THE PATENTS ACT, 1970 (39 of 1970) as amended by THE PATENTS (AMENDMENT) ACT, 2005 (15 of 2005) (with effect from )

Size: px

Start display at page:

Download "THE PATENTS ACT, 1970 (39 of 1970) as amended by THE PATENTS (AMENDMENT) ACT, 2005 (15 of 2005) (with effect from )"

Oliver Townsend
6 years ago
Views:

THE PATENTS ACT, 1970 (39 of 1970) as amended by THE PATENTS (AMENDMENT) ACT, 2005 (15 of 2005) (with effect from 1-1-2005) & THE PATENTS RULES, 2003 as amended by THE PATENTS (AMENDMENT) RULES, 2006

1 THE PATENTS ACT, 1970 (39 of 1970) as amended by THE PATENTS (AMENDMENT) ACT, 2005 (15 of 2005) (with effect from ) & THE PATENTS RULES, 2003 as amended by THE PATENTS (AMENDMENT) RULES, 2006 (with effect from ) In the matter of Application for Patent bearing the number as 474/MAS/1996 filed on 25th March 1996 by HOFFMANN La ROCHE AG of 124 Grenzacherstrasse 4070 Basel, Switzerland a Swiss Company. And In the matter of Pre-grant Opposition of by way Representation under Section 25(1) of the Patents Act (as amended) by WOCKHARDT LIMITED, Wockhardt Tower, Bandra-Kurla Complex, Bandra (East) Mumbai, an Indian Company

DECISION MIs HOFFMANN La ROCHE AG of 124 Grenzacherstrasse 4070 Basel, Switzerland a Swiss Company, hereinafter referred as applicants for patent, have filed an application for patent through their

2 Agents Asst. HEARING HELD ON 4TH FEBRUARY 2009 In the presence of for the Applicant Ms Shakira N, DEPENNING DEPENNING of Chennai. & Agent for First Petitioner No one appeared for representation from the Opponent Side & Controller of Patents & Designs. Ms.PARVEEN KAUSAR BAIG Examiner of Patents & Designs Mr.V.G.SARVANA RAM PRASAD. DECISION MIs HOFFMANN La ROCHE AG of 124 Grenzacherstrasse 4070 Basel, Switzerland a Swiss Company, hereinafter referred as applicants for patent, have filed an application for patent through their patent attorney MIs Depenning & Depenning for their invention titled "INTERFERON SOLUTION" 25th March 1996 claiming a priority of EP application number filed on April 6, 1995 The applicant filed request for examination according to section 11 B of the Patent (Amendment Act, The first examination report was issued on 2 Sept., During the prosecution the applicants have amended their title of invention from INTERFERON SOLUTION to "AN AQUEOUS, HUMAN SERUM ALBUMIN FREE INTERFERON SOUL TIONS". The agent for the applicant has responded to FER and submitted an amended claims on 18 December 2008 The instant ap~lication was published under Section 11 (A) in the Patent Journal 07/2005 on 4t March MIs WOCKHARDT LIMITED, Wockhardt Tower, Bandra-Kurla Complex, Bandra (East) Mumbai, an Indian Company, hereinafter referred as OPPONENTS have filed an opposition by way of representation under Section 25(1) on 23rd April, The applicant was informed accordingly. As both the parties requested for a personal hearing an opportunity of being heard was offered and the hearing was held on 4th February,

3 Before proceeding further I feel that it is necessary to reproduce the claims as filed and the final amended claims as left with this office on the last date. CLAIMS AS FILED 1. An aqueous interferon solution containing a. An interferon -alpha b. A non-ionic detergent c. A buffer for adjusting ph d. Benzyl alcohol and optionally e. An isotonizing agent 2. An interferon solution according to claim 1, wherein the amount of interferon-alpha is IU per ml; the amount of non-ionic detergent is about mg per ml; the concentration of buffer is about mmolar; and the amount of benzyl alcohol is about 8-20 mg per mi. 3. An interferon solution according to the claim 1 or 2 containing a. Interferon-alpha-2a or PEG-interferon-alpha-2a b. Polyoxyethylene (20) sorbitan monooleate; c. Ammonium acetate or sodium lactate; d. Benzyl alcohol; and e. Sodium chloride, mannitol, glycerol, arginine, lysine, histidine, methionine or ethanolamine 4. An interferon solution according to the claim 1 or 2 containing per ml a x 1061U of Interferon-alpha-2a b. 0.2 mg Polyoxyethylene (20) sorbitan monooleate; c. 1 OmM of Ammonium acetate or sodium lactate; d. 10 mg of Benzyl alcohol; and e. Sodium chloride, in an amount sufficient to provide an isotonic solution 5. An interferon solution according to the claim 1 or 2 containing per ml a x 1 061U of Interferon-alpha-2a b mg Polyoxyethylene (20) sorbitan monooleate; c. 13 mm of Ammonium acetate or sodium lactate., d. 10 mg of Benzyl alcohol; and e. Sodium chloride or mannitol in an amount sufficient to provide an isotonic solution 3

