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Pharmaceutical patent


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Dr. amit gangwal ka pharmaceutical patent presentation
highly exhaustive and updated ppt on pharmaceutical patents, a must watch by all those concerned with the same.

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Pharmaceutical patent

  1. 1. Pharmaceutical Patents and Paraphernalia Amit ka PPT Amit Ratn Gangwal Jain Smriti college of Pharmaceutical Education, Indore
  2. 2. Disclaimer Views expressed in this PPT are fairminded. 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.)
  3. 3. 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
  4. 4. This world is being driven by R & D, which is being incentivized by patent.
  5. 5. Requirements for Patentability USEFUL – Must have some utility; achieve some objective; not against public policy, must be disclosed NOVEL – 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 NON-OBVIOUSNESS
  6. 6. 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
  7. 7. Patents Exclusive rights two decades
  8. 8. 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 chapters various reverse engineering • Before 2005 reverse engineering was flourishing (Much to the dissatisfaction of overseas player).
  9. 9. 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
  10. 10. 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)
  11. 11. Patent of addition is granted for additional information in original application, if found adhering to the laws.
  12. 12. 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)
  13. 13. 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)
  14. 14. 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)
  15. 15. 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.
  16. 16. If products goes off patent, molecule/product goes to public domain.
  17. 17. 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.
  18. 18. 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.
  19. 19. 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. 
  20. 20. 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.
  21. 21. Such was the need and success of Imitanib that this was featured on the cover of Time magazine in 2001
  22. 22.  Dr. Brian J. Druker  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. 
  23. 23. 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).
  24. 24. 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
  25. 25. 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.
  26. 26. What  has  accelerated  is  not  so  much  patenting  or  innovation  but  evergreening,  the effort to extend patents.
  27. 27. Historical decrees by indian court natco Sorafenib tosylate
  28. 28. 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:
  29. 29. 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.
  30. 30. 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 Chennaibased 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
  31. 31. Specimen copy of notification to innovator company at USA by Government of Zambia, regarding compulsory license.
  32. 32. 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
  33. 33. What lies ahead Is very clear only three things will get cheaper molecules –Either compulsory license –Free to all policy –Rigorous R and D by most of the pharma organization
  34. 34. 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.
  35. 35. 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.
  36. 36. Importance of being pioneer
  37. 37. An ITC product Bhaiya ak lal wali maggi dena (though its not a maggy).
  38. 38. • Most of the people demand for packed water bottle by asking bhaiya ak bislery dena. • Bhaiya ak xerox kar dena.
  39. 39. Uncle Sam’s nation U.S. is now “first to file”/first to publish
  40. 40. 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 litigation, patent which relates to legal proceedings for infringement of a patent after it is granted.
  41. 41. • 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)
  42. 42. 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.
  43. 43. 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.
  44. 44. 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.
  45. 45. Many countries like Malaysia, Indonesia, Thailand, Brazil have already brought in compulsory licensing. Look at the world's topselling 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.
  46. 46. Fire in the blood: A heart touching documentary on patent issues
  48. 48. Thanks