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Indian Patent Regime after 1995 amendments, NIB patent wars


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Post'1995 Indian patent regime, Loopholes, Advantages, disadvantages, Criticality of sec-3(d), NIB patent war and litigations of foreign nnovator companies, Imatinib, sorafenib, etc...

Post'1995 Indian patent regime, Loopholes, Advantages, disadvantages, Criticality of sec-3(d), NIB patent war and litigations of foreign nnovator companies, Imatinib, sorafenib, etc...

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  • 1. Indian Patent Regime & “NIB WAR” Litigations Manasi Vakil CQA Torrent Research Center
  • 2. What are IPRs? “IPRs are legal rights which are granted to a person for CREATION of the mind or intellect which have COMMERCIAL VALUE.”  8 well defined mechanisms for protection:  Patents  Copyright  Trademark  Industrial Designs  Layout designs of Integrated Circuits  Geographical indications  Registration of Plant Varieties  Trade Secrets
  • 3. Mechanisms for Protection:  COPYRIGHT: “exclusive rights granted by the law to the creator of expressions such as Literary, Music and Cinematographic works”  As got only LIMITED PROTECTION because though one may not copy a book or audio/video CD, one can still use the idea/knowledge given in them.  E.g. Induction manual or introductory video of TPL can be protected under copyright and also as a trade secret.  Term: entire life of an author and 50 years after his/her death.
  • 4. Mechanisms for Protection:  TRADEMARK: is a word or symbol used by a manufacturer to identify and distinguish his goods from others.  Nearly all pharmaceutical products bear a distinctive TM.  Term: Initially for 10 years and can be renewed indefinitely.  INDUSTRIAL DESIGNS: refer to specific shape, configuration, surface, pattern or colour or combination thereof produces an aesthetic impression of the article. Term: 15 years  Design of a Ball pen, design of Packaging Bottle used for pharmaceutical product.
  • 5. Mechanisms for Protection:  INTEGRATED CIRCUITS: refer to the specific manner in which transistors and other circuitry elements are laid out in a semiconductor IC and includes lead wires connecting such elements.  Term: 10 years from the date of filing or date of commercialization whichever is earlier.
  • 6. Mechanisms for Protection:  TRADE SECRET: refer to proprietary commercial application and value. information having  E.g. formula of the „Coca-Cola‟ which has been preserved as a family secret, passed from one generation to another.  Some of the highest selling products in Pharma, especially based on microbial technologies are protected as trade secrets.  NDA(Non Disclosure Agreement) and CDA(Confidentiality Agreement) are one of the tools under Trade Secret.  No territorial limits, no expiry, no fee, monopoly for almost unlimited period are the benefits of this mechanism.
  • 7. Mechanisms for Protection:  GEOGRAPHICAL INDICATIONS: relate to goodsagricultural, natural r manufactured, originating from a particular geographical region situated in a particular country.  E.g. Darjeeling Tea, Petha, Basmati Rice. Bikaneri Bhujiya, Agra  Term: one time registration is valid for 10 years.  Boosts exports  Promotes economic prosperity of local small scale producers of particular geographical territory.
  • 8. Mechanisms for Protection:  PLANT BREEDERS‟ RIGHT: legal rights granted by the govt. for protection of plant varieties, right of farmers and plant breeders.  Term: 15 years for annual crops and 18 years for trees and vines.  Promotion of Biodiversity  Better research is encouraged  Easy availability of good quality seeds internationally. In absence of this mechanism, foreign companies were hesitant to release their improved seeds for fear of piracy.
