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Sunday, April 7, 2013

Novartis Patent for Beta Crystalline form of Imatinib Mesylate rejected by Supreme Court of India

Supreme Court of India while hearing the Appeal ( as a matter of exception this appeal was admitted and heard, though all appeal against Order of IPAB are to be heard by High Court first) preferred by Novartis AG against the order of Intellectual Property Appellate Tribunal (IPAB) rejected the product Patent rights for Beta Crystalline form of Imatinib Mesylate for failing in both test of invention (under Section 2(1)(j) & 2(1)(ja) as well as patentablity (under Section 3(d)). The Court consequently allowed the counter-appeal filed by two of the respondents i.e. Natco Pharma Ltd. and Cancer Patients Aid Association.

There is no separate finding on the counter-appeals preferred by Natco Pharma Ltd. and Cancer Patients Aid Association therefore it can be assumed that Novartis AG still retains the process Patent rights for manufacturing Beta Crystalline form of Imatinib Mesylate. 

It would be essential to go into the brief history of the Patent Application filed by Novartis AG for Beta Crystalline form of Imatinib Mesylate and its prosecution in India: 

1.         On July 17, 1998 Novartis AG filed Patent Application in India i.e 1602/MAS/1998, claiming priority from Swiss Patent Application dated July 18, 1997 for invention titled "Crystal modification of N- phenyl-2-pyrimidineamine derivative, process for its manufacturer and its use. The said Patent Application was opposed by way of Pre-Grant Opposition under Section 25(1) of Indian Patents Act by Cancer Patients Aid Association, Natco Pharma Ltd., Cipla Ltd, Ranbaxy Laboratories Ltd., Hetero Drugs Ltd. 
2.         Vide order dated January 25, 2006 the Assistant Controller of Patents rejected the Patent Application for following grounds
(i) Anticipated by Zimmermann Patent  (US Patent no. 5, 521,184, continuation in part of US Patent Application serial no. 08/042,232 dated September 9, 1993) and article published on May 1996 in “Nature Medicine” and Patent extension certificate issued by USPTO that mentions Imatinib Mesylate (Gleevac) as product. Also on the satisfactory proved by Natco pharma that salt normally exists in beta crystalline form which is most thermodynamically stable product.
(ii) Obvious for reasons of prior publication as mentioned above
(iii) Non Patentable under of Section 3(d) of Indian Patents Act, claims new form of a known substance without any significant improvement of efficacy.
(iv) Claiming wrong priority as Switzerland was not a conventional country on date of making of application
3.         Novartis AG filed Writ petitions against the said order of Assistant Controller of Patents in Chennai High Court as at that time the IPAB was not established, vide order dated February 23, 2007 the High Court converted said writ petitions to appeal.
4.         Simultaneously Novartis AG itself and through its POA holder in India filed two writ petitions challenging the provision of Section 3 (d) of the Indian Patent Act, as being unconstitutional and against the TRIPS obligation of India
5.         During pendency of writ petitions on April 3, 2007 the Govt. of India brought provisions as to appeal to IPAB with effect from April 2, 2007 and consequently the 5 appeals were transferred by High Court to IPAB vide order dated  April 4, 2007.
6.         The Technical member (Patents) to the IPAB previously hold post of the Controller General of Patents, therefore Novartis AG filed Petitions for ceasing the Technical member (Patents) from hearing the appeals. By Order dated July 20, 2007 the petitions were dismissed relying on doctrine of necessity.
7.         Novartis AG challenged the order by a writ petition before the Chennai High Court and the High Court directed IPAB to constitute a special bench of Chairman, Vice Chairman to hear the appeals and for seeking assistance of Scientific advisers, if they found fit. 
8.         Natco Pharma filed a SLP before Supreme Court against said order for appointment of new Technical Member to hear instant appeals because of involvement of high technology in the matter as well as for statutory requirement of presence of technical member in the Board having special qualification. Supreme Court vide order dated 1, 2008 directed reconstitution of IPAB including Dr. P.C. Chakraborti, Assistant Controller as Technical Member and to hear appeals on daily basis from November 3, 2008.
9.         IPAB vide Judgment dated June 26, 2009 allowed only the process claims for manufacture of Beta crystalline form. 
10.       Against the impugned judgment by IPAB, Novartis AG approached the Supreme Court directly and after hearing all the parties, a very detailed, well-reasoned order was passed by Supreme Court of India on April 1, 2013.

