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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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
EVERGREENING OF PATENTS
P.ILANANGAI
IP CONSULTANT
PATENT DEPARTMENT
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Patent is an exclusive right given to the right holder to reap benefits out of his invention.
• Internationally, it is the TRIPS Agreement that regulates the law relating to Copyrights, Patents, Trademarks and other forms of IPR.
• The grant of a patent is based on the premise of full 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 through the practice of ‘Evergreening‘.
• contd…
INTRODUCTION
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• As research and development of novel drugs within pharmaceutical multinationals has slowed down, they have focused their energies on patenting minor tweaks to existing drugs in order to extend monopolies, whenever possible.
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• “Patent evergreening” generally refers to the strategy of obtaining multiple patents that cover different aspects of the same product, typically by obtaining patents on improved versions of existing products.
• Although the patent system allows improvement patents to be obtained in any industry, evergreening is said to be most common in the pharmaceutical industry.
PATENT EVERGREENING
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Evergreening has been in practice since the passage of the Waxman-Hatch legislation (Drug price competition and Patent term restoration act) in 1984, in which the pioneer drug can receive an extension term equal to one-half the time of the investigational new drug (IND) period, running from the start of the human clinical trial to the time till the new drug application (NDA) is submitted.
HOW EVERGREENING CAME INTO EXISTENCE?
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Extending the patent period seizes the generic drug manufacturing. Once the generic drugs are being produced, the price of the drug can drop by as much as 90%.
• When the original patent is due to expire, the drug companies often claim large numbers of complex and often highly speculative patents by evergreening. When the generic drug manufacturers intend to market copies at the expiry of the original patent, the original patent holders can then threaten 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.
HOW DOES IT AFFECT?
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
HOW TO AVERT EVERGREENING?
• Not granting patents on the basis of trivial and insignificant changes in the original pharmaceutical patented product;
• Ensuring that generic manufactures can manufacture the patented pharmaceutical product soon after the term of patent expires, by making use of Bolar 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 authority.
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Patent law in India came into being in 1852 and aimed at giving preference to foreign pharmaceutical companies.
• Indian Patent Act 1970 was enacted and was aimed at providing medicines at affordable prices to the masses.
• Provision was made only for the process patent.
• India stopped granting drug patents in the 1970s, and only resumed granting drug patents in 2005 as part of a World Trade Organisation agreement.
• The government introduced amendments in Indian Patent Act (Amendment) Bill 2005.
• Provision was made to discourage continuation of Patent Right beyond the period of patent by preventing the grant of frivolous patents and ever-greening.
• contd..
INDIAN PATENTS ACT AND EVERGREENING
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• ‘Evergreening’ results in infinite monopoly or a lifetime of artificially high-priced medicines, as only one manufacturer is allowed to supply the drug in the market during the existence of patent right. As a result of this trend, the need to have affordable medicines intensified in 2005, when India amended its patent laws to comply with the TRIPs agreement.
• 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 preventing "evergreening".
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• To prevent the grant of patents to trivial and insignificant pharmaceutical inventions, the following provisions have been introduced under the Indian Patents (Amendment) Act, 2005:
• Section 2 (1) (l) deals with “new invention”, which means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of the application with complete specification.
• 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.
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Section 3(d) of the Indian Patent Act, 1970, states that the mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, unless such known process results in a new product or employs at least one new reactant, is not an invention within the meaning of the Patents Act.
• Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolized, pure form, particle size, isomers, mixtures 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 medicines; this effectively prevents trivial patenting or mere workshop improvement of already patented drugs in India. Section 3 (d) also prevents new use of known substances.
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
ILLUSTRATIONS
• Sildenafil Citrate was originally discovered as a cardio vascular agent and patented by Pfizer. Later, its second medical use in treating impotence was also found. Even though second medical use patents are allowed in UK, it was refused by EPO owing to obviousness determined by articles published in journals. In India, second medical use is prevented by Section 3 (d).
• Griseofulvin is an effective agent for fungal infections of skin to be applied locally. Later, it was found that if the dimensions of the 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 substances. These include Pfizer's Caduet (cholesterol and hypertension), GlaxoSmithKline's rosiglitazone salt (diabetes), Gilead Science's Tamiflu (bird flu) and Hepsera (Hepatitis B).
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• The Indian position on evergreening is best exemplified by the Novartis-Glivec case which has been the centre of debates in patent circles.
• Pharmaceutical giant Swiss drug maker Novartis first file a suit against Indian companies producing generic version of cancer drug imatinib, which was marketed as Glivec (or Gleevec in the US) after second 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 granted one of first exclusive marketing rights. For Glivec in November 2003, the price increased from $230 to $2,740.
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Novartis was refused a patent for Glivec on the basis that the beta crystalline from did not provide a significant enough “enhancement of efficacy” of the original imatinib molecule.
• Novartis responded with a writ to the High Court appealing against the ruling. It argued that Section 3(d) of the Indian Patent Act was “unconstitutional as it is vague, arbitrary and violative of Article 14 of the constitution (right to equality)”, and alleged that it contravened India’s obligations under the TRIPS Agreement.
• India differentiated genuine innovation from evergreening by using 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 more than a mere incremental improvement and thus cannot be interpreted as “ever greening”.
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Novartis maintains that Glivec boosts bioavailability (i.e. the degree to which the drug is absorbed by the patient) by 30 percent over the original form of imatinib, which should constitute an enhancement of efficacy. The Chennai Patent Ofice disagreed in rejecting the application.
• The Court held that, In the light of above observation, it was held that section 3 (d) of the Patent (amendment) Act 2005 does not violate Article 14 of the Indian Constitution.
• 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.
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• The Indian Supreme Court has refused to allow one of the world's leading pharmaceutical companies to patent a new version of a cancer drug.
• Novartis lost a six-year legal battle after the court ruled that small changes and improvements to the drug Glivec did not amount to innovation deserving of a patent. The ruling opens the way for generic companies 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.
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
CONCLUSION
• Section 3(d) forces firms to focus efforts on innovation and hard core research instead of incremental improvement and have patents for every minor innovation. Section 3(d) can also be seen as a great boon with generic pharmaceutical firms, AIDS campaign and Non-Governmental Organization (NGO) backing India.
• India can continue to produce cheap versions of life-saving drugs.
• On the other hand, pharmaceutical companies will now think twice before investing money for research in India, thereby reducing the chances of the country getting more advanced drugs.
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
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
THANK YOU
