Sanofi-Aventis v. Apotex Inc., 2013 FCA 186 (2013)

Parts:Sanofi-Aventis v. Apotex Inc.
Reporting Judge:NOËL J.A.
Docket Number:A-7-12
 
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Federal Court of Appeal - Sanofi-Aventis v. Apotex Inc. [Anonymoused]

Source: http://decisions.fca-caf.gc.ca/en/2013/2013fca186/2013fca186.html

Date: 20130724

Docket: A-7-12

Citation: 2013 FCA 186

CORAM: NOËL J.A.

PELLETIER J.A.

GAUTHIER J.A.

BETWEEN:

SANOFI-AVENTIS

Appellant and

APOTEX INC.

Respondent

BETWEEN:

SANOFI-AVENTIS and

BRISTOL-MYERS SQUIBB SANOFI

PHARMACEUTICALS HOLDING PARTNERSHIP

Appellants and

APOTEX INC.

APOTEX PHARMACHEM INC. and

SIGNA SA de CV

Respondents

Heard at Toronto, Ontario, on January 28, 2013.

Judgment delivered at Ottawa, Ontario, on July 24, 2013.

REASONS FOR JUDGMENT BY: PELLETIER J.A.

CONCURRED IN BY: NOËL J.A.

CONCURRING REASONS BY: GAUTHIER J.A.

Date: 20130724

Docket: A-7-12

Citation: 2013 FCA 186

CORAM: NOËL J.A.

PELLETIER J.A.

GAUTHIER J.A.

BETWEEN:

SANOFI-AVENTIS

Appellant and

APOTEX INC.

Respondent

BETWEEN:

SANOFI-AVENTIS and

BRISTOL-MYERS SQUIBB SANOFI

PHARMACEUTICALS HOLDING PARTNERSHIP

Appellants and

APOTEX INC.

APOTEX PHARMACHEM INC. and

SIGNA SA de CV

Respondents

REASONS FOR JUDGMENT

PELLETIER J.A.

INTRODUCTION:

[1] Plavix is a very successful anti-coagulant drug which was developed, patented, and marketed by the appellant, Sanofi-Aventis (Sanofi). Apotex Inc. (Apotex), a well known manufacturer and distributor of generic drugs, attempted to create and market its own version of the active ingredient in Plavix, clopidogrel bisulfate (clopidogrel). It applied for a Notice of Compliance from the Minister of Health, alleging that its version of clopidogrel did not infringe Sanofi’s patent which, it alleged, was invalid in any event for a number of reasons, including obviousness. Sanofi responded by applying to the Federal Court for an order prohibiting the Minister from issuing the Notice of Compliance to Apotex. That application was successful so that Sanofi continued to enjoy a monopoly with respect to the manufacture and sale of Plavix: Sanofi-Synthelabo Canada Inc. v. Apotex Inc ., 2005 FC 390, [2005] F.C.J. No. 482 (QL). Appeals to the Federal Court of Appeal, Sanofi-Synthelabo Canada Inc. v. Apotex Inc., 2006 FCA 421, [2006] F.C.J. No. 1945 (QL), and to the Supreme Court of Canada, Apotex Inc. v. Sanofi-Synthelabo Canada inc., 2008 SCC 61, [2008] 3 S.C.R. 265 ( Plavix ), were unsuccessful.

[2] Apotex then commenced an action in the Federal Court seeking a declaration that Sanofi’s patent, Canadian Patent No. 1,336,777 (the ‘777 Patent) was invalid. Sanofi replied by commencing its own action, alleging that Apotex had infringed its patent by importing clopidogrel into Canada from Mexico and then exporting it from Canada for sale in other countries including the United States. The two actions were consolidated and were heard by Boivin J. (the Trial Judge or simply, the Judge). Following a 26 day trial, the latter found that the ‘777 Patent was invalid for lack of utility on the basis that the promise of the patent had neither been demonstrated nor soundly predicted. In addition, the Trial Judge found that the invention described in the patent was obvious. Though the Trial Judge also found that Apotex had infringed the ‘777 Patent, that finding was overtaken by his conclusion that the patent was invalid. The Trial Judge’s decision is reported as Apotex Inc. v. Sanofi-Aventis, 2011 FC 1486, [2011] F.C.J. No. 1813 (QL), (Reasons).

[3] This is an appeal of that decision. It raises a variety of issues including the promise of the patent, obviousness, and the limitation period applicable to certain acts of patent infringement.

BACKGROUND

[4] The following factual background will provide context for the analysis which will follow.

[5] The ‘777 Patent is a selection patent which means that it claims a subset of compounds which are already within the scope of another patent, Canadian patent 1,194,875 (‘875 Patent). I can do no better, in terms of describing the relationship of the patents and compounds in issue, than to quote paragraphs 3 to 6 of the Supreme Court’s decision in Plavix :

3 The parties have accepted that the Sanofi respondents ("Sanofi") are the relevant holders of patent 1,194,875 (‘875 Patent). This patent disclosed a genus or class of compounds useful in inhibiting platelet aggregation activity in the blood which is important in treating coronary artery, peripheral vascular and cerebral vascular diseases. This genus patent discloses over 250,000 possible different compounds useful for this purpose. One of the compounds is a racemate described as methyl alpha-5 (4,5,6,7-tetrahydro (3, 2-c)-thieno pyridyl) (2-chlorophenyl)-acetate (the "racemate").

