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Information about Patentability

Published on October 16, 2007

Author: Jancis


Slide1:  REPORT OF THE TECHNICAL EXPERT GROUP ON PATENT LAW ISSUES Mashelkar Panel Report Conclusions and Recommendations. NICHOLAS PIRAMAL POSITION Version 4 For more info- Dr Swati Piramal Slide2:  This presentation is designed open the debate on various issues related to patentability under Indian Law It is grounded in the strong belief in Indian scientists and Indian research. Successive versions ( this is version 4) help to refine our own thinking so your feedback is valuable. I would like to thank the scientists of the Nicholas Piramal Research Center , The Patent and Legal Cell of Nicholas Piramal inputs after which this presentation is made. India is new at the patent game. India needs to move rapidly on the long road to becoming an innovative economy- some issues are discussed. Slide3:  Agenda The Mashelkar Panel Report on Patentability-Findings Background and scope of Panel The Nicholas Piramal position on the Patent Law The benefits of Incremental Innovations Comaprison of The Trips Agreement and the Indian Patent Law Suggestions for Modifications of the Patent Law to spur Indian Research Microorganisms and the Indian Patent Law Summary- the journey for a world class patent Law. Slide4:  Executive Summary Article 27.1 of the TRIPS Agreement imposes an obligation on all members to grant patents to inventions of any kind (whether products or processes) and in all fields of technology provided they are novel, involve an inventive step and are industrially useful Section 3(d) of the Indian Patents (Amendment) Act 2005 appears to put some barriers to these provision. 3(d) goes beyond the provision for establishing “inventive step” by insisting on demonstration of superior efficacy in order to discourage frivolous claims aimed at “evergreening” These may also limit Indian inventions from being patented The term “efficacy” needs to be defined and guidelines set out for examining “inventive step”. The terms “ethers”, “combinations” and “other derivatives” should be deleted from the explanation to 3(d). A discussion for the introduction of patents for “new use of a known substance” needs to be initiated Slide5:  1.1           The Patents (Amendment) Bill, 2005, introduced in the Parliament in March, 2005 with the objective of making the Patents Act compatible with India’s international obligations, particularly under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) had the benefit of detailed discussion in both the Houses. During the debate, the issues regarding patentability of micro-organisms and the definition of 'pharmaceutical substance' to mean “a new chemical entity (NCE)” or “new medical entity (NME)” were raised. A Technical Expert Group on Patent Law Issues was set up by the Government of India, Ministry of Commerce & Industry, Department of Industrial Policy & Promotion vide O. M. No. 12/14/2005-IPR-III dated April 5, 2005 in order to examine these issues and report to the Parliament. The Report of the Technical Expert Group was submitted in December 2006. BACKGROUND Slide6:  Terms of Reference of the Group:   2.1 1.whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps; and   2.2 2.whether it would be TRIPS compatible to exclude micro-organisms from patenting.   Slide7:  3.0          Approach   The Expert Group adopted a consultative approach to seek inputs from different stakeholders and examined the critical legal and technical issues involved before making its recommendations. The Group was guided by the need for access of affordable medicines to Indian people at large, encouraging innovation by Indian industry, its current capabilities in R&D, and balancing of India’s obligations under international agreements with the wider public interest. Slide8:  4.0 New Chemical Entities   4.1 In the light of the above discussion, it would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only. Slide9:  The group’s conclusion is based on the requirements of Article 27.3 of the TRIPS as articulated in 5.23 above and the provision of Indian Patent Act (Section 3 (j)). However, strict guidelines need to be formulated for examination of the patent applications involving micro-organisms from the point of view of substantial human intervention and utility. Excluding micro-organisms per se from patent protection would be violative of TRIPS Agreement. Slide10:  Microorganisms   The Patents Act, 1970 (ref: Section 3(j)) permits patenting of microorganisms and is in accordance with the obligations imposed by TRIPS. Modifications are therefore not required to the Patents Act as far as microorganisms are concerned. Slide11:  POSITION OF NICHOLAS PIRAMAL INDIA LIMITED on The Report of the Technical Expert Group on