Transcript SBG April 3 2012 FINAL IP Law Symposium Utility

Comparative Intellectual Property Law Symposium
Utility Requirements: Converging and Diverging Approaches
Ottawa, Canada April 4, 2012
Canada: The Statutory Basis for
and Judicial Application of the
Utility Requirement
Steven B. Garland
[email protected]
1
Utility – Statutory Basis
• Patent Act, Section 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
2
Utility
• A patent fails to meet the utility requirement and is
therefore invalid if it encompasses inoperable
embodiments.
• Monsanto Co. v. Canada (Commissioner of Patents), [1979] 2. S.C.R.
1108; Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77.
• An invention lacks utility if it either will not operate at
all or, more broadly, if it will not do what the
specification promises that it will do.
• Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981[ 1
S.C.R. 504.
3
Utility
• An applicant/patentee may be required to show that the
promised utility for the full scope of subject matter
claimed was demonstrated or soundly predicted at the
application filing date.
• Issues:
• What is the “promise” of the patent?
• Demonstrated utility vs. sound prediction of utility
4
Utility - Promise
• A “scintilla” of utility will suffice to satisfy Section 2 unless a
specific utility is promised.
• Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1283, aff’d 2006
FCA 64.
• The determination of promise is an aspect of patent
construction and thus a question of law.
• Bristol-Myers Squibb Co. v. Apotex Inc., 2007 FCA 379.
• Not all advantages described in a patent specification will rise
to the level of a promise.
• Eli Lilly Canada Inc. v. Novopharm Limited, 2010 FCA 197.
5
Demonstrated Utility
• There is no obligation upon the patentee to establish the
utility of the invention in the specification.
• Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd.,
[1981] 1 S.C.R. 504.
• If the patentee asserts that utility, as construed, was
demonstrated, then the patentee may rely upon data that was
obtained before filing but not disclosed in the patent to prove
utility.
• Pfizer Canada Inc. v. Novopharm Ltd., 2010 FCA 242, leave to
appeal to the Supreme Court of Canada granted. Appeal to be
heard on April 18, 2012
6
Sound Prediction
•
If utility, as construed, was not demonstrated at the
application date, then the sound prediction test might
apply.
•
For a “sound prediction” there must be:
1. a factual basis for the prediction;
2. an articulable and sound line of reasoning from
which the desired result can be inferred from the
factual basis; and
3. proper disclosure
Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77, at ¶76
7
Sound Prediction: Disclosure
• If the patentee is relying upon a sound prediction of
utility, then there is a heightened obligation to disclose
the underlying facts and the line of reasoning in the
patent.
• Eli Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97, leave to appeal
to Supreme Court of Canada refused; Eli Lilly and Company v.
Teva Canada Limited, 2011 FCA 220.
8
Utility
• Utility objections may arise with respect to any subject
matter:
• Eurocopter v. Bell Helicopter, 2012 FC 113
• Patent claimed landing gear for helicopters
• All but one claim held invalid for lack of demonstrated
utility, sound prediction of utility and overbreadth
9
Jurisprudence
10
Monsanto Co. v. Commissioner of Patents (S.C.C.)
• [1979] 2 S.C.R. 1108.
• Appeal relating to Commissioner’s refusal of application for
chemical compounds used to inhibit premature vulcanization of
rubber where claim covered 126 compounds but specification only
disclosed preparation of three of the compounds.
• Doctrine of Sound Prediction adopted by SCC applying U.K.
jurisprudence including Olin Mathieson Chemical Corp. et al. v.
Biorex Labotories Ltd. et al., [1970] R.P.C. 157 (Ch. Div.).
• The Court held that the architecture of chemical compounds was no
longer a mystery but, within limit, soundly predictable.
• The Court also stated that sound prediction “cannot mean a certainty
since it does not exclude all risk that some of the area covered may
prove devoid of utility”.
11
Apotex Inc. v. Wellcome Foundation Ltd. (S.C.C.)
• 2002 SCC 77 (“AZT”).
• The patent claimed new formulations and products
comprising AZT for use in the treatment and prophylaxis of
AIDS and HIV in humans.
• The Court sets out the tripartite test for sound prediction
(¶70) and concludes the new use of AZT was soundly
predicted.
• The Court did not define what it meant by “proper disclosure”.
Disclosure was not at issue in the case. Both the factual basis
and line of reasoning were found to have been disclosed in
the patent.
