THE PATENTS ACT, 1970 (AMENDED BY THE PATENTS ACT 2005) AND THE PATENT RULES, 2003 (AMENDED BY THE PATENTS RULES 2006)

In the matter of Patent Application no.85/DEL/1995 filed on 23/01/1995 AND

In the matter of Section 77[1(f)] and in the matter of Review petition filed in respect of the decision of the Assistant Controller dated 22.03.2007 Eli Lilly & Co., Lilly Corporate Center, Indianopolis, ……… The Petitioner

IN 46285, USA Ranbaxy Laboratories Limited, A-11, Sahibzada Ajit Singh Nagar-160055, Ropar, Punjab, India

..……..

The Respondent

Hearing held on 24th JULY 2007 Present: Sh Sanjay Kumar, Smt Ranjana Mehta Dutt And Smt Deepa K Tikoo of M/s Remfry & Sagar,……………………………………Attorneys for the Petitioner Sh Anurag Khera of……………………………………...The Petitioner Eli Lilly & Co.

Sh T Srinivasan, M/s Lakshmi Kumaran & Sridharan ………………… Attorney for the Respondent DECISION

An application titled as ,’Tetracyclic derivatives, process of preparation and use’ was filed on 23rd January 1995 by Laboratoires Glaxo S.A., 43, Rue Vineuse, 75016 Paris, France for grant of the patent as indicated in the application form filed by their agents,

M/s Remfry & Sagar, Gurgaon, NCR, India. The applicant was changed to M/s Eli Lilly & Co., Lilly Corporate Centre, Indianapolis, IN 46285, USA on 29th August 2003. Thus presently on record the applicant is M/s Eli Lilly & Co. The application claimed priority of UK application no. 9401090.7 dated 21st January 1994. The application has been published u/s 11(A) of the Act on 4th March 2005 in the VIIth volume of the Patent Office journal, page 8408.

The application as examined had 60 claims. Claims 1 to 11 pertained to the compound of formula I (tetracyclic derivatives) and its isomers and tautomers, pharmaceutically acceptable salts and metal salts and individual compounds of formula I ; Claims 12, 13 and 14 pertained to the use of the compound, method of treatment by the compound and pharmaceutical composition comprising the compound of formula I, respectively; Claim15 (product claim) related to the intermediates in the preparation of compound of formula I; claims 16 to 57 pertained to processes of preparation of the compound of formula I and claims 58 to 60 pertained to omnibus claims of the process and product. The first examination report was issued on 12th April 2005. During prosecution of the application, claims were amended as follows- Claims 1 to 7 related to the tetracyclic derivatives of formula I; Claims 8 to 10 related to its isomer; Claims 11 to 25 related to the process of preparation of the tetracyclic derivatives of formula I and its cis isomer; Claims 26 to 28 were omnibus claims of the compound, its isomer and process of preparing the isomer respectively.

An opposition to the grant of patent on the above said application was filed by Ranbaxy Laboratories Ltd. u/s 25(1) of the Patents (Amendment) Act, 2005 on 11th July 2005 and the hearing was held on 16th December 2005. Decision was issued on 22nd March 2007 in which the claims from 1 to 10, 26 and 27 i.e. the product claims pertaining to the compounds of formula I were rejected. The said application was allowed for the grant of patent with claims 11 to 25 and 28, provided the complete specification is amended by deleting the product claims as mentioned above within 30 days of issue of the decision. However, a review petition u/s 77 [1(f)] of the Patents (Amendment) Act, 2005 was filed

by the agents of the applicant on 22 May 2007. An extension was sought for one month by applying before 22 April 2008 in a prescribed manner and the controller allowed the same. In the review petition, the petitioner contended that the decision dated 22nd March 2007 is flawed and suffers from errors apparent on the face of the record, which can be summarized under the following heads –

1.Erroneous application of Section 3(d) of the Patent Act, 1970

The petitioner submitted that the said decision departs from global standards of patentability with respect to the use of the 3(d) provision to suggest the compounds are mere derivatives and the requirement for clinical data. The applicants illustrated this departure by placing the fact that the product claims of the instant application have been issued patent in at least 72 other countries and the prior art relied by the controller was cited in International Search Report of the PCT application and thus the other patent offices were well aware of this art. The applicants submitted that the compound claims were not a mere discovery of a new form of a known substance but a deliberate inventive step involving human intervention. The applicants submitted that opposition based on section 3 (d) was neither argued by the opponent nor formed part of the pleadings on record before the Patent Office.

The respondent stated that whether the provision of section 3(d) is applicable or not is a question of merit and beyond the scope of review. The respondents also stated that granting of patents in other countries does not confer a right upon the applicant to a grant of a patent unless the claims fulfill the statutory conditions of patentability in India.

2.Procedural error based on new ground of rejection

The petitioner opposed the Controllers decision to disallow the product claims on the grounds of insufficiency of disclosure. The petitioner stated that it has been fully and

completely able to achieve a commercial embodiment using the teaching of the instant specification. The petitioner submitted that the instant application was filed in the year 1995 and section 3(d) was not in existence in the year 1995. Therefore, the petitioner could not have anticipated the requirement of clinical trial results in relation to the compound claims. The petitioner stated that there was no dispute on the grounds of insufficiency at the time of grant of the EMR

The respondents stated that the documents relating to human clinical trials filed by the applicant/petitioner fail to properly establish the utility of the claimed compounds. The respondent also stated that the ground ‘the utility claimed is unsubstantiated’ has been taken for the first time in the review only. This ground was absent in reply to the opponent/respondents representation.

