PATC Module 2 – Infringement/Validity Double Patenting

Double Patenting Prohibition against double patenting (“evergreening”) is judge-made law arising from principle that public should only have to”pay” one monopoly per invention. [Aventis Pharma Inc. v Pharmascience, 2006 FCA 229]

Double Patenting “A patentee who can “evergreen” a single invention through successive patents by the expedient of obvious or uninventive additions prolongs its monopoly beyond what the public has agreed to pay.” [Whirlpool Corp. v Camco Inc., 9 C.P.R. (4th) 129]

Double Patenting Test for Double Patenting (2 branch test) (1) Claims are coterminous with those of a previously granted patent [Beecham Canada Ltd. v Procter & Gamble Co., 61 C.P.R. (2d) 1] (2) “Obviousness”–type double patenting Claims of second patent are not patentably distinct from claims in first patent [Whirlpool Corp. v. Camco Inc., [2000] SCR 1067; Aventis Pharma Inc. v. Pharmascience Inc, 2006 FCA 229]

Double Patenting NOT the disclosures Test for Double Patenting Confined to claims of patents at issue NOT the disclosures [e.g. Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 17 @ para 125]

First Branch – Coterminous Claims Double Patenting First Branch – Coterminous Claims Ask whether claims are identical Is the same invention being claimed? Like an anticipation analysis [e.g. Merck & Co v Pharmascience, 2010 FC 510 @ 117- 124; Eli Lilly Canada Inc. v. Apotex Inc, 2015 FC 875]

Second Branch – Obviousness Type Double Patenting Second Branch – Obviousness Type Claims are not identical Is subject matter patentably distinct? More flexible, less literal test [e.g. Merck & Co v Pharmascience, 2010 FC 510 @ 117- 124; Eli Lilly Canada Inc. v. Apotex Inc, 2015 FC 875]

Double Patenting ??? First Patent claims a compound 1. A sulphonyl urea of the formula X …. Second Patent claims compound + carrier 1. An antidiabetic preparation effective on oral administration to reduce the blood sugar level, said preparation comprising as the active blood sugar lowering ingredient a sulphonyl urea of the formula X…. and an orally ingestible pharmaceutically acceptable carrier therefor. .

Double Patenting ??? Answer :Yes “A person is entitled to a patent for a new, useful and inventive medicinal substance but to dilute that new sub­stance once its medical uses are established does not result in further invention. The diluted and undiluted substance are but two aspects of exactly the same invention. In this case, the addition of an inert carrier, which is a common expedient to increase bulk, and so facilitate measurement and administration, is nothing more than dilution and does not result in a further invention over and above that of the medicinal itself. If a patent subsists for the new medicinal substance, a separate patent cannot subsist for that sub­stance merely diluted. “ [Commissioner of Patents v. Fabwerks Hoechst Aktiengeselschaft Vormals Meister Lucius & Bruning, [1964] SCR 49]

Double Patenting Double patenting does not preclude   Double patenting does not preclude a selection patent for a selection from a previously patented genus Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 [Also see Pfizer Canada Inc. v. Canada, 2008 FCA 108; GlaxoSmithKline Inc. v. Apotex Inc., 27 C.P.R. (4th) 114]

Double Patenting Patents with overlapping claim territory may result, esp. if the patent with the earlier filing date is delayed in issuance because of conflict proceedings in Patent Office and the other patent issues in the interim. [Aventis Pharma Inc. v Mayne Pharma (Canada) Inc., 2005 FC 1183; but see Bayer Schering Pharma AG v. Canada, 2010 FCA 275]

Double Patenting Claim for a compound that is materially identical to the subject of a process-dependent claim is not inventive and is invalid for “obviousness-type” double patenting [Bayer Schering Pharma AG v. Canada, 2010 FCA 275]

Double Patenting Claims in 1st (Parent) Patent Claims in 2nd Patent A process for making a compound of the formula X comprising the steps ….(a) to (d) 2. The compound of formula X when made by the process set out on Claim 1 Claims in 2nd Patent 1. The compound of formula X

Double Patenting Divisional Patents Will not be invalid for double patenting, if filing of divisional was directed by Patent Office. [Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504]

Double Patenting A patent that issues from an improperly filed/unnecessary divisional is not invalid per se. But it may be invalid for double patenting [Merck & Co. v. Apotex Inc., 2006 FCA 323]

Double Patenting: Example Two patents claim the same compound The patentee dedicates the earlier patent to the public Is the later patent invalid for double patenting?

Double Patenting: Example Answer: Yes “34      Where a patentee obtains a divisional patent that does not conform to the Patent Act, the remedy is provided by the prohibition against double-patenting: From a global perspective, when considering the harm that may result from an improper divisional, it becomes clear that the principle of double patenting provides a sufficient remedy. The harm is that two patents might issue for the same invention, giving the patentee differing monopolies. (Merck & Co. v. Apotex Inc., 2006 FCA 323, 55 C.P.R. (4th) 1 (F.C.A.) at para. 49.)

Double Patenting: Example “35 As discussed above, in the circumstances of this case, Merck's dedication of the '262 patent should not immunize the '211 patent from an allegation of double-patenting. Merck also argued that the '211 patent issued in accordance with the practices of the Patent Office at the time and that the '211 patent's life-span does not exceed the 17-year statutory time-frame. 36 Practices adopted by the Patent Office cannot expand a patentee's rights under the Patent Act (see Bayer Inc. v. Canada (Minister of National Health & Welfare) (1998), 82 C.P.R. (3d) 359, 154 F.T.R. 192 (Fed. T.D.), at para. 33; aff'd (2000), 6 C.P.R. (4th) 285 (Fed. C.A.)).”

Double Patenting: Example “Further, while it is correct to say that the '211 patent itself will provide a monopoly to Merck for no more than 17 years, overall, if I were to give the dedication of the '262 patent the effect Merck desires, its monopoly on sales of dorzolamide would exceed 17 years.” [Merck & Co. v. Canada (Minister of Health), 2010 FC 1043]