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Chemical Patent
Enforcement in
Canada
Promise Little- Do Much
October 28, 2013
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Canadian Inventions for Patents
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Canadian Cultural Inventions
• THE SNOWBLOWER IN 1925;
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Canadian Cultural Inventions
• THE HOCKEY GOALIE MASK IN 1959;
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Canadian Cultural Inventions
• THE SOON TO BE NON-EXISTENT BLACKBERRY;
and
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Canadian Cultural Inventions
• THE WONDERBRA - 1964
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Unique Aspects of Canadian Patent Practice
NO DIFFERENCE
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Unique Aspects of Canadian Patent Practice
1.
FILING – ACCEPTABLE DELAYS
• late PCT national phase filing, 42 months, nominal fee;
• 12 month grace period for inventors disclosure;
Baker Petrolite Corp v Canwell Enviro-Industries Ltd (2002 FCA 158)
• No on-sale bar
2.
CLAIMS – no restriction on the number of claims/type;
3.
EXAMINATION
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defer for five years from Canadian filing date;
request advanced examination;
enter Patent Prosecution Highway (PPH);
application related to Green & Clean Technologies
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Unique Aspects of Canadian Patent Practice
4.
DIVISIONAL PRACTICE
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•
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5.
OWNERSHIP TRANSFER
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6.
assignable freely in whole or in part;
in joint ownership the assignment by one party cannot dilute the existing ownership right of the
other party
PROCEDURAL FLEXIBILITY DURING PROSECUTION
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•
7.
up to the day before parent case issues;
no voluntary divisional filing due to double patenting issues;
Whirlpool Corp v Camco Inc (2000 SCC 67)
claims co-terminus or obviousness type double patenting
no terminal disclaimer or continuation practice.
voluntary amendments and supplemental responses can be filed anytime and more than once;
final examination practice is rare.
NO OPPOSITION PROCEEDINGS
•
can file a Protest against a pending application
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Patents - Criteria for Patentability
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Patents - Criteria for Patentability
NOVELTY
Governed by Section 28.2 of the Patent Act .
Apotex Inc v Sanofi-Synthelabo Canada Inc., [2008 SCC 61]
Established the two part test for anticipation:
1. Was the subject matter of the invention disclosed to
the public by a single disclosure?
2. If there is such a clear disclosure, is the working of the
invention enabled by that disclosure?
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Patents – Criteria for Patentability
OBVIOUSNESS
Governed by Section 28.3 of the Patent Act.
Apotex Inc. v. Sanofi-Synthelabo Canada, Inc. [2008 SCC 61]
Established four part test for obviousness:
- identify the notional “person skilled in the art”, and identify the relevant
common general knowledge of that person;
- identify the inventive concept of the claim in question or, if that cannot readily
be done, construe it;
- identify what, if any, differences exist between the matter cited as
forming part of the “state of the art” and the inventive concept of the claim or
the claim as construed; and
-viewed without any knowledge of the alleged invention as claimed, do
those differences constitute steps which would have been obvious to the
person skilled in the art, or do they require any degree of invention?
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Patents – Criteria for Patentability
PATENTABLE SUBJECT MATTER
Governed by section 2 of the Patent Act
- Products, methods and improvements.
Chemical Arts:
- selection patents;
- new uses for old compounds;
- treatment for natural conditions; and
- diagnostic assays.
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Patents – Criteria for Patentability
Selection Patents
Apotex Inc. v. Sanofi-Synthelabo Canada, Inc. [2008 SCC
61]
Ruled that that the principle of selection patents is acceptable. In
the chemical field, a selection patent is one that claims a selected
compound or group of compounds chosen from a larger group of
compounds claimed in a previous genus patent.