While adjudicating on the issue Supreme Court considered interplay between qualifying criteria of invention and criteria of patentability of an invention. It had to consider if the product qualifies as “invention” within the meaning of clauses (j) and (ja) of section 2(1), can its patentability still be questioned and denied on the ground that section 3(d).

Few historic date concerning the development of product Imatinib, Imatinib Myselate and Beta crystalline form of Imatinib Myselate are as follows:

April 28, 1994                        Application for derivatives of N-Phenyl-2 pyrimidine-amine including Imatinib filed before USPTO by Jurg Zimmermann

January 1, 1995                     On March 26, 1999 Parliament passed the Patents (Amendment) Act 1999 (Act No. 17 of 1999) which amended the provisions of the Patents Act 1970 retrospectively, with effect from January 1, 1995, the date when the TRIPS Agreement came into force. By the Amendment Act of 1999, section 5 of the Parent Act was amended to provide for making “a claim for patent of an invention for a substance itself intended for use or capable of being used, as medicine or drug. The Amendment Act further incorporated in the Parent Act, Chapter IVA, which contained provisions for grant of exclusive marketing rights in respect of pharmaceutical substances for which a claim for patent was made under section 5 of the Act. The Amendment Act of 1999 thus complied with Article 70(8) and (9) of the TRIPS Agreement.

January 1996                         Cancer Research published an article under the title “Inhibition of the Abl Protein-Tyrosine Kinase in Vitro and in Vivo by a 2- Phenylaminopyrimidine Derivative” authored by several people, including Jurg Zimmermann. There was detailed discussion about the antitumoral properties of Imatinib and its methanesulfonate salt, i.e., Imatinib Mesylate.

May 28, 1996                         Patent granted by USPTO (5, 521, 184) referred herein after as Zimmerman Patent

July 18, 1997                          Application filed in Switzerland by Novartis AG, for grant of Imatinib Mesylate Patent to Beta Crystalline Form

April 9, 1998                          Novartis AG filed for Investigational New Drug Application (IND #55,666) for Gleevac before Food and Drug Administration (FDA) USA

July 17, 1998                          Application filed in India by Novartis AG, for grant of Imatinib Mesylate Patent to Beta Crystalline Form (1602/MAS/1998) claiming priority from Swiss Patent Application

November 30, 1998              Switzerland notified as convention country

January 18, 2000                   Novartis AG made application for Patent for Beta Crystalline Form of Imatinib Mesylate in USA

February 27, 2001                 Novartis AG filed for Original New Drug Application (NDA #21-335) for Imatinib Mesylate before Food and Drug Administration (FDA) USA. It declared that active ingredient of the drug is Imatinib Mesylate. The drug substance, active ingredient, drug product (composition/ formulation) and method of use were declared to be covered by US Patent no. 5, 521, 184. It was declared that said patent covers composition, formulation and/or method of use of Imatinib Mesylate.

May 10, 2001                         FDA approval granted to drug “Gleevac (Imatinib Mesyalte) 50 mg and 100mg capsules.

July 3, 2001                            Patent Term extension application made for US Patent no. 5, 521, 184 and term extended to further 586 days from original expiry date of May 28, 2013

March 27, 2002                      Novartis AG, made application for grant of Exclusive Marketing Rights (EMR) to Indian Patent Office

November 10, 2003              EMR granted to Novartis AG, by Indian Patent office

November 23, 2003              US Appellate Court reversed rejection of Beta Crystalline Form of Imatinib Mesylate by the USPTO
January 1, 2005                     Provisions related to Product Patent introduced w.e.f. January 1, 2005 in India
May 17, 2005                         Patent for Beta Crystalline Form of Imatinib Mesylate Granted in USA
January 25, 2006                    The Assistant Controller of Patents rejected the Patent Application for Beta Crystalline Form (1602/MAS/1998) of Novartis filed in India on basis of pre Grant oppositions
February 23, 2007                  Writ Petitions filed against the Assistant Controller’s order converted into Appeals
April 3, 2007                          Govt. of India brought provisions as to appeal to IPAB with effect from April 2, 2007

April 4, 2007                          Appeals of Novartis AG were transferred by High Court to IPAB.

June 26, 2009                         IPAB allowed only the process claims for manufacture of Beta crystalline form and rejected the product and use claims for beta crystalline form

April 1, 2013                          Supreme Court rejected the appeal of Novartis AG against the judgment of the IPAB

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