GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al., 2008 FC 593

• Judge: Barnes, J.
• Court: Federal Court (Canada)
• Case Date: May 09, 2008
• Jurisdiction: Canada (Federal)
• Citations: 2008 FC 593;(2008), 328 F.T.R. 241 (FC)

GlaxoSmithKline v. Pharmascience (2008), 328 F.T.R. 241 (FC)

MLB headnote and full text

Temp. Cite: [2008] F.T.R. TBEd. MY.012

GlaxoSmithKline Inc. and The Wellcome Foundation Limited (applicants) v. Pharmascience Inc. and The Minister of Health (respondents)

(T-833-06; 2008 FC 593)

Indexed As: GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al.

Federal Court

Barnes, J.

May 9, 2008.

Summary:

GlaxoSmithKline and Pharmascience (GSK) applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister from issuing a Notice of Compliance to Pharmascience until the expiry of GSK's 083 Patent in 2015. GSK claimed that the 083 Patent was a valid selection patent which would be infringed if Pharmascience was permitted to produce the antiviral compound valacyclovir. GSK's earlier genus patent from which the selection of valacyclovir was drawn was GSK's European 493 Patent. The Canadian equivalent of the 493 Patent was the 637 Patent, which expired in 2003. GSK's 493 Patent claimed a monopoly over a class or genus of compounds which included valacyclovir. Pharmascience wished to produce a generic version of valacyclovir, which would admittedly infringe several claims in GSK's later 083 Patent for valacyclovir. Pharmascience's Notice of Allegation claimed that the 083 Patent was invalid for anticipation, obviousness, non-utility, double patenting, lack of invention, insufficiency, disclosure, lack of sound prediction and because the 083 Patent did not contain or disclose a valid selection from GSK's earlier patent over valacyclovir. The issue was whether the 083 Patent was a valid selection patent.

The Federal Court dismissed GSK's application. The bioavailability advantage asserted as the inventive selection of the 083 Patent was neither anticipated by the 493 Patent nor obvious. The 493 Patent did not contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the promise of improved oral bioavailability made by the 083 Patent. Further, the prior art respecting this issue was not sufficiently compelling to meet the rigorous test for obviousness. GSK failed to meet the burden of establishing a valid selection, at least in terms of utility. There was insufficient evidence to establish an advantage in the 083 Patent that fulfilled the test for a valid selection from the compounds claimed by GSK's 493 Patent. Accordingly, the 083 Patent was invalid because GSK failed to establish an inventive selection by failing to prove a special advantage of utility vis-à-vis the genus from which valacyclovir was chosen. The 083 Patent failed for lack of utility.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court referred to the following test for obviousness: "the classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. It is a very difficult test to satisfy." - See paragraph 28.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - [See first Patents of Invention - Topic 1587 ].

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents - GlaxoSmithKline and Pharmascience (GSK) applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister from issuing a Notice of Compliance to Pharmascience until the expiry of GSK's 083 Patent in 2015 - GSK claimed that the 083 Patent was a valid selection patent which would be infringed if Pharmascience was permitted to produce the antiviral compound valacyclovir - GSK's earlier genus patent from which the selection of valacyclovir was drawn was GSK's European 493 Patent - The Canadian equivalent of the 493 Patent was the 637 Patent, which expired in 2003 - GSK's 493 Patent claimed a monopoly over a class or genus of compounds which included valacyclovir - Pharmascience wished to produce a generic version of valacyclovir, which would admittedly infringe several claims in GSK's later 083 Patent for valacyclovir - Pharmascience's Notice of Allegation claimed that the 083 Patent was invalid for anticipation, obviousness, non-utility, double patenting, lack of invention, insufficiency, disclosure, lack of sound prediction and because the 083 Patent was not a valid selection patent - The Federal Court dismissed GSK's application - The bioavailability advantage asserted as the inventive selection of the 083 Patent was neither anticipated by the 493 Patent nor obvious - The 493 Patent did not contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the promise of improved oral bioavailability made by the 083 Patent - Further, the prior art respecting this issue was not sufficiently compelling to meet the rigorous test for obviousness - However, GSK failed to meet the burden of establishing a valid selection, at least in terms of utility - There was insufficient evidence to establish an advantage in the 083 Patent that fulfilled the test for a valid selection from the compounds claimed by GSK's 493 Patent - Accordingly, the 083 Patent was invalid because GSK failed to establish an inventive selection by failing to prove a special advantage of utility vis-à-vis the genus from which valacyclovir was chosen - The 083 Patent failed for lack of utility.