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Patents – Criteria for Patentability
The Court held that the general principle of selection patents
was acceptable on the line of English case authority rooted in In re
IG Farbenindustrie AG’s Patents (1930), 47 RPC 289 (Ch D) (IG
Farbenindustrie) Establishing three conditions required for the
validity of a selection patent and reiterated by the Court:
1. There must be a substantial advantage to be secured or
disadvantage to be avoided by the use of the selected members;
2. The whole of the selected members (subject to “a few exceptions
here and there”) possess the advantage in question; and
3. The selection must be in respect of a quality of a special
character peculiar to the selected group. If further research revealed a
small number of unselected compounds possessing the same advantage,
that would not invalidate the selection patent. However, if research
showed that a larger number of unselected compounds possessed the
same advantage, the quality of the compound claimed in the selection
patent would not be of a special character.
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Patents – Criteria for Patentability
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Patents – Criteria for Patentability
Methods of medical treatment claims can usually be amended into a
use-style format to comply with section 2 of the Patent Act.
However, in the decision of Novartis Pharmaceuticals Canada,
Inc.v. Cobalt Pharmaceuticals Co. 2013 FC 985, it was held that use
claims were in fact methods of medical treatment as they included
references to intermittent dosage and dosage ranges that lie with a
physician’s skill or judgement.
“Use of zoledronic acid, a pharmaceutically acceptable salt
thereof, or a hydrate thereof for the treatment of postmenopausal
osteoporosis wherein the zoledronic acid, salt or hydrate is in a unit
dosage form of about 5 mg which is administered intermittently, with
a period of about one year between the first and each subsequent
administration, wherein each administration is intravenous.”
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Patents – Criteria for Patentability
What the jurisprudence establishes is that a claim to a vendible product,
including a substance intended for the treatment of a medical condition,
can be good subject matter for a patent claim.
Thus, claims such as the following are proper subject matter:
the substance X for the treatment of Y
the substance X in the form of a 5 mg tablet for the treatment of Y
What is improper subject matter is a claim that encompasses the skill of
medical professional, such as:
the closure of a surgical incision by the use of adhesive X
the use of substance X in a dosage range between A and B for the treatment
of X
Justice Hughes also considered the patent disclosure providing that the
mode of administration and dosage may be selected by the attending
physician taking into account the particulars of the patient and describing
intermittent administration regimens.
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Patents – Criteria for Patentability
UTILITY
Generally speaking, the threshold for meeting the utility
requirement is quite low in Canada. The Patent Act provides that
an invention must be “new and useful”.
Utility – demonstrated, but need not be disclosed, or proven
conclusively. Post filing data cannot be relied upon.
(Teva Canada v. Pfizer Canada Inc. 2012 SCC 60)
- soundly predicted, with a factual basis: a line of
reasoning by which predictions of that the claimed invention will
meet the promise of utility and a proper disclosure.
In Apotex Inc. v. Wellcome Foundation Ltd [2002] SCC 77 held
that only that one needed the elements of a factual basis, sound
line of reasoning and proper disclosure. Subsequent cases have
interpreted this to mean the factual basis and line of reasoning
needs to be disclosed, at least in part, in the patent.
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Patents – Criteria for Patentability
PROMISE OF THE PATENT
“The promise of the patent is the standard against
which the utility of the invention described in the patent
is measured.”
Failure to meet the promise of the patent is a crushing
hammer in the hands of those who challenge patents.
“explicit” promise - utility of the invention will be
assessed against such a promise.
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Patents – Criteria for Patentability
In recent Canadian decisions applying the promise doctrine, patents for
what appear to be quite useful inventions have been declared invalid
because the promised utility could not be established as of the
applicant’s filing date.
These court decisions have become so controversial that Eli Lilly filed a
Notice of Intent to submit a claim pursuant to Chapter 11 of the North
American Free Trade Agreement (NAFTA), alleging that the application
of the promise doctrine violates Canada’s obligations under NAFTA. The
claim is based on a decision of the Federal Court (upheld on appeal)
invalidating Eli Lilly’s patent for the drug Strattera, used to treat attentiondeficit disorder. The Supreme Court of Canada refused to hear Eli Lilly’s
appeal.
