…aka “the Loch Ness Monster” of Patent Law Moderator: Sheldon Hamilton Presenters: Andrew Bernstein & Sean Alexander Litigation Friendly Patents

2014 © Intellectual Property Institute of Canada Recent Trends I 1971 to 1980 Non-drug cases: 27 cases patentee won 19 (70%) Drug cases: patentee won all 3 cases 1981 to 1990 Non-drug cases: 41 cases patentee won 19 (46%) Drug cases: patentee won 1 of 2 cases (50%) 2

2014 © Intellectual Property Institute of Canada Recent Trends II 1991 to 2000 Non-drug cases: 29 cases patentee won 21 (72%) Drug cases: 26 cases patentee won 18 (70%) 2001 to 2010 Non-drug cases: 30 cases patentee won 12 (40%) Drug cases: 74 cases patentee won 29 (39%) 3

2014 © Intellectual Property Institute of Canada Trends III (From Arvie Anderson and Lawrence Welsh, Eli Lilly and Company, The Canadian Patent Promise: A Concern for Pharmaceutical Innovators?, December 2011 IPO Newsletter) 4

2014 © Intellectual Property Institute of Canada Trends IV (From Arvie Anderson and Lawrence Welsh, Eli Lilly and Company, The Canadian Patent Promise: A Concern for Pharmaceutical Innovators?, December 2011 IPO Newsletter) 5

2014 © Intellectual Property Institute of Canada So what’s causing all these problems? Utility Disclosure CIPO’s “Problem/Solution” paradigm Drafting & Prosecution practices to minimize risks 6

2014 © Intellectual Property Institute of Canada Requirement of Utility Patent Act, s. 2: “invention” means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter 7

2014 © Intellectual Property Institute of Canada What does utility mean? Actual utility: does this invention do anything? does this invention do what the specification promises that it will do? (if no promise, a “mere scintilla” of utility will suffice) TRIPs Article 27(1) Utility is synonymous with “capable of industrial application” 8

2014 © Intellectual Property Institute of Canada When dealing with the second branch… Predicted or demonstrated utility: did the inventors show, or could the inventors have predicted that the invention would do “what the specification promises it will do” before filing the patent? Predicted utility: factual basis sound line of reasoning proper disclosure (of the basis and line of reasoning) (based on s. 27) 9

2014 © Intellectual Property Institute of Canada “Promise of the Patent” “The promise of the patent must be ascertained. Like claims construction, the promise of the patent is a question of law.” claims construction is decided by asking the question “how would a POSITA view the scope of the claim to be, in light of the words used by the patentee?” no real legal test for “promise of the patent” (a question of law), although as a general principle, all patents are supposed to be viewed through the eyes of a POSITA 10

2014 © Intellectual Property Institute of Canada One promise or multiple? is there a “promise of the patent” that applies to the whole patent or, is the promise of the claimed invention determined on a claim-by-claim basis? 11

2014 © Intellectual Property Institute of Canada One promise or multiple? if on the basis of the patent as a whole does this mean that a per se compound claim will be interpreted as requiring the same utility as a claim to a use? latanaprost – invalidating the compound claim when attacked under utility imatinib – compound claims had a purely in vitro utility, while use claims were given in vivo utilities 12

2014 © Intellectual Property Institute of Canada One promise or multiple? if claim-by-claim, how do you attach what the disclosure says to particular claims? O’Reilly J.: As I read the patent, having considered the expert evidence tendered by both parties, there are really two levels of utility referred to in the patent. Accordingly, for Claim 6, Pfizer merely has to show that sildenafil had been demonstrated, or soundly predicted, to be useful simply by virtue of its capacity to act as a potent and selective cGMP PDE inhibitor. 13

2014 © Intellectual Property Institute of Canada One promise or multiple? if it’s claim-by-claim, how do you attach what the disclosure says to particular claims? However, where the patent is more specific and claims that a compound is actually useful for the treatment of particular diseases and conditions, the patentee must show the compound's utility in those areas. Accordingly, for Pfizer's Claim 17 (which is a claim for the compounds' use in particular treatments), it must demonstrate actual utility, or establish that utility was soundly predictable, in those areas. 14

2014 © Intellectual Property Institute of Canada Modest promises almost always lead to good results “aromatase inhibition” – win (anastrazole 2011 FC 1023) “potential” use to treat diabetes – win (rosiglitazone, 2011 FC 239) “ACE inhibition” – win (perindopril, 2009 FCA 222) “Selective inhibition of PKC, PDGF-R or ABL” (imatinib, 2013 FC 141) 15

