Transcript Novartis v. India: Patents & Profits v. Access to Medicines

Standards of Patentability and
Opposition Procedures: India
Patent Act & Novartis v. India
Professor Brook K. Baker
Health GAP
Northeastern University School of Law,
Program on Human Rights and the Global Economy
UKZN IP and Access to Medicines
2010
Brief History of India’s Patent
Regime
• Britain enacted India’s first patent act in 1856,
designed “to enable English Patent holders to
acquire control over Indian markets.”
• After independence (1947), it took India until
1970 to enact a new Patent Act that excluded
patents on medicinal products and foods.
• Before 1970, most of the modern medicines
used in India were imported from abroad and
sold at some of the highest prices in the world.
• It was impossible to get a compulsory licenses
–years of delay.
Emergence of India’s Generic
Industry
• Between 1972-2005, the Indian generic
industry had over 30 years to develop
technical capacity to reverse-engineer
medicines and to engage in efficient
manufacturing processes.
• India became a major producer of
generic medicines for both domestic use
and exportation.
U.S. Threatened India with Trade
Sanctions during TRIPS Negotiations
• India was part of a developing country
coalition trying to keep IPRs out of the GATT
negotiations.
• The U.S. used its Special 301 List to threaten
India and other key developing countries
including Brazil and Thailand during the
negotiations.
• Despite losing the battle to exclude IPRs, India
held out for some key flexibilities and
transition periods.
TRIPS
• In 1994, India signed the WTO TRIPS
Agreement.
• Although it was no longer permissible to
discriminate against product patents or against a
field of technology, like pharmaceuticals, India
was granted a 10-year transition period.
• However, between 1995-2005, India was
required to collect pharmaceutical patent
applications in a “mailbox” and thereafter to
grant patents under new post- Jan. 1, 2005
standards.
TRIPS Standards of
Patentability are Flexible
• Art. 27.1: “[P]atents shall be available for any
inventions … provided that they are new,
involve an inventive step and are capable of
industrial application.[5]
• Fn 5. For purposes of this article, the terms
“inventive step” and “capable of industrial
application” may be deemed by a Member to be
synonymous with the terms “non-obvious” and
“useful” respectively.
Members Have Interpretive
Flexibility
• Art. 1.1: Members shall be free to determine
the appropriate method of implementing the
provisions of this Agreement within their own
legal systems.
• Art. 8.1: Members may, in formulating or
amending their laws and regulations, adopt
measures necessary to protect public health …
provided that such measures are consistent
with the provisions of this Agreement.
Doha Declaration
• Para. 4: We agree that the TRIPS Agreement
does not and should not prevent Members from
taking measures to promote public health. …
[W]e affirm that the Agreement can and should
be interpreted and implemented in a manner
supportive of WTO Members’ right to protect
public health and, in particular, to promote
access to medicines for all.
India Adopted Multiple TRIPS
Flexibilities
• In its amended Patent Act of 2005, India
adopted virtually all of the flexibilities granted
by the TRIPS Agreement and confirmed by the
Doha Declaration to ensure access to more
affordable generic medicines:
– Compulsory license mechanisms, including for
export
– Licenses of right for generic producers already
producing “mailbox” generics, even if 1995-2005
patent applications were granted
– Strict definitions of patentability
India’s Strict Standard of
Patentability for Drugs
• Section 2(1)(j): An “invention” is “a new
product or process involving an inventive step
and capable of industrial applicability.”
– Straight from TRIPS
– Excludes “discoveries,” which are patentable under
U.S. law
• In addition, India enacted some key exclusions
from patentability
Section 3(d)
• The following are not inventions within the meaning of
the Act –
The mere discovery of a new form of a known substance which
does not result in the enhancement of the known efficacy of that
substance or the mere discovery of any new property or new
use for a know substance ...
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 [a] known substance shall be considered to
be the same substance, unless they differ significantly in
properties with regard to efficacy; ...
The Efficacy Standard
• Relatively new concept in the patent
context but quite familiar in the drug
registration context.
• Note, full clinical trial evidence of
efficacy will ordinarily be lacking at the
time a first patent application is filed, but
is much more likely for productimprovement patents.
The New Use Exclusion
• Although “new uses” patents are routinely granted
under U.S. law.
• Although the U.S. is increasingly seeking to impose
“new use” standards in its FTAs, India’s refusal to
grant patents for new uses is clearly TRIPS-compliant.
• Art. 27.2 of TRIPS permits Members to exclude
“diagnostic, therapeutic and surgical methods for the
treatment of humans” from patentability.”
• Note: Section 3(i) of the Patent Act also excludes
methods of treatment.
Exclusion of Combinations
• The exclusion of combinations is also
significant given the role that therapeutically
appropriate fixed-dose combination medicines
have played in treating resistance-prone diseases
like AIDS, TB, and malaria, and given their
benefit for patient adherence.
• The mere fact of combination should not itself
be considered evidence of increased efficacy.
Impact of Section 3(d)
• This explicit exclusion of minor, incremental
“innovations” is unique, though the Philippines
and Zanzibar have now adopted the same
provision.
• The exclusion expresses a strong antipathy
towards “me-too” drugs and towards the
evergreening of pharmaceutical patents
(successive 20-terms)
Most India Mailbox Applications
are for “me-too” drugs
• 9000+ pharmaceutical product patent
applications were filed between 1995-2005;
there were only 300+ new chemical entity
patents during this same time frame.
• The vast majority of these do not comprise
new chemical entities or evidence significantly
enhanced efficacy and thus should be subject
to exclusion under section 3(d).
