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PATENT ACT IN PHARMACY

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ALL PATENT FORM AND REGULATION

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PATENT ACT IN PHARMACY

  1. 1. Patents    Mr:Roshan G Bodhe. M Pharm Pharmaceutics. R. C. Patel Institute of Pharmaceutical Education and Research Shirpur.
  2. 2. Defining a Patent A patent application, for a utility patent in the United States (as opposed to a design patent), must explain how to work (i.e., make and/or use) the invention (s) ( Here invention is a drug) and must also include claims that particularly point out the invention (s) and define the scope of the subject matter for which exclusive rights are sought by the patent applicant. The exclusive rights are limited to the subject matter encompassed by the patent's claims.
  3. 3. Patents & the Pharmaceutical Industry     Patent protection is granted for 20 Years to a pharmaceutical drug product. Reason for patent protection: Cost of research, development & clinical trials is high & FDA takes time to approve the drug. Patent Protection can be extended beyond the stipulated period----Hatch-Waxman Act. Various tactics are employed pharmaceutical companies in extending their patents through legislative loopholes , lobbying, initiating litigation to prevent patent infringement, etc Source: www.okjolt.com
  4. 4. Introduction to US Drug Approval Process
  5. 5.         The Food and Drug Administration (FDA), established in 1930, a part of the US Department of Health and Human Services (HHS), It has more than 9,000 employees Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Device and Radiological Health Center for Food Safety and Applied Nutrition Center for Veterinary Medicine National Center for Toxicological Research Office of Regulatory Affairs The Patent Approval Agency: FDA
  6. 6. The Orange Book      •Therapeutic equivalence codes “A” = Substitutable “B” =In equivalent, NOT Substitutable Expiration dates: patent and exclusivity Reference Listed Drugs: brand drugs identified by the FDA for generic companies to compare with their proposed products Electronic Orange Book –http://www.fda.gov/cder/ob/
  7. 7. Terms & Conditions of a Patent    Patents grant a legal monopoly on an invention for twenty years, which begins on the date the patent application is filed with The United States Patent and Trademark Office. A three-year extension changed the law prior to 1995; the law prior to 1995 initially granted a period of exclusivity for only seventeen years from the time a patent had been granted. This change in the law was promulgated through The Uruguay Round Agreement Act as a piece on The General Agreement on Tariffs and Trade. Essentially, it synchronized U.S. patent terms with other nations. The different durations for patent protection are still
  8. 8. FDA Approval  Any new drug must go through an extensive governmental approval process before it can be marketed to the public. The Food and Drug Administration (“FDA”) may take many years to approve a new pharmaceutical.
  9. 9. Patent Life   Accordingly, drug companies are granted the right to apply for a patent extension for up to five years so that they can have a maximum effective patent life of fourteen years. However, since clinical trials and FDA approval takes about eight and a half years to complete, the viable patent term may be even shorter than the fourteen years specified.
  10. 10. New Drug Development—FDA Time
  11. 11. Hatch-Waxman Act   The Hatch-Waxman Act of 1984 limits developers of new drugs. The current law in the area of patents is The Hatch- Waxman Act, which proposes to balance the competing interests of brand name companies, generic companies, insurance companies, and the public by promoting competition and decreasing drug costs.
  12. 12. The Act   The Act has two provisions of great interest in the dispute between brand name companies and other interested parties. The first is the automatic 30-month stay granted to the patent holder when the patent holder brings an infringement suit against a new generic manufacturer. This stay prevents the approval of a generic version of the name brand drug regardless of whether the original patent has expired. The second provision of interest allows a 180-day period of exclusivity granted to the first generic company to enter the market after the patent expires. In both instances, brand name manufacturers are able to manipulate the Act in order to extend the life of their patent.
  13. 13. Patent Extension Tactics   There are at least four ways brand name drug companies effectively extend the life of their patents. These include the following: (1) extending patents through legislative loopholes and lobbying; (2) initiating litigation alleging patent infringement; (3) layering of patents and the combination of drugs to create new patents; and (4) advertising and developing brand names to increase barriers for generic entry.
  14. 14. Patent Extension Tactics  Brand name drug companies continue to abuse the two major provisions of The Hatch-Waxman Act. By initiating litigation, whether legitimate or not, pharmaceutical companies are able to keep generics out of the market for at least thirty months after the original patent expires.
