Download Amendments to the PM(NOC) Regulations

University of Ottawa - Faculty of Law
CML 3396 / DCL 7315
PHARMACEUTICAL LAW
Patrick Smith
February 27, 2008
Presentation Topics
 DATA PROTECTION
 PM(NOC) REGULATIONS
 RECENT PHARMACEUTICAL LITIGATION
Government Jurisdiction: Pharmaceuticals
Federal
 Drug Approvals
Provincial
 Interchangeability
 Federal Formulary
 Provincial Formulary
•
List of drugs approved for
reimbursement under federal
drug benefit plans
(Approximately 1 million
Canadians eligible for federal
drug benefits)
 Price Control (PMPRB)
 PM(NOC Regulations)
•
List of drugs approved for
reimbursement under provincial
drug benefit plans (Over 9
million Canadians eligible for
provincial drug benefits)
Court Jurisdiction: Patents and Pharmaceuticals
Federal
Provincial
 Patent Infringement (jointly
with provincial courts)
 Patent Infringement (jointly
with federal courts)
 Patent Validity
 Provincial Formulary Issues
 Judicial Review:
•
•
•
PMPRB
Section 55.2 proceedings under
PM(NOC) Regulations
Drug approvals
Data Protection Regulations – Part I
History of Data Protection
• Article 1711 of NAFTA / Article 39 TRIPS
• Section C.08.004.1 of the Food and Drug Act
Regulations – 1995
• Bayer Inc. v. Canada (Attorney General ) - 1999
Data Protection Regulations
Food and Drug (Data Protection) Regulations
• Provides effective data protection for drug
submissions that receive a NOC after June 17,
2006
• Amendments registered October 5, 2006
Data Protection Regulations
Protection provided to “Innovative Drugs”:
• includes: drugs that contain medicinal ingredients
not previously approved
• does not include: variation of a previously
approved medicinal ingredient, eg. salt, ester,
enantiomer, solvate, or polymorph
• ‘arguably’ includes: metabolites
• No further protection for NOC’s for new uses or
combinations of previously approved medicinal
ingredients
Data Protection Regulations
Eight Year Term of Data Protection
• 6 year “no filing” period for generic submissions
• Exceptions:
• Where consent of manufacturer is given
• Where manufacturer files application for authorization to export
to third world country (Jean Chretien Pledge to Africa Act –
JCPA Act). However, no NOC will issue until expiry of data
protection term.
• 2 year no marketing period during which the Minister will
not grant a NOC to a generic
• Exceptions:
• Where consent of manufacturer is given
Data Protection Regulations
Pediatric Extension
• There is a 6-month “pediatric extension” in addition to the
the 8-year period
• Pediatric clinical studies must be submitted with
innovator’s NDS or contained in a supplement within 5
years of issuance of NOC
• Minister must determine that clinical trials were conducted
to increase knowledge of the use of the innovative drug
and this knowledge provides a health benefit to pediatric
populations
Data Protection Regulations
Loss of Protection
• Data Protection is lost if the drug is “not being
marketed in Canada”
• Applies to the 6, 8 or 8 ½-year term
• It is questionable whether protection can be restored
if the product is reintroduced onto the market
Data Protection Regulations
Register of Innovative Drugs
• Includes:
• the name of the drug
• the medicinal ingredient
• expiry date of data protection
Data Protection Regulations
Challenges to New Data Protection Regulations
• In November 2006, separate judicial review
applications were launched by the CGPA and Apotex
in the Federal Court
• Both are seeking a declaration that the Data
Protection Regulations are ultra vires and of no force
or effect
Data Protection Regulations
Generic Attacks
• Data Protection Regulations are unnecessary
• Data Protection Regulations are not connected with
the grant of the authority of section 30(3) of the Food
and Drugs Act
• Data Protection Regulations are beyond the
jurisdiction of the Federal Government as they are a
matter of property and civil rights exclusively within the
jurisdiction of the provinces
PM(NOC) Regulations – Part II
 A patent enforcement scheme which works in
conjunction with, not in lieu of, the standard patent
enforcement scheme under the Patent Act
 Purpose: Balances the effective enforcement of
patents against the timely market entry of generic
medicines
 Designed to balance out the effect of the “earlyworking exception” in the Patent Act
Patented Medicines (Notice of Compliance) Regulations
Process Under the Regulations
 A second person (i.e. generic) wishing to bring a drug to market
must file a submission for a notice of compliance (NOC)
(ANDS, similar to an ANDA in the U.S.)
 When a submission makes reference to or compares a drug
with another drug for which an NOC is already issued to a first
person (i.e. innovator) and a patent list has been submitted, the
second person has 2 choices:
a)
b)
Accept that the NOC will not issue until the patent expires; or
Allege that the patent has expired, the patent is invalid, or the drug will not
infringe the patent

