Download aka *the Loch Ness Monster* of Patent Law

Litigation Friendly Patents
…aka “the Loch Ness Monster” of Patent
Law
Moderator: Sheldon Hamilton
Presenters: Andrew Bernstein & Sean
Alexander
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%)
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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%)
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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)
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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)
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So what’s causing all these problems?
Utility
Disclosure
CIPO’s “Problem/Solution” paradigm
Drafting & Prosecution practices to minimize risks
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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
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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”
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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)
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“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
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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?
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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
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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.
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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.
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Modest promises almost always lead to good
results
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)
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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
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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
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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
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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
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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”
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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
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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.
2014 © Intellectual Property Institute of Canada
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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 638.
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Drafting Considerations
• Canada is usually not the primary market
• Requirements evolving in different jurisdictions
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Statutory subject-matter
Sufficiency & written description
Utility
Obviousness/Inventive Step
Priority claims & self collision
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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
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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
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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
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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?)
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After Grant…
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s. 53 likely not available
Reissue
Disclaimer
NAFTA
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