Pharma Patent Law and Recent Trends - India
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Pharma Patent Law and Recent Trends - India / A presentation by Dr. Kalyan C Kankanala and Mr. Vikram Pratap Singh Thakur

Pharma Patent Law and Recent Trends - India / A presentation by Dr. Kalyan C Kankanala and Mr. Vikram Pratap Singh Thakur

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Pharma Patent Law and Recent Trends - India Presentation Transcript

  • 1. Dr. Kalyan C. Kankanala Vikram Pratap Singh Thakur © 2011 BananaIP
  • 2.  Patent Act  First Patent legislation - Act VI of 1856  Patent Act, 1970 (brought into force w.e.f. 20th April, 1972)  Patents (Amendment) Act, 1999  Patents (Amendment) Act, 2002  Patents (Amendment) Act, 2005  Patent Rules  Patents Rules, 1972 (brought into force w.e.f. 20th April, 1972)  Patents (Amendment) Rules, 2005  Patents (Amendment) Rules, 2006  Patent Manual  Draft Patent Manual 2010 © 2011 BananaIP
  • 3.  From 1.1.1995  Mail-Box for pharmaceutical and agrochemicals products  Exclusive Marketing Rights  From 1.1.2000  Patent term increased to 20 years  Definition of invention – inclusion of inventive step  Right of patentee (importation also included)  From 1.1.2005  Product patents for food, chemical and pharmaceutical © 2011 BananaIP
  • 4.  Subject matter  Industrial applicability  Novelty  Inventive step  Specification © 2011 BananaIP
  • 5.  Patentable Subject Matter  Product or process  Non Patentable subject matter  3 (d)  New form  Efficacy  New property or new use  Mere use of a known process  New product  New reactant  Explanation- 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.  efficacy © 2011 BananaIP
  • 6.  Imatinib Masylate  beta crystal form of Imatinib Masylate, which is non-needle shaped, having better flow properties, thus better processible, less hygroscopic and more thermodynamically stable, thus better storable than its needle shaped, alpha crystal form,  Pre grant opposition  Increased efficacy (therapeutic effect in healing a disease)  Challenged constitutional validity of sec. 3(d)  Not vague, ambiguous and arbitrary  Section along with explanation – clear and has inbuilt measures to guide controller © 2011 BananaIP
  • 7.  Non Patentable subject matter  3 (e)  Mere admixture  Aggregation of properties  Synergistic effect © 2011 BananaIP
  • 8.  capable of industrial application  Test  Make  Repeat  Use © 2011 BananaIP
  • 9.  Anticipation:  Public knowledge or public use  Exemption - Secret use  Prior publication  Wrongful obtainment  Govt.  Learned society  Grace period  On sale  Reasonable trial  Public display  Central govt. notified exhibition  Grace period  Public working  Reasonable trial  Grace period © 2011 BananaIP
  • 10.  Technical advance as compared to the existing knowledge ; or  having economic significance; or  both  not obvious to a person skilled in the art © 2011 BananaIP
  • 11.  Human epidermal growth factor type 1 / epidermal growth factor receptor (Her/Egfr) inhibitor popularly known as Erlotinib  Clarified the concept of inventive step  Test of obviousness– whether in light of prior art, it was possible for a normal but unimaginative person skilled in the art to discern the inventive step of the invention on the basis of general common knowledge of the art at the priority date.  Whether the differences between the prior art would, without knowledge of the alleged invention, constitute steps which could have been obvious to the skilled man or whether they required any degree of invention © 2011 BananaIP
  • 12.  Written Description  Enablement  Best mode  Claims © 2011 BananaIP
  • 13.  Novartis patent IN212199 claiming single-pill combination of aliskiren and valsartan marketed as Valturna rejected  Post grant opposition by Sun pharma  lack of inventive step, insufficient disclosure, not an invention and non-patentable under the Act  Claims amended  None of examples exemplified the compositions of amended claims. © 2011 BananaIP
  • 14. Filing Publication 18 months FER Putting app in order for grant 6 months 12 months Request for Examination © 2011 BananaIP
  • 15.  Pre grant  Post grant © 2011 BananaIP
  • 16.  Bayer’s IN/PCT/2002/410/CHE claiming contraceptive formulation of drospirenone and ethinylestradiol (EE) marketed as Yasmin and Yaz/Yasminelle in Europe and the US refused  Opposed by cipla and natco  The decision was more or less influenced by the District Court and the CAFC decisions in Bayer Schering Pharma AG v. Barr Laboratories, Inc. which held US6787531 obvious and invalid.  Equivalent of ‘531 patent  “obvious-to-try” test © 2011 BananaIP
  • 17.  Literal infringement  Infringement by equivalence  Substantial equivalence test © 2011 BananaIP