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents - The Federal Court stated that "the law in the area of disclosure has recently been clarified to a degree by ... the Federal Court of Appeal ..., which held that, for a selection patent, the patentee need not disclose anything more than the surprising and unexpected advantage of the selection. No data or other evidence to support that assertion is required to be published within the patent. Suffice it to say, though, that when a patentee is attempting to establish the utility of a selection by relying upon evidence of sound prediction, there may be an obligation to disclose in the patent the underlying facts and the line of reasoning which support the prediction. ... It seems to me that if a patentee is relying on sound prediction to establish that its selection has some unexpected advantage over the genus, it does have a heightened obligation to disclose in the patent its line of reasoning because that is part of the quid pro quo for the claimed monopoly over the selection." - See paragraphs 71.

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents - The Federal Court set out the requirements for finding a valid selection patent: "(a) the selection invention must 'add something of a substantial character to existing knowledge'; (b) the result achieved must not be obvious to persons skilled in the art; (c) a selection patent does not in its nature differ from any other patent and is open to attack on the usual grounds of want of subject-matter, want of utility, want of novelty and so forth; (d) a valid selection patent must be based on some substantial advantage to be secured (or disadvantage avoided) by the use of the selected members; (e) the whole of the selected members must possess the advantage asserted or the patent will fail for insufficiency and non-utility; (f) the selection must be in respect of a quality of a special character which is peculiar to the selected group or compound. This special characteristic must not be one which those skilled in the art would expect to find in a large number of the members of the genus; (g) it is necessary for the patentee to define in clear terms the nature of the characteristic which is asserted to be possessed by the selected compounds." - See paragraph 48.

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents - The Federal Court stated that "in a pharmaceutical selection patent, the invention is the discovery of a surprising or unexpected advantage of the selection over the genus of compounds from which it was chosen. The utility of such a selection is not found in the fact that it works to successfully treat some human condition or ailment but rather that it works surprisingly better than the compounds monopolized by the genus patent. That is the inventive promise made and the inventive promise that must be established." - See paragraph 66.

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - The Federal Court referred to the following test for anticipation: "anticipation, or lack of novelty, asserts that the invention has been made known to the public prior to the relevant time. The inquiry is directed to the very invention in suit and not, as in the case of obviousness, to the state of the art and to common general knowledge. Also, as appears from the passage of the statute quoted above, anticipation must be found in a specific patent or other published document; it is not enough to pick bits and pieces from a variety of prior publications and to meld them together so as to come up with the claimed invention. One must, in effect, be able to look at a prior, single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the claimed invention. Where, as here, the invention consists of a combination of several known elements, any publication which does not teach the combination of all the elements claimed cannot possibly be anticipatory." - See paragraph 27.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - [See first Patents of Invention - Topic 1587 and Patents of Invention - Topic 1602 ].

Cases Noticed:

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2007), 311 F.T.R. 21; 58 C.P.R.(4th) 353; 2007 FC 455, refd to. [para. 14].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 27].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116; 2007 FCA 217, refd to. [para. 28].

I.G. Farbenindustrie A.G. Patents, Re (1930), 47 R.P.C. 283, refd to. [para. 48].

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. 50].

E.I. DuPont De Demours & Co., [1982] F.S.R. 303 (H.L.), refd to. [para. 50].

Dreyfus et al., Re (1945), 62 R.P.C. 125 (H.L.), refd to. [para. 51].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., [2007] 2 F.C.R. 137; 351 N.R. 189; 2006 FCA 214, refd to. [para. 52].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 377 N.R. 9; 2008 FCA 108, refd to. [para. 52].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 2006 FCA 64, refd to. [para. 53].

Authors and Works Noticed:

Bungaard, Hans, Design of Prodrugs (1985), para. 9.3 [para. 9, footnote 1].

Colla et al., Synthesis and Antiviral Activity of Water-Soluble Esters of Acyclovir (1983), 26 J. Med. Chem. 603, generally [para. 37].

Counsel:

Patrick Kierans, Nadine D'Aguiar and Kenneth Sharpe, for the applicants;

Carol Hitchman, Paula Bremner and Brendan Lounsbery, for the respondents.

Solicitors of Record:

Ogilvy Renault LLP, Toronto, Ontario, for the applicants;

Hitchman & Sprigings, Toronto, Ontario, for the respondents.

This application was heard on March 3-7, 2008, at Toronto, Ontario, before Barnes, J., of the Federal Court, who delivered the following judgment on May 9, 2008.