Patent Law Issues   We agree with the Expert Group’s recommendations and conclusions as stated in Sections 4.1, 5.1 and 5.2 of the Report in light of Articles 27.1 and 27.3(b) of the TRIPS Agreement However, several steps need to be taken to ensure correct and unambiguous interpretation of the law and strict examination of patent applications to prevent grant of frivolous patents. At the same time, a balance would have to be achieved between the need to encourage innovation by Indian industry and facilitating access to affordable medicines to the Indian people   NICHOLAS PIRAMAL INDIA LIMITED COMMENTS OBSERVATIONS RECOMMENDATIONS:  NICHOLAS PIRAMAL INDIA LIMITED COMMENTS OBSERVATIONS RECOMMENDATIONS Slide13:  Incremental Innovation – definition and benefits An incremental step, which creates a new medical entity, should be treated in the same manner as a new chemical entity, if such incremental step meets the test of patentability. Slide14:  New Medical Entity Vs. New Chemical Entity As per Section 3(d) of the Patent Act, 1970 following activities are not considered to be inventions capable of being patented: (a) Mere discovery of a new form of a known substance which does not result in enhancement of the known efficacy of that substance; (b) Mere discovery of any new property or new use for a known substance; and (c) Mere use of a known process, machine or apparatus except where such process results in a new product or employs at least one new reactant. Slide15:  Test of patentability Must be new, not obvious (inventive step), have utility (industrial application) New invention Obligation of TRIPS Agreement All inventions which pass the test of patentability must be allowed NCE NME Slide16:  Test of patentability Must be new, have inventive step (significantly different efficacy) and utility (industrial application) New invention NCE NME ?? Indian Patents (Amendment) Act 2005 allowed salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. Under Section 3(d), stricter standards for inventive step applied in terms of requirement of enhanced efficacy Slide17:  Going beyond the test for patentability Derivatives of known substances cannot be patented unless they can be shown to differ in terms of efficacy. If a drug is developed and patented but a newer , more effective version is subsequently created, the newer version could not be patented unless clinical improvements are demonstrated to the satisfaction of the Indian government. Slide18:  Section 3(d) therefore imposes an artificial barrier to patentability even though the invention may otherwise satisfy the patentability criteria viz. it is new, involves an inventive step and is capable of industrial application. Stop- Limit Slide19:  Thus, the new form of a known substance would be patentable only if it differs significantly in properties with regard to efficacy A closer examination reveals that Section 3(d) attempts to introduce stricter tests for establishing “inventive step” by insisting on demonstration of enhanced efficacy in order to discourage frivolous claims aimed at “evergreening” This may also limit Indian inventions which are genuine. The term “efficacy” needs to be defined in the explanation to Section 3(d) and guidelines set out for examining “inventive step”. The terms “ethers”, “combinations” and“other derivatives” should be deleted from the explanation to Section 3(d). A discussion for the introduction of patents for “new use of a known substance” needs to be initiated Slide20:  New England Journal of Medicine. NEJM Volume 356:541-543 February 8, 2007 Number 6 Taking TRIPS to India — Novartis, Patent Law, and Access to Medicines Janice M. Mueller, J.D. Section 3(d) of India's Patents Act forbids the patenting of derivative forms of known substances (e.g., salts, polymorphs, metabolites, and isomers) unless they are substantially more effective than the known substance. Neither the Indian patent statute nor its implementing rules define "efficacy." They give the patent office no guidelines for applying the new test. Slide21:  Incremental Drugs work leads to Nobel awards October 10, 2001 Knowles, Noyori and Sharpless   STOCKHOLM, Sweden -- Two Americans and a Japanese scientist who worked on research for new drugs won the 2001 Nobel Prize in chemistry. William Knowles, K. Barry Sharpless and Ryoji Noyori worked on projects to improve control of chemical reactions, helping development of heart drugs and a treatment for Parkinson's disease. The awards were announced in Stockholm, Sweden. "The results of their basic research are being used in a number of industrial syntheses of pharmaceutical products such as antibiotics, anti-inflammatory drugs and heart medicines," said the Royal Swedish Academy of Sciences. Per Alberg, of the academy's Nobel Committee, said the three laureates had