PRE-GRANT OPPOSITION

Ganesan

ABOUT FEROZ ALI

Founder of Ali Associates Advocate L.L.M Books

Touchstone effect Law of Patents

http://www.fastreporter.org/

INNOVATION

All swans are white

Australia Black swan Prediction of

Rarity Extreme Impact Retrospective Predictability

Google, Cellular Phone

next Big Thing killer innovation Serendipitous discovery

what you do not know far more relevant than what you do
Black Swan Protected by patent - Pharma

INNOVATION

Innovation refers the process of bringing out patentable inventions. Legal vs Management Technological Innovation can be:

Radical innovation Eg. Post-it Incremental innovation Eg Colour, Shapes

Innovation as the effort to create purposeful focused change in an enterprises economic or social potential-Peter Drucker
Every serendipitous discovery qualifies for a radical or Black Swan Innovation.

Penicillin was discovered serendipitously. The same is true about Pfizers anti-impotence drug, Viagra (sildenafil citrate), which was initially used for treating hypertension and angina pectoris.

INNOVATION

Pharma Industry
Patent Blockbuster Drug off patent Decrease in pipeline tendency to paint a white swan black or to repaint a faded old Black Swan Evergreeing

Touchstone Opposition
Pre-grant Post grant

PRE-GRANT OPPOSITION REQUIRED?

Statement from Mr Venu MD TVS

the company lost about Rs 120 crore in sales because of the delay in launching the Flame

Bajaj sued it for patent infringement of its twin-spark plug technology IN195904 The experts at TVS knew about Bajajs patent application and yet did not oppose. Thought that it wouldnt grant.

Pregrant Opposition doesnt cost much. But not initiating one

does.

PATENT DISPUTE RESOLUTION SYSTEM

Source; Evalueserve

Flow

Filing new application Publication

Request for Examination

Pre-Grant Opposition
after publication of the application and until grant of the Patent S25(1)

First Examination Report

Reply to Examination Report

In Order for Grant

Publication of Grant Post Grant Opposition
1 year from the date of publication of grant S25(2)

Issuance of Letters Patent Document Payment of Annuities

PRE-GRANT OPPOSITION ADVANTAGE!

No Form No Fee Simplified Procedure Burden of Proof is not on opponent Amicus Brief (friend to patent office) Use to prevent grant of frivolous patent Not appealable no clear mechanism Any person can file Section 25(1) Rule 55

GROUNDS SEC25(1)
Section 25(1) begins as follows: Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground a-k And concludes thus: but on no other ground, and the Controller shall, if requested by such person for being heard, hear him and dispose of such representation in such manner and within such period as may be prescribed.

GROUNDS - SEC 25(1)

Wrongful obtainment of the invention by the inventor. Publication of the claimed invention before the priority date. Block Box application Sale or Import of the invention before the priority date. Public use or display of the invention. The invention doesnt satisfy the patentability requirements. Disclosure of false information to patent office. Application for the invention is not filed within twelve months from the date of convention application. Nondisclosure or wrongful disclosure of the biological source. Invention is anticipated by traditional knowledge. Section 25(1)

FLOWCHART

SOME FACTS

i) The total number of pharmaceutical applications filed between 2005 and 2008 were around 9719. ii) The number of pharmaceutical patents granted during the above time frame was around 2734. iii) Of the 9719 pharma applications filed, only 34 were challengedan abysmal .3%!

iv) Out of the 34 challenges, one was a post grant oppn (in favour of Roche covering Pegasus) and the remaining 33 were pre-grant challenges.
v) 25 out of 34 oppositions resulted in rejections i.e. a significantly high ratio of 73.5%! The patent applicant won in only 9 cases (9/34 or 26.5% of the time)

v) 20 out of the 25 rejections above were based on section 3(d). In other words, 80% of the rejections were based on section 3(d), indicating the "efficacy" of this controversial section.

WRITING PREGRANT OPPOSITION

TEMPLATE 1 TEMPLATE 2

SECTION (8)

Valganciclovir Section (8) with information about any foreign application(s) Form 3 six month Rule 12 Breach of Trust if not filed Roche had failed to disclose the information which it was required to submit within the specified time to the patent office under s.8 of the Patents Act and so fell under the ground mentioned in s.25(1)(h) of the Act. non-compliance of this requirement forms a ground of pre-grant opposition under s.25(1)(h), post-grant opposition under s.25(2)(h) and revocation under s.64(1)(m) any irregularity in procedure which the Controller may choose to ignore if it is not detrimental to the interests of any person Rule 137

PERSON INTERESTED

any person under s.25(1) person interested under s.25(2)? Are they same? person interested includes a person engaged in, or in promoting, research in the same field as that to which the invention relates s 2(t) primary distinction between a pre-grant opposition and a post-grant opposition is that the former is not a proceeding inter partes. This means that it is not a proceeding between the pre-grant opponent and the applicant for a patent. primary respondent in an appeal to the IPAB from the rejection of a patent application in a pre-grant opposition is the Controller or the Assistant Controller and not the pre-grant opponent, whereas the primary respondent in an appeal from a post-grant proceeding is the post-grant opponent NGO pregrant not every pre-grant opponent can qualify as a person interested under Section 25(2).