2014 © Intellectual Property Institute of Canada Higher promises are much more of a “mixed bag” ACE inhibition leading to treatment of hypertension – lost (on multiple isomers in a single claim) – ramipril (2009 FC 676) Treatment of glaucoma (brimonidine and timolol) – won (2011 FC 1316) Treatment of Alzheimer’s (donepezil) – won (2011 FC 547) – but both toxicity and pharmacokinetics are not promises Treatment of PDGF-R and ABL related tumours (imatinib) – won 16

2014 © Intellectual Property Institute of Canada Therapeutic and chronic promises are doomed to fail Latanaprost: “chronic treatment in a human, with no side effects” Atomoxetine: “alleviate manifestations of [ADHD] in some patients to such a degree that a doctor would consider prescribing it” Clopidogrel: “the medicine can be used in the treatment of certain human thrombotic diseases” BUT: reversed in the Court of Appeal: no human promise, patent valid 17

2014 © Intellectual Property Institute of Canada So what are the problems? Unpredictable promise can literally be anything from in vitro activity to chronic use in humans without side effects Arbitrary You can win on the evidence but still lose on promise (e.g., donepezil) No deference to this “question of law” on appeal so it’s never over until it’s over 18

2014 © Intellectual Property Institute of Canada Some relief from the Court of Appeal Sanofi v. Apotex (2013), Court of Appeal: promises need to be unequivocal inferences from matters such as the use of the word “patient”, methods of dosing, the listing of diseases and the word “medicine” are not a valid basis for a promise goal of the research program is not a promise Searle v. Mylan; Searle v. Apotex (FC) applying the Sanofi decision, finds no promise in humans and no promise of reduced side effects 19

2014 © Intellectual Property Institute of Canada Other interesting questions Do promises come predominantly from the claims or the disclosure or both? Fournier Pharma case: “where that promise – the claimed utility – is clearly and unequivocally expressed by the inventor in the claims of the patent then that expression ought to be viewed as the promise of the patent. Any statement found elsewhere should be presumed to be a mere statement of advantage unless the inventor clearly and unequivocally states that it is part of the promised utility” 20

2014 © Intellectual Property Institute of Canada But… The Supreme Court will hear Sanofi in 2014 When the Supreme Court hears a patent case, absolutely anything might happen: the standard for promise might be reduced … or increased the disclosure requirement of sound prediction might be eliminated … or solidified the Supreme Court uses a lot of loose language – big mystery as to where it will lead… Searle cases heard September 30 21

2014 © Intellectual Property Institute of Canada Also – is “Sound Prediction Disclosure” a real thing? We all know this story: Justice Binnie in Apotex v. Wellcome put in a throw-away line about the need for “proper disclosure” when the case is a matter of sound prediction. The FCA picked it up and has been applying a rule that the patent must contain the factual basis and (sometimes) the sound line of reasoning for the disclosure. 22

2014 © Intellectual Property Institute of Canada Sound Prediction Disclosure – is there hope on the way? The Supreme Court in Teva v. Pfizer (Viagra) cast some serious doubt on whether this requirement does (or should) exist Justice Rennie recently found that the requirement only applies in the case of new uses of old compounds: AstraZeneca Canada Inc. v. Apotex Inc., 2014 FC

2014 © Intellectual Property Institute of Canada Drafting Considerations Canada is usually not the primary market Requirements evolving in different jurisdictions Statutory subject-matter Sufficiency & written description Utility Obviousness/Inventive Step Priority claims & self collision 24

2014 © Intellectual Property Institute of Canada Drafting Considerations Support for the utility Demonstrate through data Soundly predict Factual basis Line of reasoning Included in the disclosure Craft claims to ensure those with demonstrated utility are separate from those soundly predicted “Promises” require careful consideration 25

2014 © Intellectual Property Institute of Canada Drafting Considerations Why make a “promise”? Problem-solution Selection inventions How do we make a “promise”? Claims? Specification? ‘Promising’ language Who interprets the “promise”? POSITA, Expert witness, Judges 26

2014 © Intellectual Property Institute of Canada Drafting Considerations Making a ‘promise’ is not really necessary Carefully stating an advantage, goal or problem does not make a ‘promise’ Stating the industrial applicability of an invention does not make a ‘promise’ Provide the solution to a problem requirements implicitly and/or reference to specific examples 27

2014 © Intellectual Property Institute of Canada Prosecution Considerations Cases from outside of Canada may have issues Claims cover demonstrated utility & soundly predicted utility Specification contains promises Split out claims that have ‘demonstrated’ utility Cover individual compounds/embodiments in separate claims Deleted/amend ‘promising’ language (added subject-matter?) 28

2014 © Intellectual Property Institute of Canada After Grant… s. 53 likely not available Reissue Disclaimer NAFTA 29