Section 48(a) and 48(b) of The Indian Patents Act 1970 confers exclusive rights to a patentee to the patented product or process respectively. The act prevents third parties from making, using, offering for sale, selling, or importing a patented product in India, unless consented by the patentee. It also prevents third parties from using a patented process or offering for sale, selling, or importing, the product obtained directly by the patented process, unless consented by the patentee.

 

 

The act gives an impression that when a patented product/ process is allegedly infringed, the patentee is empowered with sweeping rights from preventing third parties from infringement. However, that is not true. Section 13(4) of the Indian Patents Act lays down that when a patent is granted, it should not be deemed that it amounts to granting the validity of the patent and that there is no liability of the government for the validity of a patent. In other words, the patent office may have erred in granting a patent and the remedy for the same lies in opposition or filing a revocation petition. A patent is valid only till it remains unchallenged. Section 107 of the Patents Act allows an alleged infringer with defenses whereby grant of interim injunction against infringing can be avoided. The alleged infringer needs to show that the patented product/ process violates the Patents Act on the grounds listed under Section 64.

 

 

When a patentee files a case for an interim injunction against an alleged infringer, the court walks on thin ice and tries to strike a balance between the rights of a patentee and the rights of a defender. The court generally keeps the following considerations in mind:

 

 

• prima facie case

• balance of convenience and

• loss suffered.

 

 

 

 

A patentee can file a case for an interim injunction against the alleged infringer and prima facie submit evidence with respect to infringement. A patentee may state relevant facts about the subject matter of the patent and infringement including priority and patent grant date. A defendant, in turn, can raise a credible challenge to the validity of the patent. In the case of Bristol Myers Squibb Company & Ors. Vs. J.D. Joshi & Anr , a single judge of the court held that old patents have a kind of a ring of validity and if a revocation petition is filed just before the expiry of the suit patent term, it cannot be reckoned as a proper way of clearing the way. It averred that if a defendant intends to launch a drug, knowing fully well that the plaintiff had been granted a suit patent, it must clear the way by filing a revocation patent well in advance.

 

 

The alleged infringer may try to show how a person skilled in the art can arrive at the invention from the available prior art or he may show that an alleged invention lacks novelty / inventive step /industrial applicability or is in violation of other provisions of the Patents Act. He can show how the invention is vulnerable to invalidity. By citing lack of novelty / inventive step / industrial applicability or any other thing which violates the Patents Act on the grounds listed under Section 64, a defendant can escape the imposition of interim injunction. It is the vulnerability to invalidation and not the actual invalidation which needs to be brought out for avoiding an interim injunction. Actual invalidation during a trial demands greater proof than what is required for an interim injunction. In the case of Boehringer Ingelheim Pharma GMBH & Co and Boehringer Ingelheim (India) Pvt Ltd., vs. Vee Excel Drugs , the court averred that the defendants failed to raise a credible challenge to the validity of the patent as it did not try to show how a person skilled in the art could arrive at the invention from the available prior art and thus the court did not agree for granting the interim injunction. However, an interim injunction was granted when a credible challenge to the patentability of Indian patent 235625 was raised, for the product Dapagliflozin, granted to Bristol Myers Squibb Company1, which was subsequently assigned in favour of AstraZeneca AB Sweden (Astrazeneca) on 1st Feb 2014.

 

 

 

 

Balance of convenience is meant to assess the ratio of hardship it is likely to cause to a defendant if an interim injunction is granted and the hardship it is likely to cause to a plaintiff in case an interim injunction is not granted. The balance of convenience may also relate to financial aspects, which shall be discussed separately.

 

 

In the case of Hoffman La Roche vs, Cipla Ltd. , while leaving aside a credible challenge to the validity of the patent, a lot of discussions revolved around the price differential between a generic product launched by the defendants and the product of the plaintiff. In view of the fact that the price differential of the cancer treatment drug was more than 300%, a bench of the Delhi court averred that granting the interim injunction would deny access to the cheap essential drug to the public at large and therefore, the balance of convenience did not lie in favour of granting the interim injunction.

 

 

In the case of Boehringer Ingelheim (India) Pvt Lt., vs Vee Excel Drugs2, the court averred that the defendants were aware of the patent of the plaintiff but they preferred to wait till the expiry of the alleged genus patent and then raised a credibility challenge against the alleged species patent. Further, the defendants did not file any pre-grant or post-grant opposition. The plaintiff had the patent under which a drug was launched whereas the defendant did not have any such patent. The defendants could have sought revocation of the subject matter before starting the manufacturing process of the alleged infringing product. The fact of the defendants neither own a patent related to the product proposed to be launched nor have filed opposition/ revocation petition timely, the court averred that a balance of convenience was created in favour of the plaintiff.

 

 

 

 

The House of Lords, in (1975) All England Law Reports 504, American Cyanamid Co. v. Ethicon Ltd., averred that a court should assess that if a patentee succeeds in a trial for establishing infringement, could he be adequately compensated for the loss suffered between the date of filing for interim injunction and the trial decision. If an alleged infringer is assessed to be in a position to compensate the patentee adequately, no interlocutory injunction should be granted, no matter how strong the infringement case. If the court assesses that damages would not be an adequate remedy, an injunction can be granted but at the same time, it needs to be ensured that a defendant is compensated suitably in case the defendant prevails in the trial. In such a case, the court also needs to assess the adequate remedy and ability of a patentee to compensate the defendant.

 

 

In the case of Hoffman La Roche vs. Cipla3, though the court refused to grant an interim injunction, it directed that the defendant Cipla should render accounts and that the Joint Registrar shall maintain a record of profits made by Cipla.

 

 

In case, other factors seem to be evenly balanced, a court can maintain the status quo. In case a defendant has not started making an alleged infringing product / using an alleged infringing process, an injunction may be granted but if the alleged infringing product/ process has been in place for some time, careful assessment is necessary for the grant of interim injunction.