helped the development of beta-blockers, antibiotics and ulcer medicine. "The discovery can move frontiers of research forward in medicine, chemistry and biology," Alberg told a news conference. "It's a breakthrough that started 33 years ago but the development is incremental." Knowles, 84, from St. Louis, Missouri and now retired, and Noyori, 63, of Nagoya University, shared half of the 10 million kronor ($943,000) prize for their work on "chirally catalyzed hydrogenation reactions." Sharpless, of the Scripps Research Institute, La Jolla, California, received the other half for his work on "chirally catalyzed oxidation reactions." Slide22:  Incremental Innovations are important in medicine. The entry to market of the first product in a new class is followed by a number of other products offering alternative therapeutic and side effect profiles. The resulting market includes a competitive class of products that have a range of variable attributes. For patients the third, fourth or fifth class entrant may offer a better balance of therapeutic benefits to side effect risks then the first. Innovation Models and their Application to the Pharmaceutical Sector Imperial College London, Tanaka Business School Dr Jim Atridge. Slide23:  Innovation Models and their Application to the Pharmaceutical Sector Imperial College London, Tanaka Business School Dr Jim Atridge. Slide24:  Small Improvements in Pharmaceuticals Have Large Positive Impact on Patient Care and Health Care Spending, Study Finds Choice in Prescribing Especially Important to Elderly Patients and Others with Chronic Illness PHILADELPHIA, PA (July 10, 2001) — The small incremental improvements to existing drugs that make up the majority of the new drug approvals by the FDA each year provide important health benefits to patients, especially elderly patients, according to a study released today by the Center for Pharmaceutical Health Services Research at Temple University. Newer drugs in a therapeutic class often have fewer side effects, improved drug safety and effectiveness, and are used more easily, which facilitates compliance with prescribed treatments. A wide variety of product alternatives permit treatments to be better tailored to individual patient needs Slide25:  New uses for medicines are often discovered as a result of extensive clinical experience, often many years after introduction. For example, tissue plasminogen activator (tPA) was originally developed to treat heart attacks but is now used in stroke victims. Some incremental innovations have been demonstrated to save overall health care costs as well. For example, a study by the National Institute for Neurological Diseases and Stroke found that patients treated with tPA had shorter hospital stays than other patients and were more often discharged to home rather than to institutional care. Although hospital costs for treated patients increased by $1,700 per patient, rehabilitation and nursing home costs were reduced by $6,200, a net savings of $4,500. Slide26:  Nature- the best example of incremental innovation. One of the ways biological diversity is produced is by random genetic mutation Slide27:  Genuine Incremental Innovation benefits all If the recommendations of the Expert Committee are accepted by the Government and patents for “new forms of known substances” where there is a genuine incremental innovation Indian companies would also benefit by working out incremental innovations on their own NCEs and the NCEs of large MNCs (with a view to licensing them back to the innovator company as in the case of Ranbaxy’s once a day ciprofloxacin). In the latter context, the implication and interpretation of Section 47(3) of the Indian Patent Act (Grant of patents to be subjected to certain conditions) would have to be examined. Slide28:  Incremental Innovation "The FDA would like to offer patients a choice of drugs within the same class, since not every patient responds to every drug in the same manner." Janet Woodcock, M.D., Director of the FDA Center for Drug Evaluation and Research (CDER)[i] Slide29:  Nikola Testa, Marconi and Edison, contemporaries in radical innovations could get to their respective breakthroughs building on a compounding and cumulative impact of their own or others (during the late 19th and early 20th century's) incremental innovations.A good drug discovery chemist, for example, can arrive at a sequence which might click for a specific target based on the trend visible or noticeable in a series of sequential inventions. Incremental innovations in drug research Chronicle Thursday, November 30, 2006 08:00 IST Dr Gopakumar G Nair Slide30:  Incremental innovation is vital for drug discovery and many Indian companies and institutions including govt like CSIR, Indian Institute of Science etc. Therefore the patent Law