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(now Canada's Access to Medicines Policy) ... Application for Leave to Appeal was filed with the Supreme Court of Canada in June 2006. ... – PowerPoint PPT presentation

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Title: September 21, 2006


1
September 21, 2006
  • Recent Developments in Intellectual Property Law
    in Canada
  • By
  • Mitch Charness

2
Recent Developments in Canadian Patent Law
Outline
  • Legislative Update
  • Bill C-29 Small Entity Fees
  • Proposed Amendments to Patented Medicines (Notice
    of Compliance) Regulations
  • Jean Chrétien Pledge to Africa Act
  • (now Canadas Access to Medicines Regime)
  • Case Law Update
  • Non-Notice of Compliance Patent Law
  • Patent Assignment and Competition Law
  • Doctrine of Sound Prediction
  • Invention v. Discovery
  • Claim Construction
  • Patented Medicines (Notice of Compliance) Law
  • Listing of Patents for Publicly available
    compounds
  • Patents for Medicine Delivery
  • Interpretation of NOC Regulations

3
Legislative Update
4
Legislative Update Bill C-29
  • When is a payment not a payment?
  • An incorrect payment is not a payment when it is
    an underpayment.

5
Legislative Update Bill C-29 Contd Small
Entity Definition
  • Not the same as U.S.
  • "Small entity" in respect of an invention, means
    an entity that employs 50 or fewer employees or
    that is a university, but does not include an
    entity that
  • has transferred or licensed, or is under a
    contractual or other legal obligation to transfer
    or license, any right in the invention to an
    entity, other than a university, that employs
    more than 50 employees or
  • has transferred or licensed, or is under a
    contractual or other legal obligation to transfer
    or license, any right in the invention to an
    entity that employs 50 or fewer employees or that
    is a university, and has knowledge of any
    subsequent transfer or license of, or of any
    subsisting contractual or other legal obligation
    to transfer or license, any right in the
    invention to an entity, other than a university,
    that employs more than 50 employees.

6
Legislative Update Bill C-29 contd
  • Barton No-till Disk Inc. Flexi-coil Ltd.
  • v. Dutch Industries Ltd. (2003 FCA 121)
  • Federal Court
  • Removed Canadian Intellectual Property Office's
    flexibility to allow patent holders and
    applicants to top-up fee payments if payments
    were paid at the wrong level.
  • If fees were paid incorrectly, the patent
    application would become irrevocably abandoned or
    the patent would lapse with no opportunity for
    correction
  • Federal Court of Appeal
  • The relevant fee scale (entity status) is set
    when the patent regime is first engaged.
  • i.e. if a person qualifies as a small entity at
    the time of first submitting a patent
    application, all fees for that patent shall be
    paid on the small entity scale, regardless of
    subsequent events.

7
Legislative Update Bill C-29 contd
  • Section 78.6 of the Patent Act (formerly known as
    Bill C-29)
  • Government response to Dutch Industries decision.
  • Enacted February 1, 2006
  • Gives patentees or applicants 12 months from the
    time the Bill came into force to make a
    retroactive payment to "top-up" an incorrectly
    paid small entity fee without payment of an
    additional reinstatement fee.
  • DEADLINE February 1, 2007.

8
Legislative Update NOC Regulations
  • BACKGROUND
  • The Patented Medicines (Notice of Compliance)
    Regulations and the Food and Drug Regulations
    allow generic drug manufacturers to develop
    generic drugs during the innovator's patent term
    while ensuring that the rights of the patentee
    are respected
  • Currently, the Canadian law is modeled on the
    U.S. Hatch-Waxman Law and is similar in many
    respects.

9
Legislative Update NOC Regulations contd
  • PROPOSED AMENDMENTS
  • The Canadian Government recently published
    proposed amendments to the Patented Medicines
    (Notice of Compliance) Regulations and the Food
    and Drug Regulations (Data Protection
    Regulations).
  • These proposed changes replace prior proposed
    amendments published in December 2004 which never
    came into force.
  • The current proposals take into account the
    results of 18 months of Government consultations
    following the previous proposed amendments.
  • Areas affected Eligibility Requirements, the
    Patent Register, and Data Exclusivity.

