Evergreening of patents

2,066 views
1,858 views

Published on

0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
2,066
On SlideShare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
81
Comments
0
Likes
2
Embeds 0
No embeds

No notes for slide
  • © Altacit Global 2009 Email: info@altacit.com
  • Evergreening of patents

    1. 1. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE EVERGREENING OF PATENTS Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 P.ILANANGAI IP CONSULTANT EMAIL info@altacit.com PATENT DEPARTMENT WEBSITE www.altacit.com
    2. 2. INTRODUCTION CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, • Patent is an exclusive right given to the right holder Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 to reap benefits out of his invention. BANGALORE Suite 920, Level 9, • Internationally, it is the TRIPS Agreement that Raheja Towers, 26-27, M G Road, regulates the law relating to Copyrights, Patents, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 Trademarks and other forms of IPR. COIMBATORE BB1, Park Avenue, # 48, Race Course Road, • The grant of a patent is based on the premise of full Coimbatore - 641018. Tel: +91 - 422 – 6552921 disclosure by the patentee the best method of performing the invention so that the others are able to use the invention after the expiry of patent rights. However, sometimes, this patent protection is sought to be extended indefinitely by the patentee EMAIL info@altacit.com through the practice of ‘Evergreening‘. WEBSITE www.altacit.com • contd…
    3. 3. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, • As research and development of novel drugs within pharmaceutical multinationals has Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, slowed down, they have focused their energies on patenting minor tweaks to existing drugs in Raheja Towers, 26-27, M G Road, Bangalore - 560 001. order to extend monopolies, whenever Tel: +91 - 80 - 6546 2400 COIMBATORE possible. BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com
    4. 4. PATENT EVERGREENING CHENNAI3rd Floor, ‘Creative Enclave’, • “Patent evergreening” generally refers to the148-150, Luz Church Road, Mylapore, Chennai - 600 004. strategy of obtaining multiple patents that cover Tel: +91 - 44 - 2498 4821 different aspects of the same product, typically by BANGALORE Suite 920, Level 9, obtaining patents on improved versions of existing Raheja Towers, 26-27, M G Road, Bangalore - 560 001. products. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, • Although the patent system allows improvement patents to be obtained in any industry, evergreening Coimbatore - 641018. Tel: +91 - 422 – 6552921 is said to be most common in the pharmaceutical industry. EMAIL info@altacit.com WEBSITE www.altacit.com
    5. 5. HOW EVERGREENING CAME INTO EXISTENCE? CHENNAI • Evergreening has been in practice since the passage3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. of the Waxman-Hatch legislation (Drug price Tel: +91 - 44 - 2498 4821 competition and Patent term restoration act) in 1984, BANGALORE Suite 920, Level 9, Raheja Towers, in which the pioneer drug can receive an extension 26-27, M G Road, Bangalore - 560 001. term equal to one-half the time of the investigational new drug (IND) period, running from the start of the Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, human clinical trial to the time till the new drug Coimbatore - 641018. Tel: +91 - 422 – 6552921 application (NDA) is submitted. EMAIL info@altacit.com WEBSITE www.altacit.com
    6. 6. HOW DOES IT AFFECT? CHENNAI3rd Floor, ‘Creative Enclave’, • Extending the patent period seizes the generic drug148-150, Luz Church Road, Mylapore, Chennai - 600 004. manufacturing. Once the generic drugs are being produced, the Tel: +91 - 44 - 2498 4821 price of the drug can drop by as much as 90%. BANGALORE Suite 920, Level 9, • When the original patent is due to expire, the drug companies Raheja Towers, 26-27, M G Road, Bangalore - 560 001. often claim large numbers of complex and often highly Tel: +91 - 80 - 6546 2400 speculative patents by evergreening. When the generic drug COIMBATORE BB1, Park Avenue, manufacturers intend to market copies at the expiry of the # 48, Race Course Road, Coimbatore - 641018. original patent, the original patent holders can then threaten Tel: +91 - 422 – 6552921 these potential generic competitors with breaching their now "evergreened" patents and seek a court order preventing their marketing approval. • The ultimate consequence could be elderly and poor patients paying several times the present price for drugs. EMAIL info@altacit.com WEBSITE www.altacit.com
