Transcript generic download

The Story of IP Coming to
India….
Dr. Srividhya Ragavan
Professor of Law
University of Oklahoma College of Law
www.law.ou.edu/faculty/ragavan.shtml.
Historical Background

Pre-1970: Process patents for food,
pharmaceutical and chemical innovation.


Compulsory licensing after 3 years of grant
Indian Patent Act, (post-1995):


Two statutory amendments
Two amendments using Presidential Ordinance
Patentability



Requirements for Patentability (post-’95):
(j) 'invention' means a new product or process
involving an inventive step and capable of
industrial application;
“new invention" (novelty) means any invention
or technology which has not been anticipated
by publication in any document or used in the
country or elsewhere in the world before the
date of filing ….

Note: definition is broader than 35 USC 102
(restricts knowledge & use to US activities).

(ja) 'inventive step' - synonymous to
nonobviousness




(ja) 'inventive step' … invention not obvious to a
person skilled in the art;‘ (amended again in 2005)
"inventive step" … 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;
Re: 35 USC 103 – Graham, Hybertech standard
Industrial application: utility
Patent Litigation & Implications
The Novartis Dispute

Novartis, in 1993, invented imatinib. Novartis has a
patent on the free base of imatinib.

Imatinib mesylate – a salt of imatinib- was used to treat
leukemia.

Imatinib mesylate is the polymorphic form of salt that results
when imatinib is treated with methanesulfonic acid.

Mail-box application on July 17, 1998 on the polymorph
The Novartis Question

Generic drug companies opposed as lacking the
efficacy requirement of sec. 3(d)


India has pre & post-grant opposition (allowed within the first
year after grant)
Novartis filed a writ in MDS High Court and asserted:


Patent validity
Unconstitutionality of §3(d)

§3(d) outlines exclusions from patentability:
d) the mere discovery of a new form of a known substance which does
not result in increased efficacy of that substance or the mere
discovery of any new property or new use for a known substance or
of the mere use of a known process, machine or apparatus unless
such process results in a new product or employs at least one new
reactant.
Explanation: For the purposes of this clause, salts, esters, ethers,
polymorphs, metabolites, pure form, particle size, isomers,
mixtures of isomers, complexes, combinations and other derivatives
of known substance shall be considered to be the same substance,
unless they differ significantly in properties with regard to
efficacy.

Meanwhile, in Madison Place, Washington D.C.,:
Pfizer v. Apotex :

Pfizer sued Apotex for infringing the patent on Norvasc - besylate
form of amlodipine.



Norvasc is used to treat hypertension and forms of angina.
Apotex alleged that Pfizer’s earlier ‘909 patent over amlodipine
anticipated the patent over amlodipine besylates – (salt form of
amlodipine).
Federal Circuit agreed with Apotex on the grounds that the besylate
form lacked enhanced utility from the base compound.

The Federal Circuit reiterated an established principle that
salts of known compounds are deemed obvious unless
there is an unexpected utility or improvement or efficacy!!
Roche v. Cipla

Roche patented erlotinib (2007) and sold as Tarceva
at Rs.4,800 ($120) a tablet.

Tarceva covered by US Pat. 5747498 (1996 filing date)

Cipla sold a low-cost version at Rs1,600 ($ 40).

Cipla asserted invalidity

Tarceva (Erlotinib) is not efficacious than an earlier known
compound (Gefatinib).
Patent v. Patient


CIPLA could continue producing generic
versions of Erlotinib.
Case established:
1.
2.

Price as a criterion to determine access
Statutory CL
Bottom Line: If your client wants to market a
pharmaceutical product in India, price
consciousness is required
Price as a determinative factor

DPCO in India

Price control decisions of the US


PhRMA v. Maine
Biotechnology Industry Organization v. District of
Columbia

Excessive Pricing Act preempted by federal patent
statute
Statutory CL v. Judicial CL in India

Statute:



§ 84 of Patents Act, 1970 (§ 92A)
3 years from grant
After Roche v. CIPLA: Patentee is not entitled to an
injunction if a generic manufacturer can prove:



Patented drug is priced more than the generic, and
not locally manufactured (about 90% of MNC drugs would
qualify)
Generic is already manufacturing the drug(?)
Judicial CL in the US?





Amgen v. Roche (March, 2008)
Validity of Amgen’s patent on epogen questioned
Roche manufactured cheaper generic- Mircera
Amgen’s patent held valid by a Federal Dist. jury
(Boston)
But, Judge refused permanent injunction based on
eBay factors


Mircera ("follow on" biologic version of Epogen) requires
less-dosing and hence, tips the "public interest" balance
Roche agreed to the Judge’s suggestion of a 22.5%
royalty on sale of Mircera on Amgen.
Temporary Injunctions in India

Temporary injunctions seemingly not automatic
when the counterclaim is invalidity (Roche, Bilcare,
Star Plough from MDS)


Exception 1: More than 6 years of grant – possibility of
injunctions
Exceptions 2: Exhaustion of opposition rights.


Eg: Telemecanique v. Schneider
But, once infringement is established, injunction
would not be refused (Telemecanique v. Schneider)

Possibly different from eBay: injunctions need not follow
infringement
Other practice issues
No presumption of validity of patents in
India (§ 13(4))


Bilcare v. M/S Amartara (ND HC) & Bilcare v.
Supreme Industries (ND Dist)
Geographic Indicators










Byadgi Chilli - from Karnataka
gamosa – white and red Assamese material
Muga Silk from Assam (filed by Assam Science and Technology
Council)
Mysore Mallige – Karnataka
Palakkadan matta rice
The medicinal ‘Navara rice – both from Kerala
Chikan embroidery from UP
Madhubani paintings of Bihar
Orissa handloom designs
Spices Board applied for:
 Alleppey Green Cardamom
 Coorg Green Cardamom,
 Sannam chillies
 Alleppey Turmeric
PPVFA

Protection of plant varieties

Disclosure requirements

Gene Fund

Benefit - sharing
The End