10
Legislative Update NOC Regulations Contd
  • Eligibility Requirements
  • New Drug Submission (NDS)
  • Previously, only a patent for the medicine itself
    could be listed.
  • Proposed amendments change the requirement for
    listing to include patents for a medicinal
    ingredient, a formulation, dosage form that
    contains the medicinal ingredient, or the use of
    the medicinal ingredient.
  • i.e. At least some delivery systems may now be
    submitted.
  • e.g. patch, pill structure, etc.
  • Supplementary New Drug Submission (SNDS)
  • Again, categories of patents eligible for
    submission expanded to include changes in the
    formulation, dosage form or use of the medicinal
    ingredient.
  • Proposed amendments would require that the patent
    be relevant to the submission in relation to
    which it is submitted.
  • The patent list must be submitted with the
    specific submission to which the patent list
    relates or within 30 days after the issuance of
    the patent if its filing date precedes the filing
    date of that submission.

11
Legislative Update NOC Regulations Contd
  • Patent Register
  • The current requirement that the generic has to
    address all patents on the Register prior to the
    issuance of the generic's NOC will be repealed.
  • The generic only need address those patents on
    the Register prior to the filing of the generic's
    submission Frozen Register.
  • New rules would apply to a generic which has
    filed its submission prior to the amendments
    coming into force, but the freeze date would be
    the date at which the amendments came into force.
  • If a innovators drug is not subject to the new
    data protection provisions, the freeze would be 6
    years from the date of the first NOC of the
    innovator (e.g. the deemed date of filing of the
    generic submission).

12
Legislative Update NOC Regulations Contd
  • Data Exclusivity
  • Guaranteed minimum period of data exclusivity
  • 8 years for new drugs
  • an additional 6 months for drugs that have been
    the subject of clinical trials in children.
  • 6 year no-filing period for generic submissions.
  • Would apply where a generic seeks an NOC for a
    new drug on the basis of any comparison between
    it and an "innovative drug".
  • Innovative drug contains a medicinal
    ingredient not previously approved in a drug by
    the Minister and that is not a variation of a
    previously approved medicinal ingredient such as
    a salt, ester,

13
Legislative Update NOC Regulations Contd
  • TIMING
  • The proposed amendments were published on June
    17, 2006
  • A 30-day consultation period took place, closing
    on July 17, 2006.
  • Uncertainty regarding when the new regulations
    will come into force, or what form they will
    take.
  • TRANSITIONAL PROVISIONS
  • New listing requirements will apply retroactively
    to all Patent Lists filed on or after June 17,
    2006.

14
Legislative Update Jean Chrétien Pledge to
Africa Act (now Canadas Access to Medicines
Policy)
  • Allows the export of pharmaceutical products made
    under compulsory licenses within the terms set
    out in the Act.
  • Implements the Decision of the WTO General
    Council of August 30, 2003, and paragraph 6 of
    the Doha Declaration.
  • Intended to facilitate access to pharmaceutical
    products to address public health problems
    afflicting many developing and least-developed
    countries, especially those resulting from
    HIV/AIDS, tuberculosis, malaria and other
    epidemics.
  • Permits exports of 56 defined products to all WTO
    countries plus all non-WTO least-developed
    countries, except the 23 WTO countries that have
    opted out.

15
Legislative Update Jean Chrétien Pledge to
Africa Act Contd
  • ADMINISTRATION
  • Published intention was for process to be easy,
    straight forward.
  • If a generic manufacturer meets the requirements
    set out in regulations, there is no discretion
    for Commissioner of Patents to refuse a license.
  • No opportunity for patentees to provide
    submissions regarding the appropriateness of the
    grant of a license.
  • Patentees can apply for termination of compulsory
    license where there are abuses of the system.
  • Do adequate safeguards exist?
  • licenses granted only for humanitarian purposes
  • potential for diversion minimized

16
Legislative Update Jean Chrétien Pledge to
Africa Act Contd
  • Has the legislation had any effect?
  • No takers, therefore no drugs have gone out.

17
Case Law Update
18
Case Law Update Patent Assignment and
Competition Law
  • Eli Lilly and Co. v. Apotex
  • 44 C.P.R. (4th) 1 (F.C.A.).
  • FACTS
  • Infringement action brought against Apotex by Eli
    Lilly citing 8 different patents
  • 4 out of 8 patents were assigned to Eli Lilly by
    Shionogi Co. Ltd.
  • Eli Lilly simultaneously granted Shionogi
    non-exclusive license respecting patents
    assigned.
  • Apotex alleged that assignment of patents
    constituted conspiracy to unduly lessen
    competition contrary to the Canadian Competition
    Act.