4 An interferon solution according to anyone 5.0 ~ 0.1. of claims 1-5 having a ph of The invention as described hereinbefore, especially with reference to Examples 2-5. FINAL SET OF CLAIMS AS ON 18 December, 2008 An aqueous, human serum albumin-free interferon solution containing a. An interferon -alpha; b. A non-ionic detergent; c. A buffer for adjusting ph d. Benzyl alcohol and optionally e. An isotonizing agent 2. An interferon solution as claimed in claim 1, wherein the amount of interferon-alpha is IU per ml; the amount of non-ionic detergent is about mg per ml; the concentration of buffer is about mmolar; and the amount of benzyl alcohol is about 8-20 mg per mi. 3. An interferon solution as claimed in claim 1 or 2 wherein it contains a. Interferon-alpha-2a or PEG-interferon-alpha-2a b. Polyoxyethylene (20) sorbitan monooleate; c. Ammonium acetate or sodium lactate; d. Benzyl alcohol; and e. Sodium chloride, mannitol, glycerol, arginine, lysine, histidine, methionine or ethanolamine 4. An interferon solution as claimed in claim 1 or 2 wherein it contains per ml a x 1061U of Interferon-alpha-2a b. 0.2 mg Polyoxyethylene (20) sorbitan monooleate; c. 10 mm of Ammonium acetate or sodium lactate; d. 10 mg of Benzyl alcohol; and e. Sodium chloride, in an amount sufficient to provide an isotonic solution 5. An interferon solution according to the claim 1 or 2 containing per ml a x 1 061U of Interferon-alpha-2a b mg Polyoxyethylene (20) sorbitan monooleate; c. 13 mm of Ammonium acetate or sodium lactate; 4

5 6. d. 10 mg of Benzyl alcohol; and e. Sodium chloride or mannitol in an amount sufficient to provide an isotonic solution An interferon solution according to anyone 5.0:!:O.1. of claims 1-5 having a ph of It is also pertinent either to reproduce or discuss in brief about the invention as disclosed in the specification which part is almost remained unchanged till the last amendment. It is stated in page 2 of the complete specification that manufacturing of aqueous solution of interferon alpha involves a number of problems which are caused by the sensitivity of the active ingredient against physical and chemical influences such as proteolysis, oxidation, disulfide exchange, oligomerisation, deamidation and beta-elimination, aggregation, precipitation and adsorption. To counteract these effects the interferon solutions contain additives such as Human serum albumin (HSA). However use of HSA is problematic in view of the danger of viral contamination and formation of aggregates which in turn may lead to antibody formation. The applicant has further stated that the interferon solutions which avoid the use of HSA is already tried and is given in other application WO 89/04177 and Japanese Patent Publication Applicant had further stated in page 2 that the present combination of the interferon solution results in stability of interferon preparation and guarantees a constant concentration of the active ingredient thereby ensuing optimal utilization of the composition. The applicant had further given example to show the efficacy of the present composition and has also given comparative result with respect to WO and the Japanese patent publication The applicant has also stated that the use of benzyl alcohol has resulted in better storability of the composition as shown by way of example 2-4. The hearing was scheduled on 4/02/2009 at am. The applicants were represented by M/s Depenning and Depenning. However the opponent was not interested in attending the hearing and asked the office to proceed for the hearing based on the opposition representation. The hearing was continued with the applicant defending themselves based on the statement given by the opponent while submitting the opposition ground u/s 25(1), The agent for the opponent has opposed the grant of application stating 1. anticipated by prior document u/s 25(1)(e) 2. anticipated by prior use 25(i,)(d) 3. not a invention or not patentable 25(i)(f) :' 4. sufficiency of disclosure 25(1.)(g) 5

