INTRODUCTION:
Indian Patent Act 1970, offers provision to community to raise objection against grant of patent by filing opposition with patent office. There are two types of oppositions:
1) Pre-grant opposition: Opposition can be done before the grant of patent.
2) Post-grant opposition: Opposition can be done after the grant of patent.
Here, we are focusing on post-grant opposition in India.
POST-GRANT OPPOSITION:
A Post-Grant opposition in India is described in Section 25(2) of the Patents Act, 1970. This section explains the meaning, grounds and procedure for commencing an opposition proceeding in India.
Grounds for opposition under section 25 (2) of the Act:
a) Invention obtained wrongfully.
b) Prior publication.
c) Prior claiming.
d) Publicly known or used in India before filing.
e) Obviousness and clearly does not involve any inventive step.
f) Non patentable subject matter as per Act.
g) Insufficient disclosure.
h) Failure to disclose information under section 8 of the Act.
i) In case of a convention application, the patent application in India was not filed within 12 months of filing the first application in the convention country.
j) Non-Disclosure or wrongful disclosure of the source or geographical origin of the biological material as used in the invention.
k) The invention is anticipated as traditional knowledge of any local or indigenous community in India or anywhere in the world.
Procedure for Post-grant opposition:
Rules 55A to 70 of Patent Rules, 2003 explains the procedure for a post-grant opposition.
- As per rule 55 A, after the grant of patent but before expiry of period of 1 year after publication of grant of patent, any “interested person” may file post-grant opposition by filling Form 7 in duplicate along with fees, mentioned under Second Schedule of the Patent Rules, 2003 on the grounds listed in Section 25(2) of the Patent Act, 1970.
Fees for filing Post-grant opposition: (First Schedule of Patent Rules, 2003)
1) For e-filing: 2400 (natural person and small entity), and 12000 (others, industry person, start-up).
2) For the physical filing: 2600 (natural person and small entity), 13200 (others, industry person, start-up)
- The representation for post-grant opposition must be filed at patent office at which application is filed. Representation must include statement and supporting evidences.
- A copy of the statement and evidence shall be delivered to the patentee by an opponent.
- The Controller shall notify to the patentee about such notice.
- The patentee within two months of the receipt of the opponent’s statement and evidence, can file a reply along with the evidence supporting his invention.
- If the patentee does not want to contest the opposition and does not file a reply within two months, then the patent is considered to be revoked.
- If a reply has been filed by a patentee then, within one month of filing reply by the patentee the opponent can file his reply and evidence. No further reply will be submitted by either party, except on the direction of the controller.
- As per rule 56, once the Controller receives notice of pre-grant opposition, he shall establish an ‘Opposition Board’ comprising 3 members. One of the member is the chairman, second may be an examiner but not the same examiner who has dealt with the application.
- The opposition board shall examine the all statements and evidences of both parties and issue a report with reasons regarding each ground challenged by the opponent.
- As per Rule 62, any party who wishes to be heard must send a request for hearing to the Controller.
- The Controller shall fix the date of hearing and notify to both parties at least 10 days in advance. The member of opposition board must be present at the time of hearing.
- Upon considering all statements and evidences and taking into consideration the recommendation made by the Opposition Board, the Controller may:
- Reject the post-grant opposition and maintain the patent or;
- Require the amendment of the patent specification or other documents or;
- Accept the post-grant opposition and Revoke the patent.
- The final decision must be communicated to both parties by the Controller.
The decision of the Controller can be appealed within 3 months from decision. Earlier, such appeal can be made to IPAB. Now the IPAB board is abolished so applicant can appeal to High Court.
Cases related to post-grant opposition:
1) Sugen, Inc. USA vs Cipla limited, Mumbai
- A PCT application was filed on August 09, 2002 for the drug Sunitinib, which is used to treat gastrointestinal tumor and patent was granted on August 23, 2007 Cipla filed post grant opposition for Sugen’s patent.
- Cipla had used four basic grounds to oppose the patent:
(a) Claimed invention was publically used in India before priority date of claim;
(b) Invention as claimed is obvious and did not include an inventive step;
(c) Subject matter of any claim of the patent is not an invention within the meaning of the [Indian patent] Act; and
(d) Patentee failed to disclose information as required under section 8 of the patent act.
Cipla dropped grounds of section 8 and prior use and argued on the grounds of obviousness and lack of inventive step in view of cited documents.
- The controller revoked the patent as it does not involve inventive step and is obvious to skilled person in the art hence not patentable under section 2 (1) (j).
2) Novartis AG & Anr vs. Natco Pharma Limited
- Swiss Pharma major Novartis was granted a patent for novel and inventive patent compound “Ceritinib”, a drug meant for the treatment of non-small cell lung cancer. The patent application was filed as a PCT (Patent Cooperation Treaty) application claiming priority since 2007 and was granted a patent on 28 September 2015.
- Novartis came across NOXALK (Natco Pharma’s product) at a pharmaceutical conference at Kolkata and noticed the launch of “Ceritinib Capsules.”
- Novartis filed a case in High court against Natco Pharma seeking a permanent injunction, damages, rendition of accounts, and delivery up in respect of its granted patent and restraining Natco Pharma from manufacturing and selling “Ceritinib” capsules.
- Natco Pharma claimed that the Ceritinib molecule is neither novel nor inventive as it is covered under the broad “Markush” formula which is disclosed in the patent granted to AstraZeneca nor two other patents granted to Rigel. Based on such contentions, Natco Pharma opposed Novartis’s patent by post-grant opposition.
- The controller revoked the patent as it does not involve inventive step and is obvious to skilled person in the art hence not patentable under section 2 (1) (j).
- The Delhi High court lifted its injunction against Natco, allowing it to manufacture generic versions of Ceritinib. Novartis then appealed to the IPAB, which has stayed the revocation order.
- IPAB has stayed the revocation of the patent as the Controller’s order was based on additional evidence filed by Natco (on 4th April) after the fixing of the hearing.