Dr. Amit Gangwal Ka pharmaceutical patent presentation

Information about Dr. Amit Gangwal Ka pharmaceutical patent presentation

Published on August 1, 2014

Author: amitratn

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Pharmaceutical Patents and Paraphernalia : Pharmaceutical Patents and Paraphernalia Amit Ratn Gangwal Jain Smriti college of Pharmaceutical Education, Indore Amit ka PPT PowerPoint Presentation: Disclaimer Views expressed in this PPT are fair-minded. Proprietary names used in this article are of respective firms. Efforts have been made to make this PPT comprehensive but owing to space limitations and continuous development and case studies in the field, PPT can not be termed highly exhaustive.) Amit ka PPT: Amit ka PPT Where language per se is used, original reference/source/photos of personality have been mentioned at appropriate place. This PPT of mine ( Amit ka PPT ) is not to make money; this I have prepare to spread right information for various readers. All the images are taken from internet. Thanks This world is being driven by R & D, : This world is being driven by R & D, which is being incentivized by patent . Requirements for Patentability: Requirements for Patentability USEFUL NOVEL NON-OBVIOUSNESS Must have some utility; achieve some objective; not against public policy, must be disclosed Must be new, i.e., different from available information Subject matter as a whole would not have been obvious at the time to person of ordinary skill in the art What is not patentable: What is not patentable Naturally occurring things Generally you cannot patent living things, although you can patent certain live matter, such as genetically engineered animals, plants, etc., or the process of extracting a natural product. You cannot patent laws of nature, mathematical formulas and abstract ideas.  Idea Patentee: Patentee Gets exclusive rights for two decades * . * Until patent is revoked or compulsory license is granted. PowerPoint Presentation: No Patentee may I use your invention ? h Patents: There is provision for pre-grant rejection. May be revoked any time, if something foul is reported. (post grant opposition) Product and process patent (from 2005) both are in force Closing down various reverse engineering chapters Before 2005 reverse engineering was flourishing (Much to the dissatisfaction of overseas player). Patents PowerPoint Presentation: Types of patent application (1) Ordinary patent application - It is a simple application for patent without any priority claim and not being convention or National phase application .It should be accompanied by a provisional or complete specification at the time of filling. (2) Convention Application - An application who files an application for patent in a convention country can make convention application in India within 12 months from the date of basic application (3) National phase application under PCT- PCT stands for the patent co-operation treaty. It is a sister treaty of the Paris convection administered by the world intellectual property organization. The PCT system facilitated filing of patent application under a single umbrella and provide for simplified procedure for the search and examination of application PowerPoint Presentation: National, regional and international applications National applications generally filed at a national patent office. Regional applications A regional patent application is one which may have effect in a range of countries. The European Patent Office (EPO) is an example of a Regional patent office. The EPO grants patents which can take effect in some or all countries contracting to the European Patent Convention, following a single application process. (Taken from Wikipedia) PowerPoint Presentation: Patent of addition is granted for additional information in original application, if found adhering to the laws . WIPO: WIPO The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. (Taken from Wikipedia) PTC: PTC The  Patent Cooperation Treaty  ( PCT ) is an international patent law treaty, concluded in 1970. It provides a unified procedure for filing patent applications to protect inventions in each of its contracting states. A patent application filed under the PCT is called an international application , or  PCT application . (Taken from Wikipedia) TRIPS: TRIPS The  Agreement on Trade Related Aspects of Intellectual Property Rights  ( TRIPS ) is an international agreement administered by the world trade organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. It was negotiated at the end of the Uruguay round of the general agreement on tarrifs and trade (GATT) in 1994. (Taken from Wikipedia) Generic versions (ANDA): Generic versions (ANDA) If products goes off patent, molecule/product goes to public domain. Its open for generic players. F2F (first to file) will get the green signal to launch first generic version in world/chosen area/protected area. F2F will get exclusive rights for 6 months. Then anybody may launch with permission. PowerPoint Presentation: If products goes off patent, molecule/product goes to public domain. PowerPoint Presentation: Paragraph IV filing Patent listings are important in the generic drug approval process because challenges to listed patents can lead to stays in approval of generic versions of original molecule. As per the FD&C Act, a generic drug applicant need to include in its application; a certification