  15. 15. Patent Extension Tactics  Drug companies facing the expiration of a patent will develop a new use or different version of their old drug. This practice is referred to as layering. Eli Lilly’s Prozac demonstrates one example of a drug company obtaining a new patent on an additional aspect of an old drug.
  16. 16. Current Patent Filings & Trends   The number of patents filed in the US in 2004 stood at 165,485. In comparison, the Indian tally stood at only 1,216 patents in 2004. During 1997-2001, India produced only 77, 200 patents as compared to the US, which produced 1.2 million patents. Source: India Economic Summit November 28
  17. 17. Patenting Over Time in the Antidepressant Patent Industry
  18. 18. Patent Scenario In India
  19. 19. Patents and India        1856 - Protection for inventions formally started Based on the British Patent Law of 1852 1911 - The Indian Patents & Designs Act Product patents / composition of matter patents available 1972 - The Patents Act came into force on April 20, 1972 Only process patents in pharmaceuticals, agrochemicals and food Term – 5 years from date of grant or 7 years from date of application, whichever was earlier
  20. 20. Patents & India      1994 – Indian signs GATT agreement 1997 – India becomes a PCT member-state Amendments to the 1970 Act 1999 - (effective Jan 1, 1995) – introduced EMRs, mail-box applications and 20-year term 2002 (effective Jan , 2005)
  21. 21. Indian Patent Office         http://patentoffice.nic.in/ Locations Four metro cities East – Kolkata (Calcutta) – Headquarters Current CG is based in Mumbai West – Mumbai North – Delhi South – Chennai         Number of examiners Two years ago – less than 100 Now – more than 300 Examiner qualifications Masters degree holders, doctorates being hired Training examiners Intellectual Property Training Institute, Nagpur Hands on training at USPTO, EPO, JPO, etc.
  22. 22. Indian Patent Office  Online search facilities have been established and the patent offices have been provided with ISDN facility to ensure uninterrupted connectivity. Similar facilities has also been provided to Trade Marks offices and Designs offices. Improved novelty search in patents is being ensured through connectivity to international databases. Further, CD-ROMs were also acquired for this purpose and library facilities strengthened.
  23. 23. Patent Office Publications    Official Journal of the Indian Patent Office http://patentoffice.nic.in/ipr/patent/ journal_archieve/patent_journal_2005.htm Commenced weekly publication effective Jan 21, 2005 Mail-box applications filed between Jan 1, 1995 and Dec 31, 2004 have also been published (to enable request for examination)
  24. 24. Examination Process       Approximate time taken for a grant Was 5-6 years, now 2-3 years Examination reports,normally start arriving 6-12 months after filing the complete specification Quality of examination reports Under process patent regime, just one independent claim was allowed in a patent Examiners generally insisted on including all limitations in that independent claim.
  25. 25. Interviews    Personal interviews Arguing on highly complex technical issues was virtually impossible “Educating the examiner”
  26. 26. Implications on the Industry • • India faces a deadline of January 1, 2005 to comply with WTO requirements, set out in TRIPS (the Agreement on Trade-Related Aspects of Intellectual Property Rights) that it protect product patents on medicines (TRIPS Art. 65.4). India has not protected product patents on medicines for the last 35 years. Competitive domestic manufacturers have kept medicine prices low in India, for domestic and export markets. According to the WHO, India ranks 4th in the world in production of pharmaceuticals by volume and is the world’s leading supplier of generic medicines, with 66.7% of its exports going to developing countries.
  27. 27.    Two categories of drugs will be affected First, those discovered after January 1, 2005. If a medicine is patentable, the patent holder will be granted a 20-year monopoly from the date of filing as a result of the new rules. The second category of medicines that will be affected by the change in India’s Patents Act are those that have been patent protected outside of India since January 1, 1995. According to WTO rules (TRIPS Art. 70.8), India was required to establish a “mailbox” where patent applications could be filed between 1995 and 2005. Implications on the Pharmaceutical Industry
  28. 28. Ranbaxy Patent Filings
  29. 29. Indian Patent Law: Critical Provisions Sec 3 : What are Not Inventions Sec 11A : Publication of Applications Sec 25 : Opposition to Grant of Patent Sec 39 : Prohibition to Apply for Patents Outside India Sec 92A : Compulsory License for Export Sec 159 : Power of Central Government to Make Rules
  30. 30. Source: WHO-CIPIH: Commission on Intellectual Property Rights, Innovation and Public Health Number of Patent Filings by MNCs-1995-2004

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