  • 18.  Lallubhai Cakubhai Jariwala v. Chimanlal Chunilal  Process of treating dry fruits  Sulphuric acid – washing soda  3% bleaching solution – 4 and 2 % bleaching solution  Acetic acid – Muriatic acid  Sulphur dioxide fumes under presssure – sulphur dioxide fumes without pressure © 2011 BananaIP
  • 19.  Patent invalid  Govt. use  Research exemption  Parallel imports © 2011 BananaIP
  • 20.  Section 84  Application for compulsory license  (a) that the reasonable requirements of the public 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 in the territory of India. © 2011BananaIP
  • 21.  Compulsory license for export  Country having Insufficient or no manufacturing capacity in pharma sector to address public health problem  Such Country  Granted compulsory  Allowed importation © 2011 BananaIP
  • 22. © 2011 BananaIP
  • 23.  Traditionally this communication was treated by the patent office as confidential  Complete Specifications of only granted patents were available  As per notification of April 15, 2010; patent office to supply upon request all correspondence between the applicant and patent office  Helpful for pre grant opposition © 2011 BananaIP
  • 24.  Well accepted principle internationally  No case supporting the principle in India  Making available the entire prosecution history on request may lead towards PHE © 2011 BananaIP
  • 25.  Patent application for a molecule used in the treatment of diabetes  First Examination Report  “…The molecule lacks novelty and inventive step because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.” © 2011 BananaIP
  • 26.  Applicant responds by giving a detailed explanation of differences between the extract disclosed in the text and the molecule.  Applicant further states that a hearing must be given before making an adverse decision.  Second Examination Report-  “…The molecule lacks novelty and inventive step because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.” © 2011 BananaIP
  • 27.  First Examination Report  “…The molecule lacks novelty and inventive step because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.”  Second Examination Report-  “…The molecule lacks novelty and inventive step because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.” © 2011 BananaIP
  • 28.  Not a speaking Order  Hearing must be given- adherence to principles of natural justice  Magical Sentence- “Kindly provide hearing in case of adverse decision on the application.”  Valencia CTT v. Union of India (decided on 26th Feb 2010) © 2011 BananaIP
  • 29.  Abandonment  Application considered abandoned if all requirements not complied with  Cannot be appealed  Refusal  General power of the Controller to Refuse  Can be appealed  Patent Office Practice-  Application abandoned whether reply to examination report filed or not. © 2011 BananaIP
  • 30.  Ericsson v. UOI (Decided on March 11, 2010)  29th July 2005- Ericsson filed national phase patent application  8th October 2007- First Examination report issued and defects pointed out which was replied on 10th Dec. 2007  25th July 2008- Another examination report sent by controller restating points already mentioned in first information report. Replied on 22nd Sept 2008  10th October 2008- Patent office wrote a letter to the petitioner stating that despite response of the petitioner on 22nd September 2008, the specification of the petitioner was still defective on various grounds and the application was deemed to be abandoned under section 21(1). © 2011 BananaIP
  • 31. Delhi High Court Held: Abandonment- When reply to examination report is not filed at all. Refusal- If reply is filed then the application cannot be abandoned and has to be refused. © 2011 BananaIP
  • 32.  Bayer Corporation v. Union of India  Decided on 9th Feb 2010  CIPLA filed for a drug license for the generic drug ‘Soranib’.  Bayer corporation sent a letter to the drug controller requesting him not to grant approval as Bayer holds a patent on ‘Sorafenib Tosylate’ and Soranib is a substitute of their patented drug.  Drug Controller granted the drug license. © 2011 BananaIP
  • 33.  Bayer filed a petition in the Delhi High Court against the approval granted by the Drug Controller.  Bayer’s contention- If drug controller had previous knowledge of potential patent violation he should not grant approval.  Decision- Drug Controller doesn’t have to travel beyond the scope of Drugs & Cosmetics Act and rules. Shouldn’t refuse license on the pretext of possible violation of a patent. © 2011 BananaIP
  • 34.  2010 Patent draft manual released  Scientific advisors  Application status search available  TKDL involved in rejection and withdrawal of patent application © 2011 BananaIP
  • 35. © 2011 BananaIP