Delhi High Court to hear the ‘Nexavar’ patent infringement suit tomorrow

Bayer’s patent infringement suit against Cipla, for the Nexavar patent is now slated for a hearing tomorrow the 23rd of March, 2011 before the Delhi High Court. Regretably Justice Ravindra Bhat will, in all probability, not be hearing the matter any longer as he has been shifted to a Division Bench deciding criminal appeals. Justice Bhat was the person responsible for putting this litigation on a fast-track. As blogged by us earlier, the Court had already framed the issues in the case with the intention of referring certain questions to ‘scientific advisors’ appointed by it under Section 115 of the Patents Act, 1970. Both parties are to be given a chance to cross-examine the ‘scientific advisors’. In the last hearing on the 9th of December, 2010 Justice Bhat had framed the following questions that were to be referred to the ‘scientific advisors’, who were required to submit their report before the next hearing on the 23rd of March, 2011:
Image from here.

CS (OS) 523/2010
I.A. Nos.3714, 6065 and 12765/2010

BAYER CORPORATION and ANR ….. Plaintiffs
Through: Mr. Sudhir Chandra Aggarwal, Sr. Advocate with Mr. Sanjay Kumar and Ms. Arpita Sawhney, Advocates.
CIPLA LTD ….. Defendant
Through: Ms. Pratibha M. Singh with Ms. Saya Choudhary, Advocates.



With the consent and assistance of the learned counsel for the parties, the following are framed as questions/points, on which scientific experts appointed by the court would enquire into and render assistance through their report: –

(i) Whether the defendant?s formulation ‘Soranib’ in its chemical constituents and other essential ingredients is identical or so closely similar to the plaintiffs? formulation Sorafenib (covered by Indian patent no.215758) as to lead to the same results/therapeutic effects.

ii) Whether in view of the disclosures contained in US 5773459 and US 4904668 can compounds of claim 1 of Indian Patent No.215758 of be arrived at?

(iii) If answer at point 2 is in affirmative, whether a person skilled in the art, on a combined reading of US 5773459 and US 4904668 will clearly predict that urea derivatives wherein one of the N atom bears a chlorotrifluoromethyl phenyl substituent and the other N atom bears an N-methycarbamoyl pyridyloxy phenyl substituent (Sorafenib) will have the potential to exhibit anti-tumor properties?

(iv) Whether US 5773459 and US 4904668 provide motivation and expectation to a person skilled in the art to arrive at Sorafenib?

(v) Whether US 5773459 and 4904668 disclose urea derivatives and a chlorotrifluoromethyl phenyl substituent on one N atom and an N-methylcarbamoyl pridyloxy phenyl substituent on other N atom, the combinations of which will lead to a compound possessing anti-tumor activity?

(vi) Whether US 5773459 and US 4904668 teach and/or make it obvious to a person skilled in the art to arrive at Sorafenib which is also urea derivative bearing a chloro trifluoromethyl phenyl substituent on the N atom and an N- methylcarbamoyl pridyloxy phenyl substituent on other N atom of urea, claimed in the impugned suit patent?

(vii) Whether the substitution of chloro trifluoromethyl phenyl substituent for the N atom and an N-methylcarbamoyl pridyloxy phenyl substituent for the N atom of urea, obvious to a person skilled in the art?

(viii) If the impugned compound (Sorafenib) was obvious, would selection of a Tosylate salt of sorafenib be obvious?

(ix) Whether Sorafenib would be a mere obvious modification of compunds envisaged in US 5773459 and US 4904668?

(x) Whether the anti-tumor activity of compounds with the skeletal structure of urea bearing a chloro trifluoromethyl phenyl substituent on the N atom and an N- methyl carbamoyl pridyloxy phenyl substituent on the N atom, is known in view of the state of the art?

(xi) What is the routine procedure in drug designing when it involves selection of salt and the selection of substituents in a basic skeletal structure?

(xii) How will the cumulative information flowing from each of the aforesaid documents assist in the evolution of sorafenib?

This Court is of the opinion that in the event it is necessary to do so, at a later stage, in view of the submissions of the parties, further report and any question of fact or such supplementary enquiry may be conducted by one or more experts.

Learned counsel for the parties agree to prepare a joint compilation of all the documents on the record and furnish it to the scientific expert appointed by the Court. The fee of scientific experts is determined tentatively @ Rs.2.5 Lakhs each to be borne in equal proportion by the plaintiff and defendant/counter claimant. A copy of the order shall be furnished dasti to the parties as well as to the scientific experts by the Registry. The experts are requested to furnish their reports within eight weeks from the date of receipt of the compilation by them. The compilation shall be prepared and furnished to the experts within four weeks.

List on 23rd March, 2011, for directions.
DECEMBER 09, 2010

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

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