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 .

‡ Changes to be made with respect to: ± Inclusion of Data Exclusivity ± Removal of Section 3d ± Introduction of Patent Linkage .INDIA-EU TRADE AND INVESTMENT PACT ‡ EU has been proposing changes in Indian Patent Act.

‡ Provision in the Indian law to issue compulsory license to override a patent. ‡ 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. however no such provision exists for overriding data exclusivity on a patented drug. .DATA EXCLUSIVITY ‡ Preventing health authorities from accepting applications for generic medicines during the period of exclusivity(currently 6 or 10 years).

‡ New EU Pharmaceutical Legislation . the holder obtains authorization for 1 or more new therapeutic indications . 2004 ‡ 8 year data exclusivity provision ‡ 2 year market exclusivity provision ‡ extended 1 year if.

B DOHA DECLARATION . ‡ Even the US Government suggests removal of the term therapeutic efficacy in article 3d .SECTION 3D ‡ Section 3 of Indian Patent Act defines what is not patentable.The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. ‡ 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. ‡ Section 3d gives out that the mere discovery of a new form of an old drug does not make it an invention.

and Mexico ‡ Bayer Vs Cipla ± CIPLA markets the anti-cancer drug Sorafenib. thereby rendering compulsory licenses useless and neutralize the Bolar exception (marketing approval by submitting Bioequivelence studies) . sold by Bayer under the name Nexavar.Bayer s patent would be violated ± One state authority (DCGI.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.responsible for giving marketing authority) cannot act against another one (the patents office) ‡ Arguments: ± Patent linkage could block marketing approval of generics.

± They believe that although this route is more expensive. destined for Brazil and Colombia ± domestic companies are rerouting their products through ports in South Africa rather than using Europe for transit. it is more secure .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.

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. effectively granting a compulsory license. have not enjoined the generic company. ‡ 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. or improved patient compliance. as the court has indicated that the generic company can compensate the patent holder.