pre-grant & post-grant opposition_ PPT

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prepared by Surendra IPM

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Patents Act 1970 CHAPTER V OPPOSITION PROCEEDINGS TO GRANT OF PATENTS Section 25 Opposition to the patent 1 Surendra Tr. Chemist - IPM 9/11/2015

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CONTENTS WHAT IS PATENT OPPOSITION..?? TYPES OF PATENT OPPOSITION GROUNDS FOR OPPOSITION PRE GRANT OPPOSITION POST GRANT OPPOSITION DIFFERENCE BETWEEN PRE GRANT AND POST GRANT OPPOSITION NOVARTIS GLEEVEC UNDER CHANGING SCENARIO CONCLUSION REFERENCE 9/11/2015 2

WHAT IS PATENT OPPOSITION..??:

WHAT IS PATENT OPPOSITION ..?? The Indian patent office also provides a period during which third parties may oppose the grant of patent. Opposition proceedings may be Pre-grant/Post-grant and may be initiated within specified time limits Types of patent opposition Pre grant Opposition [Section 25(1)] Post grant Opposition [Section 25(2)] 9/11/2015 3

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GROUNDS FOR OPPOSITION The grounds on which the opposition can be filed are provided under section 25 of the Patents Act 1970. The grounds on which opposition may be filed can be summarized as follows : a ) Invention wrongfully obtained U/S 25(a ); b) Invention has been published before the priority date of the claim U/S 25(b ) ; c) Prior claim U/S 25 (c ); d) Invention publicly known or publicly used U/S 25(d ) ; e) Obviousness and lack of inventive step U/S 25(e ) & 2(j) f) Not an invention or not patentable U/S 25(f ) ; 9/11/2015 4

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g) Insufficiency of description U/S 25(g) h) Non-disclosure of information U/S 25(h ) ; Time-barred applications U/S 25(I)&25(1 )(I ) ; j) Non-disclosure of source of biological material U/S 25(j ); k) Invention anticipated by local knowledge U/S 25(k ) ; 9/11/2015 5

Pre grant Opposition:

Pre grant Opposition [Section 25(1)] Upon publication but before the grant of patent, any person, based on different grounds may file a pre grant opposition, in writing, represent by way of opposition to the Controller against the grant of patent. However the opposition will be taken by the patent office only after the filing of Request for Examination . Time limit: May be filed within 3 months from the date of publication of the application [sec 25(1); rule 55(1)] or Before the grant of patent, whichever is later . Fee: NO FEE Form and Content [Rule 55(1)]: Form 7A along with the representation comprise of following particulars: 1. Statement regarding opposition; 2. Evidence regarding opposition; (if any) 3. Request for hearing (Optional). 9/11/2015 6

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Appeal: An applicant can go for an appeal against the decision of the Controller. Such an appeal can be filed in the Intellectual Property Appellate Board (IPAB). 9/11/2015 7

POST GRANT OPPOSITION:

POST GRANT OPPOSITION [Section 25(2)] Upon grant of patent any interested person, based on different grounds may file a post grant opposition in Form 7 to the Controller against the grant of patent . Time limit: [Section 25(2)] Within one year after the grant of a patent . Form and Content: 1. Notice of opposition shall be in Form 7 (in duplicate) [Rule 55A]; 2. Written Statement setting out nature of the interest (in duplicate) [Rule 57]; 3. Evidence regarding opposition; 4. Statutory fees; 5. Request for hearing (Optional ). 9/11/2015 8

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Appeal: An applicant can go for an appeal against the decision of the Controller. Such an appeal can be filed in the Intellectual Property Appellate Board (IPAB). 9/11/2015 9

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PRE-GRANT OPPOSITION POST-GRANT OPPOSITION Form 7A Form 7. Within a time period atleast 3 months form date of publication of application Within 1 year after the grant of the patent No fee Statutory fees for notice of opposition for Physical Filing:-2, 640(N), 6, 600(S) & 13, 200(L) E-Filing:-2, 400(N), 6, 000(S)& 12, 000(L) Any person can file opposition Only interested person can file opposition Infringement proceedings can not be initiated as patent is still in application stage Infringement proceedings can be initiated N :- Natural person, S :- Small Entity & L:- Large Entity DIFFERENCE BETWEEN PRE GRANT AND POST GRANT OPPOSITION 9/11/2015 10

Novartis gleevec under changing scenario:

Novartis gleevec under changing scenario Important clauses: Mailbox/EMR Novel form of known substance….i.e. section 3(d) Gleevec Case History 9/11/2015 11

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In 1993 Novartis filed a patent for a free base called “Imatinib” ß-crystalline version of one of the salt of Imatinib(Imatinib mesylate)……Treatment of CML The corresponding drug was sold by the name Gleevec. unavailability of product patent, Novartis filed a mailbox application on July 17, 1998. 2001 Novartis AG received USFDA approval for Gleevec to treating myeloid leukemia. 2003 Gleevec was granted EMR in the Indian market. April 4, 2005: Indian Patent Act, 1970 was amended September 2005: CPAA filed a Pre-grant opposition to Novartis patent application in Chennai patent office on several grounds such: 9/11/2015 12

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January 2006: Patent controller rejected Novartis AG’s patent application holding that the b-crystal form of Imatinib mesylate is: Not novel, Does not Involve an inventive step Is a crystalline form (Imatinib mesylate) of an already known substance (Imatinib) with no significant difference in efficacy . Madras High Court On 17 May 2006 Novartis challenged controller’s order & provision of Indian patent law by filing writ petitions Madras high court. The high court transferred the first petition to IPAB & dismissed both the writ petitions. However IPAB agreed with patent controller that it was hit by section 3(d) and rejected patent application Then Novartis filed the special leave petition in Supreme Court . On 01 April 2013, supreme court rejected Novartis appeal by stating that Gleevec fails in both the test of invention and patentability as provided under clauses Section 2(1)(j), ( ja ) & 3(d) respectively of Indian patent Act. 9/11/2015 13

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CONCLUSION The most drawback of Indian pre-grant opposition is that competitors can file wrong notice of opposition and by delaying the grant of patent and subsequently shortening the lifetime of patent. It is a significant problem in pharmaceutical patents. In international treaties (Paris Convention, TRIP S and PCT) there has not been provided obligation for members to set up opposition system. In the Indian patent system, an opponent may participate in challenging the patent in all existing processes (both opposition systems as well as revocation) with the same grounds of opposition, one after the other if he fails in each stage. 9/11/2015 14

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Reference Indian patent act, 1970 ( http://ipindia.nic.in/ipr/patent/eVersion_ActRules/sections-index.htm ) THE PATENTS RULES, 2003 ( http:// ipindia.nic.in/ipr/patent/eVersion_ActRules/rules-index.htm ) 2) HANDBOOK ON PATENT FILING PROCEDURES ( http:// www.patentwire.co.in/images/Handbook.pdf ) PATENT OPPOSITION; AN ANALYSIS BASED ON INDIAN, EPC AND UNITED STATES PATENT SYSTEM by Taghi Amani SSRANA ( http://www.ssrana.in/Intellectual%20Property/Patents/Patents-Lawyers-Patents-Agents-Attorneys-Patent-Law-Firms-In-Delhi-India.aspx ) 9/11/2015 15

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