12
Eli Lilly Canada Inc. v. Apotex Inc. (F.C.A.)
• 2009 FCA 97
• Appeal affirming the decision of Justice Hughes (2008
FC 142) dismissing Eli Lilly’s application to prohibit the
Minister from issuing an NOC to Apotex.
• The patent claimed raloxifene (EVISTA) for use in the
prevention and treatment of osteoporosis, particularly in
postmenopausal women.
13
Eli Lilly Canada Inc. v. Apotex Inc. (F.C.A.)
• FCA interpreted the SCC decision in AZT requiring
“proper disclosure” element of doctrine of sound
prediction as a “heightened obligation” to disclose in the
patent the underlying facts and the line of reasoning
(¶14).
• Hong Kong Study conducted on 251 post-menopausal
women was considered as the factual basis for sound
prediction, but not disclosed in patent and therefore
patent invalid.
• Leave to appeal to S.C.C. refused.
14
Eli Lilly and Company v. Teva Canada Limited (F.C.A.)
• 2011 FCA 220
• Appeal affirming decision of Justice Barnes (2010 FC
915), that patent in issue invalid for lack of utility.
• Patent claimed the use of atomoxetine (STRATTERA) for
treatment of attention deficit hyperactivity disorder
(ADHD) – a chronic condition.
15
Eli Lilly and Company v. Teva Canada Limited (F.C.A.)
• Barnes J. construed the “promise” as being the fact that the drug
would be clinically effective in treating ADHD, and that this implied
that the drug will work in the long term given the chronic nature of
the condition.
• Lilly had conducted one clinical trial of 21 people over three weeks
that provided “statistically significant” results that the drug may be
useful in treating ADHD.
• Barnes J. concluded that the trial was too small and of too short a
duration to demonstrate or prove utility as of the filing date.
• He also concluded that Lilly could not rely upon the doctrine of
sound prediction as the study was not disclosed in the patent and
therefore there was no disclosed factual basis for prediction.
• Leave to appeal to SCC dismissed December 8, 2011.
16
Apotex Inc. v. Pfizer Canada Inc. (F.C.A.)
• 2011 FCA 236
• Appeal from the decision of Justice Heneghan (2010 FC
447) granting Pfizer an order prohibiting the Minister of
Health from issuing a Notice of Compliance to Apotex.
• Patent claimed latanoprost (XALATAN) and its use in
treating glaucoma or ocular hypertension.
17
Apotex Inc. v. Pfizer Canada Inc. (F.C.A.)
• Justice Heneghan applied the same construction that had
been given to the patent in a previous NOC matter, and which
had been affirmed by the FCA, to the effect that the promise
of the patent was to the use of the compound to treat
glaucoma or ocular hypertension per se.
• Nevertheless, the FCA held that Justice Heneghan erred in her
construction of the claims and the promise of the patent.
• FCA: “Like claim construction, the promise of the patent is
also a question of law” (¶17)
18
Apotex Inc. v. Pfizer Canada Inc. (F.C.A.)
• The Federal Court of Appeal agreed with Apotex that when
the patent was properly construed, the promise of the patent
was the use of the drug to treat glaucoma and avoid side
effects on a chronic basis.
• Accordingly, the FCA held that “utility would be demonstrated
if the patent disclosed studies showing that latanoprost, when
administered on a chronic basis, reduced intraocular pressure
without causing substantial side effects”.
• However, at time of filing, Pfizer had only performed “single
dose” studies on animals and healthy humans.
19
Apotex Inc. v. Pfizer Canada Inc. (F.C.A.)
• Therefore, the FCA was not persuaded that at the time of
filing, Pfizer had a factual basis to conclude that the drug
would be effective for chronic use without side effects.
• Also, no disclosure in the patent of the reasoning.
• Therefore, patent invalid for lack of sound prediction.
• Note: Leave to appeal to the Supreme Court of Canada
refused.
20
Eli Lilly v. Novopharm (F.C.)
• Decision of O’Reilly, J., November 10, 2011(2011 FC 1288)
• Follow-up to the decision that was overturned by the Federal
Court of Appeal (2010 FCA 197) and sent back to the Federal
Court for reconsideration.
• The judge at first instance held the patent invalid as being an
improper selection patent for not meeting the 3-part
description of the same provided by SCC in Sanofi, [2008] 3
S.C.R. 265.