    7. 7. HOW TO AVERT EVERGREENING? CHENNAI3rd Floor, ‘Creative Enclave’, • Not granting patents on the basis of trivial and148-150, Luz Church Road, Mylapore, Chennai - 600 004. insignificant changes in the original pharmaceutical patented product; Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, • Ensuring that generic manufactures can manufacture Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 the patented pharmaceutical product soon after the COIMBATORE BB1, Park Avenue, term of patent expires, by making use of Bolar # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 provision. • “Bolar” provision under Section 107 A (a) of the Indian Patents Act that permitted a drug manufacturer to experiment with any patented drug for generating data that could then be submitted to a drug control EMAIL info@altacit.com authority. WEBSITE www.altacit.com
    8. 8. INDIAN PATENTS ACT AND EVERGREENING CHENNAI3rd Floor, ‘Creative Enclave’, • Patent law in India came into being in 1852 and aimed at148-150, Luz Church Road, Mylapore, Chennai - 600 004. giving preference to foreign pharmaceutical companies. Tel: +91 - 44 - 2498 4821 • Indian Patent Act 1970 was enacted and was aimed at BANGALORE Suite 920, Level 9, Raheja Towers, providing medicines at affordable prices to the masses. 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 • Provision was made only for the process patent. COIMBATORE • India stopped granting drug patents in the 1970s, and only BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. resumed granting drug patents in 2005 as part of a World Tel: +91 - 422 – 6552921 Trade Organisation agreement. • The government introduced amendments in Indian Patent Act (Amendment) Bill 2005. • Provision was made to discourage continuation of Patent EMAIL Right beyond the period of patent by preventing the grant info@altacit.com of frivolous patents and ever-greening. WEBSITE www.altacit.com • contd..
    9. 9. CHENNAI3rd Floor, ‘Creative Enclave’, • ‘Evergreening’ results in infinite monopoly or a148-150, Luz Church Road, Mylapore, Chennai - 600 004. lifetime of artificially high-priced medicines, as only Tel: +91 - 44 - 2498 4821 one manufacturer is allowed to supply the drug in the BANGALORE Suite 920, Level 9, Raheja Towers, market during the existence of patent right. As a result 26-27, M G Road, Bangalore - 560 001. of this trend, the need to have affordable medicines Tel: +91 - 80 - 6546 2400 COIMBATORE intensified in 2005, when India amended its patent BB1, Park Avenue, # 48, Race Course Road, laws to comply with the TRIPs agreement. Coimbatore - 641018. Tel: +91 - 422 – 6552921 • Indian patent law has provision which prohibits a new form of a known substance from receiving a patent unless it significantly improves the medicine’s "efficacy". The provision was ostensibly aimed at EMAIL preventing "evergreening". info@altacit.com WEBSITE www.altacit.com
    10. 10. CHENNAI3rd Floor, ‘Creative Enclave’, • To prevent the grant of patents to trivial and insignificant148-150, Luz Church Road, Mylapore, pharmaceutical inventions, the following provisions have been Chennai - 600 004. Tel: +91 - 44 - 2498 4821 introduced under the Indian Patents (Amendment) Act, 2005: BANGALORE Suite 920, Level 9, • Section 2 (1) (l) deals with “new invention”, which means any Raheja Towers, 26-27, M G Road, invention or technology which has not been anticipated by Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 publication in any document or used in the country or elsewhere COIMBATORE in the world before the date of filing of the application with BB1, Park Avenue, # 48, Race Course Road, complete specification. Coimbatore - 641018. Tel: +91 - 422 – 6552921 • Section 2 (1) (ja) defines “inventive step” which means those features of invention that involve technical advancement as compared to existing knowledge, or that have economic significance or both and which make the invention not obvious to a person skilled in the art. EMAIL info@altacit.com WEBSITE www.altacit.com
