Sanofi-Aventis Canada Inc. v. ratiopharm Inc. et al., 2010 FC 230

• Judge: Phelan, J.
• Court: Federal Court (Canada)
• Case Date: March 05, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FC 230;(2010), 367 F.T.R. 307 (FC)

Sanofi-Aventis Can. v. ratiopharm Inc. (2010), 367 F.T.R. 307 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. MY.013

Sanofi-Aventis Canada Inc. (applicant) v. ratiopharm Inc. and The Minister of Health (respondents) and Sanofi-Aventis (respondent/patentee)

(T-370-08; 2010 FC 230)

Indexed As: Sanofi-Aventis Canada Inc. v. ratiopharm Inc. et al.

Federal Court

Phelan, J.

March 5, 2010.

Summary:

Sanofi-Aventis Canada Inc. applied pursuant to s. 55.2(4) of the Patent Act and s. 6 of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the issuance of a Notice of Compliance (NOC) to ratiopharm Inc. for its generic version of Irbesartan tablets for oral administration in tablet sizes of approximately 75mg, 150mg and 300mg until after the expiration of Canadian Letters Patent No. 2,057,913 (the '913 patent) and Canadian Letters Patent No. 2,177,772 (the '772 Patent). ratiopharm agreed that no NOC would issue until the '913 Patent expired in March 2011. The '772 Patent would expire in May 2016. At issue on the application were whether the claims of the '772 Patent were invalid and whether ratiopharm's drug would infringe the '772 Patent.

The Federal Court dismissed the application. The court held that the claims of the '772 Patent were invalid and, alternatively, ratiopharm's proposed drug would not infringe the '772 Patent.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Sanofi-Aventis Canada Inc. applied for an order prohibiting the issuance of a Notice of Compliance to ratiopharm Inc. for its generic version of Irbesartan tablets for oral administration in tablet sizes of approximately 75mg, 150mg and 300mg until the expiration of Canadian Patent No. 2,177,772 - Sanofi-Aventis complained that ratiopharm's Notice of Allegation (NOA) was deficient particularly regarding infringement because ratiopharm characterized one of its excipients as a binder, not a diluent, and then argued that it was both primarily a disintegrant and secondly a binder - The Federal Court stated that "Viewed as a whole, ratiopharm's NOA met the critical test of giving Sanofi-Aventis sufficient understanding of the case it had to meet ... The critical point is that ratiopharm said it did not infringe the Patent because ratiopharm's excipient was not a diluent and the absence of a diluent in the formulation avoided infringement. What other role ratiopharm's excipient might play is only a subset of the basic premise that it does not act as a diluent in ratiopharm's tablets. Sanofi-Aventis knew this point and met it. There is no prejudice to Sanofi-Aventis. Both parties knew that ratiopharm's excipient had multiple uses and that it was a disintegrant and a binder. Therefore, the NOA was not deficient" - See paragraphs 29 to 32.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - Sanofi-Aventis Canada Inc. sought an order prohibiting the issuance of a Notice of Compliance to ratiopharm Inc. for its generic version of Irbesartan tablets for oral administration in tablet sizes of approximately 75mg, 150mg and 300mg until the expiration of Canadian Patent No. 2,177,772 (the '772 Patent) - Sanofi-Aventis claimed that the burden of proof on the issue of validity of the '772 Patent shifted to ratiopharm because only ratiopharm knew the basis upon which it claimed the patent to be invalid - The Federal Court stated that "This is not a proper interpretation of the existing law. At most, as Justice Nadon held in Pfizer Canada Inc. v. Canada (Minister of Health), 2007 FCA 209, the second person (ratiopharm in this case) only has the burden of putting the issue in play on some evidentiary basis ... The burden of proof remained with Sanofi-Aventis to prove ratiopharm's allegations were not justified. Sufficient material was advanced to put the issue of validity in play" - See paragraphs 25 to 28.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - Sanofi-Aventis Canada Inc. sought an order prohibiting the issuance of a Notice of Compliance to ratiopharm Inc. for its generic version of Irbesartan tablets for oral administration in tablet sizes of approximately 75mg, 150mg and 300mg - Sanofi-Aventis' Canadian Letters Patent No. 2,177,772, (the '772 Patent) claimed pharmaceutical compositions containing Irbesartan (the active ingredient) alone or in combination with a diuretic, preferably in the form of tablets with a high relative amount of the active ingredient - The Federal Court found that claims 1, 2, 22, 33, 34 and 35 of the '772 Patent were invalid - The court stated that "The breadth of the '772 Patent not only goes beyond the scope of the disclosure but because of its breadth the Applicant cannot establish either utility or sound prediction. The Applicant could not show that it reached 70% active ingredient (Irbesartan) in any of its tests, yet it claims in the patent 70% ... The best that Sanofi-Aventis could achieve was 50% Irbesartan" - The '772 Patent gave no disclosure of the factual basis or sound line of reasoning which would lead to the higher concentrations of Irbesartan - Sanofi-Aventis had claimed too much with 70% and provided too little instruction to show how that which was claimed could be achieved - The '772 Patent did not provide sufficient disclosure to achieve its promise - See paragraphs 71 to 81.

