Intellectual Property Rights & Generic Pharmaceutical Industry

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Intellectual Property Rights & Generic Pharmaceutical Industry By Dr. Mahendra B. Thakre IPDO-IPM St. Peter's Institute of Pharmaceutical Sciences- 1 st July 2011

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Overview of GATT and WTO TRIPS and Intellectual Property Rights Patents and its importance Developing concept of Patentability Patents and its enforcement Status of Patent Act Pharmaceutical Industry as an case study ROAD MAP

General Agreement on Tariff and Trade (GATT):

General Agreement on Tariff and Trade (GATT) It was singed on Oct. 30, 1947 at Geneva The fundamental principles of GATT includes:- Trade should be carried on non-discriminatory basis Domestic industry should be protected by means of custom tariff and not through commercial means The aim of consultations should be avoidance of damage to members interest GATT served as a frame work within which negotiations could be held to reduce tariff and other trade barriers

WORLD TRADE ORGANISATION (WTO):

WORLD TRADE ORGANISATION (WTO) WTO came into effect on Jan 1, 1995 Currently 146 countries are members It is full fledged international organization It contains much improved version of the original GATT rules plus a lot more It administers a unified package of agreements to which all members are committed. TRIPs agreements

INTELLECTUAL PROPERTY RIGHTS:

INTELLECTUAL PROPERTY RIGHTS Patents Copyright Trademark Design Trade Secrets Geographical indication Integrated Circuits

WHAT IS NOT PATENTABLE:

WHAT IS NOT PATENTABLE Discoveries are not patentable Ideas are not patentable Laws of nature Physical Phenomena Abstract ideas

WHAT CAN BE PATENTED:

WHAT CAN BE PATENTED New and useful Process Machine Manufacture Composition of matter Or any new and useful improvement thereof

Developing concept of what can be patented:

Developing concept of what can be patented Diamond Vs . Chakrabarty, 206 USPQ 193 (1980), held that microorganisms produced by genetic engineering are not excluded from patent protection. Test was not whether they were ‘living’, but whether they were produced by human intervention.

PATENT RIGHTS:

PATENT RIGHTS Right to exclude others A patent is not a grant of a right to make use or sell. Quid pro quo of Patent protection- grant of patent in return for full disclosure

Why are patents valuable to an organization? :

Why are patents valuable to an organization? Experience has shown that rivals are less likely to go to court when they know that their opponent can also wield a patent IPR protection is key for companies to recoup costs and generate returns (active ingredient, formulation, process) Asserting your patent back in an infringement action A good patent portfolio can affect the market valuation of a company and used as a bargaining chip

COCEPTS OF PATENTABILITY:

COCEPTS OF PATENTABILITY Utility Anticipation Obviousness Enablement Best mode

UTILITY:

UTILITY Level of utility to be disclosed by pharmaceuticals patents In vitro activity Animal tests Does not have to prove safety or efficacy of the drug in human beings Reasonable correlation between the activity in question and the asserted utility Function of the FDA and patent office are distinct

NOVELTY AND ANTICIPATION:

NOVELTY AND ANTICIPATION The invention was known or used or patented or described in a printed publication before the invention thereof by the applicant for patent Anticipation-only by a single prior art reference

OBVIOUSNESS :

OBVIOUSNESS If the difference between the subject matter sought to patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains Definition of one of ‘Ordinary skill in the art’ Combining two or more prior art references Motivation to combine Some teaching, suggestions, or motivation to modify or combine found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art

ENABLEMENT :

ENABLEMENT 35 U.S.C. 112 The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set for the the best mode contemplated by the inventor of carrying out his invention

INFRINGEMENT:

INFRINGEMENT Making, using, selling or offering for sale Importing Experimental use defense Bolar exemption is not an experimental use defense

STATUS OF PATENT ACT:

STATUS OF PATENT ACT In India Recognition of Product 20 years from date of filing In US Patent filed before June 8 th 1995 – 20 years from the date of filing or 17 years from the date of granting whichever is more After 1995 – 20 years form the date of filing

FDA:

FDA Regulatory approval-time and cost Focus of FDA approval process-safety and efficacy Difference between the conditions for patentability and approval Only one out of every 2,500 patents make it to the market

HATCH WAXMAN ACT :

HATCH WAXMAN ACT Commonly known as “The Drug price competition and patent term restoration Act of 1984”. The Act deals with approval of generic drugs and conditions for getting approvals from FDA, market exclusivity, Patent term extension and orange book listing

Patent challenges and generic exclusivity:

Patent challenges and generic exclusivity Overview of the legal process ANDA Requirements: i . Information to show that the listed drug is approved; ii. That the listed drug has the same active ingredient as the new drug; iii. That the route of administration, the dosage forms, the strength of new drug etc. Are the same as the listed drug; iv.That the new drug is bio-equivalent to the listed drug.

PARA CERTIFICATIONS:

PARA CERTIFICATIONS Section 505(j)(2)(A)(vii) (I) That such patent information has not been filed; (II) That such patent has expired; (III) That the proposed drug will not be marketed until expiration of the patent. (IV) That either the proposed generic drug does not infringe the patent or the patent is invalid (known as Paragraphs IV certification)

CONCLUSION:

CONCLUSION Protection of Intellectual property is at most important for knowledge based industry Exploitation of patent landscape would be a driving factor for expanding business.

CARRIER OPPORTUNITIES IN IP:

CARRIER OPPORTUNITIES IN IP Intellectual Property Management – Generic business IPM - Drug discovery Business Development Strategic Development IP Law firms KPO (Knowledge Processing Organization)

THANKS ….. mahendrat@drreddys.com:

THANKS ….. mahendrat@drreddys.com