A detailed statement of the legal and factual basis for the above
allegations must be served on the Minister of Health and the first
person
Patented Medicines (Notice of Compliance) Regulations
Process Under the Regulations (continued)

Within 45 days, the first person may apply for an order preventing the
Minister from issuing an NOC to the second person

First person obtains a 24 month stay preventing the second person
from entering the market until the litigation is resolved

If the first person’s application is dismissed, withdrawn, or overturned
on appeal, the first person is liable to second person for any loss
suffered from the date the NOC would have been issued (section 8)

First person maintains the right to sue for patent infringement under the
Patent Act despite the outcome of any NOC proceedings

Recent case found patent valid and infringed despite having dismissed
prohibition proceeding under the Regulations
Patented Medicines (Notice of Compliance) Regulations
Process Under the Regulations (continued)
 If first person is successful, the second person can
send another NOA as long as it does not constitute
an abuse of process
 If first person is not successful, the NOC will likely
issue to the second person
 Appeal is moot
Patented Medicines (Notice of Compliance) Regulations
Eligibility for Protection under the Old Regulations
 Timing: the Canadian filing date of the patent must precede the date
of the drug submission (priority filing does not count)
 The patent must contain a claim for the medicine itself or its use, or a
formulation in which the medicine is the active medicinal ingredient
• Patents without direct therapeutic application such as processes,
intermediates or vectors do not come within the protection of the
Regulations
 Relevance: the patent sought to be listed must be relevant to the
dosage form, strength, and route of administration of the drug in
respect to which the NOC was filed
Amendments to the PM(NOC) Regulations
 Amendments to the PM(NOC) Regulations came into
force on October 5, 2006
Amendments to the PM(NOC) Regulations
 A patent on a patent list in relation to a NDS is
eligible to be added to the Register if the patent
contains:
 A claim for the medicinal ingredient and the medicinal
ingredient has been approved through the issuance of
a NOC in respect of the submission;
 A claim for the formulation that contains the medicinal
ingredient and the formulation has been approved
through the issuance of a NOC in respect of the NDS;
 A claim for the dosage form and the dosage form has
been approved through the issuance of a NOC in
respect of the NDS; or
Amendments to the PM(NOC) Regulations
 A patent on a patent list in relation to a NDS is
eligible to be added to the Register if the patent
contains (CONT’D):
 A claim for the use of the medicinal ingredient, and the
use has been approved through the issuance of a NOC
in respect of the NDS
 There is no opportunity to list patents with an NDS
based solely on the change of name of the
manufacturer
Amendments to the PM(NOC) Regulations
 With respect to an SNDS, a patent is eligible to be
listed if the supplement is for a change in formulation,
a change in dosage form or a change in use of the
medicinal ingredient and the patent contains a claim
for the new formulation, a claim for the new dosage
form or a new use of the medicinal ingredient that
has been approved through the issuance of a NOC
Amendments to the PM(NOC) Regulations
Transitional Rules
 The prior rules on listing will apply to patents submitted
prior to June 17, 2006
 The current rules on listing, including those on relevance,
apply to patents submitted after June 17, 2006
 Patents submitted after this date but before October 5,
2006, which do not comply with the new rules, will be
audited on a complaints-driven basis
Amendments to the PM(NOC) Regulations
 Cancellation of DIN – Section 3(3)
 Manufacturers are required to notify the Minister if a
product is not being sold, and its DIN will be
cancelled
 The Minister is now required to delist patents
associated with a product when the DIN is cancelled
because the product is not being sold
 Innovator has 90-day grace period before Minister will
de-list
 Does not apply where DIN is cancelled due to change