needs to make the journey to world class by modifying clause 3 (d) Failing this would mean the loss for Indian scientists doing drug discovery and getting patents. Could it mean that we might miss a Nobel Prize ? Slide31:  Comparison of the TRIPS Agreement With the Indian Patent Law Slide32:  Article 27 of the TRIPS Agreement elaborates the scope of patentable subject matter as follows:   “1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. Slide33:  Members may also exclude from patentability:   (a)  diagnostic, therapeutic and surgical methods for the treatment of humans or animals; (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.” TRIPS agreement- Allowed Exclusions surgeon In this example A surgeon who has a new method of surgery could not patent that method. Slide34:  Exclusions are allowed under TRIPS Concern Serious environmental impact, public orderMembers may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. Slide35:  In this example A genetically modified new species of fish may have a lasting environmental impact. Slide36:  Patents Act 2005   Section 2 (1) (j) of the Indian Patents Act defines “invention” as a new product or process involving an inventive step and capable of industrial application. The term “pharmaceutical substance” has also been defined in Section 2 (1) (ta) as any new entity involving one or more inventive steps. The term “inventive step” has been defined in Section 2 (1) (ja) as a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art. Thus, a chemical to be patentable must be new, non-obvious and have utility. However, Section 3 excludes certain inventions from being patented. This, inter alia, includes the exclusions under Section 3 (d) as under:   “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, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Slide37:  Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”   Thus, the new form of a known substance would be patentable only it differs significantly in properties with regard to efficacy. Slide38:  Efficacy is not well defined and would need to unnecessary scientific waste and litigation. Example 1.Company A has compound xx which is absorbed 30%.Would an increase of of 5% be an increase or 30%? Iron is poorly absorbed if drug xx increased iron availability by 5% it would be a clinical advantage. Example 2, If a compound is first used in injectable dosage form. It takes years and new clinical studies to make an oral dosage form- a quantum jump in efficacy. Would that pass the test for efficacy? The term “efficacy” in the Indian Patent Act needs to be amplified , clarified Slide39:  INVENTIONS NOT PATENTABLE Section 3(j) : "plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals."   The above provisions clearly identify micro-organisms as patentable subject matter, provided they fulfill the prescribed criteria. Patents (Amendment) Act 2005 Slide40:  Suggestions for Modifications of the Indian Patent Law 2005 Slide41:  The Indian Patent Law should Define Efficacy The granting of patent protection to “incremental innovations” such as pure form, polymorphs, isomers, etc. under the current Indian patent law is restricted by the requirement to prove superior efficacy of the new form. This is essential to prove the presence of an inventive step, an essential criterion of patentability. However, inclusion of a definition of the term “efficacy” is recommended in order to avoid ambiguity and subjective interpretation. Slide42:  Combination A combination consists of two different compounds, therefore the combination cannot be considered as the same as either of the two compounds. Some examples of possible combined medications include Schering-Plough’s Claritin® (for allergies) with Merck’s Singulair® (for asthma), and Glaxo Wellcome’s Retrovir® and Epivir® (both treat AIDS). In the US, such combination drugs may be patentable both as new compositions if unexpected synergies are identified, and for new uses that they may have. In India they may be patentable if unexpected synergies are demonstrated. In both cases the combinations must satisfy other conditions for patentability i.e. novelty and non-obviousness/inventive step. Another example is the effectiveness of an azithromycin/sulfadiazine combination for the treatment of toxoplasmosis (in mice) when either drug by itself did not provide any protection against death due to toxoplasmosis. Slide43:  Combinations Drug A and Drug B are both known compounds but by combining them you could get a different therapeutic advantage. e.g. Drug A has an only slight advantage in killing tuberculosis. On adding a synergistic drug B the therapeutic advantage in tuberculosis is increased substantially Under the Indian Patent Law such a combination may be patentable if a synergistic effect is found. Provisions already