for each patent listed in the Orange Book for the innovator drug. Similar information is required for applicants filing 505(b)(2) applications under section 505(b)(2) of the FD&C Act. This certification must state one of the following:  Para I: that the required patent information relating to such patent has not been filed;  Para II: that such patent has expired;  Para II:I that the patent will expire on a particular date; or  Para IV: that such patent is invalid or will not be infringed by the drug, for which approval is being sought. PowerPoint Presentation: 30 month stay provisions If the generic counterpart of a branded product is intended to be marketed before expiration of the patent, then applicant is liable for legal action against him and the ANDA applicant, filing an application citing a paragraph IV certification, may be tried for patent infringement. Within 45 days the NDA holder or patentee can file a patent infringement suit against the ANDA applicant after receiving notice from FDA which may be followed by disapproval (of ANDA application) by FDA. This disapproval remains in force for at least 30 months from the date of that notice. PowerPoint Presentation: Recent never-before announcement by Indian courts There has been series of pronouncements by Indian courts, including the Apex Court (Supreme Court). Most of these were not in favour of MNC. Few notable cases are: Nexavar and Gleevac . Moreover, both these products are used in treatment of rare cancers for which these are the most successful medicaments so far. Nexavar ruling was historical in that, it became the first product in pharmaceutical realm in India, which is now being produced and sold (other than the innovator company) by Indian company using compulsory license provision . Gleevac became the historical brand in the sense that first time in India, Apex Court rejected the ground (minor change in drug form) furnished by defendant MNC and not granted the fresh patent to milder modification in the molecule present in Gleevac. Historical decrees by Indian court : Historical decrees by Indian court Glivec/Gleevec was already in the market, however company decided to seek a patent on a slightly modified version potentially giving it longer period of market exclusivity .  PowerPoint Presentation: Such was the need and success of Imitanib that this was featured on the cover of Time magazine in 2001 PowerPoint Presentation: Dr. Brian J. Druker an oncologist at Oregon Health and Sciences University and a Howard Hughes Medical Investigator, played a major role in discovering Imitanib. Dr. Brian J. Druker PowerPoint Presentation: Section 3(d) of the Indian Patents Act does not allow patents of new version of known drug molecules if they don’t make it more effective than before. In the mean time many Indian companies produced generic drugs at very cheap rate which was consumed by 300000 people . Whereas 16000 people use glivec. (Generic versions can be manufactured when the product expires the patent). http://www.slideshare.net/BizandLegis/patent-overview-in-novartis-case Word efficacy is important. : Word efficacy is important. Until efficacy is increased and proved, new patents are not granted in India, after slight/bigger change in existing molecule/product Patent evergreening: Patent evergreening What is Patent evergreening? Patent evergreening is a potentially dubious and sometimes derogatory term that generally refers to the strategy of obtaining multiple patent that covers different aspects of the same product, typically by obtaining patents on improved versions of existing products. PowerPoint Presentation: What has accelerated is not so much patenting or innovation but evergreening, the effort to extend patents. Historical decrees by Indian court Natco: Historical decrees by Indian court Natco Sorafenib tosylate Compulsory license: Compulsory license In certain cases, without patentee’s consent and with state intercession, generic version can be produced and sold through the provision of compulsory license. A compulsory license, also known as statutory license or mandatory collective management, provides owner of a patent patentee) the rights against payment either set by act or determined through some form of negotiation. Government intervention is indispensable. It is one of the flexibilities in patent rules mentioned in the world trade organization (WTO)’s agreement on intellectual property, the TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement. The TRIPS agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, the Doha declaration on TRIPS confirms that countries have liberty to decide the basis on which compulsory licenses could be granted. The TRIPS agreement lists a number of conditions for issuing compulsory licenses, in Article 31. In particular: PowerPoint Presentation: Nexavar became a blockbuster with $1 billion in sales in 2011 for Bayer. The revenue growth was 7% over the 2010 sales of $934 million. Bayer holds Indian patent (215758) for this chemotherapeutic agent. But all that changed on March 13, 2012, when India's patent office accepted a request from Hyderabad-based Natco Pharma and granted permission to compulsorily make Bayer's patented drug and make it available to patients at 97 percent discounted price of 8,800 rupees for a month's dose (while Bayer charges 284,428). Of course, Natco has been ordered to pay 6 percent royalty on Nexavar’s