The Patent Act 1970 Section 25(1) In the matter of the application for Patent No.4724/DELNP/2009 filed on 20thJuly, 2009 M/S.BOEHRINGER INGELHEIM INTERNATIONAL GMBH …………………………Applicant In the matter of opposition to the grant of Patent thereto by Cipla,Mumbai India ………Opponent Date of Hearing 15/09/2015 Present:M/S.S.Majumdar & Co………………………………………………………….Agent for opponent 1.Dr.Rajander Lohiya…………………………………………Examiner of Patents & Design DECISION AND ORDER M/S Cipla Limited,Mumbai the Opponent had filed in patent office Delhi the instant Representation for opposition to the grant of Patent pursuant to the above mentioned Patent application No.4724/delnp/2009 on 04 grounds as cited therein vide through there Agent M/S.S.Mujamdar & Co. after completion of formalities as provide in rule 55 of the Patent Rules,2003 the hearing u/s 25(1) of the Patent Act 1970 had been fixed on 15/09/2015 under intimation to opponent as well as the applicant. The applicant had not filed reply of the instant Representation of opposition within the prescribed period of 3 months. The above mentioned application no.4724/DELNP/2009 had been filed in the Patent office by M/S.Remfry & Sager Attorneys Gurgaon,First examination report (FER) containing 16 objections on the said Patent application had been sent by Patent office to the applicant on 17/01/2014 to meet the requirement of the Patent Act 1970 within prescribed period of time i.e. up to 17/01/2015 (hereinafter referred as last date) the agent for applicant had filed the reply to

FER within prescribed time but still objections were not met, for that patent office inform to the agent for applicant about representation u/s 25(1) filed by the opponent and copy of representation sent to the agent for applicant the agent for applicant must file reply to the representation within 3 month time but the agent for applicant could not filed reply within prescribed time, after not receiving the reply from the applicant this office had fixed hearing u/s 25(1) on 15/09/2015 and same had been inform to the agent for applicant as well as opponent. The applicant did not attend the hearing on the stipulated day but the agent for opponent had attended the hearing fixed by the controller. also the agent for applicant had inform to the controller that we are not interested to attend hearing fixed u/s 25(1). Since the agent for applicant had not filed reply for representation and also not attend the hearing fixed, therefore objections raised by the examiner in FER as well as objection raised by the opponent in representation were still maintained. The outstanding objections in FER is as fallows. 1. Claims 1-2,3 are mere new forms of the known compound and do not differ significantly in properties with regard to efficacy. Therefore, these Claims fall within the scope of such clause of section 3(d) of the patent act 1970 as amended in 2005. 2. Claims 1-2 ,3 fall u/s 3(e) of the Patents (Amended) Act, 2005 as the said claims defines a mere admixture resulting only in the aggregation of the properties of the components thereof. It is not clear if the combined agents act together to provide a technical effect that is greater than just the sum of the two or more agents alone, or whether the combination is in fact a mere juxtaposition with no interaction of the agents. 3. Claim 1 and its dependent claims does not constitute an invention under section 2[1(j)] of Patents Act 1970 (as amended in 2005) as the claims are lacking in inventive step in the view of cited Patent documents following documents: D1:US2002/0006439 D2:WO00/35419 D3:WO2007/047371 D4:US2002/0068085 .The document D1 discloses a method of forming particles comprising the following steps: providing an aqueous solution comprising coprecipitant

molecules and bioactive molecules, each coprecipifant molecule, wherein the aqueous solution is . capable of forming a coprecipitate which comprises the coprecipitant and bioactive molecules with a melting point of above about 90 C ; rapidly admixing the bioactive molecule/coprecipitant molecule (arginine) solution with a greater volume of a substantially water miscible organic solvent such that the co precipitant and bioactive molecules coprecipitate from solution forming said particles. A pharmaceutical formulation comprising particles wherein the particles comprise: a substantially non-hygroscopic inner crystalline core comprising coprecipitant molecules wherein said coprecipitant (lysine/arginine/glucosamine) molecules; and an outer coating comprising one or more bioactive molecules wherein the particles have been formed in a single step by-coprecipitating said core forming coprecipitant molecules and said bioactive molecule .. Implicit features: the same particles comprising micro crystals will have the same physical characteristics, like storage stability in a sealed vial, under the same conditions (claim 23). Suspension of particles are formed with low water content, otherwise these micro crystals will have a tendency to solubilise (claim ) (in Of p. 4 column 1 Paragraph [0037]: Active like Nevirapine indosage form form 0,5-650 mg, Tables and claims). Consequently, the subject-matter of the claims 24 is not novel over D1.The document D2 discloses a controlled release liquid filled gelatin capsules, by multi-coating with barrier, expandable, and semipermeable layers. The liquid carrier medium containing the active agent like Nevirapine 25ng-1.0 g., can be an emulsion of gum arabic, water and ethyl cellulose, acting as the release matrix. (See 02 page 27, 1.1-4 page 31 I. 8-9, claims). Consequently, the subject-matter of the claims 1-24 is not novel over D2. The document D3 discloses a pharmaceutical delivery package comprises fixed unit dose quantities of two or more different pharmaceutical ingredients combined in a single delivery package, nevirapine in controlled release dose (see example 29, claims 1, 24). Consequently, the subject-matter of the claims 5-7 is not novel over D3.The document D4 discloses an anti-viral pharmaceutical products, useful for combating · viral disease, comprise three dosage forms having different release profiles. Antiviral active is Nevirapine (see paragraph [0056), claims). Consequently, the subject-matter of the claims 5-7 is not novel over