19
Case Law Update Patent Assignment and
Competition Law Contd
  • ISSUE
  • What is the relationship between Patent Law and
    Competition Law?
  • HELD
  • The exercise of Patent rights may be subject to
    scrutiny under the Competition Act where
    competition may be unduly lessened.
  • Can occur where an assignment of a patent
    increases the assignees market share to a
    greater degree than is inherent in the patent
    itself.
  • Potentially an issue in an assignment where the
    assignee owns other related patents.

20
Case Law Update Doctrine of Sound Prediction
  • Aventis v. Apotex
  • 43 C.P.R. (4th) 161 (F.C.).
  • FACTS
  • Application for an order prohibiting the issuance
    of a NOC for ramipril, an ACE inhibitor drug, to
    Apotex until after the expiration of an Aventis
    patent.
  • Aventis argued that the manufacture and sale by
    Apotex would infringe their patent
  • Apotex asserted that the Aventis patent was
    invalid for lack of sound prediction.
  • ISSUES
  • What is the relevant date for determining the
    soundness of a prediction?
  • Does each element of the 3-Part test for the
    soundness of a prediction need to be met, or is
    it an overall evaluation?

21
Case Law Update Doctrine of Sound Prediction
Contd
  • HELD
  • Relevant date for determining soundness of
    prediction is the Canadian filing date, not the
    priority date.
  • Each of the 3 parts of test must be met
  • There must be a factual basis for the prediction
  • The inventor must have an articulable line of
    reasoning from which the desired result can be
    inferred from the factual basis and
  • There must be proper disclosure, although it is
    not necessary to provide a theory as to why the
    invention works.
  • Application for Leave to Appeal was filed with
    the Supreme Court of Canada in June 2006.

22
Case Law Update Invention v. Discovery
  • Calgon Carbon Corp. v. City of North Bay
  • 45 C.P.R. (4th) 241 (F.C.A.).
  • FACTS
  • Patent described a method for preventing
    replication of water-borne pathogenic protozoa
    (cryptosporidium oocysts) using low levels of
    ultra violet light to irradiate water.
  • Low-level UV light to irradiate water had
    previously been used to treat water by killing or
    inactivating protozoa to prevent crypto
    infection.
  • The level of UV light required to prevent
    infection by stopping replication was lower than
    that required to kill or inactivate the protozoa.

23
Case Law Update Invention v. Discovery Contd
  • ISSUE
  • Is the discovery of a previously unknown
    advantage of an existing invention a mere
    discovery, or an invention capable of being
    patented?
  • HELD
  • The discovery of a new use for an old invention
    which is capable of practical application is an
    invention.
  • The patent claims should be a practical solution
    to a practical problem.
  • More than a mere discovery.
  • Summary Judgment denied.
  • Trial on the merits continuing.

24
Case Law Update Invention v. Discovery
Contd Contrast with U.S.
  • Wedeco UV Technologies, Inc. v. Calgon Carbon
    Corporation,
  • 2006 U.S. Dist. LEXIS 48657 (D.N.J.) (Lexis).
  • In late June 2006, U.S. District Court of New
    Jersey ruled on Calgons U.S. Patent, identical
    to the Canadian Patent in Calgon Carbon
    Corporation v. City of North Bay.
  • Confirmed that newly discovered result of a known
    process is not patentable.
  • Held that the patent was invalid due to
    anticipation.
  • Calgon has stated its intention to appeal.

25
Case Law Update Claim Construction
  • Pfizer Canada Inc. v. Canada (Minister of Health)
  • 46 C.P.R. (4th) 244 (F.C.).
  • FACTS
  • Pfizer applied for an order preventing the
    Minister of Health from issuing a NOC to Mayne in
    respect of its proposed injectable ready-to-use
    Epirubicin. Hydrochloride solution in a strength
    of 2mg/ml until the expiry of Pfizers patent.
  • Mayne alleged that no claim of Pfizers patent
    would be infringed.

26
Case Law Update Claim Construction Contd
  • ISSUE
  • How should patent claims be construed?
  • HELD
  • First patent decision from the bench by Hughes J.
  • The court set out 7 principles of purposive
    construction of patent claims

27
Case Law Update Claim Construction Contd
  • Who construes the claims?
  • The Court, not expert witnesses, construes the
    claims.
  • When are the claims construed?
  • Claims are construed by the Court at the outset
    of its decision before considering issues of
    validity or infringement.
  • It is not to be a "results oriented" exercise,
    rather, it is to be carried out without an eye
    either to the alleged infringement or the prior
    art.