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - [See Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 1502

Grounds of invalidity - Onus and standard of proof - [See Food and Drug Control - Topic 1111.4 ].

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - Sanofi-Aventis Canada Inc. sought an order prohibiting the issuance of a Notice of Compliance to ratiopharm Inc. for its generic version of Irbesartan tablets for oral administration in tablet sizes of approximately 75mg, 150mg and 300mg - Sanofi-Aventis' Canadian Letters Patent No. 2,177,772, (the '772 Patent) claimed pharmaceutical compositions containing Irbesartan (the active ingredient) alone or in combination with a diuretic, preferably in the form of tablets with a high relative amount of the active ingredient - The Federal Court held that claim 36 of the '772 Patent was invalid as ratiopharm's allegation of obviousness was justified or, alternatively, it was anticipated - The court stated that "the only difference between the prior teachings of the '778 Application, the '913 Patent, prior art (particularly the monograph for Hydro Diuril HCTZ and the Desai Paper) and the inventive concept of Claim 36 is an explicit disclosure in the '772 Patent that the absence of the excipients povidone and poloxamer reduces HCTZ degradation. However, this result would inevitably have been achieved by the formulations claimed in the '778 Application because povidone and poloxamer are absent" - The court stated that "Sanofi-Aventis has set up a 'straw man' as the prior art never taught that povidone and poloxamer should be used with HCTZ. There is nothing inventive in finding a solution to a problem that never existed or where the solution was taught in the prior art" - See paragraphs 82 to 88.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - [See Patents of Invention - Topic 1593 ].

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - [See Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 2945

Infringement of patent - Chemical products and substances intended for food and medicine - Particular patents - Sanofi-Aventis Canada Inc. sought an order prohibiting the issuance of a Notice of Compliance (NOC) to ratiopharm Inc. for its generic version of Irbesartan tablets for oral administration in tablet sizes of approximately 75mg, 150mg and 300mg - Sanofi-Aventis' Canadian Letters Patent No. 2,177,772, (the '772 Patent) claimed pharmaceutical compositions containing Irbesartan (the active ingredient) alone or in combination with a diuretic, preferably in the form of tablets with a high relative amount of the active ingredient - The basic issue in the infringement aspect of the litigation was whether ratiopharm's excipient in the ratiopharm tablet performed the function of a diluent - If it did, then the ratiopharm formulation would infringe the '772 Patent - The Federal Court held that Sanofi-Aventis had not established on a balance of probabilities that ratiopharm's excipient in ratiopharm's tablets filled that primary role as a diluent - Therefore, the court found that for purposes of a NOC proceeding, ratiopharm's proposed formulation did not infringe the '772 Patent - See paragraphs 89 to 104.

Cases Noticed:

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 26].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 322 F.T.R. 86; 2008 FC 11, refd to. [para. 27].

Merck Frosst Canada Inc. et al. v. Canada (Minister of Health) et al., [2000] F.T.R. Uned. 663; 8 C.P.R.(4th) 87 (T.D.), affd. (2001), 274 N.R. 297; 12 C.P.R.(4th) 447; 2001 FCA 192, refd to. [para. 30].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 34].

Purdue Pharma v. Pharmascience Inc. et al. (2009), 347 F.T.R. 224; 2009 FC 726, refd to. [para. 51].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 53].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 53].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 351 N.R. 189; 2006 FCA 214, refd to. [para. 69].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 73].

American Home Products Corp. v. Novartis Pharmaceuticals, [2001] R.P.C. 8 (C.A.), refd to. [para. 78].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al. (2002), 291 N.R. 168; 2002 FCA 216, refd to. [para. 87].

Counsel:

James E. Mills and Chantal Saunders, for the applicant;

Douglas Deeth and Nicholas Wong, for the respondent, ratiopharm Inc.

Solicitors of Record:

Gowling Lafleur Henderson, LLP, Ottawa, Ontario, for the applicant;

Deeth Williams Wall, LLP, Toronto, Ontario, for the respondent, ratiopharm Inc.

This application was heard on October 19 to 21, 2009, at Ottawa, Ontario, before Phelan, J., of the Federal Court, who delivered the following decision on March 5, 2010.