OPPOSITION AND REVOCATION OF PATENT

PRESENTED BY: RAHUL KUMAR M.PHARMA (PHARMACEUTICS)

BITS PILANI RAJASTHAN

CONTENTS

• OPPOSITION• PREGRANT OPPOSITION [section 25 (1)]• POST GRANT OPPOSITION[section 25 (2)]• REVOCATION • REFERENCES

OPPOSITION AND REVOCATION

• Pre grant Opposition: Right to oppose grant of a patent

• Post grant Opposition: Request to revoke a granted patent within one year of grant of patent. • Revocation: Terms beyond post-grant opposition.

Description Pre-grant Opposition 25(1) Post-grant Opposition 25(2)

Hearing No procedure for Hearing Procedure as detailed in R. 62

Relief

Form

Rejection of Application

No prescribed form

Revocation of Patent

Form 7

Fee

Time limit

No Fee

Within 3 month after publication

Rs.1500/- for Individuals and Rs.6,000/- for Legal EntityOne year within grant of patent

Costs

Appeal

No provision for costs

In IPAB

Cost can be awarded under R.63In IPAB

Content of opposition:

There is no prescribed form for pre grant opposition Comprise of following particulars:

1. Statement regarding opposition2. Evidence regarding opposition; (if any)3. Request for hearing (Optional).• Procedure:The Controller shall forward the Representation to the applicant.Hearing, if requestedController’s decision

Case Study

Positive Women’s Network vs Boehringer Ingelheim

• Plaintiff: Positive Women’s Network and the Indian Network for People Living with HIV/AIDS in 2006•Defendant: German pharmaceutical company Boehringer

Ingelheim • Product : Nevirapine syrup

• The opposition argued that the syrup formulation of nevirapine was a new form of a known drug first invented in 1989, and thus older than the 1995 cut-off that India’s Patents Act considers eligible for patenting. • Pharmaceutical companies make variations to existing

medicines in order to extend their monopolies for as long as possible – a tactic called ‘evergreening.’ • To extend its patent monopoly to 2018, Boehringer in

1998 applied for patents on the syrup formulation of nevirapine in many developing countries, including India.

•Verdict: Accused under 3d•Post grant Opposition:•Person Interested•Hearing •Fix tenure

Case study Roche's vs Cipla

Plaintiff: Cipla Defendant: Roche's osteoporosis drug Bonviva (ibandronate sodium ) The dispute was on patent number 208718, for an oral drug used to treat osteoporosis, in which the active medicine is released uniformly and almost completely within 30 minutes, controlling its dissolution rate.

• The patent application was filed on April 3, 2001 and patent was granted by the Patent Office on August 7, 2007.• Cipla filed its post-grant opposition on September 2008 and the

Patent Office dismissed the opposition on August 26, 2010, upholding the patent. • Cipla moved an appeal in the IPAB, seeking a relief.

• IPAB set aside the order, stating: “The Controller has not at all considered, discussed and appreciated the expert evidence of Cipla and the expert of Roche and the Controller has also miserably failed to assign the reasons for deviating the opinion of the opposition Board.” • Following the IPAB order, the Assistant Controller of

Patents and Designs considered the matter afresh and issued an order on December 19, 2014.

• The order said: "...Considering all the relevant documents and pleadings of both the parties, expert evidences, opposition board recommendations and in view of my findings above, the opponent has succeeded on the grounds under section 25(2)(e) and 25(2)(f) of the Patents Act, 1970, and hence the granted Patent 208718 is hereby cancelled. There is no order to costs."

• Cipla was represented by S Majumdar & Co, while Roche was represented by De Penning & De Penning

Revocation of patents

Apart from challenging the grant of patent or opposing the granted patent under sections 25 (1) and 25 (2), another opportunity to file petition- Revocation of patent.

Section 64, (36) Indian Patent Act, 1970.

Patent may be revoked anytime during the life of patent by any person interested.

Unlike post grant opposition, revocation of patent is not a time bound procedure

Who can file revocation

Person interested in the appellate boardThe Central Government

The High Court has the power to settle disputes between the patentee and the central government.

Form 19

Grounds for revocation of patent:

Claimed in complete specification of another patent which is valid and claims earlier priority date.

Not following PATENTIBILITY criteria as per the act.Fall under section 8 ,99,65 & 66

Case study

Cipla vs Boehringer Ingelheim • Plaintiff: Cipla• Defendant: German major Boehringer Ingelheim • Product Name: Spiriva (tiotropium bromide monohydrate)• Verdict: The patent was revoked on grounds that it lacks inventive

step, fails to demonstrate therapeutic efficacy as well as requirements of Section 3 (d).

Thank you all !