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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