DHC maintains the injunction on Cipla for Onbrez

The Delhi High Court (DHC) by its decision dated 9th March 2017 continues to bar Cipla Ltd from selling copies of Novartis AG’s drug Onbrez in India.

The entire controversy is respect of Indacaterol, which Novartis holds a patent for. Novartis markets Indacaterol under the name Onbrez. Indacaterol is a bronchodilator and provides symptomatic relief to persons suffering from chronic obstructive pulmonary disease (COPD). Cipla launched its generic version of the drug, Unibrez, in October, 2004. Cipla changed the name from Unibrez to Indaflo due to an undertaking which Cipla gave in a trademark infringement action filed by Novartis.

An order was passed by Justice Manmohan Singh in January 2015 which restrained Cipla from selling copies of Onbrez (Indacaterol).

An appeal was thereafter filed by Cipla against the order of January 2015. Cipla argued that, Novartis does not manufacture Indacaterol in India. The drug is manufactured by the Novartis in Switzerland and only small quantities are imported catering to a negligible number of patients. Thus, according to the appellant, the respondents are not working the patent in India and consequently, they are not entitled to an injunction.

It was also argued that right under section 48 would be subject to the fact that the patent is worked in India on a commercial scale; that the patent is not used by a patentee merely to enjoy a monopoly for the importation of the article

It was submitted that the non-availability was further aggravated by the fact that the price of the respondents Indacaterol was exorbitant as compared to Indacaterol manufactured, supplied and sold by the appellant. The price of the respondents product was five times that of the price of the appellant‘s product

The Respondent argued that, while public interest considerations may be a relevant factor in certain circumstances such as in the case of life saving drugs, it cannot by itself outweigh the rights of a patentee in the case of infringement of the patent as provided under the said Act.

It was also submitted on behalf of the respondents that the statistics said to have been provided by the appellant with regard to the extent of COPD patients in India is not reliable. References were made to certain articles to suggest that COPD does not include an asthma-like respiratory symptom or chronic bronchitis and, therefore, the number of patients suffering from asthma or chronic bronchitis cannot be considered as part of COPD patients. It was also stated that manufacturing in India is not necessary for the working of a patent. The respondents have patents in several countries and this does not mean that they have to manufacture in each country. All that is required is that the manufacturing facilities must be capable of supplying worldwide depending on the demand.

The Division bench, after considering the arguments of both he parties, held that the injunction granted by the learned single Judge ought not to be disturbed.

The various reasons for the same stated by the bench are as follows: –

  • There is no credible challenge to the respondent‘s patent No.222346. Therefore, prima facie, the respondent is straightaway entitled to an injunction in view of the rights available to it as a patentee under Section 48 of the said Act;
  • The provisions of Section 83 (working and CL ) do not curtail or circumscribe the rights of the patentees under Section 48, except in the backdrop of compulsory licences and ancillary issue;
  • It is not at all necessary that for a patent to be worked in India, the product in question must be manufactured in India. A patent can be worked in India even through imports. All that is to be seen is that the imports are of a sufficient quantity so as to meet the demands for the product. Whether the extent of imports is not sufficient for meeting the demands of COPD patients in India, would be a matter of evidence which can only be thrashed out in the course of a trial.
  • Even though the question of public interest may be a factor in considering the grant of an injunction, it is only one of the factors which needs to be kept in mind.

Generation of foreign exchange is not in public interest

The plaintiff, Bayer sued BDR Pharmaceuticals for injunction restraining infringement of Product Patent no.IN225529 and Process Patent no. IN188419 and for other reliefs. Bayer asserted that the patents cover vardenafil, a drug used to treat erectile dysfunction.

Previously, Bayer sued Ajanta for injunction restraining infringement of the same patents. Justice Gauba of the Delhi High Court in the Ajanta Suit held that Bayer did not merit injunctive relief as the patent in question is a non-worked patent, and exports by Ajanta generated employment and tax revenue for the state, and it was therefore in the public interest to allow them to continue.

In the BDR case, a hearing was held on 14 February, and BDR cited Justice Gauba’s order in Ajanta case to argue that an injunction was not merited in its case either. BDR also argued that its exports earn foreign exchange for India and encourage economic activity. Justice Endlaw rejected the Ajanta order’s precedential value being an ad-interim order and ordered the case to be listed in two days. The court also held that if such parameters are to be adopted, then in each case of a non-working of patent, infringement of the patent would be allowed. The court also noted that the drug is also not a life saving drug.

On 16 February, the BDR case was referred to mediation. It is set to be listed again on 8 March.

PROPOSED GUIDELINES FOR SIMILAR BIOLOGICS

Central Drugs Standard Control Organization (CDSCO) has notified draft guidelines for biosimilar developers. The guidelines lay down a regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic. The CDSCO has invited suggestions and /or comments of the stakeholders by 30th April, 2016.

We shall upload a digest of these guidelines, especially on how they vary from the existing 2012 guidelines. Stay tuned for more updates on this section.