sales to Bayer. PowerPoint Presentation: When Natco’s approach for voluntary license [{s. 84(6) (IV)}] was turned down by Bayer then state intervention lead to historical verdict on March 12, 2012 in favour of Natco. Bayer had appealed against this order. This ruling was further upheld by Chennai-based Indian patent appellate board (IPAB). The earlier order had relied on Section 84 (1) (a, b and c) of the Patents Act, which states that “after three years of grant of a patent, a compulsory license can be granted to any applicant on any of the following justifications: (a) the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not ‘worked’ (manufactured to some satisfactory extent) in the territory of India18 PowerPoint Presentation: Specimen copy of notification to innovator company at USA by Government of Zambia, regarding compulsory license. Western world raises eyebrows on : Western world raises eyebrows on the issuance of unwarranted compulsory licenses the unfair revocation of valid patents, and the denial of patentability of inventions in India What lies ahead: What lies ahead fvfggggg PowerPoint Presentation: While addressing at Government College of Pharmacy, Bangalore, former President of India APJ Abdul Kalam suggested concept of open source, introduced by CSIR (Council of Scientific and Industrial Research). Open source drug delivery (OSDD) focuses on collaborative effort to achieve breakthroughs in the world of medicines and bringing down cost of medicines. This concept would provide medicines free from monopoly and only generics would be produced. What research and development brings to the organization: What research and development brings to the organization It brings name and fame to product Product then becomes brand Brand then makes brand range Ultimately people purchase product of that category by your brand name. Importance of being pioneer: Importance of being pioneer PowerPoint Presentation: An ITC product Bhaiya ak lal wali maggi dena (though its not a maggy). PowerPoint Presentation: Most of the people demand for packed water bottle by asking bhaiya ak bislery dena. Bhaiya ak xerox kar dena. Uncle Sam’s nation: Uncle Sam’s nation U.S. is now “first to file”/first to publish PowerPoint Presentation: The process of "negotiating" or "arguing“ (or putting one’s point) with a patent office by patentee, and interaction with a patent office with regard to a patent after its grant, is known as  patent prosecution . Patent prosecution is distinct from patent litigation , which relates to legal proceedings for infringement of a patent after it is granted. PowerPoint Presentation: Leading scientist, Padma Bhushan awardee and chairman of pharma major Cipla, Yusuf Hamied shot to global fame in early 2001 when he announced that his company, Cipla, would supply a combination of AIDS drugs to developing countries for less than $1 a day, at a time when first-line antiretroviral (ARV) medication sold for up to more than $15,000 per patient per year. ( October 20, 2013, Times of India 11 page) PowerPoint Presentation: In other words, the drug companies in the USA who were charging $15,000 a year for this medication were saying that without their brand name, these generic medications were simply not the same despite the fact they were both made with the same cheap active ingredients, as pointed out by Cipla’s Hamied. India is committing selective genocide in healthcare. : India is committing selective genocide in healthcare. Drugs for cancer, HIV/AIDS, TB, Malaria should be free from clutches of patents law. There should be provision for compulsory licensing. There must be policy for compulsory license ; presently system varies case to case. In canada there is system of obligatory licenses ; which allows Canadians to copy any drug and pay the patent holder 4 % royalty . PowerPoint Presentation: India cannot afford a monopoly in drugs. If there is a monopoly, people won't be able to afford drugs, like the cancer drugs sold today. For example, the top-selling AIDS drug in the world, Atripla, costs $20,000 per patient per year in the US. Cipla's US FDA-approved equivalent product, is being sold for less than $100 per patient per year in Africa where it is not under patent. If they block India, they are essentially blocking the Third World's supply of newer cheaper anti-AIDS drugs and other newer medicine. PowerPoint Presentation: Many countries like Malaysia, Indonesia, Thailand, Brazil have already brought in compulsory licensing. Look at the world's top-selling drugs; 70% of them are made and marketed by companies that haven't invented them. They are all in-licensed products. They are paying royalty to the guy who did the invention. So in-licensing is on all the time, but now, it is a specific in-licensing on exclusive basis to one company. I want non-exclusive in-licensing. I want the obligatory licensing system. I don't mind paying royalty. PowerPoint Presentation: http://www.frontrowreviews.co.uk/reviews/fireintheblood/21252 Fire in the blood : A heart touching documentary on patent issues Heavy inputs from my earlier published article : Heavy inputs from my earlier published article “ PHARMACEUTICAL PATENTS: THE HATCH – WAXMAN AMENDMENTS, EVERGREENING, 180 DAYS EXCLUSIVITY, LISTING IN ORANGE BOOK AND FEW RECENT UNPRECEDENTED DECREES BY INDIAN COURTS” PowerPoint Presentation: Thanks

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