Explanation for obviousness and inventive step u/s 25(J )(e): The opponent to argue their case has cited the following documents Exhibit 1 Abstract of the Japan Patent publication 61-277699 Exhibit 2

6 5. Failed to disclose to the Controller information required by Section 8. As the pre grant opposition was while during the examination agents of the opponent have use the original claims for their argument. states the 1. Explanation for obviousness and inventive step u/s 25(J )(e): The opponent to argue their case has cited the following documents Exhibit 1 Abstract of the Japan Patent publication Exhibit 2 US patent No Exhibit 3 WO 89/04177 Exhibit 4 WO 94/26302 Exhibit 5 EP The opponent has stated in their statement at page 7 that exhibit 1 discloses interferon composition which has improved stability without the use of conventional HSA. The said exhibit 1 achieves the desired stability by adding a surfactant like polyoxyethylene alkyl ether to interferon. The opponent has further stated that non-ionic detergent such as polysorbate 20 or 89 which is often used in pharmaceutical products has been used as surfactant in the present application. The opponent has also stated that the other ingredient present in the composition of exhibit 1. Opponent in this statement on page 9 has stated that the features of exhibit 2 except HSA are present in the composition of the present invention. Hence by combining the exhibit 1 and exhibit 2 the skilled person can come to the conclusion of the present invention. Hence the present invention lacks inventive step with respect to exhibit 1 and exhibit 2. On page 15 the opponent had stated that the difference between exhibit 3 and the alleged invention is that the composition disclosed in exhibit 3 contains interferon gamma and absence of benzyl alcohol. The opponents further states that it is obvious to a person skilled in the art to get motivated to replace interferon gamma by interferon alpha and the use of benzyl alcohol as a preservative to enhance the storage stability of inject able formulation is known in the field of pharmaceutical. 6

Similarly with respect to exhibit 4 the opponent on page 17 of their statement states the only difference between exhibit 4 and the alleged invention is that exhibit 4 contains interferon gamma and

The applicant has based there argument on the basis of the final claims as submitted on 18 Dec., 2008.

It is further argued that exhibit 1 cannot be taken into account as the comparative example given in the specification clearly shows the better storability of the present invention.

7 Similarly with respect to exhibit 4 the opponent on page 17 of their statement states the only difference between exhibit 4 and the alleged invention is that exhibit 4 contains interferon gamma and that it would be obvious to a person skilled in the art to replace interferon gamma with interferon alpha and seek whether a stable composition is obtainable. The applicant has based there argument on the basis of the final claims as submitted on 18 Dec., During the hearing the applicant has argued that in the present invention the use of benzyl alcohol has resulted in better storability of the interferon composition. It is further argued that exhibit 1 cannot be taken into account as the comparative example given in the specification clearly shows the better storability of the present invention. Looking at the example 6 which gives the result of exhibit 1 it is clear that the storability of the present invention is higher than exhibit 1. Similarly exhibit 2 clearly state the use of HSA in the composition and moreover it option with respect to other ingredient is broader and there is no example to show or point towards the present invention. Hence there is no teaching directly or in combination with exhibit 1 that the use of Non HSA interferon solution with benzyl alcohol will give better storability of the composition. Exhibit 3 and 4 both uses interferon gamma. The applicant has argued that interferon gamma and interferon alpha are two different compounds having a very different physicochemical and biological properties. In their support the applicant has presented further documents namely Exhibit 6 Abstract of Nathan et al., Nature 292, (1981) Exhibit 7 Gray et alo, Nature 295, (1982) Exhibit 8 Abstract of Wetzel et al., Jou. of Interferon Research 3, (1981 ) The applicant in presence of the above exhibit 6-8 has argued that interferon gamma is acid -labile while interferon alpha is acid -stable and the molecular weight of interferon alpha being more that interferon gamma. The applicant has also said that the isoelcetric point of interferon alpha is distinctly lower than interferon gamma. Moreover in exhibit 3 it is stated that interferon gamma works well in ph range of 6-9 which is greater than what is been claimed in the present invention. Hence exhibit 3 and 4 cannot be taken into account as it involves interferon gamma. In their defense against exhibit 5 the applicant argued that exhibit 5 states a composition as lyophilized Iymphokine which in addition may contain a stabilizing agent such as HSA. Moreover it doesn't teach use of benzyl alcohol which is integral part of the present composition. 7

Based on the submission of all the above exhibit and the argument of the applicant it is clear that the HSA free interferon solution appears to novel and inventive.