D4.As the subject-matter of the claims 1-24 not new is, it cannot contribute to the prior art. Consequently, the subject-matter of the claims 1 -24 does not involve an inventive step so that the claims of the present invention are lacking in novelty and inventive steps under section 2(1)(j) of the patent act 1970 as amended in 2005. 4. Claim 1 and its dependent claims do anticipated by-prior claiming n the view of cited Patent documents following documents:D1: US2002/0006439 ,D2: WO 00/35419, D3: WO2007/047371 D4 and US2002/0068085. 5. Claims do not meet the requirements of section 2(1)(j) patent act 1970 in that the matter for which protection is sought is not clearly defined. The claims attempts to define the subject-matter in terms of the result to be achieved, namely in the form of specific in vivo release characteristics/ pharmacokinetic parameters. Such a definition is only allowable under specific conditions. These conditions do not appear to be fulfilled in the present case. In addition, said in vivo release characteristics/pharmacokinetic parameters, although measurable by the skilled person, are not suitable for unambiguous characterization of a composition (formulation; dosage form; due to the inherent variation-among-different subjects and different testing conditions i.e. "fasting human", which make it impossible to distinguish the subject-matter claimed from the prior .. art. Also the terms "fasting human" are vague and unclear and leave the reader in doubt as to the meaning of the technical feature to which they refer, thereby rendering the definition of the subject-matter of said claims unclear, Present claims 5, 8, 11, 21 relate to a pharmaceutical compositions comprising nevirapine in an extended release matrix defined (inter alia) by reference to the following parameter, " ... having an in-vitro dissolution profile such that at least 5% w/w and no more than 20% w/w of the nevirapine is released at 2 hours; at least 30% w/w and no more than 80% wlw of the nevirapine is released at 8 hours; at least 50% wlw and and up to 1 00% w/w of the nevi rapine is released at 14 hours, when dissolution is measured by the USP Paddle Method at 50 rpm at a volume of 900 ml aqueous buffer containing 6% w/w of sodium lauryl sulfate, having a pH of 6.8 at 370C." · This wording attempts to define the subject-matter, i.e "extended release", in terms of functionality, namely in the form of specific Drug Release profile. In this instance, however, such a formulation can not be used to distinguish the invention from the prior art

documents and suggest an essential feature is missing from claims 5, 8, 11 and 21. 6. Claim1 (and thus dependent claims) are not clear and succinct and sufficiently definitive to the scope of alleged invention in the absence of mention of all significant elements/components of composition, like constituents and their proportions, percentage etc. that reflects technological contribution to establish the novelty and inventive step and define the scope of alleged invention. [Requirements of Sec. 2(1) (j) and Sec. 10] 7. In claims 1-2,3 dosage forms can not be allowed under section 3(i) of the Patent Act 1970 as amended in 2005. The ground of opposition as filed by the opponent in the form of representation u/s 25(1) is as follows. 1.Claims lack of inventive step u/s 2(1)ja 2.Claims not invention as per section 2(1)ja 3.Claims not patentable u/s 3(d) 4.Claims not patentable u/s 3(e). In view of the above said final objections raised by examiner in FER and objections raised by opponent in his representation filed u/s 25(1) and nature of the objections the attorney were given an opportunity of being heard u/s-25(1) and submit their arguments in favor of the application the date for hearing u/s 25(1) was fixed on 15/09/2015. But No one appeared in hearing before the Controller from applicant side the agent for opponent had appeared before controller for hearing and strongly argued in fever of representation filed by opponent the objections raised by the Ld. Examiner in FER and objections raised by opponent in representation found justified.

DECISION Since attorney for applicant did not appear in the hearing fixed u/s 25(1) before the Controller, and no arguments come to rebut the objections raised by Ld. Examiner in FER (First examination report) and objections raised in representation filed u/s 25(1) by the opponent, hence objections found correct. Therefore I hereby refuse this application No.4724/DELNP/2009 to proceed for grant of Patent. Dated:-19/10/2015

N.R.Meena Deputy Controller of Patents & Designs

Copy to:-Ramfry & Sager

Regarding objection no. 1, in respect of novelty and inventive step, the submission offered by the attorney is satisfactory