exist in the Patent Act to ensure that a mere additive effect will not make a combination patentable See Section 3 - What are not inventions: (e) A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; The term “combinations” should therefore be deleted from Section 3(d) Slide44:  Ethers An ether is formed when a hydrogen(H) of an alcohol(R-OH) or phenol is replaced by an alkyl, aryl/heteroaryl or substitued alkyl or substituted aryl/heteroaryl group. Simple ethers such as methyl ethers may be cleaved by enzymes in the body, but more complicated ethers may not be readily cleaved. The properties of ethers may be quite different from those of the parent alcohols or phenols. Therefore ethers should be considered as different compounds from the parent compound. Slide45:                    Ethers are also derivatives Morphine Codeine Codeine is the methyl ether of morphine Both are opiates but have different actions and side effects Slide46:  “Derivative” is a very broad term and is generally used to describe a chemical compound which is prepared from another compound of related structure. An example is acetyl salicylic acid and salicylic acid. These days, in a product patent, we would normally claim both compounds in the same patent.   Sometimes the term “derivative” is also loosely used to mean a related compound which has something in common with another compound, but which may not have been prepared from it (e.g. functional groups on a ring are different, or an oxygen atom is replaced by a nitrogen atom). However, properties of different derivatives may be completely different and they should be considered as different compounds. That is why the words “other derivatives” should be deleted from the explanation to 3(d). Slide47:  The words “ethers”, “combinations” and “other derivatives” should be deleted from the explanation to Section 3(d) because they cannot mean the same substance. e.g. A derivative Compound A has a side chain at position X. This chemical has activities abc. Scientists cleave the side chain at position X and move it to position Y. This may be an entirely new compound (Compound Z). Novelty may be ascertained by a Markush search (STN) If Compound Z is new to the world, the step to make it is inventive and it has efficacy, then under the Indian Patent Act, Compound Z should be patentable. All these compounds are azole derivatives but three separate patents have been granted and they vary in functionality.:  Omeprazole Lansoprazole Pantoprazole US 4,255,431 US 4,628,098 US 4,758,579 (AB Hassle) (Takeda) (Byk Gulden) All these compounds are azole derivatives but three separate patents have been granted and they vary in functionality. Slide49:  Use Patents No Use patent for a chemical entity whose structure is already described under the Indian law. There are many compounds that are used as intermediates in the synthesis of another compound or have simply been synthesized for academic interest. Many of them have been found to be very potent drugs. Under this law, they will not be patentable in India - a serious drawback to their development in India as they will be freely copied. Indian scientists have many compounds isolated from natural product whose structure as been elucidated by academicians but their use in the treatment of diseases is not described. They are unable to develop this product. Slide50:  India and the Drug Patent Wars Print Mail By Roger BatePosted: Tuesday, February 6, 2007 HEALTH POLICY OUTLOOKAEI Online   Publication Date: February 7, 2007 There are several reasons why the terms outlined in section 3(d) are not compatible with the WTO TRIPS agreement: Article 27 of the TRIPS agreement[5] provides a bounded list of patentable subject matter that can be excluded from patent coverage. “New forms of known substances lacking enhanced efficacy” are not included in this bounded list. The TRIPS agreement forbids WTO member states to make it more difficult to obtain a patent in one technical field, such as engineering, over another, such as drug development. Only patents filed for drug development have to comply with section 3(d). The “other derivatives of known substances” clause of section 3(d) of the Indian patent law is nebulous and arbitrary. It could be interpreted to deny nearly any new patent claim since so many drugs are derived, at least in part, from previously known substances. And even if a patent was granted, it could be easily challenged by some party that currently copies it (or would want to). Section 3(d) is so arbitrary that it encourages litigation and undermines incentives for innovation. Slide51:  Use patents The issue of “new use of a known substance” not being a patentable invention under Section 3(d) is likely to come up for discussion as to whether it complies with TRIPS provisions. This issue could