Bayer Healthcare Limited (Bayer) filed a case for interim injunction against Natco Pharma Limited (Natco) restraining them from infringement of Indian Patent no IN 240207 related to the drug Regorafenib used for metastatic colorectal cancer and advanced gastrointestinal stromal tumors. The case was heard by a single judge of Delhi High Court, who passed an order of interim injunction, No.CS (COMM) 314/2019 dated 31st May 2019. The interesting part of the order was that a copy of the order served in the case of Sterlite Technologies vs. V.ZTT India Ltd was also attached with the order. The order for both the cases was passed by the same judge. In the order, the judge mentioned that it was not possible to frame an opinion, even prima facie, and that an interim injunction should invariably be passed in favour of a patentee as was passed in the case of Sterlite Technologies vs. V.ZTT India. The learned single judge attributed two reasons for this. One, in case the decision is given in favour of a patentee during a trial, the patentee would be entitled to far less profit than that he would have made in absence of infringement. The reason for this was attributed to less profit as the alleged infringer was proposing to sell the product at a much lower price than that by the patentee. NATCO in the instant case revealed substantially lower priced medicine than that of the patentee. Second, the alleged infringer takes undue advantage of delays in court processes. The single judge was of the opinion that orders of interim injunction shall ensure purity of court processes. 

Appeal against the decision of the single judge was filed by Natco in the High Court of Delhi. The order of the single court was set aside. The court directed that an opinion is to be framed by the single judge of the High Court based on the prima facie evidence of infringement / invalidation, balance of convenience and financial injury that may be caused to Bayer / Natco.   

Discussion

The single judge, while granting interim relief on the grounds discussed herein above, felt that such an experimentation was the need of the hour.

The instant case raised questions whether an interim relief order could be passed without consideration of prima facie evidence of infringement / invalidation, balance of convenience and financial loss.

Interim injunctions are temporary and discretionary. However, the courts have laid down broad guidelines over a period of time for the cases related to interim injunction and are enumerated hereunder:

  • A safe approach for a Single Judge is to deny interim relief in the first hearing and if there is doubt regarding the same, the application for hearing may be set down at the earliest opportunity. (Merck Sharp and Dohme Corporation v. Glenmark Pharmaceuticals)[1]
  • Assessing whether a plaintiff could be adequately compensated for the loss by a defendant if the case is decided in favour of the plaintiff. In case a defendant is in a position to do so, interim injunction may not be granted. (Wander v. Antox[2])
  • Assessing if a plaintiff would suffer irreparable loss / injury / damage in case interim relief is denied and in such a case the plaintiff is entitled to relief ex debito justitiae. (Shiv Kumar Chadda v. Municipal Corporation of Delhi[3])
  • Assessing whether a defendant could be adequately compensated for the loss if the case is decided in favour of the defendant. In case a plaintiff is in a position to do so, interim injunction may be granted. (Wander v. Antox2).
  • Assessing whether a plaintiff has been able to establish prima facie evidence of infringement.
  • Assessing whether a defendant has been able to raise a credible challenge to the patentability of the subject matter of a suit patent. A defendant can show vulnerability to invalidation of the suit patent whereas actual invalidation can be proved or disproved during the trial. (Boehringer Ingelheim Pharma GMBH & Co and Boehringer Ingelheim (India) Pvt Ltd., vs. Vee Excel Drugs)[4]
  • Assessing whether balance of convenience lies in favour of a plaintiff or a defendant.
  • Assessing public interest at large. For example, in case a court finds that access to cheap essential drugs shall be curtailed, the court may refuse to grant interim injunction even though balance of convenience lies in favour of a plaintiff. (Hoffman La Roche vs, Cipla Ltd.)[5]
  • Assessing whether maintaining status quo is in the best interests of a case or assessing whether grant of interim relief or its denial would cause a greater harm. Dorab Cawasji Warden v. Coomi Sorab Warden[6].
  • Considering balance of convenience if an infringing product is already in the market.
  • Considering balance of convenience if an infringing product is not in the market yet.
  • Assessing maintainability of a suit patent.

It appears that the learned single judge had not taken into consideration the guidelines discussed herein above. It was stated by the learned single judge that Bayer would suffer loss because of inadequate compensation by the defendant as the infringing product was to be sold at a lower price than that of the plaintiff. Such a statement presupposes infringement of the granted patent and validity of the granted patent without having heard the parties and without having framed an opinion on the case. The statement tends to ignore section 13(4) of the Patents Act 1970 which states that when a patent is granted, it should not be deemed that it amounts to granting validity to the patent. Presumption of validity of a patent, without any discussion or having provided any opportunity to the defendant for establishing prima facie evidence regarding invalidation, runs contrary to the section. An alleged infringer can try to establish vulnerability to the patentability of subject matter of a suit patent on the grounds listed under section 64 and escape interim injunction.

Each case of interim injunction is unique in its own way and needs to decided in the light of guidelines given by the Courts over a period of time and discussed herein above. It may not be appropriate to draw a parallel between the cases of interim relief even though there may be some similarities. A Court needs to weigh pros and cons for interim injunction and form an opinion about a case in view of the guidelines discussed herein above and arrive at a decision accordingly.