4 A racemate is a substance containing equal amounts of two structurally different compounds, called enantiomers or optical isomers. The two isomers, the dextro-rotatory isomer and the levo-rotatory isomer, are mirror images of each other and rotate plane-polarized light in opposite directions.

5 The parties have accepted that Sanofi is also the relevant holder of subsequent Canadian patent 1,336,777 (‘777 Patent), the patent in suit. It discloses and claims clopidogrel bisulfate, which is marketed by Sanofi under the trade name of Plavix as an anti-coagulant that inhibits platelet aggregation activity in the blood.

6 Clopidogrel bisulfate is encompassed within the scope of the claims in the ‘875 Patent. Clopidogrel is the dextro-rotatory isomer of the racemate, having beneficial properties over both the racemate and the levo-rotatory isomer. The dextro-rotatory isomer exhibits a platelet aggregation inhibiting activity and is less toxic and better tolerated than the levo-rotatory isomer and racemate. The salts of the dextro-rotatory isomer, such as clopidogrel bisulfate, have a better therapeutic index than the salts of the racemic mixture and in fact, the levo-rotatory isomer exhibits almost no platelet aggregation inhibiting activity, and its toxicity is markedly higher than that of the dextro-rotatory isomer.

[6] While there are differences in the evidence which was before the Supreme Court in the Notice of Compliance proceedings (which gave rise to the Plavix decision) and the evidence in this action, none of those differences affect the accuracy the Supreme Court’s description of the relationship of the compounds in issue and their structure.

The ‘777 Patent

[7] The issues raised by this appeal require an understanding of the ‘777 Patent.

[8] The patent begins with a description of its subject matter:

The present invention relates to the dextro-rotatory enantiomer of methyl alpha-5 (4,5,6,7-tetrahydro (3,2-c) thieno pridyl) (2-chorophenyl)-acetate, a process for its preparation and pharmaceutical compositions containing it.

[9] Following a description of the formula of the invention, the patent describes its advantages:

In an unexpected manner only the dextro-rotatory enantiomer I d exhibits a platelet aggregation inhibiting activity, the levo-rotatory enantiomer I l being inactive. However, the inactive levo-rotatory enantiomer I l is the less well tolerated of the two enantiomers.

The invention also relates to the addition salts of the compounds of formula (I d ) with pharmaceutically acceptable mineral or organic acids.

[10] The patent then describes the processes by which the invention can be made, setting out detailed instructions by which the enantiomer can be separated from its racemate and a suitable salt obtained.

[11] The next section of the patent is entitled “Pharmacological Activity”. In it, one finds a comparison between the compound of the ‘777 patent and the racemic mixture from which it was derived with respect to platelet inhibiting activity and toxicity. Platelet aggregation studies in rats showed that the levo-rotatory isomer is inactive and that the dextro-rotatory isomer is at least as active as the racemate. A test of anti-thrombotic activity showed that the levo-rotatory isomer showed no anti-thrombotic activity whereas the racemate and the dextro-rotatory isomer did. Toxicity studies in rats showed that the toxicity of the racemic mixture was similar to that of the levo-rotatory isomer while the dextro-rotatory isomer is markedly less toxic.

[12] This section concludes as follows:

The pharmacological study just presented has demonstrated the interesting inhibitory properties towards platelet aggregation of the compound I d and the absence of any activity of its isomer I l .

The medicine of the invention can be made available for oral administration in form of tablets, sugar-coated tablets, capsules, drops, granules, or a syrup. It can also be made available in the form of suppositories or for parenteral administration in the form of an injectable solution.

On account of its interesting inhibitory properties towards platelet aggregation and its interference in the mechanism of formation of arterial and venous thromboses, the medicine of the invention can be usefully administered in the treatment and prevention of platelet disorders due to extracorporeal blood circuits or the consequence of complications in artheroma.

[13] The patent concludes with 11 claims which can be summarized as follows:

- Claim 1 claims the dextro-rotatory isomer of methyl alpha-5 (4,5,6,7-tetrahydro (3,2-c) thieno pridyl) (2-chorophenyl)-acetate,

- Claims 2 to 5 claim salts of the compound in Claim 1,

- Claims 6 to 9 claim processes for preparation of the compound described in Claim 1,

-Claim 10 claims a pharmaceutical composition comprising an effective amount of the compound in Claim 1 in admixture with a pharmaceutically acceptable carrier, and

-Claim 11 claims a composition according to Claim 10 within a given dosage range.

THE DECISION UNDER APPEAL

[14] After disposing of a number of preliminary questions which are not in issue in this appeal, the Trial Judge addressed the construction of the patent. He first described the “inventive concept” of the patent, quoting the Supreme Court’s statement in Plavix :

78 In the present...

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