus Healthcare Ltd., ERIS Lifesciences Ltd., USV Pvt. Ltd., and MSN Laboratories Pvt. Ltd. for restraining them from manufacturing, selling online retailing of the products comprising of the compound Dapagliflozin thereby infringing the patent owned by the plaintiffs being IN 235625 and IN 205147. The plaintiffs sought the decree of permanent injunction against the defendants, their employees and agents from manufacturing, selling online retailing of the products. On the other hand, defendants challenged the validity of the patent.

The Main Contention of the Defendants

1. The plaintiffs should have not been granted the suit patent IN 235625 as a specie patent but could have been granted as a patent of addition only. Further, they contended that patent IN 235625 is covered under the genus patent IN 205147 and thus hit by Section 10 of the Patent Act.
2. Further, the defendant’s claims that as per the definitions under Sections 2(j) and 2(1) (ja) of the Patents Act, the species patent cannot be held to be an invention or an inventive step involving technical advancement.
3. The defendants further state that the suit patent is also invalid for non-compliance of Section 8 as neither before the Indian Patent Office while seeking the patent IN 235625 nor before this Court, the plaintiffs have disclosed that species patent US 6515117 equivalent to patent IN 235625 were granted in the United States. Thus the defendant contended that in view of concealment of this document before the Indian Patent Office, the Indian Patent Office did not have the complete record to form an opinion thereon and hence, the suit patent IN 235625 is invalid.
4. The defendants further claim that the plaintiff has not deposited its renewal fee and thus their patent lapsed. In the absence of the same being republished in the Gazette, the plaintiff as on date does not have a valid and subsisting patent IN 235625.
5. 3. 1. That as per Section 8 of the Patent Act 1970, the applicant is required to submit the particulars of all the applications for the patent of same or substantially the same invention filed in other countries and besides the detailed particulars, an undertaking is also required to be furnished that the Controller will be kept informed in writing, from time to time, of detailed particulars in respect of every other application relating to the same or substantially the same invention, filed subsequently to the filing of the statement within the prescribed time. But the Plaintiff failed to disclose the details about its patent applications, if any, in any of the patent offices across the world such as United States Patent and Trademark Office (USPTO), European Patent Office (EPO), Japan Patent Office (JPO), etc.That the prima facie vulnerability of the validity of Suit Patent has outweighed the balance of convenience and irreparable loss caused to the Plaintiff.The defendant submits that the suit patent IN 235625 is hit by anticipation due to prior claiming.The Main Contention of the Plaintiff
         1. Rebutting the arguments of the learned counsel for the defendants that the specifications in IN235625 are the same as IN205147 the plaintiff states that that on the date of priority even the inventor may not be fully aware of the advantages and the properties of the invention.
         2. Further, the plaintiff states that under/for Section 10(4) Patents Act it is sufficient if the inventor discloses the best method known to the inventor.
         3. In response to the defendant’s arguments learned counsel for the plaintiffs submits that a bare reading of Section 8(1) discloses that only applications which were being prosecuted are required to be filed and when the application in respect of IN 235625 was filed before the Indian patent office, the US patent 6515117 had already been granted. They further asserted that they have been able to clearly show compliance with Section 8(1) of the Patents Act when Form-3 was filled up along with necessary requirements.

         Observation of the Court

      2. Despite repeated requests made by the Indian Patent Office for submission of mandatory documents, the Plaintiff failed to comply with the said requirements, hence, the High Court held that the validity of the Patent Suit is vulnerable for non-compliance with Section 8 (2) of the Act. But the Court refused to delve further into the issue of invalidity of Patent Suit, as this was a Suit for Interim Injunction only.

       

   Judgment given by the Court

   Thus, based on the aforesaid observations, the Delhi High Court has held that the Defendants have prima facie laid a credible challenge to the validity of the Patent Suit on the ground of obviousness and for non-compliance of Section 8(2) of the Patent Act. The court further states that balance of convenience and an irreparable loss even though in favour of the plaintiff, the prima facie vulnerability of the validity of the suit patent outweighs these factors. Therefore, the Delhi High Court refused to grant an interim injunction in favor of the Plaintiff and therefore, dismissed the Suit. The court further directed defendants to maintain complete accounts of the manufacture, sale, and supply of the products and file in this Court on affidavits statements of such accounts on a quarterly basis.

   Concluding Remark

   Though the court denied to discuss the issue of invalidity of Patent Suit the court clearly propounds that compliance with patent law is necessary for seeking an injunction against the defendants. The court ruled that prima facie vulnerability of the validity of Suit Patent has outweighed the balance of convenience and irreparable loss caused to the Plaintiff. The legal maxim of equity can be rightly cited for such circumstances that- ‘he who comes into equity must come with clean hands’.