Delhi High Court Revives Gilead’s Patent Application

In a big setback to the Indian Generic Drug-makers, Delhi High Court has allowed the writ petition filed by Gilead Pharmasset LLC against the Union of India for an adverse order passed against it by the Deputy Controller of Patents & Designs. The Deputy Controller had rejected Gilead’s application for failing to satisfy the criterion under section 3(d) of the Indian Patents Act, 1970 stating that the invention lacks efficacy in the eyes of law. Gilead has developed a drug called Sovaldi (INN-sofosbuvir) which is effective in curing Hepatitis C Virus (HPV). The drug is significant in terms of invention because of its low toxic levels and shorter duration of treatment which gives it an edge over earlier treatments involving Interferons (IFNs) and drug Virazole (INN-Ribavirin). IFNs didn’t had a long lasting effect on the virus while Virazole had severe side-effects like causing anemia and increasing level of toxins in the body. If the stats are to be believed, there are approximately 170 million patients worldwide that suffer from HCV Virus with 18 million being from India only. Gilead agreed to grant license over the drug to seven drug makers in India to fulfill the demand, but the agreed price couldn’t convince Generic Drug-makers and therefore to protect its interest, Gilead applied for patent in India.

The proceedings before Deputy Controller in the Parent Order were invoked under section 14 of the Act because of the pre-grant opposition filed by Natco Pharma and Delhi Network of Positive People (DNP+) that opposed the application under various grounds enumerated in section 25 of the Act. The controller rejected the oppositions that alleged lack of novelty and non-obviousness by taking cue from the approach of authorities in US and Japan with respect to the same patent. However, it accepted their contention under section 3(d) which bars patent-ability of an invention which is new form of a known substance and doesn’t results in enhancement of known efficacy of the substance. It supplemented its assertion by referring to the Supreme Court’s judgment in Novartis v. Union of India case, in which it was stated that efficacy stands for therapeutic efficacy which can be proved by clinical trials. The application was thus rejected. However, rather than filing an appeal before the Intellectual Property Appellate Board (IPAB), Gilead filed a writ Petition alleging violation of Principles of Natural Justice.

The detailed judgment of the High Court came out only on 30^th January, 2015 after the initial order was released on 22^nd January, 2015. But the contents of the detailed judgment are pretty surprising. The ground for violation of Natural Justice raised by the applicant sustained because the Deputy Controller didn’t issued (or may be failed to issue) notice to the applicants regarding the applications filed by the opposers under section 25 of the Act. Not to mention the fact that in his order, it was observed that the controller had significantly copied the contents of the application (Yes… “lifting of para and verse from opponents application” as the order puts is) which technically raised suspicion for bias against the applicants. The High Court thus allowed the writ and remanded the matter before the controller for a fresh decision.

Now it will be interesting to see how the Controller decides this matter. For it had succinctly rejected applicant’s submissions before it without proper reasoning and by taking inferences from a document on record, which it didn’t supplied to the applicants before hearing begun under section 14. The matter will require addressing technical questions like whether change in orientation of a component, which not only satisfies the novel and inventive step criterion, but also enhances the effectiveness of already existing compound is sufficient to satisfy ‘efficacy’ norm of the Patent Law? If no, then what “significant” (as pointed out in the order) level of enhanced therapeutic efficacy is required to satisfy the requirement stated under section 3(d)? Besides, can only reports of clinical trials can prove improvements in therapeutic efficacy or well-reasoned scientific data like cytotoxicity data would also suffice. The controller rejected the rationale of Delhi High Court’s decision in Roche v. Cipla without supplying a proper reasoning for the same. This time, Controller will be required to elucidate as to whether substitution of one chemical group with other is akin to orientation of a compound’s group, given that both result in enhancing the curing ability of the compound?

The case study in hand presents a good example of as to why developed countries lose faith in Indian authorities when it comes to Intellectual Property Rights. First they misuse Public Policy norms to favor small corporations and now they go to the extent of violating Rules of Natural Justice. Union of India has decided to appeal against the order of High Court, of which there is no need. Just because you went till Supreme Court doesn’t means you have done your job. Successful Execution of policies requires balancing the needs of masses with the genuine business needs of the corporates, not biased actions intended to garner accolades from media and high-profile activists.

For More Information, Contact Lex Protector.