    11. 11. CHENNAI3rd Floor, ‘Creative Enclave’, • Section 3(d) of the Indian Patent Act, 1970, states that the mere148-150, Luz Church Road, discovery of a new form of a known substance, which does not Mylapore, Chennai - 600 004. result in the enhancement of the known efficacy of that substance or Tel: +91 - 44 - 2498 4821 the mere discovery of any new property or new use for a known BANGALORE Suite 920, Level 9, substance or of the mere use of a known process, unless such known Raheja Towers, 26-27, M G Road, Bangalore - 560 001. process results in a new product or employs at least one new Tel: +91 - 80 - 6546 2400 reactant, is not an invention within the meaning of the Patents Act. COIMBATORE BB1, Park Avenue, • Explanation: For the purposes of this clause, salts, esters, ethers, # 48, Race Course Road, Coimbatore - 641018. polymorphs, metabolized, pure form, particle size, isomers, mixtures Tel: +91 - 422 – 6552921 of isomers, complexes, combination and other derivatives of know substances shall be consider to be the same substances, unless they defer significantly in properties with regard to efficacy. • Section 3(d) is aimed at preventing pharmaceutical companies from obtaining patents on minor variations of existing patented EMAIL medicines; this effectively prevents trivial patenting or mere info@altacit.com workshop improvement of already patented drugs in India. Section 3 WEBSITE (d) also prevents new use of known substances. www.altacit.com
    12. 12. ILLUSTRATIONS CHENNAI3rd Floor, ‘Creative Enclave’, • Sildenafil Citrate was originally discovered as a cardio vascular148-150, Luz Church Road, Mylapore, agent and patented by Pfizer. Later, its second medical use in Chennai - 600 004. Tel: +91 - 44 - 2498 4821 treating impotence was also found. Even though second medical use BANGALORE patents are allowed in UK, it was refused by EPO owing to Suite 920, Level 9, Raheja Towers, obviousness determined by articles published in journals. In India, 26-27, M G Road, Bangalore - 560 001. second medical use is prevented by Section 3 (d). Tel: +91 - 80 - 6546 2400 • Griseofulvin is an effective agent for fungal infections of skin to be COIMBATORE BB1, Park Avenue, # 48, Race Course Road, applied locally. Later, it was found that if the dimensions of the Coimbatore - 641018. Tel: +91 - 422 – 6552921 particles of the drug were reduced, it could be used orally. This change in physical form of Griseofulvin is patentable as it shows increased ‘functional’ efficacy. • The Patent Office recently struck down the attempts of evergreening by multinationals and rejected a series of applications on the grounds that they were mere modifications or extensions of known EMAIL substances. These include Pfizers Caduet (cholesterol and info@altacit.com hypertension), GlaxoSmithKlines rosiglitazone salt (diabetes), WEBSITE www.altacit.com Gilead Sciences Tamiflu (bird flu) and Hepsera (Hepatitis B).
    13. 13. CHENNAI3rd Floor, ‘Creative Enclave’, • The Indian position on evergreening is best148-150, Luz Church Road, Mylapore, Chennai - 600 004. exemplified by the Novartis-Glivec case which has Tel: +91 - 44 - 2498 4821 been the centre of debates in patent circles. BANGALORE Suite 920, Level 9, Raheja Towers, • Pharmaceutical giant Swiss drug maker Novartis first 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 file a suit against Indian companies producing generic COIMBATORE version of cancer drug imatinib, which was marketed BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. as Glivec (or Gleevec in the US) after second Tel: +91 - 422 – 6552921 amendment of Indian patent Act 1970, claiming generic producers of the drug violates it’s (Novartis’s) patent rights. • The company was granted interim relief and was EMAIL granted one of first exclusive marketing rights. For info@altacit.com WEBSITE Glivec in November 2003, the price increased from www.altacit.com $230 to $2,740.