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Patents – Criteria for Patentability
Luckily, better decisions have arrived…………
Apotex Inc. v. Sanofi-Aventis, 2013 FCA 186
The FCA overturned the FC decision stating that the courts should
avoid reading a promise into a patent where one does not explicitly
exist. The patent did not promise that the clopidogrel bisulfate
compounds would be useful in humans only that the selected
compounds had greater platelet aggregation inhibiting activity and
less toxic than the unselected compounds.
In Apotex/Teva v Novartis, 2013 FC 141, the court found the
promised minimum utility of the compound claims was in vitro
selective enzymatic inhibition.
Failure to meet promises is equally applicable to mechanical
patents (Bell Helicopter Textron Canada Limitee v Eurocopter, 2013
FCA 219)
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Does invention do what patent promises?
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Patents – Criteria for Patentability
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Patents – Criteria for Patentability
Section 27(3) of the Patent Act governs the disclosure requirements
for a patent.
Claims 6 and 7 claimed the uses of a specific compound for
treatment of erectile dysfunction. However, the description did not
identify which compound, if either of them, was effective for the
treatment of erectile dysfunction.
Without further testing, a skilled person could not determine which
of the claimed compounds was effective for the treatment of erectile
dysfunction.
The description referred to especially preferred compounds, but
didn’t specifically identify which of the compounds this referred to.
The disclosure failed to state in clear terms what the invention was.
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Canadian Court Proceedings
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Canadian Patent Litigation
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Initiated in Provincial or Federal Courts before a judge;
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No juries;
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Experts, adopted the approach of “hot tubbing” for panels of experts, no pretrial examination of expert witnesses;
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Litigant’s have a right to privacy;
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Extraordinary remedies, Anton Piller Orders are available;
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No Markman hearings in patent cases, claim construction is a matter of law;
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To determine infringement the claims are first construed to determine the
essential elements of the invention and the non-essential elements. Claims are
given a purposive construction.
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No file wrapper estoppel;
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Canadian Patent Litigation
- No treble damages; party claiming damages has the burden of proving
the nature and extent of damages suffered;
- Costs of litigation, timeline 3-5 years $500,000+;
- Information obtained at discovery may not be used for any purpose
collateral to the Canadian proceeding;
- Sealing and protective orders are generally granted to seek to preserve
confidential information of the parties;
- Interloculatory relief is available.
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Notice of Compliance (NOC)
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Notice of Compliance
The Patented Medicines (Notice of Compliance) Regulations is a legislative
scheme to link drug regulatory approval to patent protection.
Once engaged, a pharmaceutical patentee may delay regulatory approval
for a second party (typically a generic) to sell the patentee’s medicine.
To enter the NOC, a patent must be listed on the Patent Register
maintained by the Minister of Health. Eligible patents for listing are those
that claim the medicine or use of the medicine.
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Notice of Compliance
Typical Scenario:
Brand name drug company lists Patent, a generic drug company develops and
wishes Health Canada to approve a generic version of drug for which a patent is
listed.
Generic must respond to the patents on the register and does this either by (a)
agreeing it will not get its approval (Notice of Compliance or NOC) until any
listed patent expires, or (b) sending a document called an “allegation” to the
brand name drug company in which it asserts that the patent would not be
infringed by its product, or is invalid.
When it receives an allegation, the brand name drug company can then start a
judicial review application, a kind of mini-patent action, for an order that the
generic not get approval until the patent expires.
When the brand drug company starts the court case, Health Canada is
automatically prevented from granting the NOC for 24 months to the generic
drug. In other words, the brand immediately gets what amounts to an automatic
interloctory injunction against competition.
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CONCLUSION - TIPS
1. DO NOT PROMISE ANYTHING!
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CONCLUSION - TIPS
2. INCLUDE AS MUCH INFORMATION AS POSSIBLE
FOR THE FACTUAL BASIS AND SOUND LINE OF
REASONING, E.G. REFERENCE TO THE STATE OF THE
ART, HYPOTHESES, DESCRIPTIONS OF WORK DONE,
TESTS AND RESULTS.