None of the other document mentions the use of benzyl alcohol to increase the storability of the interferon solution, though exhibit 5 does uses benzyl alcohol.

Hence a person skilled in the art might not be motivated to replace the interferon gamma with interferon alpha. 2.

agents, stabilizers, non-ionic detergents have been in public domain much prior to the date of application and therefore forms the subject matter of prior public knowledge.

8 Based on the submission of all the above exhibit and the argument of the applicant it is clear that the HSA free interferon solution appears to novel and inventive. The exhibit 1 which appears to be the closest prior art doesn't teaches the use of benzyl alcohol for better storability of the composition. None of the other document mentions the use of benzyl alcohol to increase the storability of the interferon solution, though exhibit 5 does uses benzyl alcohol. However the fact that interferon alpha and interferon gamma shows different physiochemical and biological properties as shown by exhibit 6-8. Hence a person skilled in the art might not be motivated to replace the interferon gamma with interferon alpha. 2. Anticipated by prior use 25(t )(d) The opponent has stated in page 19 that the cited documents viz exhibit 1 to exhibit 5 teaches interferon compositions comprising buffer to maintain ph, isotonizing agents, stabilizers, non-ionic detergents have been in public domain much prior to the date of application and therefore forms the subject matter of prior public knowledge. The opponents also states that the process of the alleged invention has been used in India and elsewhere, However none of the cited documents has use HAS free interferon solution in the desire combination as such. Hence prior knowledge cannot be considered. Similarly mere statement of prior use without any further proof cannot be taken as ground of opposition under prior use. Hence the argument of anticipated by prior use cannot be accepted. 3. Not a invention or not patentable 25(t)(f) The opponent states that the alleged invention falls under the mischief of section 2(1)Ua) being devoid of inventive step. However the argument of the opponent is based on the original claims hence the use of HAS free interferon is not taken into account. With respect to the amended claim the novelty and inventive step is already been established as stated above. The opponent has also objected the alleged invention under section 3(e). Here again the applicant has given comparative examples to show the improvement in the storability and bioavailability with respect to the amendedclaims. Hence the amended claim does not attract provision of section 3(e). Hence opponents argument not an invention u/s 25(1)(f) cannot be considered. 3. Sufficiency of disclosure 25(t)(g) The opponent in their statement has stated that the specification doesn't provide a single working example which exhibits the claimed feature without using the optional feature of the said claim. However the examples given are 8

9 usually for the best method of performance. Hence the ground of insufficiency cannot be accepted as no submission or proof is given by opponent to suggest that the composition will not working in absence of the optional feature 4. Failed to disclose to the Controller information required by Section 8. This objection was complied during the examination stage. valid now. Hence is not My inference from the above arguments with respect to amended claims is as follows: 1. The claim as claimed in the amended application is novel as none of the cited document explicitly states the presence of all the components of claim1 as single composition. 2. Based on the example the efficacy of the present composition is established. Hence claims as claimed in the application has inventive step with respect to prior art cited by the opponents. Since the results show increased storability and bioavailability of the composition it doesn't attract the provision of section 3(e). 3. The specification has given ample example to proof the efficacy and also the best method of performing the claims as claimed in the application. Hence there is sufficiency of disclosure. Therefore I conclude that the alleged invention as claimed in the instant applicant do meet the requirements of Sections viz., 2(1 )0) of the Patents Act 1970 [Amendment Act 2005]. Dated this 13th day of March ,"~ y (PARVEEN KAUSAR BAIG) ASSISTANT CONTROLLER OF PATENTS & DESIGNS. 9

USOO A United States Patent (19) 11 Patent Number: 5, Gross et al. 45) Date of Patent: Jun. 9, 1998

USOO A United States Patent (19) 11 Patent Number: 5, Gross et al. 45) Date of Patent: Jun. 9, 1998 III USOO5762923A United States Patent (19) 11 Patent Number: Gross et al. ) Date of Patent: Jun. 9, 1998 54 STABILIZED INTERFERON ALPHA 0396 777 11/1990 European Pat. Off.. SOLUTIONS 0.440 100 8/1991 European