Decision under Section 15 of the Indian Patents [Amendment] Act, 2005 In the matter of

Patent Application No.: 5435/DELNP/2005 Dated

25/11/2005

And

THE MATTER OF

Representation under Section 25(1) of The Patents Act, 1970 as amended by The Patents (Amendment) Act, 2005. And

And IN THE MATTER OF Rule 55 of the Patent Rules, 2003, as amended by The Patents (Amendment) Rule, 2006. Applicant: GENENTECH,

INC.

Applicant’s Agent: ANAND & ANAND

1 .G. M. Pharma Ltd……....The Opponent ….pre grant representation filed dated 17th July 2008 2. GLENMARK PHARMACEUTICALS LIMITED………The Opponent …….pre grant representation filed dated 14th November 2011 3. ARVIND RAJAMANI………....The Opponent….pre grant representation filed dated 27th April 2009 DECISION I.

II.

Application for a patent application number 5435/DELNP/2005 was filed in Patent Office, Delhi on 25/11/2005 entitled "TREATMENT WITH ANTI-VEGF ANTIBODIES".The said application was examined under Section 12 and 13 of Patents Act and first examination report containing a statement of objections was forwarded on 13th Jan 2009 and the applicant’s agent filed response to first examination report on 30th December 2009. A pre-grant opposition under Section 25(1) and Rule 55(1) was filed by the three (03) opponents as mentioned above. Applicant was issued the notice of opposition on 13/01/2009 regarding pre grant opposition filed by GM Pharma Ltd, on 12/11/2010 w.r.t pre grant opposition filed by Arving Rajamani and on 24/09/13 w.r.t said opposition filed by Glenmark Pharmaceuticals ltd under Rule 55(3) along with the copy of representation filed by the opponents.

III. IV.

The applicant had filed the reply statement u/r 55(4) w.r.t above three pre grant representations. As per the provisions under Section 13(3) of Patents Act, the said amended case after reply to first examination report, was examined and investigated in like manner as the original specification and hearing u/s 14 has been fixed for 18/08/2015 which was further adjourned dated 23rd September 2015 containing statement of objections which were to be discussed during hearing and be complied consequently are as follows:

1 i)Claims 1-15 fall within the scope of sub clause (i) of section 3 of The Patent Act 1970 as amended 2005. Claim 1 relates to a safety assessment mechanism for a candidate subjected to cancer treatment comprising assessing said candidate for gastrointestinal perforation when subjected to treatment with an anti-VEGF antibody either alone or in combination with an anti-neoplastic composition comprising at least one chemotherapeutic agent.The claims 14 and 15 defines the administration means of the said antibody Thus the claims are related to the method of using anti-VEGF antibody for treating cancer and pathological conditions and thus falls in not patentable subject matter. ii)Claims 1-15 falls within the scope of such clause(d) of section 3 of Patents (Amendment) Act 2005 .As mentioned above all the components of the invention are known in the prior art (admitted in complete specification) and the claims are related to mere combination of known substances , hence data showing efficacy of the combination of the compounds needs to be provided. 2.Subject matter of claims 1-15 fall u/s 2(1)(j) of Indian Patent Act 1970 as amended 2005 and lacks novelty and inventive step in view of documents as cited in International search report: (1) K.MARGOLIN ET AL.: "Phase Ib trial of intravenous recombinant humanized monoclonal antibody to vascular endothelial growth factor in combination with chemotherapy in patients with advanced cancer:Pharmacologic and long-term safety data",JOURNAL OF CLINICAL ONCOLOGY, FEB2001, VOL.19, NO.3 Pages 851-856XP002302377. (2)F. KABBINAVAR ET AL, "Phase II,randomized trial comparing bevacizumab plus fluorouracil(FU)/leucovorin(LV)metastatic colorectal cancer."JOURNAL OF CLINICAL ONCOLOGY", Jan. 2001, Vol. 21, no.1, pages 60-65,XP002302378. 3) L.B. SALTZ ET AL, "Irinotecan plus flurouracil and leucovorin for metastatic colorectal cancer",NEW ENGLAND JOURNAL OF MEDICINE,The,Massachusetts medical society,Waltham,MA,US,vol.343,no.13 (28.9.2000),pages 905-914,XP008033436 (4) WO1998/45331(15.10.1998). This objection is still maintained in view of absence of satisfactory reply and are being considered anticipated for the claims filed. 3 Claims 1-15 lacks industrial applicability as the presently claimed invention which is related to treatment of a candidate with an anti-VEGF antibody is not capable of being made or used in an industry

V. A notice of pre grant opposition hearing u/r 55 was also issued to both applicant and opponents on 14/07/2015 and hearing was fixed on 18/08/2015 at 10.30 am. However applicant’s agent has asked for one month adjournment in hearing u/s 14 and u/r 55 vide letter dated 10th August 2015 and finally hearing u/r 55 along with u/s 14 of the Patents Act was fixed on 23/09/2015 at 10.30AM . VI.The Opponent ‘s agent S Majumdar who is representing three opponents G. M. Pharma Ltd,GLENMARK PHARMACEUTICALS LIMITED,ARVIND RAJAMANI in the instant case has informed dated 23 July 2015 that the opponents in the above cases are not interested in attending the hearing and they being the common agent hereby inform they will not attend the hearing fixed on August 18 2015. VII. The Applicants agent has also informed dated 10th September 2015 that applicant is not interested in further pursuing the case so they will attend the hearing u/s 14 and u/r 55 of the Patents Act,1970. VIII. Thus both the applicant and the opponent’s have lost interest in the instant case. Thus the present application is refused u/s 15 in view of outstanding objections raised in the hearing letter dated 14th July 2015 and the pre grant opposition u/s 25(1) is also disposed off as both the applicant and the opponent are not interested in further pursuing the case. IX. In view of above discussion, the application is refused u/s 15 for grant of patent and the pre grant opposition u/s 25(1) in the instant case stand disposed off.

Date – 21/09/2015 (Anita Jatav) Assistant Controller of Patents and Designs Patent Office, Delhi