PATENT ISSUES

• WHAT IS A PATENT?
– Set of exclusive rights granted by a state (national
government) to an inventor or their assignee for a limited
period of time in exchange for a public disclosure of
an invention.
• KEY REQUIREMENTS
– Novelty
– an 'inventive step'
– an industrial application
• WHAT CAN BE PATENTED?
– new and useful process
– machine
– article of manufacture
– composition of matter
– any new and useful improvement thereof
INDIA-EU TRADE AND INVESTMENT PACT

• EU has been proposing changes in Indian

Patent Act.
• Changes to be made with respect to:
– Inclusion of Data Exclusivity
– Removal of Section 3d
– Introduction of Patent Linkage
 DATA EXCLUSIVITY
• Preventing health authorities from accepting
applications for generic medicines during the period of
exclusivity(currently 6 or 10 years).
• Provision in the Indian law to issue compulsory license to
override a patent; however no such provision exists for
overriding data exclusivity on a patented drug.
• Arguments:
– An invalid patent cannot be challenged in the Court of Law
– data exclusivity can be used to extend market exclusivity
(monopoly) of a product even after the expiry of patent
– impede exports of generic medicines to other developing
countries.
• New EU
Pharmaceutical
Legislation , 2004
• 8 year data
exclusivity
provision
• 2 year market
exclusivity
provision
• extended 1 year if,
the holder obtains
authorization for 1
or more new
therapeutic
indications
 SECTION 3D
• Section 3 of Indian Patent Act defines what is not patentable.
• Section 3d gives out that the mere discovery of a new form
of an old drug does not make it an invention.
• Novartis Vs Government Of India
– Novartis claims 2 things one that it was unconstitutional law and
two that it violated TRIPS
A The madras High Court affirmed that Section 3(d) of the Indian
Patent Act was not unconstitutional.
B DOHA DECLARATION - “The TRIPS Agreement does not and should
not prevent Members from taking measures to protect public
health.”
• Even the US Government suggests removal of the term
“therapeutic efficacy” in article 3d
 PATENT LINKAGE
• Linking patent status and registration 
• communication process between the Health Ministry and the
Patent Office to prevent marketing approval of generic drugs
until after the expiration of patents
• In US, Canada, and Mexico
• Bayer Vs Cipla
– CIPLA markets the anti-cancer drug Sorafenib, sold by Bayer under
the name Nexavar- Bayer’s patent would be violated
– One state authority (DCGI- responsible for giving marketing
authority) cannot act against another one (the patents office)
• Arguments:
– Patent linkage could block marketing approval of generics, thereby
rendering compulsory licenses useless and neutralize the Bolar
exception (marketing approval by submitting Bioequivelence studies)
PROBLEMS FACED BY INDIAN COMPANIES

• Customs action against goods suspected of

infringing certain intellectual property rights
– In 2009 the Dutch authorities detained a Rs2.4 crore
blood pressure lowering drug Losartan shipment of
DRL, destined for Brazil and Colombia
– domestic companies are rerouting their products
through ports in South Africa rather than using
Europe for transit.
– They believe that although this route is more
expensive, it is more secure
 PATIENT PROTECTION AND
AFFORDABLE CARE ACT, US-2010
• Authorizes the Food and Drug
Administration(FDA) to approve generic
versions of biologic drugs and grant biologics
manufacturers 12 years of exclusive use
before generics can be developed
 CONCERNS
• Section 3 (d) of the law does not include innovations such as
enhanced safety of a drug, or improved patient compliance.
• Long delays in court proceedings with no substantive actions
• Delays in grants for allowed cases due to Patent Office
backlogs
• Court proceedings even when infringement is
acknowledged, have not enjoined the generic company, as
the court has indicated that the generic company can
compensate the patent holder, effectively granting a
compulsory license.