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CONCLUSION - TIPS
3. ADD ADDITIONAL INFORMATION TO THE PATENT
SPECIFICATION LEARNED DURING THE PERIOD
BETWEEN PRIORITY FILING AND THE CANADIAN
FILING DATE. NOTE, HOWEVER, THE CANADIAN
FILING DATE FOR PCT APPLICATIONS IS THE PCT
FILING DATE AND IT IS TOO LATE TO SUPPLEMENT
THE DISCLOSURE UPON NATIONAL ENTRY IN
CANADA.
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CONCLUSION - TIPS
4. CONSIDER EACH CLAIM INDIVIDUALLY AND WHAT
SUPPORT EXISTS IN THE DISCLOSURE FOR IT.
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CONCLUSION - TIPS
5. ADD AS MANY CLAIMS AS POSSIBLE BECAUSE
THERE ARE NO EXCESS CLAIM FEES. THE MORE
CLAIMS THE BETTER CHANCE OF CATCHING AN
INFRINGER AND THE MORE DIFFICULT IT IS FOR
INVALIDATING ALL OF THE CLAIMS.
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CONCLUSION - TIPS
6. WHEN CLAIMING A BROAD GENUS, CLAIM
VARIOUS PREFERRED SUB-GENERA AND
PREFERRED SPECIES DISCLOSED WHICH ARE
ESPECIALLY RELEVANT TO THE WORK DONE.
WHERE ONE IS CLAIMING NEW USES, HAVE CLAIMS
THAT MIRROR THE ACTUAL COMMERCIAL USE AS
SEPARATE INDEPENDENT CLAIMS, DISTINCT FROM
POTENTIAL USES INFERABLE FROM INITIAL
RESEARCH.
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CONCLUSION - TIPS
7. BE AWARE OF HOW STATEMENTS OF
ADVANTAGE, OR DISCUSSION OF POTENTIAL
APPLICATIONS MAY BE ARGUED TO BE PROMISES
OF THE PATENT. THINK ABOUT HOW THAT
STATEMENT CAN BE SUPPORTED, EITHER WITH
INFORMATION IN THE PATENT OR WITH
INFORMATION THAT WOULD BE UNDERSTOOD AT
THE FILING DATE OF THE PATENT.
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CONCLUSION - TIPS
8.
IF YOU INTEND TO LIST YOUR PATENT ON THE PATENT REGISTER,
ADVISE YOUR AGENT EARLY IN PROSECUTION THAT A PATENT
APPLICATION RELATES TO A PRODUCT FOR WHICH REGULATORY
APPROVAL FROM HEALTH CANADA HAS OR WILL BE OBTAINED.
CLAIMS CAN BE ADDED OR AMENDED AT ANY TIME DURING
PROSECUTION OF A CANADIAN PATENT APPLICATION, AND IF THERE
ARE INITIALLY NO CLAIMS GIVING RISE TO A LISTABLE PATENT,
AMENDMENTS CAN BE MADE THAT MAY DO SO.
ADD CLAIMS REFLECTING TO ALL ASPECTS OF THE INVENTION
RELATED TO THE MEDICINE ITSELF OR ITS USE. FOR INSTANCE, IN THE
CASE OF CONTROLLED DELIVERY, THE INVENTIVE ASPECT MIGHT
ALSO BE EXPRESSED AS A USE, SUCH AS A USE OF THE DRUG
ACCORDING TO A PARTICULAR DOSING REGIMEN/FORM KEEPING
CLEAR OF MEDICAL TREATMENT LANGUAGE.
FOR DOSAGE, RECITE EACH POINT IN THE RANGE INDEPENDENTLY
RATHER THAN THE RANGE.
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Applause - thank you!
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Questions
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