Opposition Mechanisms In Indian
Patent Law
• Pre-grant opposition (any time before grant), any person
can file, no fees
• Post-grant opposition (one year from date of publication
of grant), aggrieved parties can file
• Standard patentability criteria and 3d exclusions are
applied – novelty, inventive step and industrial
application
• Failure to inform Patent Controller of corresponding or
similar foreign applications; failure to disclose genetic
resources or traditional knowledge
• Other opposition mechanisms: Revocation and Counterclaim of patent invalidity in infringement proceedings.
Pre- and Post-Grant Oppositions
• Between 2005-09, a total of 250 pre- and postgrant oppositions were filed at the Indian Patent
Office.
– Successful oppositions to Forteo, an osteoporosis drug,
gifitinib and Givec, cancer drugs; Combivir (withdrawn),
nevirapine (pediatric formulation), tenofovir and darunavir, all
antiretrovirals, and valganciclovir (AIDS-related eye disease
and river blindness).
– Important opposition pending to, heat stable lopinavir/ritonavir
(pre-grant: ARV)
Technical Lessons
• Focus on priority medicines (HIV, cancer, psychiatric)
• Identify the relevant applications (what could
potentially block generic versions)
• Seek status updates from patent office
– Procedural problems, e.g., refusal by patent office to
furnish copy of reply statement and evidence of
patent application
• Search prior art & seek expert evidence
Novartis’ Patent Application for Glivec
• In 1998, Novartis filed a “mailbox” application for a
new beta-crystalline form of imatinib mesylate, the
active ingredient in anti-cancer drug, Glivec.
• Six generic companies began manufacturing a generic
version of Glivec and selling it at one/tenth the cost.
• Novartis, which had gained exclusive marketing rights
for Glivec, obtained a stay in Jan. 2004, against the six
companies.
• Companies resumed production in 2005 pursuant to the
new Patent Act (based on significant investments), but
were required to pay royalties to Novartis if a patent
were to be granted.
The Patent Office Denied the Patent
• When Novartis asked that its Glivec patent
application be processed, India cancer patient
groups and several generic drug manufacturers
filed a pre-grant opposition claiming that
Glivec was a new form of an old (1993, preTRIPS) drug.
• Novartis submitted evidence that Glivec had
30% greater bioavailability.
• The India Patent Office disagreed that Novartis
had shown significantly increased efficacy and
on Jan. 25, 2006 refused to grant a patent on
Glivec.
Novartis Appealed to the High Court
• Novartis appealed the denial of its patent
application to the High Court in India
making three claims:
– First, that the denial of the Glivec
application was erroneous;
– Second, that Section 3(d) of the Patent Act
was not compliant with TRIPS; and
– Third, because of non-TRIPS-compliance,
Section 3(d) was unconstitutional.
Novartis’ Claims
• In its Constitutional claim, Novartis argued:
(1) courts are obligated to interpret Indian law so as to
harmonize it with binding international law if at all
possible and
(2) section 3d was unconstitutionally arbitrary and
irrational because (a) it upsets "established
expectations," (b) it is inconsistent with the stated
intent of three Patent Act Amendments to comply with
TRIPS, and (c) it is internally inconsistent with the
basic definition of an invention in the Patent Act.
The Merits of the Case were
Extraordinarily Weak
• India’s treaties not self-executing, according to
Article 57 of its Constitution (like the U.S.)
• Permissible to differentiate between field of
technology under TRIPS Art. 27.
• Implementing flexibility, under TRIPS Article
1.1 and under the broadly interpretable
meanings of newness and inventive step, to
limit pharmaceutical product patents as it has.
The Implications of the Case were
Quite Important
• 67% percent of India’s generic production
was being exported to developing countries.
• No patients have benefited more than people
living with HIV, 70% of whom receive
treatment with low-cost generic drugs of
assured quality from India.
• Due to Indian competition, first-line AIDS
treatment regimes cost approximately $87130/patient/year, a quarter the price of the
R&D industry’s “discount” prices.
Novartis’s Defense of its Lawsuit
• “We are entitled to sell to middle class consumers”
(Note: 95% of Indians are not middle-class)
• “We support India’s rights to issue compulsory
licenses to solve its access problems” (Note: opposite
position in Thailand)
• “We have solved the access problem through our
Glivec donation program” (Note: the access program
is inaccessible for many)
• High mark-up sales in India are crucial to finance
future research and development (Note: India is
1.3% of the global pharmaceutical market)
Internationally, activists fought
Novartis’s lawsuit – Chennai India
Cambridge – Valentine’s Day
Broken-Heart Award Demo
Campaign Strategy – Key Lessons
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Engage patent experts, i.e., I-MAK
Involve patient groups
Seek involvement of generic companies
Recruit public interest lawyers – The
Lawyers’ Collective
• Use the media
• Activate international solidarity/network
Novartis Lost Court Case
• On August 6, 2007, the Madras High Court ruled
against Novartis’s challenge to the constitutionality and
TRIPS-compliance of Sec. 3d of the Patent Act on three
main grounds:
– Because TRIPS had not been domesticated into India’s positive
law, Novartis could not challenge TRIPS compatibility
– The meaning of “enhancement of efficacy” was not so vague,
uncertain, or discriminatory so as to render Sec. 3d
unconstitutional or unreasonable
– There was no unconstitutional delegation of a legislative
function to the Patent Office.
• Novartis’s separate appeal from the decision of the
patent office is still pending.
Other challenges to access-tomedicines in India
• Bayer v. Union of India – challenge to
generic registration, attempts to establish
patent/registration linkage by litigation
• EU-India EPA proposal seeks higher
IPRs: data exclusivity, patent term
extension, increased enforcement
• Divisional patents defeat opposition
procedures (Kaletra, atazanavir)