In this landmark judgement the Division Bench of the Delhi High Court upheld the order of a single judge restricting Indian pharmaceutical company Cipla Ltd (hereinafter referred as Cipla) from selling pharmaceutical products containing INDACATEROL, a respiratory drug which was patented by Novartis AG (hereinafter referred as Novartis). This drug was used to treat chronic obstructive pulmonary disease (COPD) and was sold in India under the brand name ONBREZ. Novartis manufactured this drug in Switzerland and was sold in India by Lupin. Brief facts of the case are as follows:
- ‘Indacaterol’, a bronchodilator drug approved for the treatment of COPD is protected under a patent (Patent No. IN 222346) held by Novartis.
- In November 2014, Cipla had launched a cheaper generic version of this drug under the brand name ‘UNIBREZ’.
- Cipla had priced its drug at Rs 130 per pack as compared to Rs 677 for Onbrez by Novartis (about 1/5th of the price)
- After this, Novartis filed a patent infringement suit before Delhi High Court seeking permanent injunction restraining Cipla from infringing its patent over Indacaterol along with an application of interim injunction.
- On 9 Jan 2015, the Single Judge of Delhi High Court granted temporary injunction restraining Cipla from selling its generic version.
- However, the said injunction was granted only until a determination of compulsory license application if filed by Cipla.
- Further if no application is filed the interim injunction would continue until the final disposal of the patent infringement suit.
- After this, on appeal Cipla approached the Division Bench of the Delhi High Court
Issues
The main issues before the Hon’ble Court were:
- Whether the interim injunction granted to Cipla was valid?
- Whether Novartis’s patent ‘Indacaterol’ (Patent No. IN 222346) is valid?
- Whether Cipla’s manufacture and sale of ‘Indacaterol’ (under brand name ‘Unibrez’) infringe the said patent (Patent No. IN 222346)?
Arguments
- By Plaintiff i.e., Cipla
- They argued that Novartis’s patent must be revoked under Section 92(3) and Section 66 of the Patents Act, 1970 alleging that COPD has reached ‘epidemic’ proportions and Novartis’s product Onbrez has less availability.
- They contended that the general principles regarding working of patented inventions stipulated in Section 83 of the Indian Patent Act would govern and sit over the right of patentees provided by Section 48 of the Act.
- Cipla contended that the generic version is cheaper and available at 1/5th price of Onbrez. They further alleged that Novartis was importing Onbrez at a lower quantity and a very high price.
- They argued that public interest is an important aspect while considering the grant of injunction. Therefore, the patented product must be available at a reasonably affordable price.
By Defendant i.e., Novartis
- They argued that it is not essential that the patent must be worked by manufacturing the patent product in India. They further said that they have fulfilled the requirements of patients in need and have supplied the drug according to the demand.
- Right of patentees under Section 48 was in no manner reduced by the provisions of Section 83. This section is not in respect of the rights of the patentees. Therefore, the element of public interest, which is sought to be introduced by Cipla through the route of Section 83 of the said Act, would not, in any way, impinge upon the rights of the patentees.
- They contended that there is a huge amount of financial investment in the research and development of the patented drug ‘Indacaterol’.
- Further they stated that Cipla was able to sell its drug at a little cheaper price as it has not invested in the research and development of the drug which depletes the efficacy and safety of the drug.
Judgement
Court relying on various judgements held that:
“On 9 March 2017, the Hon’ble Delhi High Court upheld the decision of Single Judge and rejected Cipla’s appeal and held that Novartis had established the prima facie validity of its patent and Cipla had not been able to make a credible challenge to it. Therefore, the submission of invalidity of patent was set aside and it further held that Novartis is entitled to an injunction as per Section 48 of the Patents Act, 1970. The Court further held that it is not necessary for a patent to manufacture in India. Even imports will fulfill the purpose. It was held that all the considerations under Section 83 are directed towards the authorities, to exercise power under the said Act which also includes the power of compulsory licenses under Section 84. Hence the general principles under Section 83 of the Patents Act, 1970 don’t curtail to the rights of patentee under Section 48 of this Act. Lastly on the question of public interest it was held that Cipla was unable to prove that public interest would be disserved by the grant of an injunction. The Court, therefore, refused to interfere with the Single Judge’s grant of injunction and dismissed Cipla’s appeal.”
This judgement is well reasoned and reflects a balanced approach in cases of patent infringement and compulsory licensing. It was pointed out by the Court that the ground of compulsory license is no defense in patent infringement suits where the patent is prime facie valid. Hence, such patents must be protected at all costs.
By: Runjhun Sharma, School of Law, Mody University
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