The Curious Case of ‘Sorafenib Tosylate’

‘Sorafenib Tosylate’ drug, which is sold as ‘Nexavar’, has hit the headlines once again. Brushing off Bayer Corporation's claims, the Bombay High Court ruled out the German based drug maker's challenge of the Controller of Patents decision to grant compulsory license to Natco Pharma Ltd, a Hyderabad based pharmaceutical company. The court rejected Bayer’s plea and thus declined to intervene with the Controller's original decision. A division bench of Justice M S Sanklecha and Chief Justice Mohit Shah observed that the rights of a patent holder of a drug or medicine should not strip a patient from getting the required medication, and hence the IPAB’s decision was upheld.

Let me recap you briefly. The contenders in the arena are Bayer and Natco. Sorafenib Tosylate, a drug used in the treatment of kidney and liver cancer, was developed by Bayer and Onyx. It was traded under the name ‘Nexavar’. Bayer is a drug invention giant company, based in Germany. In April 2011, an Indian company Natco Pharma Ltd, a generic medicine maker, registered an application with the Bayer, asking for a voluntary license to manufacture and distribute 'Nexavar' in India. The request was refused and hence Natco went to the doors of the Controller of Patents to apply for a compulsory license. According to the new WTO rules, the then Controller of Patents, Mr. P.H. Kurian, on March 9th, 2012 granted Natco permission to manufacture generic version of Nexavar in India. This judgment was a landmark in the history India’s Patent Law, as it became the first ever case of compulsory licensing in India. Surely this news broke all grounds, and Bayer was shown a cold cheek.

The Controller General (CG) ascertained three reasons to justify its decision. Firstly as Bayer provided Nexavar only to 2% of the total cancer patient population in India, public requirements were far from being met. Secondly, the pricing of the drug at Rs.2.8 Lakhs was exorbitant and this was suffice to say that it was not a “reasonably affordable” price. And lastly, it stated that Bayer has not shown proof of the patented invention being “worked” in India.

The order is completely justified. While it’s a well-known fact the treatment process of cancer is extremely expensive, Bayer Corporation's tactics of pricing the drug at a whooping Rs.2.84 lakhs does no good to those in need. Given the fact that Bayer has invented this breakthrough drug, I would place it on record, that, Natco is the Robin Hood to all those people counting hopes and days by making the drug available at Rs.8800. I mean, what good is a drug if the one who needs it can't afford it? India is a country where millions still go to sleep hungry, as the food produced does not reach everyone. At least we can expect the medicine to be available to almost every patient who needs it. With Natco now free to manufacture and distribute the drug, there’s another reason for Cancer patients and Natco to celebrate this Diwali!

For more information, contact Lex Protector

Monaco ne peut pas être une marque

                                                      

Being patriotic is one thing and being affectionate about something is different. But in the garb of your patriotism, you can’t just go to the extent of seeking exclusivity over your country name to distinguish your goods and services. The General Court of EU has rejected appeal of Les Marques de (the applicant that replaced Principality of Monaco as proprietor of the trademark) against an order of Office for Harmonization in the Internal Market (OHIM) for rejecting its application for the registration of its trademark ‘MONACO’. Interestingly, WIPO had Okayed the application and forwarded it to EU’s OHIM as a part of its processing of an International Application under the Madrid Protocol. The ground for refusal being lack of distinctiveness owing to the descriptive nature of the trademark for it tend to offer services originating from a geographic territory to which the mark belongs. The only thing that required court’s consideration was to see if the term ‘MONACO’ indeed implies the geographical territory of the same country to the people of Europe or not, of which it found ample evidence. (MONACO shares its boundaries with European Nations like France, but it’s not a member of European Union).

Obviously you can’t trademark a country name. Just imagine a scenario where an American national procures registration for the trademark ‘India’ and starts sending legal notices to proprietors all over the United States who are using the term merely to designate the source of their products. From a legal point of view, such a mark would inherently lack distinctiveness and would always create impression in customer’s mind with respect to the geographical origin of the goods and services. The situation however would change if a country name constitutes merely a part of the whole trademark. In such cases there is still a chance of procuring a trademark registration if it can be established that the goods have originated from the country that is mentioned in the trademark. (For Instance, trademarks like INDIA GATE and TAB INDIA are registered with the USPTO) Only if the usage of a country’s name is arbitrary and has no link with the namesake country, a ground for objection can arise on the ground of its being misleading with respect to the origin of the products.

From the news reports, an application for appeal in the European Court of Justice seems pretty likely. From a logical point of view, I think that the applicant should put an end to its quest for registering its trademark for the decision of General Court looks pretty sound.

(I said 'seems' and 'think' because judgment is not available in English and my Estonian not pretty good :P)

The heading of the blog is in French. It means “MONACO cannot be a Trademark”.

-Courtesy Google Translator :P

For More Information, Contact Lex Protector.