  • 9. Patents:  Exclusive rights granted by the govt. to an inventor for protection of his/her work from being illegally copied.  Term: 20 years from the date of filing.  Patentability Criteria: (N.I.I.)  Novelty  Inventive Step/Non-obviousness  Industrial applicability  Non-Patentable Articles:  Frivolous, contrary to society/environment. public order or  Mere discovery  Rearrangement or duplication of known devices harmful to
  • 10. Patents:  Substance produced by merely mixing of components, resulting in aggregation of the properties of the components.  Method of agriculture, horticulture, treatments, plants and animals as whole.  Mathematical or business methods.  Literary, aesthetic, artistic works, method of playing games.  Presentation of information.  Traditional knowledge  Inventions pertaining to Atomic energy. medical
  • 11. Definitions:  Patent: is an exclusive right granted by the govt. to the original inventor/developer/researcher of an invention, which prohibits others from making, using or selling that invention.  Infringement: is illegal entry into other‟s restricted area.  Opposition:  Pre-Grant: can be filed by any person after publication of application to prevent grant of patent application. (questioning the patentability)  Post-Grant: can be filed by any interested person within one year from the grant of patents. To revoke the patent. (questioning the validity)
  • 12. Definitions:  Voluntary License:  Granted by innovator company to multiple generic companies.  Helps innovator reach newer markets and focus on their core R&D.  Helps generics to generate revenue.  Facilitates affordable priced drugs supply to public.  Compulsory License:  Granted to remedy non-affordable drug prices, emergency, health crisis of public or for govt. use. national  A royalty is paid by the compulsory licensee to the patent holder  Respective govt. has the right to determine the grounds for granting compulsory license.
  • 13. Scope:  NIB WAR:  New Anti-Cancer life saving drugs like Imatinib(Novartis), Erlotinib(Roche), Sunitinib(Sugen/Pfi zer), Sorafenib(Bayer) are the subject matters of ongoing “NIB War” litigations against Indian generic companies.  These litigations are based on: Infringement related injunctions and damages Patent Regulatory Linkages
  • 14. Background:  Indian Patent Act, 1970  No product patent provision (only process patent)  Lengthy and delayed procedure for patent application and publication  India having multiple patent offices  Non-uniformity and diverse approaches to implementation of the policies and provisions of the Patent Act‟1970  Unreasonable delay in resolution of IP-disputes Such restricted environment destroyed all interests in patenting in India, during 1970-2005.  During this 35 years under the protected environment of process patent regime, the Indian generic companies grew exponentially, by REVERSE ENGINEERING and developing generic versions of new drugs.  Consequently, India has now emerged as one of the top players in Global Generic market.
  • 15. Background: (cont...)  TRIPS: (Trade Related aspects of Intellectual Property Rights)  Since trade at global level was hindered as the developed countries were reluctant to sell their products in the countries where sufficient protection was not given.  Under the 8th round of GATT (General Agreement on Tariffs and Trade), IPRs were brought within the scope of GATT.  TRIPS was established under which the rules for protecting IPs were made uniform in all countries which signed the Agreement. India was one of them.  Since, the rules for IP protection was governed by national laws, a 10 year transition period was allowed to all countries to make their law complaint with TRIPS.
  • 16. Background: (cont...)  Indian Patent Act was not amended since its first implementation in 1970.  India was dragged to the DSB (Dispute Settlement Board) of the WTO by US and EU, for non-compliance with TRIPS.  Thus, 1st Amendment Act of 1999 was unanimously passed in the Indian Parliament.  2nd and 3rd amendments were passed in 2003 and 2005 respectively.  Implementation from 1st January, 2005.
  • 17. Reasons for NIB War and related litigations in other countries:  Attractive revenues for generics:  Increase in number of blockbuster drugs during last decade, now facing patent expiry.  This interests the generic firms to launch their “COPYCAT” version with very less investment than that of discovery.  Generic entry can be done by 3 ways: i. Safe Entry – longest duration for approval and more competition. ii. At-Risk Entry iii. Licensing options  Amendments in Indian Patent Act, making it more stringent and Introduction of Product Patent Regime leading to overflow of innovators with new drugs.  Lack of Patent Linkage system in India.
  • 18. At-Risk Entry:  Launching a generic drug (ANDA Filing) involves market authorization from NDRA of their respective countries.  In countries (e.g USA) following patent linkage system, the generic drug filer has to prove: --Patent invalidity --Confirmation for non-infringement  In countries (e.g. India, EU) not following linkage system, marketing may be granted on the basis of --scientific criteria concerning the Quality, Safety and Efficacy of the drug product. --without involving any patent law related issues.  The approach to harmonize regulatory and patent system brought in India by innovators, proved to be very inconsistent and created contradictions from case to case.