also be examined by the patent office. This issue is also crucial to stimulate research into The Indian systems of medicines. Without any patent protection there is little incentive for scientists to work on clues from Ayurvedic medicine which may prove answers for many new diseases. For example a plant which is defined an Ayurveda as a tonic may find use in attacking the bird flu or SARS virus. Slide52:  Evergreening- Patents can also have frivolous modification to extend their patent life. This is perhaps reflected in clause 3 (d) Standards for non-obviousness must be defined. The patentability criteria, especially “inventive step” and “non-obviousness”, should be strictly evaluated by patent examiners to distinguish between genuine incremental inventions and frivolous claims aimed at “evergreening” to block competition and get an unfair monopoly. Patents issued after strict examination will also help cut down on possible litigation arising due to challenges to the validity of issued patents. This can be done by the patent office and must be transparent. Slide53:  Further Checks in the Indian patent law The Indian patent law currently in place already has a provision of pre-grant opposition (as well as post-grant opposition) to a patent application on the grounds of novelty and obviousness, which provides an additional check to ensure that frivolous patents are not granted. However, these provisions are likely to delay the grant of a patent. There is an urgent need to formulate detailed guidelines for examining patent applications in the pharmaceutical sector and rigorously implement them so that the remotest possibility of granting frivolous patents is eliminated. Slide54:  In the definition of pharmaceutical substance in Section 2 (1) (ta), the word “entity” should be defined.   The term “inventive step” has been defined in Section 2 (1) (ja) as a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art. Slide55:  This should read “… a feature of an invention that involves technical advance as compared to the existing knowledge and has economic significance and that makes the invention not obvious to a person skilled in the art.” in which the main consideration must be technical advance which would be a functional feature while economic significance may be examined as a secondary criterion. Alternatively, the term “economic advance” may be deleted from the definition but it may still be used during examination as a secondary consideration (Could be laid down in the detailed guidelines for examiners). In the current definition of “inventive step”, a feature that has economic significance but no technical advance may also qualify as an invention. Slide56:  "The process of incremental innovation in the pharmaceutical industry mirrors how product development is done in most manufacturing and high tech industries," said Wertheimer. "In fact, most of the top 10 prescription drugs sold in the United States in 1999 were incremental improvements on existing products. Policies that foster incremental innovations stimulate research, broaden access to important therapies and help to promote a competitive market." According to a recent Johns Hopkins University study, 125 million Americans suffered from chronic illnesses in 2000, and that figure is expected to reach 157 million in 2020, at which time 25 percent of all Americans will be living with multiple chronic conditions, many common results of aging. Most of these conditions are treated by one or more drugs that have seen incremental improvement. The study was conducted by the Center for Pharmaceutical Health Services Research of Temple University School of Pharmacy, in cooperation with the National Pharmaceutical Council (NPC). The Center conducts externally funded and academic research in treatment outcomes, pharmacoeconomics, and health policy analysis. Slide57:  Don’t throw out the baby with the bath water! A German proverb of unknown origins, it was current in German at least as early as the seventeenth century, when the astronomer Johannes Kepler included the passage, 'This is a caution.lest you throw out the baby with the bath water,' in Tertius Interveniens' (1610). The saying apparently first appeared in English (1853) in the writings of Thomas Carlyle, who reported, 'The Germans say, 'You must empty out the bathing-tub, but not the baby along with it.' Slide58:  Analogy In the 70s the Monopolies Restrictive trade practice limited the number of looms. The fear was off large company dominance. The law killed modernization of the industry. With liberalization once again the industry is reviving. Limiting the patent act is similar. India could be a creator of new drugs using chemistry skills and making new drugs from old molecules-using well established chemistry skills. Slide59:  NEJM Taking TRIPS