 "Patent office refuses patent for tosylate salt form of Bayer's sorafenib")
The Indian Patent Office has refused patent application of German drug major Bayer Healthcare AG for a form of tosylate salt of its anticancer drug Sorafenib, known under the brand Nexavar, on the grounds of lack of inventive step and Section 3(d) among others.
Hyderabad-based Natco Pharma Ltd and Gurgaon-based Fresinius Kabi Oncology Ltd had filed pre-grant opposition against the application.
It may be noted that the country's first Compulsory licence was issued to manufacture the generic form of Nexavar in India, which also received a favourable decision from the Supreme Court last year.
Bayer has filed an application for a patent bearing number 1960/DELNP/2007 in Delhi Patent Office on March 14, 2007 entitled, "Thermodynamically stable form of a tosylate salt", with claims on the polymorphic form I of the tosylate salt of sorafenib. Two pre-grant oppositions were filed against this application, first one by Natco Pharma Limited, Hyderabad and second one by Fresenius Kabi Oncology Limited, Gurgaon.
After hearing the argument of the two opponents and the reply of Bayer Healthcare, Ajay S Thakur, assistant controller of Patents & Designs, Patent Office, Delhi, ordered, "After having considered all the circumstance of this case, representation and expert evidence of opponents, reply of the applicants, expert evidence in support of the applicant, written submissions and arguments in the hearing made by both parties and also my discussion and findings as mention above, I am of the opinion that the opponents have succeeded in proving their grounds relied upon by them."
"The application is refused on the ground of lack of Inventive step(Section 2(1)(ja), Section 3(d), Section 3(e) and finally Section 25(1)(h) of The Patents Act, 1970. In view of the above, I accept the representation and refuse to proceed with the application for grant and therefore, there shall be no patent in pursuance of this application. There is no order as to costs," said the Patent Official in the order issued on February 24, 2015.
Secion 2(1)(ja) says "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.
Natco raised its opposition on the grounds that the claims are drawn to polymorphic forms of Sorafenib, which is a known substance and not patentable under Section 3(c), Section 3(d) which says the mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of the substance is not patentable, 3(e) which says a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not patentable, Section 25(1) (b)/(c) on lack of novelty, Section 25(1) (e) for lack of inventive step, among others.
Fresinius Kabi raised opposition on grounds including Section 25(1) (b) of the Patent Act, Section 25(1) (d) related to Prior Knowledge or Prior Use, Section 25(1) (e) related to obviousness or lack of inventive step, Section 25(1) (f) related to not patentable subject matter and Section 25(1) (g) related to insufficient disclosure.
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Bayer Healthcare refuted all the grounds of oppositions raised by both the opponent companies. It said that the polymorphic form I of the tosylate salt of sorafenib as claimed in the present application is not disclosed in any of the cited documents by the Opponent. It also submitted that the complete specification of the patent application sufficiently and clearly describes the invention as well as the method by which it is to be performed and the opponent's objection on this ground as well should be rejected outrightly.
While the Assistant Controller concluded against many of the grounds raised by the opponents, including those related to insufficient disclosure and lack of novelty as they were not validly established by the opponents, on other grounds such as the Section 3(d), he said the ground has been established validly.
It may be noted that the Patent Controller granted a compulsory licence to Natco Pharma to market a generic version of Nexavar at around Rs 8,800 per person per year, as against Bayer's brand Nexavar, which was sold at Rs 2,84,000 per patient per month. Bayer has challenged the decision with the Intellectual Property Appellate Board (IPAB), with the Bombay High Court and later in the Supreme Court of India.
The IPAB, while upheld the controller's decision to issue compulsory licence to Natco, has increased the royalty rate from six per cent to seven per cent, which Natco has to pay to Bayer. The Bombay High Court upheld IPAB's order. The Supreme Court, in December, 2014, refused to entertain the appeal of Bayer, according to reports.
As reported earlier, Bayer, under a patient assistance programme(PAP), is also being offered at around Rs 30,000 a month. Cipla Ltd introducing a generic version in 2010 and has later reduced the price from initial Rs 30,000 a month to around Rs 5,400 a month, Bayer argued in the IPAB earlier.