1. PATC Module 2 – Infringement/Validity
Sound Prediction

2. Sound Prediction
Chemical and pharmaceutical inventions often pertain to classes of compounds that are characterized by therapeutic utility
Claims must be broadly drafted to protect full scope of invention

3. Sound Prediction
Where invention is class of compounds, inventors will not have made or tested each member of the claimed class
Utility of some compounds is extrapolated to class as a whole
This is permissible so long as criteria for patentability (sound prediction) are met

4. Sound Prediction
“  The doctrine of "sound prediction" balances the public
interest in early disclosure of new and useful inventions,
even before their utility has been verified by tests
(which in the case of pharmaceutical products may
take years) and the public interest in avoiding
cluttering the public domain with useless patents, and
granting monopoly rights in exchange for misinformation.”
[Apotex Inc. v Wellcome Foundation Ltd., [2002] 4 S.C.R. 153]

5. Sound Prediction Three Part Test for Sound Prediction
(1) Factual basis for the prediction
(2) An articulable and “sound” line of reasoning
(3) Sufficient disclosure
[Apotex Inc. v Wellcome Foundation Ltd.,
[2002] 4 S.C.R. 153]

6. Sound Prediction All three conditions for sound prediction
must be met. Otherwise, patent is invalid.
Sound prediction is a question of fact
(evidence driven inquiry)
Patent also invalid if prediction is
shown to be wrong

7. Sound Prediction Sound prediction not validated after
the fact or by commercial success
[Aventis Pharma Inc. v Canada (Apotex-ramipril),
2005 FC 1283;
Does not require certainty
[Astrazeneca Canada Inc et al v Canada
(Pharmascience) , 2012 FC 1189]

8. Sound Prediction Criteria for Sound Prediction
(1) Factual basis for the prediction – is there factual
basis to support the prediction/promised result?
-i.e. data with respect to compounds
actually made/tested by inventors )
[see Pfizer Canada Inc. v. Mylan
Pharmaceuticals ULC, 2011 FC 547;
affd 2012 FCA103; Pfizer Canada Inc. v
Canada (Minister of Health), 2011 FCA 236]

9. Sound Prediction Criteria for Sound Prediction
(2) An articulable and “sound” line of reasoning
from which inventors can infer or extrapolate
utility beyond embodiments of the invention
that have been actually made
e.g. reasonable scientific theory;
“architecture” of compounds;
function theory
[e.g. Pfizer Canada Inc. v Mylan
Pharmaceuticals ULC, 2011 FC 547;2012 FCA 103]

10. Sound Prediction Factual basis and reasoning need not be
disclosed if part of common
general knowledge
Context driven exercise
See Gilead Sciences, Inc. v. Idenix
Pharmaceuticals Inc., 2015 FC para 352;
quoting from Bell Helicopter

11. Sound Prediction [e.g. Eli Lilly & Co. v. Teva Canada Ltd.,
(3) Invention must be properly described with
sufficient detail to enable
the invention to be put into practice
Factual basis underlying prediction and
line of reasoning must be disclosed
[e.g. Eli Lilly & Co. v. Teva Canada Ltd.,
2011 FCA 220; Eli Lilly Canada Inc. v. Apotex Inc.,
2009 FCA 97]

12. Sound Prediction Higher threshold of disclosure
The disclosure must include the prediction
[Eli Lilly Canada Inc. v. Apotex Inc.,
2009 FCA 97]

13. Sound Prediction To assess whether a prediction is sound,
Court will identify the prediction and
ascertain the state of existing public knowledge
including prior art, as of the material date
Material date is the filing date of the
application
[Aventis Pharma Inc. v Canada (Apotex-ramipril),
2005 FC 1283]

14. Sound Prediction “Obviousness is not merely the reverse of
sound prediction. A finding that an invention is
based on a sound prediction
does not necessarily mean that the
invention was obvious.”
[Sanofi-Aventis Canada v. Apotex Inc., 2009 FC 676]

15. Sound Prediction Sound Prediction Obviousness
Who is the relevant person
Inventor
Person of ordinary skill in the art
Abilities of the relevant person
Someone who is by definition “inventive”
Average person, no imagination; not “inventive”
What information can be considered
Common general knowledge, previous private work
Common general knowledge published before the date of the invention;
Level of certainty required
Must be more than a lucky guess, but certainty is not required. a reasonable prediction
Must be very plain that it would work

16. Sound Prediction: Example
12.      The compound 1- [N- (l-carboethoxy-3-phenylpropyl) –
(S) – alanyl] octahydrocyclopenta [b] pyrrole-2 (S) -carboxylic
acid and its pharmaceutically acceptable salts thereof. 
Claim 12 includes eight possible compounds
(stereoisomers –
different configurations/spatial orientation)
Said to be ACE inhibitors
(anti-hypertensive agents)
[Sanofi-Aventis Canada v. Apotex Inc., 2009 FC 676]

17. Sound Prediction: Example
Claim 12 compounds not synthesized as
of application date
State of art was uncertain
[Sanofi-Aventis Canada v. Apotex Inc., 2009 FC 676]

18. Sound Prediction: Example
“[202]      In sum, the combination of Schering’s work and
the available literature or knowledge does not, in my view,
form a factual basis upon which one could form a
sound prediction that the four compounds of Claim 12 with
an R configuration at the carboethoxy position
would be active as ACE inhibitors and antihypertensive
agents”
[Sanofi-Aventis Canada v. Apotex Inc., 2009 FC 676]

19. Sound Prediction: Example
Scientific theory that was unknown to
(or not used) the inventors cannot define
sound line of reasoning
“[208]  The main problem with Dr. Bartlett’s theory is that I have
no evidence that the Schering scientists had incorporated this
theory or concept into their conceptualization. Dr. Bartlett,
with the help of today’s sophisticated software provides a
fine explanation of why many of the compounds included in the
'206  Patent could be effective ACE inhibitors. However,
this does not assist with the question of whether the Schering
scientists had, as of October 20, 1981, considered this as part
of the factual basis for their  prediction.”
[Sanofi-Aventis Canada v. Apotex Inc., 2009 FC 676]

20. Sound Prediction: Example
Insufficient Disclosure:
no test data included in the specification
of the patent. Test data may provide the
public with enough information from which
to make significant inferences.
no discussion that the active site of the ACE
inhibitor has sufficient volume to fit all
stereoisomers

21. Sound Prediction: Example
Insufficient Disclosure:
no explanation how activity for all the clamed
compounds can be inferred from the limited
information the inventors had with respect to
these compounds.
no reference to any publications relied upon by
inventors that all permutations would have utility
no reference to any work done on analogous
compounds from which activity could be
extrapolated.

22. Sound Prediction: Example
Insufficient Disclosure:
no reference to any work done on analogous
compounds from which activity
could be extrapolated
[Sanofi-Aventis Canada v. Apotex Inc., 2009 FC 676]

23. Sound Prediction
“[358] Patent protection rests on the concept of a bargain between the inventor and the public (Free World Trust, above, at para. 13). In the case before me, the Schering scientists chose to include compounds in their patent for which they had no data or sound line of reasoning. It seems that, as Dr. Smith states, Claim 12 was drafted just to cover off future possibilities. While it may be “what is done in patents”, this practice is not in keeping with the fundamental principles of patent protection. Schering failed to live up to its side of the bargain. [Sanofi-Aventis Canada v. Apotex Inc., 2009 FC 676]