  • 19. At-Risk Entry: (US) Generic files ANDA along with Para-IV FDA has 60 days to accept this application Generic filer sends a notice to each of the patent owner and to the approved NDA holder Once the notice has been served, the patent holder has 45 days to sue the generic manufacturer This automatically triggers the 30 months stay of FDA approval to the ANDA If ANDA applicant/generic manufacturer prevails the litigation ANDA applicant receives a 180-day period of marketing exclusivity
  • 20. Licensing Option:  US Patent law does not explicitly provide for a CL (Compulsory License), but more than 100 licenses have been granted in special cases.  Provisions for CL were incorporated as amendment in 2002 in Indian Patent Act.  India granted its 1st CL on 9th March 2012 to Natco for Bayer‟s Anti-Cancer drug Nexavar.
  • 21. Amendments in Patents Act, 1970  Provisions of TRIPS agreements was implemented in 10 years in stages:  Jan 1 1995: (1999) Filing of Black Box applications Provision of Exclusive Marketing Rights  May 20, 2003: Uniform Patent term of 20 years from filing  Jan 01, 2005 Grant of product patents in all fields of technology including drugs, food and chemical substances  Procedural amendments  Patentability related amendments  Amendments related to remedial options for third parties at IPO  Administrative and other amendments
  • 22. Procedural amendments:  Time to file complete specification after provisional patent application – 12 months without extension.  Requirements under Section 8  Statement and undertaking regarding foreign filing and details of corresponding application till its grant.  Disclosure of details about objections issued by other patent offices in other countries.  Example: Cipla) Sutent case for Sunitinib (Pfizer/Sugen Vs
  • 23. Patentability related Amendments  Definition of Inventive step and Novelty inserted “Inventive step” means a feature of an invention that involves technical advancement 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;  “New invention” 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 patent application with complete specification, i.e., the subject matter has not fallen in public domain or that t does not form part of the state of the art;  Example: Sutent case for Sunitinib (Pfizer/Sugen Vs Cipla) Tarceva for Erlotinib (Roche Vs Cipla)
  • 24. Patentability related Amendments  Section 3(d): Non Patentability Criteria:  The mere discovery of a new form of a substance which does not result in enhancement of a known efficacy of that substance or the mere discovery of a new property or new use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.  Explanation: for the purpose 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 prior arts.  Examples: Glivec case for Imatinib mesylate (Novartis Vs Cipla)
  • 25. Amendments related to remedial options for third parties at IPO:  Pre-Grant or Post-Grant Oppositions  Grounds of Pre and Post Grant opposition are same.  Compulsory license:  At any time after the expiration of three years from the date of grant of a patent, any person interested may make an application to the Controller for grant of compulsory license on patent on any of the following grounds, namely: Non-availability or  Over priced or  Non-working in India  Example: Nexavar case for Sorafenib Tosylate (Bayer Vs Natco)
  • 26. Administrative and other amendments:  Enactment of IPAB- Specialized IP board (Intellectual Property Appellate Board)  Residents not to apply for patents outside India without prior permission and intimation.
  • 27. Landmark Litigations: 1. Glivec/ Imatinib mesylate – Novartis Vs Cipla 2. Nexavar/ Sorafenib – Bayer Vs Natco 3. Nexavar/ Sorafenib – Bayer Vs Cipla 4. Tarceva/ Erlotinib – Roche Vs Cipla 5. Sutent/ Sunitinib – Pfizer/Sugen Vs Cipla
  • 28. 1. Glivec/Imatinib mesylate  Indian Patent application #: 1602/MAS/1998  Date of filing: 17th July 1998 (via Black Box application)  Specification: this patent claimed β-crystalline form of Imatinib mesylate.  It distinguished the only physical properties of the β form as superior to that of α form.  According to sec-3(d), this is not patentable. (refer slide#24)  Though the claims were to focus on β form, a separate Divisional Patent Application was filed specifically claiming α form.
