1. PATC Module 2 – Infringement/Validity
Double Patenting

2. 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]

3. 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]

4. 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]

5. 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 para 125]

6. 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 ; Eli Lilly Canada Inc. v. Apotex Inc, 2015 FC 875]

7. 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 ; Eli Lilly Canada Inc. v. Apotex Inc, 2015 FC 875]

8. 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. .

9. 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]

10. 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]

11. 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]

12. 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]

13. 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

14. 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]

15. 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]

16. 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?

17. 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.)

18. 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.)).”

19. 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]