    14. 14. CHENNAI3rd Floor, ‘Creative Enclave’, • Novartis was refused a patent for Glivec on the basis that the beta148-150, Luz Church Road, crystalline from did not provide a significant enough “enhancement Mylapore, Chennai - 600 004. of efficacy” of the original imatinib molecule. Tel: +91 - 44 - 2498 4821 • Novartis responded with a writ to the High Court appealing against BANGALORE Suite 920, Level 9, the ruling. It argued that Section 3(d) of the Indian Patent Act was Raheja Towers, 26-27, M G Road, “unconstitutional as it is vague, arbitrary and violative of Article 14 Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 of the constitution (right to equality)”, and alleged that it contravened COIMBATORE India’s obligations under the TRIPS Agreement. BB1, Park Avenue, # 48, Race Course Road, • India differentiated genuine innovation from evergreening by using Coimbatore - 641018. Tel: +91 - 422 – 6552921 the “enhancement of efficacy” concept. The High Court suggested only that efficacy can be defined as the ability of a drug to produce a desired therapeutic effect. • The whole process of developing the Mesylate salt of Imatinib and the beta crystal form of Imatinib Mesylate and to make it viable in the form of a pill, took many years of efforts involved. This was EMAIL more than a mere incremental improvement and thus cannot be info@altacit.com interpreted as “ever greening”. WEBSITE www.altacit.com
    15. 15. CHENNAI3rd Floor, ‘Creative Enclave’, • Novartis maintains that Glivec boosts bioavailability (i.e.148-150, Luz Church Road, Mylapore, the degree to which the drug is absorbed by the patient) by Chennai - 600 004. Tel: +91 - 44 - 2498 4821 30 percent over the original form of imatinib, which BANGALORE should constitute an enhancement of efficacy. The Chennai Suite 920, Level 9, Raheja Towers, Patent Ofice disagreed in rejecting the application. 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 • The Court held that, In the light of above observation, it COIMBATORE was held that section 3 (d) of the Patent (amendment) Act BB1, Park Avenue, # 48, Race Course Road, 2005 does not violate Article 14 of the Indian Constitution. Coimbatore - 641018. Tel: +91 - 422 – 6552921 • With its arguments having been rejected, Novartis brought its final challenge before India’s highest court, with the hearing before Honourable Justices Aftab Alam and Ranajan Prakash Desai. EMAIL info@altacit.com WEBSITE www.altacit.com
    16. 16. CHENNAI3rd Floor, ‘Creative Enclave’, • The Indian Supreme Court has refused to allow one of148-150, Luz Church Road, Mylapore, Chennai - 600 004. the worlds leading pharmaceutical companies to patent Tel: +91 - 44 - 2498 4821 a new version of a cancer drug. BANGALORE Suite 920, Level 9, Raheja Towers, • Novartis lost a six-year legal battle after the court ruled 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 that small changes and improvements to the drug COIMBATORE Glivec did not amount to innovation deserving of a BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. patent. The ruling opens the way for generic companies Tel: +91 - 422 – 6552921 in India to manufacture and sell cheap copies of the drug in the developing world and has implications for HIV and other modern drugs too. EMAIL info@altacit.com WEBSITE www.altacit.com
    17. 17. CONCLUSION CHENNAI3rd Floor, ‘Creative Enclave’, • Section 3(d) forces firms to focus efforts on innovation and hard148-150, Luz Church Road, Mylapore, core research instead of incremental improvement and have Chennai - 600 004. Tel: +91 - 44 - 2498 4821 patents for every minor innovation. Section 3(d) can also be seen BANGALORE as a great boon with generic pharmaceutical firms, AIDS Suite 920, Level 9, Raheja Towers, campaign and Non-Governmental Organization (NGO) backing 26-27, M G Road, Bangalore - 560 001. India. Tel: +91 - 80 - 6546 2400 COIMBATORE • India can continue to produce cheap versions of life-saving drugs. BB1, Park Avenue, # 48, Race Course Road, • On the other hand, pharmaceutical companies will now think Coimbatore - 641018. Tel: +91 - 422 – 6552921 twice before investing money for research in India, thereby reducing the chances of the country getting more advanced drugs. EMAIL info@altacit.com WEBSITE www.altacit.com
    18. 18. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, THANK YOU # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com

    ×