SUFFICIENCY - SPECIFICATION
S (10) of Patent act 1970 S 10 (4) Every complete specification shall(a) fully and particularly describe the invention and its operation or use and the method by which it is to be performed; (b) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; and (c) end with a claim or claims defining the scope of the inventions for which protection is claimed. 190/MAS/1998

Sec 3(d)

enhancement in efficacy in terms of Section 3(d) requirement is to be interpreted as therapeutic efficacy for drug patents Factors do contribute to efficacy

Bioavailability; side effects; Response time; treatment period; Stability

During prosecution, production of evidence in the form of Preclinical/clinical or experimental data supplemented by technical affidavit will be helpful

APPEALABLE

UCB Farchim SA v Cipla Ltd S-77 confers the power of a civil court on controller

CAN BE FILED ANY TIME BEFORE GRANT

869/DEL/2002

Pre-grant filed after amendment in claim Till Grant Snehalatha vs UOI grant of a patent vs the issue of the certificate vs publication of grant Serial opposition Abuse ? Safeguard Innovator right

CASE STUDY

2485/DEL/1998

Nevirapine Hemihydrate

relates to the suspension form of Nevirapine used in the manufacture of pediatric dosages. patent application filed by Boehringer Ingelheim Pharmaceuticals

opposition filed by Positive women Network and Indian Network for People living with HIV/AIDS Decision of the Controller

Application rejected on the following grounds

lack of inventive step as the aqueous suspension of Nevirapine hemihydrate can be prepared in a customary manner. It is a combination of known substances with evidence to show enhanced efficacy. This squarely falls under Section 3(d) new forms of known substances includes combinations That it is a mere admixture resulting in aggregation of properties. [Section 3(e)]

CASE STUDY

Astra Aktiebolags Application (print)

CASE STUDY
OSI Pharmaceuticals Application Process Patent IN/PCT/2002/00497/DEL

CASE STUDY
Wockhart vs Cipla 308/MUM/2002

CASE STUDY

Geftinib

CASE STUDY

537/DEL/1996 QUINAZOLINE DERIVATIVES COMPOUNDS AND COMPOSITION THEREOF

CASE STUDY

1255/DEL/1995

Sec 5(2) Mail Box application Process claim

CASE STUDY

Gleevac

CASE STUDY
413/MUM/2003 Clopidogrel vs Glochem Hearing Sec 3(d)

CASE STUDY

Gleevac

ROLE OF IN-HOUSE IPM

Monitor regularly and find the application relevant to your business Review the specification and claim Search for prior art/publications relating to the claimed invention (IPER, equivalent U.S patent, science journals, in-house knowledge). Draft representation in suitable format and if require support using Affidavits/ expert witness statements.

Submit the representation at the patent office where the application was filed.

POST GRANT OPPOSITION

[Section 25(2)] Upon grant of patent, any interested person, based on different grounds may file a post grant opposition Form 7

Time limit: Within one year after the grant of a patent.

Statutory Fee

Natural person is Rs.1,500 for other than natural person is Rs.6,000

CONCLUSION

Pre-grant opposition is a way to protect your rights and commercial interests. Simple procedure No Fee Assisting the patent office in its examination and ensuring only genuine inventions granted. Safeguards public health and consumer rights. A mechanism for ensuring true innovation is not hindered.

How Indian Patent Office Decides in 2009-10

S. Mohan IPM 31.07.2010

3123/DEL/2005

Application filed by the agent 3123/DEL/2005 filed on 22.11.2005 5980/DELNP/2005 filed on 21.12.2005 Request For Examination on 01.06.2006 Inadvertently mentioned-07.02.2008 20 months later than the date of filing request Wrong Representation of application number Petition u/r 137-Power of controller
For Further details Ref.: http://www.fastreporter.org/pfr/2009/5

371/DEL/1997
Objected u/s 5(1)(b) No response-Abandoned u/s 21(1) Div. filed as 1427/DEL/1999 u/s 16 FER issued with objection Not to be considered as divisional appln Divisional appln is to divide for more than one invention, not to revive the abandoned appln.

For Further details Ref.: http://www.fastreporter.org/pfr/2009/13

IN/PCT/2001/01802/CHE
An indicator of the proper direction of exit of paper and of other materials in rolls Objected u/s 3(n) the manner of, (re)presentation of information which is not patentable

For Further details Ref.: http://www.fastreporter.org/pfr/2009/16

1003/DEL/2006

Use of agomelatine in obtaining medicaments intended for the treatment of bipolar disorders Objected u/s 2(1)(j), 3(d) and 3(e) Improved properties of a composition- comparative data with respect to the prior art, and claimed composition while claiming the. No data provided Application refused under section 15 to proceed for grant of patent
For Further details Ref.: http://www.fastreporter.org/pfr/2009/19

4262/DELNP/2005
A method of Diagnosis and Treatment Objected u/s 2(1)(j), 3(d),3(e) and 3(i) the claimed method is nothing but a diagnostic method and any process of treatment including medicinal, surgical or diagnostic is not patentable Application refused under section 15 to proceed for grant of patent

For Further details Ref.: http://www.fastreporter.org/pfr/2009/20

IN/PCT/2002/00497/DEL

Claims A process for the production of the polymorph B of quinazolinamine derivatives

Preparation Recrystallization

Dependent claim recrystallization using alcohol optionally containing water Opposition filed by Cipla on various grounds Withdrawal of opposition if the claims are amended recrystallization using alcohol containing water as an independent claim Claims are amended Opposition withdrawn
For Further details Ref.: http://www.fastreporter.org/pfr/2009/21

811/DEL/2003

An Improved Laminate Film Application opposed under section 25(1) (a), (b), (c), (d), (e), (f) and (g) Applicant filed two interlocutory petitions

(i) for dismissal of the pre-grant opposition on the grounds that it had been filed after closure of prosecution of the application, and (ii) for the right to cross-examine the opponent,

Controller rejected the interlocutory petition grant of application refused

For Further details Ref.: http://www.fastreporter.org/pfr/2009/44

896/DEL/2002

For Further details Ref.: http://www.fastreporter.org/pfr/2009/45