  • 29. 1. Glivec/Imatinib mesylate  Divisional Patent: is filed when a patent application contains more than one invention.  This divisional patent leads to EVERGREENING of patent, which keeps extending the term of patent, for every new divisional patent.  Evergreening is not preferred practice, since it hinders the technological advancement of developing countries.  Thus, both the patents were subjected to Pre-Grant opposition by Sun, Ranbaxy, Natco Cipla and Cancer Patients Aids Association.
  • 30. 1. Glivec/Imatinib mesylate  Controller of IPO rejected both the patent applications of Novartis being non-patentable under sec-3(d).  Novartis filed its improved efficacy data later, which was rejected on the basis of the Patents Act provision for „non-acceptance of later submitted data‟.  Novartis filed a WRIT petition against the controller‟s decision.  Case was transferred to IPAB, which also held the controller‟s decision and rejected the petition.  At present, Cipla is manufacturing its generic named „IMATIB‟.
  • 31. 1. Glivec/Imatinib mesylate  Current status: pending at supreme Court against interpretation of section-3(d).  Meaning of term „Efficacy‟ has been defined as „Therapeutic Efficacy‟.  Grant of patent applications of polymorph, salt etc has become tougher in India.  Later submitted data would not be accepted for overcoming Rejections under sec-3(d) subject matters.  For sec-3(d), data comparison is required which should be between known (improved) form of substance and claimed form of substance.
  • 32. 2. Nexavar/Sorafenib tosylate (Bayer Vs Natco)  Granted Patent #: IN215758  Post-Grant opposition by: Natco  1st CL was granted on 9th March 2012 to Natco.  Grounds on which CL can be granted:  Non-availability [sec-83(a)]  Over priced [sec-83(g)]  Non-working in India [sec-83(b)]
  • 33. 2. Nexavar/Sorafenib tosylate (Bayer Vs Natco)  In this case:  The patentee claimed to have manufacturing facilities in India for several products, including anti-cancer drugs.  Bayer imported in India a small quantity (only 2% of patient population) of Sorafenib and did not produce any pill in India. (non compliance to sec-83-(b))  Bayer could have granted voluntary license also.  Bayer also argued for low quantities requirement of the product in India, which was rejected by the controller.
  • 34. 2. Nexavar/Sorafenib tosylate (Bayer Vs Natco)  Bayer‟s Nexavar was priced 2,80,000 INR for monthly dose, which is obviously out of reach of any middle class man in India and where there is 40% population is living below poverty line.  On the basis of above reasons, the controller countered every objection raised by Bayer and granted CL to Natco under specific terms: > A sale price of 8,800 INR per month dose > Royalty to Bayer at rate of 6% on net sales.
  • 35. 2. Nexavar/Sorafenib tosylate (Bayer Vs Natco)  Though India amended its Patent act, didn‟t go accordingly with the TRIPS in this case. TRIPS Indian Patent Act According to article-27(1), there is no compulsion on patentee for local working to enjoy its right in the territory. There is non-discrimination between importation and local production. India amended its sec83(a) and (b) stating that, “the patentee shall be working in India and patent can not be granted for merely importing the product.
  • 36. 3. Nexavar/Sorafenib tosylate (Bayer Vs Cipla)  Date of filing: 5th July, 2001  Date of grant: 3rd March, 2008  Title: Carboxylated substituted Diphenyl Urea  Cipla announced its probable launch of generic Nexavar (Soranib) in April 2010. (because of no patent linkage system in India)  Bayer sued Cipla for patent infringement.  Cipla defended the case by arguing that Bayer‟s patent is invalid.  [Note: in most patent litigations, the defendant doesn‟t waste time on asserting non-infringement. Their line of defense is ONLY limited to challenging the VALIDITY of Patent.]