28
Case Law Update Claim Construction Contd
  • As of what date is the claim to be construed?
  • Application filed in Canada before October 1,
    1989
  • Date the patent was issued and granted.
  • Application filed in Canada after October 1,
    1989
  • Date of publication.
  • What are the criteria for construction?
  • Identification by the court, with the assistance
    of the skilled reader, of what the inventor
    considered to be the "essential" elements of his
    invention.
  • The words chosen by the inventor will be read in
    the sense the inventor is presumed to have
    intended.
  • What a reasonable person to whom the words were
    addressed would have understood the author to
    mean.

29
Case Law Update Claim Construction Contd
  • What resources may be used for purposes of
    construction?
  • A claim is to be read in the context of the rest
    of the specification.
  • The Court may be assisted by expert witnesses in
    order to understand the context of the invention
    described and the particular meaning of terms
    used in the patent.
  • The expert is not to displace the Court in the
    role of the person who is to interpret the
    claims.

30
Case Law Update Claim Construction Contd
  • Through whose eyes is construction to be made?
  • Patent is addressed to the "ordinary person
    skilled in the art" to which it pertains. This
    hypothetical person
  • Is sufficiently versed in the art to which the
    patent relates to enable them on a technical
    level to appreciate the nature and description of
    the invention
  • Has a mind willing to understand a specification
    that is addressed to him
  • Is reasonably diligent in keeping up with
    advances in the field to which the patent relates

31
Case Law Update Claim Construction Contd
  • What is to be made of the resulting construction?
  • Purposive construction may be capable of
    expanding or limiting the literal text of the
    claim.
  • Claims are read in light of expert evidence on
    the technical meaning of the terms and concepts
    used in the claims.
  • If the inventor has misspoken or otherwise
    created an unnecessary or troublesome limitation
    in the claims, it is a self-inflicted wound.
  • The public is entitled to rely on the words used
    provided the words used are interpreted fairly
    and knowledgeably.

32
Case Law Update Notice of Compliance Listing
of Patents for Publicly Available Compounds
  • Biolyse Pharma Corp v. Bristol-Myers Squibb
    Company et al
  • 39 C.P.R. (4th) 449 (S.C.C.).
  • FACTS
  • Bristol-Myers Squibb sought to quash NOC issued
    to a Biolyse drug containing paclitaxel, a
    medicine known by scientists in the public realm.
  • Bristol-Myers Squibb has 3 subsisting patents
    related to paclitaxel formulation and
    administration, but no patent on paclitaxel
    itself.
  • NOC was issued for Biolyse product based on its
    own clinical studies, without reliance on
    Bristol-Myers Squibb's patented drug.

33
Case Law Update Notice of Compliance Listing
of Patents for Publicly Available Compounds
  • ISSUE
  • Should a NOC be issued for an innovator drug that
    contains the same public domain medicine
    (paclitaxel) as a patented drug, but does not
    rely on bioequivalence?
  • HELD
  • NOC Regulations do not provide a monopoly on
    drugs containing a public domain medicine.
  • A provision of the NOC Regulations preventing a
    NOC from being issued until a patent expires are
    confined to situations where the drug at issue is
    a generic copy, not innovative.
  • May be rendered moot by proposed amendments to
    NOC Regulations.

34
Case Law Update Notice of Compliance Patents
for Medicine Delivery
  • Biovail Corp. v. Canada (Minister of Health)
  • 42 C.P.R. (4th) 193, affd 46 C.P.R. (4th) 321
  • FACTS
  • Biovail sought to have its patent for a medicine
    delivery system listed under the NOC Regulations.
  • Patent did not protect a particular medicine or
    the use of a medicine
  • ISSUE
  • Are patents for devices or systems that aid the
    delivery of medicines eligible for listing under
    the NOC Regulations?

35
Case Law Update Notice of Compliance Patents
for Medicine Delivery Contd
  • HELD
  • Patent that protects the delivery system, not a
    particular medicine or the use of a medicine, is
    ineligible for listing under the NOC Regulations.
  • NOC Regulation require that a patent contain a
    claim for a medicine itself or a claim for the
    use of a medicine
  • Listings beyond medicine itself are part of
    proposed amendments to NOC Regulations.

36
THINGS TO REMEMBER
  • Intersection between Patent Law and Competition
    Law
  • Dont get too big!
  • Sound Prediction
  • Make sure it works!
  • Invention vs. Discovery
  • Everything Old is New Again!
  • …at least in Canada
  • Claim Construction
  • 7-Steps to a Better Claim!

37
THANK YOU! Mitchell B. Charness Ridout
Maybee LLP mcharness_at_ridoutmaybee.com
With thanks to Erica Fraser, Student-at-Law
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