PATC Module 2 – Infringement/Validity Sound Prediction

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

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

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]

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]

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

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]

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]

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]

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 1156 @ para 352; quoting from Bell Helicopter

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]

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

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]

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]

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

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]

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]

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]

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]

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

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.

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]

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]