  • 37. 3. Nexavar/Sorafenib tosylate (Bayer Vs Cipla)  Grounds on which Cipla challenged the validity : 1. Lack of inventive step: there are 2 prior art documents filed by SUGEN and provide motivation to arrive at compounds structurally similar to Sorafenib.  Cipla said that plaintiff‟s invention is OBVIOUS to a person skilled in the art, to carry out trial and error with different substitutes.  Cipla would have to be careful about raising such defense so that it doesn‟t look like HINDSIGHT reconstruction or BIAS.
  • 38. 3. Nexavar/Sorafenib tosylate (Bayer Vs Cipla) 2. False suggestion/mis-representation: Cipla said that Bayer had suppressed 2 prior arts which disclose the similar compounds, from Patent Office. 3. Objection on Working the invention: Cipla said that Bayer did not manufacture the product in India. 4. Over Priced: Bayer‟s Nexavar costs 2,330 Rs/tablet, while Cipla‟s Soranib costs 230 Rs/tablet.
  • 39. 3. Nexavar/Sorafenib tosylate (Bayer Vs Cipla) 5. No technical advancement:  Cipla said that there is no technical advancement shown by the invention over what was already known. (sec-3d)  For fulfillment of sec-3(d), there must be a previously known compound with which one can compare the NEW FORM. E.g. new polymorph or a new salt with the same parent molecule.  But here Sorafenib compound.  Here, Cipla‟s argument is totally absurd, as sec-3(d) does not apply to this case. tosylate is altogether a new
  • 40. 3. Nexavar/Sorafenib tosylate (Bayer Vs Cipla)  The case is still in court.  Court rejected the permanent injunction on Cipla and permitted to manufacture and market its generic Soranib.  Decision is pending on validity of the patent.
  • 41. 4. Sutent/Sunitinib (Pfizer/Sugen Vs Cipla)  Patent #: IN209251  Grounds for Post-Grant opposition: 1. Invention is obvious and didn‟t include inventive step.  Cipla cited 3 prior arts US5886020, WO/9850356, WO/99/61422, disclosing very similar compounds, except for one difference in substitution and activity of all was same.
  • 42. 4. Sutent/Sunitinib (Pfizer/Sugen Vs Cipla) 2. Patentee failed to disclose information as required under sec-8.  This patent was identified in media as Pfizer Patent, while Pfizer is only the licensee.  Patent is actually owned by Sugen Inc. and Pharmacia & Upjohn.  Sugen failed to disclose before IPO, that the patent was licensed to Pfizer. 3. Non-availability:  Sugen imported only a mere 7000 units into India, where 500,000 people die of cancer every year.
  • 43. 4. Sutent/Sunitinib (Pfizer/Sugen Vs Cipla)  Controller ruled that “where there is a case based upon closeness of structure, then it is mandatory for the patentee to demonstrate that there are actual differences between the claimed compound and the prior art such that the invention as a whole is nonobvious.  Revocation of product patent of Sunitinib.  Final decision as per 29/11/2012:  SC returned the case to patent authorities to reexamine the patent.  SC also lifted the injunction granted by HC against restraining Cipla from launching its generic in market.
  • 44. 5. Tarceva/Erlotinib (Roche Vs Cipla)  Patent #: IN196774  Date of grant: September 2007  Tarceva by Roche: 4,800 Rs/Tablet  Erlocip by Cipla: 1,600 Rs/Tablet  Roche sued Cipla for infringement of their Tarceva Patent and demanded interim injunction on Cipla.  Cipla (again!!) challenged validity of the Tarceva patent.
  • 45. 5. Tarceva/Erlotinib (Roche Vs Cipla)  Interim injunction was refused by Delhi HC on the ground of public interest by decision. (mainly due to cost difference)  HC ordered Cipla not to export their generic to he countries where Roche has the Patent.  Final Verdict:  HC upheld the Tarceva patent valid.  At the same time, Cipla won the infringement case against Roche, as polymorphic form used by Cipla (Polymorph-B) was different than the Roche‟s Tarceva (A+B).
  • 46. Conclusions:  Examination of patents including product patent wrt inventive step would become more strict.  At the time of filing of patents, it would be required to incorporate data for substantial improvement over the known substance.  Provisional application provides priority to the disclosed subject matter only – Maximum disclosure is beneficial.  Non-disclosure of required subject matter and its supportive data within 12 months from provisional application may lead to loss of rights.
