GLOCHEM INDUSTRIES LTD Vs. CADILA HEALTHCARE LTD

JUDGEMENT

(1.) Rule. Advocate for the private contesting Respondents waive notice. Notice to other Respondents is dispensed with being formal parties. Rule made returnable forthwith, by consent. Having regard to the nature of challenge involved, we decided to finally dispose of the matter at the admission stage itself, by consent.

(2.) This Writ Petition under Article 226 of the Constitution of India essentially takes exception to the order passed by the Assistant Controller of Patents & Designs-Respondent No. 4 dated 7/1/2009 on the Petitioners representation by way of opposition against Patent Application No. 413/MUM/2003A. In the Petition as filed, the Petitioners at the outset have given short background of the alleged invention claimed by the Respondent No. 1. It is stated that on 26/7/1985 a Patent being US Patent No. 4529596 was granted in the United States to Sanofi S.A.... This document discloses the compound Clopidogrel. By another patent issued on 11/7/1989 to Sanofi bearing US Patent No. 4847265 titled Dextrorotatory enantiomer of methyl alpha-5 (4,5,6,7,-tetrahydro (3,2-c) thieno pyridyl) (2-chlorophenyl)-accetate and the pharmaceutical compositions containing it, was granted to Sanofi. This document discloses Clopidogrel Besylate and admits customary preparation of the salts of Clopidorgrel in a standard manner. It is then stated in 1998, an article authored by Caira M.R. Titled Crystalline Polymorphism of Organic Compounds, was published in Topics in Current Chemistry, which describes that a systematic investigation of a compound to determine whether it is prone to polymorphism or not is a matter of routine practice in pharmaceutical pre-formulation studies. It is stated that Clopidogrel is a known anti-platelet agent with known therapeutic effects. It is used to inhibit blood clots and is used in the treatment of heart ailments. According to the Petitioners since 17/11/1997, Sanofi has been marketing Clopidogrel Bisulfate (plavix). It is stated that the subject of patent application in the present case relates to Clopidogrel Besylate, a salt of Clopidogrel.

(3.) The Petitioners have then adverted to relevant facts giving rise to this petition. It is stated that Respondent No. 1 herein on 25/4/2003 filed a Patent Application along with the provisional specification at the Mumbai office of the Respondent No. 3, which was later on allotted Patent Application No. 413/MUM/2003A. Thereafter, on 22/4/2004, the Respondent No. 1 filed International Application No. PCT/IN2004/000112 under the Patent Cooperation Treaty, corresponding to Patent Application No. 413/MUM/2003A. It is stated that on 2/9/2004, Patent Publication No. WO/2004/074215 A titled Process for preparation of Clopidogrel, its salts and pharmaceuticals compositions, claiming priority from Indian Patent Application No. 54/KOL/2003 dated 03/02/2003, filed by Nadkarni, et al, (Torrent) was published. Even though Torrents Patent Publication No. WO/2004/074215 is published later, its priority date (54/KOL/2003 filed on 03/02/2003) is earlier than 25/04/2003, the date of filing of Respondent No. 1s Patent Application No. 413/MUM/2003A. As per the information made available to the Petitioners, the said Indian Patent Application No. 54/KOL/2003 published on 11/2/2005 appears to have been rejected or abandoned. It is stated that on 9/12/2004 the corresponding PCT International Patents Application No. PCT/IN2004/000112, filed by Respondent No. 1 was published as WO/2004/106344. The International Search Report with regard to said PCT International Patents Application was issued on 18/1/2005. Thereafter, on 11/2/2005, Respondent No. 1 Patent Application was published in issue No. 04 of 2005 of the Patent Official Journal at page 2704. Thereafter, on 5/9/2005 the International Preliminary Report on Patentability of the corresponding International Application of the Respondent No. 1 was issued. It is stated that the Petitioners through its agents, obtained a copy of the complete specification accompanying the said patent application which pertain to Clopidogrel Besylate, a known salt of a previously known compound Clopidogrel. According to the Petitioners, as on the date of the alleged invention, the therapeutic efficacy of Clopidogrel and Clopidogrel Bisulfate (Plavix) in treating heart ailments were well known. Accordingly, the Petitioners filed a representation by way of opposition on 10/7/2008 in terms of Section 25(1) of the Patent Act 1970 (hereinafter referred to as the Act)raising diverse issues.