3.Wrongful requirements of details of clinical trials

The petitioner submitted that the Controller failed to take cognizance of the fact that at the stage of filing the patent application, it was not possible to submit clinical data as the said tests were conducted post-filing of the patent application and no country in the world requires clinical data or rejects application based on lack of clinical data. The petitioner placed USPTO’s Manual of Patent Examination Procedure, 2107.03, to support their arguments. The petitioners stated that the Controller has not cited any legal or factual reason as to why human clinical trial results are required to substantiate the utility of the invention.

The respondents argued that the applicant to come out with sufficient evidence by way of clinical trials or otherwise to substantiate the utility disclosure.

4.Errors apparent on the face of record in the conclusions of the Controller and the grounds on which claims have been rejected

The petitioners submitted that in ‘oppositions’, it must be shown that the invention “clearly” does not involve any inventive step as stated in Section 25 (1) (e). The petitioner argues that the benefit of any doubt must go to the petitioner. The petitioner submitted [1971] RPC 7 at 21 and [1972] RPC 624 at 634 (Annexure IV and V) to support their argument.

The petitioner submitted that neither the Controller nor the respondent has been able to empirically show that the invention can be obtained from the descriptions in the prior art and the Controller is only relying on hindsight knowledge. The petitioner quoted AIR 1969 BOM 255 at paragraph 16 of Hon’ble Bombay High Court to support their argument.

The petitioner argued that the new compounds should be specifically mentioned or indicated in the prior art, failing which, the petitioners application should be allowed to proceed to letters patent. The petitioners placed their reliance in the book ‘A practical guide to Patent law’ by Brian C Reid, , 2nd Edition of 1993 at page 50, which has been quoted in the book ‘Patent law’ by P Nararyanan, 4th Edition at page 492 (Annexure VII).

The respondent argued and denied all the allegations made by the petitioner.

I have perused through the invention as claimed in the instant application the arguments made by both the parties.

I observe that according to section 77 [1(f)] of the Patent (Amendment) Act 2005, the power of review may be exercised where some mistakes or error apparent on the face of record is found, but it may not be exercised on the ground that the decision was erroneous on merit. The error apparent on face of record are such an error

which must strike on mere looking at the record and would not require any long drawn process of reasoning on points where there may be conceivably two opinions.

The issues regarding the application of section 3(d) erroneously; insufficiency of disclosure, are wholly a matter of consideration on merits. Reappraisal of the evidence on the record for finding out the error would amount to an exercise of appellate jurisdiction, which is not permissible in review. The question of hindsight is of no relevance; as such question would revert to the merits of the case, which is out of context when it concerns an application for review. The observations made by Hon’ble Bombay High Court relate to merits of a given case and does not talk about any review proceedings or any error on the face of record.

Notwithstanding after perusing through the arguments and revisiting exhibits 1 to 5, I observe that the product claims 1 to 10, 26 and 27 are not allowable in view of insufficient disclosure in respect of the utility of the claimed compound.

My

findings were arrived at after a proper appreciation of the disclosure of exhibits in conjunction with the pleadings by the both parties. The said decision cannot be agitated in this review petition, as the rejection of the claims does not show any error apparent on the face of the record. Presently any analysis of inventive step and section 3(d) with respect to the product claims cannot be carried out without furnishing further actual substantiating material by the parties, which none of the parties produced. The book of Brian Reid deals with laws of UK, US and EP and the passage referred to in the book of P Narayanan does not refer to any drug related patents but only to chemical patents and is of no use in view of latest amended laws in India which addresses specific concerns in respect of pharmaceutical products distinct from other products.

Regarding insufficiency of disclosure, I observe that the petitioners have failed to satisfactorily establish the utility of the claimed compounds in the complete specification.

Regarding the allowance of the product claims in many other countries, I observe that the grant of a patent in a foreign country is not binding upon the Controller and he is empowered to reject a claim if the same in his opinion is not patentable in accordance with the Indian Patent law.

In drawing my final conclusion on the instant review petition I rely on the Hon’ble Supreme court decision where the Hon’ble court has stated in Lilly Thomas and others versus Union of India and Others (2000) 6 SCC 224, that ‘…the power of review can be exercised for correction of the mistake but not to substitute a view. Such powers can be exercised within the limits of the statute dealing with the exercise of the power. The review cannot be treated like an appeal in disguise’.

The petitioner has failed to show any error apparent on the face of the record in the order passed dated March 22, 2007 passed by me and therefore the instant review application is dismissed.

Further, in my said decision of dated 22.03.2007, I had directed the applicant/petitioner to amend the specification by placing the revised claims in the specification as per the directions given within 30 days from the date of issue of the said decision. Now, after the disposal of this review petition, the petitioner may comply with the above said directions on or before 26.06.2008 failing which the application no. 85/DEL/1995 shall stand refused for grant of patent from 27.06.2008 in accordance with section 25 (1) of the Patents (Amendment) Act, 2005 and rule 55(6) of the Patents (Amendment) Rules, 2006. No order for cost. Dated – June 20, 2008

(HARDEV KARAR) Assistant Controller of Patents & Designs Patent Office, Delhi