  • 47. Conclusions:  Improvement of the invention from prior art should be convincingly incorporated in patent application.  Compared to US and EP laws, Indian Patent Act is more stringent wrt subject matter and criteria of patentability.  If a patent application complies with all the requirements of Indian Patent Act, chances of the grant of patent in other countries become higher.  India govt. should provide subsidiaries and health insurance reimbursement to all patients for life saving and/or non-affordable dugs.
  • 48. Conclusions:  E.g. Alexion Pharma (USA) sells a drug – SOLIRIS that treats a very rare disease called PNH (Paroxysmal Noctural Haemoglobinurea).  Price: US$ 400,000 per patient per year  National Health Services (UK) agreed to reimburse the price of the drug.  Similarly, Australian govt. agreed to reimburse full price of the drug.  This led to increased productivity and life-quality of patients.  WIN-WIN situation for both Innovators and Patients.
  • 49. Post TRIPS Effects:  Contrary to negative perception, India survived the Post-TRIPS „Rough Weather‟ period most successfully.  The law-makers are making best use of the flexibilities permitted in TRIPS.  India acquired patent proficiency and Indian Pharma companies have moved onto globally dominant position at least as the leader of generic medicines.  Domestic Pharma industries are taking preventive and defensive measures as well as offensive where the patents are vulnerable.
  • 50. Post TRIPS Effects:  The practice of new Patent Regime directed the Indian Pharma companies to regulated markets with Largest number of USFDA and EMA approved manufacturing sites.  Large number of DMF/ANDA filings and approvals.  With increased govt. funds, the Indian Pharma industry is gearing up for entering the Drug Discovery Band Wagon.  Pharma MNCs are facing increased competition for new molecules from India-based generic companies.
  • 51. Post TRIPS Effects:  Indian Pharma companies have generated „Largest New Drug Pipeline‟ among generic companies worldwide.  Innovators are witnessing growth in generic drug industry and possible decline in revenue due to some blockbuster drug patent nearing expiry.  Thus, innovators have turned towards M&A activities to retain their monopoly also in the generic market. E.g. Pfizer with Aurobindo and Novartis with Sandoz.  Few Contract Drug Discovery initiatives have been triggered: ADVINUS, SUVEN…
  • 52. Post TRIPS Effects:  Availability of new life saving drugs in developing countries and LDCs.  Availability of affordable generic drugs of the same life saving innovators‟ drugs due to best use of flexibilities under TRIPS.  Due to „Working‟ provision for the innovators for their patented drugs, technology transfer has been triggered to less developed nations, leading to technological development.  Establishment of TKDL (Traditional Knowledge Digital Library)
  • 53.  84. Compulsory licences.(1) At any time after the expiration of three years from the date of the sealing of a patent, any person interested may make an application to the Controller alleging that the reasonable requirements of the public with respect to the patented invention have not been satisfied or that the patented invention is not available to the public at a reasonable price and praying for the grant of a compulsory licence to work the patented invention.  (2) An application under this section may be made by any person notwithstanding that he is already the holder of a licence under the patent and no person shall be estopped from alleging that the reasonable requirements of the public with respect to the patented invention are not satisfied or that the patented invention is not available to the public at a reasonable price by reason of any admission made by him, whether in such licence or otherwise or by reason of his having accepted such a licence.
  • 54.  (3) Every application under sub- section (1) shall contain a statement setting out the nature of the applicant' s interest together with such particulars as may be prescribed and the facts upon which the application is based.  (4) In considering the application filed under this section the Controller shall take into account the matters set out in section 85.  (5) The Controller, if satisfied that the reasonable requirements of the public with respect to the patented invention have not been satisfied or that the patented invention is not available to the public at a reasonable price, may order the patentee to grant a licence upon such terms as he may deem fit.  (6) Where the Controller directs the patentee to grant a licence he may as incidental thereto exercise the powers set out in section 93.