to India — Novartis, Patent Law, and Access to Medicines Janice M. Mueller, J.D. The counterargument is that TRIPS does not define "inventive step." It permits (but does not require) WTO members to equate this criterion with the "nonobviousness" requirement of U.S. patent law — and thus gives member countries the flexibility to fine-tune their inventive-step criteria to reflect national socioeconomic conditions. Moreover, Section 3(d) of India's patent law does not necessarily impose stricter requirements than are used elsewhere; it may be seen as simply creating a general presumption of nonpatentability for modifications of known chemical compositions — and shifting to patent applicants the burden of rebutting this presumption in each particular case. For example, the U.S. Patent and Trademark Office may reject a claimed drug as "prima facie obvious" on the basis of its structural similarity to existing chemical compositions. A classic way to overcome the rejection is to demonstrate the drug's unexpectedly good results. India's new efficacy test might well operate in a similar fashion India has an independent judiciary and an established rule-of-law tradition. Novartis's litigation needs to run its course, and the system must be allowed to do its job, since a number of important results could flow from this case. Indian courts probably cannot use the WTO's rules to strike down laws enacted by India's parliament, but the Chennai High Court will have to grapple with the meaning of Section 3(d) and other untested patent rules. Regardless of the outcome, the system will benefit from the judicial analysis. And even if Novartis ultimately obtains an Indian patent on Gleevec, the current safeguards give the government multiple options for ensuring public access to this and other lifesaving drugs. Ms. Mueller is a professor of law at the University of Pittsburgh School of Law, Pittsburgh. Slide60:  The Patent Law on Microorganisms Slide61:  Providing patent protection for microorganisms will facilitate the discovery of novel drugs from hitherto unexplored microorganisms from a variety of sources. The provision to document, protect and modify new microorganisms as well as prove their utility would promote research and benefit the Indian biotech industry. Slide62:  Strict guidelines need to be formulated for examination of the patent applications involving micro-organisms from the point of view of novelty, substantial human intervention required to isolate them in pure form from the original source, and their utility. Patent examiners may have to be trained to be able to evaluate novelty of a particular strain of microorganism. e.g. Scientists can pick up a mud slick with lots of microbes but isolating, cloning and proving the organism is new and works requires scientific inputs and equipment. Slide63:  Although provisions have been made for depositing microorganisms with International Depositary Authorities, one of which has been established in India, conditions under which the microorganism would be made available to the public need to be specified. (See Section 11A (6)(a) which says that upon publication of an application for a patent under this section, the depositary institution shall make the biological material mentioned in the specification available to the public). Provisions for public access to microorganisms in the USA and Europe which are stricter should be studied, and appropriate measures taken in India to ensure that early access to microorganisms does not result in misuse or inappropriate use of the microorganisms. Slide64:  CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PART 725_REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS – i) A person who submits information to EPA under this part may assert a claim of confidentiality for portions of the specific microorganism identity at the time of submission of the information. This claim will apply only to the period prior to the commencement of manufacture or import for general commercial use. Slide65:  The Biodiversity Act, 2002 lays down restrictions on the acquiring and transfer of biological resources occurring in India as well as on making an application for any IPR for an invention based on a biological resource obtained from India. These need to be elaborated and strictly enforced so as to ensure that the indigenous biological resources including microorganisms are used for the benefit of the local people. Slide66:  Sunday, January 28, 2007 MASHELKAR REPORT MISSTATES INDIA’S RIGHT TO DEFINE SCOPE OF PATENTABILITY AND THREATENS ACCESS TO MEDICINES by Brook Baker Professor Brook K. Baker Northeastern U. School of Law, Program on Human Rights and the Global Economy; Health GAP (January 26, 2007) The Mashelkar Committee in India was tasked with determining “whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substances to new chemical entity or to new medical entity involving one or more inventive steps.” In its recently released report, “Report of the Technical Expert Group on Patent Law Issues (Dec. 2006)” [Mashelkar Report], not only did the Expert Committee misinterpret India’s flexibility under international law to limit patents of pharmaceutical products to new chemical entities, it exceeded its mandate to critique section 3(d) of the India Patents (Amendment) Bill, 2005. The errors in the Report include: 1. The Mashekar Report asserts without argumentation that “[g]ranting patents to only NCEs or NMEs and thereby excluding other categories of pharmaceutical inventions is likely to contravene the mandate under Article 27 to grant patents to all ‘inventions’.” (¶ 5.6.) In ¶5.7, it goes even further and concludes that such a limitation “is not consistent with the TRIPS Agreement.” In doing so, the Report erroneously concludes that the definition of invention (newness, inventive step, and industrial capacity) contained in Article 27.1 has any particular and definite meaning within the WTO TRIPS Agreement. In particular, the Report ignores (does not even address) the flexibility that countries like India have under Article 1.1 of the TRIPS Agreement, which states that “Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.” (Emphasis added.) This article is available on Google. Slide67:  “The Mashelkar Report is a betrayal of the interests of people suffering from life-threatening diseases worldwide, especially people living with HIV/AIDS, and a capitulation to the interests of the multinational drug companies and a narrow spectrum of India manufacturers that subverted the process and stand to benefit from increased rights to charge unconscionable prices and to extract monopoly profits at the cost of denied access and millions of lives in India and abroad. “ MASHELKAR REPORT MISSTATES INDIA’S RIGHT TO DEFINE SCOPE OF PATENTABILITY AND THREATENS ACCESS TO MEDICINES by Brook Baker Professor Brook K. Baker Northeastern U. School of Law, Program on Human Rights and the Global Economy; Health GAP (January 26, 2007) We do not agree with the suggestion that Mashelkar is funded by MNCs. The panel is made up some of India’s leading scientists. Mashelkar fought and won the patent case for India in turmeric and basmati.! What if Indian scientists were to invent a better and cheaper drug in the future? Slide68:  Nicholas Piramal invents a new and potentially better version of Gleevec. Gleevec- a drug by Novartis causes resistance in some cases of cancer Nicholas Piramal may have a POTENTIAL , BETTER,CHEAPER DRUG than Novartis’ Gleevec! We cannot file a patent in India due to the limitation. We have filed global patents. The product is is phase II If the drug succeeds it will change the paradigm. Indian law makers should not throw the baby out with the bathwater. Slide69:  March 21st 07 Mashelkar Report with drawn for correction. Parts of the report have been drawn from but not correctly credited to Prof Shamnad Bashi of George Washington University. Prof Shamnads’ report annexed to the final report. Dr Mashelkar requests time for correction to keep up with international scientific conventions. Left parties urge the govt to disband the committee. Slide70:  The Long Road India’s patent Act needs to be modified to make clear and transparent so that there is no unnecessary litigation for our already overburdened judiciary. Patent examiners need better training and better pay. India’s Patent Act has a small book and just 3 pages to explain terms such as efficacy , obviousness, utility. In comparison, US patent law is in volumes and has a good case law books. There could be a lot of scientific waste for not defining terms well. Patent Examiners are very well trained and are often scientists themselves Indian courts need training in patent infringements which will gradually rise. Transparent legislation is beneficial to the consumer and industry both. Slide71:  Let us Focus on science Making India an innovation economy Slide72:  The intention of the Patent Act 2005 in making certain exclusions was under section 3(d) was to protect the Indian public from frivolous incremental innovations in order to extend patent life. This can be done by stricter patent examination with strong , transparent guidelines. Currently, the law as present is deficient and is not compatible with TRIPS The deficiency may hurt Indian innovation as well use Indian strengths such as chemistry to make NMEs derived from previously known compounds The patent law needs transparent definitions for the terms efficacy and obviousness. Use patents must be allowed to spur research into Indian systems of Medicine. Summary

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