• Patent claimed olanzapine (ZYPREXA) and its use in the
treatment of schizophrenia.
21
Eli Lilly v. Novopharm (F.C.)
Utility of a Selection Patent
• The promise of the selection patent must be greater than what
is promised in the genus patent.
“It is simply not enough for a selected compound to achieve
what was promised in the genus patent” (¶111)
• To be valid, a selection patent must contain an explicit promise
of a substantial and particular advantage over the compounds
of the genus patent, and the alleged invention must meet that
promise.
22
Eli Lilly v. Novopharm (F.C.)
Utility of a Selection Patent
• Court concludes that patent invalid for failure to meet the test
for sound prediction in view of the promise of the patent,
namely that olanzapine would treat schizophrenia in a
“markedly superior manner with a better side effects profile
than other antipsychotics”. (¶258 - 260)
• Decision appears to be based, in part, on conclusion that
human trials would be needed to determine long term efficacy
of the drug.
23
Eli Lilly v. Novopharm (F.C.)
Sufficiency (s. 27(3))
· Justice O’Reilly finds that the patent is not invalid for lack of
sufficiency.
· To meet the requirement of s. 27(3) the patent must simply state
what the invention is and how it works.
· For a selection patent, the specification must “set out clearly what is
better and different about the selected compound as compared to
the genus from which it derives. The patent must give enough detail
that a person skilled in the art would know what the advantages are.”
· However, for purposes of s. 27(3), the patent is not required to set
out the factual basis and line of reasoning supporting the prediction
of efficacy.
24
Apotex Inc. v. Sanofi-Aventis (F.C.)
• Decision of Boivin, J., December 6, 2011 (2011 FC 1486)
• Patent impeachment/infringement action pertaining to
drug clopidogrel bisulfate (Brand name PLAVIX) for use
as an anticoagulant.
• Patent was the subject of the SCC decision in Sanofi,
[2008] 3 S.C.R. 265, a NOC decision.
• Selection patent (‘777 patent) claimed the “dextrorotatory isomer” of the racemate disclosed in the genus
patent (‘875 patent).
• In NOC case, SCC affirmed issuance of prohibition
order.
25
Apotex Inc. v. Sanofi-Aventis (F.C.)
• Justice Boivin:
• Promise of the selection patent cannot be same as
the genus patent
• For the selection patent, promise was use of drug in
humans where efficacy greater, and toxicity less,
than compounds disclosed in genus patent
• Utility not proven as of filing date
• Factual basis and sound line of reasoning existed but
not disclosed in patent and therefore patent invalid
• Claims also invalid as “obvious to try” in view of the
fact that PLAVIX is enantiomer of compound
disclosed in genus patent.
26
AstraZeneca Canada v. Mylan Pharmaceuticals (F.C.)
• Decision of Rennie, J., August 29, 2011 (2011 FC 1023)
• Drug at issue is anastrozole (brand name ARIMIDEX) for
use in the treatment of breast cancer.
• Claims to the compound per se (as a novel compound)
and to its use in inhibiting enzyme aromatase.
• NOC case – Prohibition order granted.
27
AstraZeneca Canada v. Mylan Pharmaceuticals (F.C.)
• Court notes that given the compound is novel, while the utility
must be disclosed in the disclosure, it need not be included in a
claim to the compound per se.
• To assess utility, the Court had to first consider what was
promised, if anything, by the patent, and this includes a review
of the disclosure and the claims.
• Mylan argued the patent made three promises, including
therapeutic utility in treating cancer and fewer side effects.
• Court concludes only promise was aromatase inhibition.
28
AstraZeneca Canada v. Mylan Pharmaceuticals (F.C.)
• Using this construction, and considering the two studies mentioned in
the patent (in vitro human tissue test and in vivo rat tests), the Court
concludes on the evidence that utility had been demonstrated as of the
filing date of the patent.
• Standard of proof is not equivalent to regulatory standard required by
Minister of Health, or standard required for publication in a peer
reviewed journal.
• Standard of proof for utility is low. Test results that are “strongly
suggestive” of utility are sufficient.
• Court also notes that pursuant to Pfizer v. Novopharm “the disclosure
requirement [where utility is proven] can be satisfied by simply making
reference to a test or study that demonstrates utility”.
29
Thank You
Steven B. Garland
[email protected]