in manufacturer
Amendments to the PM(NOC) Regulations
 Innovator can add the patents to the Patent Register
if the product is sold again
  But a generic could file its ANDS while the product
is not on the market and would not have to address
patents added afterwards
Amendments to the PM(NOC) Regulations
 SECTION 5 – when notice is required
 NOA is required if a second person files a submission
for a NOC that directly or indirectly compares the drug
with, or makes reference to, another drug marketed in
Canada under a NOC issued to a first person and in
respect of which a patent list has been submitted
Amendments to the PM(NOC) Regulations
 SECTION 5 – when notice is not required
 A second person is not required to send a NOA in respect of
a patent added to the Register in respect of the innovator’s
drug on or after the date of filing of the second person’s
submission [similar timing as a result of the AstraZeneca
Supreme Court decision for existing proceedings]
 The deemed date of filing of the second person’s submission
or supplement is 6 years after the date of issuance of the
first NOC in respect of the innovative drug (i.e. data package
rules)
 If the brand name product is not currently being marketed
Amendments to the PM(NOC) Regulations
 SECTION 5 – when to retract the notice
 A second person who has served a NOA shall retract
the NOA and serve a notice of the retraction on the first
person within 90 days after either of the following
dates:
The date on which the Minister notifies the second
person of their non-compliance with the requirements of
the Food and Drug Regulations; or
The date of the cancellation by the second person of the
submission or supplement to which the allegation relates
Amendments to the PM(NOC) Regulations
 SECTION 5 – when to retract the notice
 If the NOA is retracted by the second person, the first
person who has commenced a prohibition proceeding
shall apply without delay for discontinuance of the
proceedings
Amendments to the PM(NOC) Regulations
 SECTION 5 – transitional provisions
 Subsection 5(1) of the NOC Regulations applies to a
second person who has filed a submission prior to the
coming into force of these Regulations and the date of
filing of the submission is deemed to be the date of the
coming into force of these Regulations, namely
October 5, 2006
 The same applies with respect to subsection 5(2)
Amendments to the PM(NOC) Regulations
 Allegation re: Use Patents – Section 6(5)
 Under the new Regulations, an allegation of non-infringement is
to be determined only with respect to whether the generic’s
“making, constructing, using or selling” would infringe a patent
 So infringement by others – eg. patients via formulary
substitution policies and practices – is not an issue for
determination in NOC proceedings
 This revision is an attempt to clarify case law on this issue
Amendments to the PM(NOC) Regulations
 Partial Summary Judgment – Section 6(5)
 The amended Section 6(5) allows the court, on the
motion of a generic, to summarily dismiss a
proceeding brought by an innovator “in whole or in
part” in respect of those patents that were not eligible
for inclusion on the register
 Case law had held that the previous provision only
applied where the proceeding could be dismissed
against all patents
Amendments to the PM(NOC) Regulations
 Damages - Section 8
 Under the new amendments, the court may make “any order for
relief by way of damages” in respect of any loss incurred by a
generic due to delayed market entry
 The Minister is not liable for damages under this section
 The previous section referred to “damages or profits” -- the word
“profits” does not appear in the amended section, so innovators’
profits should not be reachable under the section
 Only applicable to Section 8 damages cases brought after
October 5, 2006
Recent Pharmaceutical Patent Decisions
 Merck & Co. v. Apotex Inc.– Prinivil/Zestril (lisinopril)
 Patent infringement action
 Patent found valid and infringed
 Upheld on appeal
 Janssen Ortho Inc. v. Novopharm Ltd. – Levaquin (levofloxacin)
 After prohibition proceeding dismissed, patentee brought action
for infringement
 Patent found valid and infringed in infringement action
 Sanofi v. Apotex Inc. – Plavix (clopidogrel bisulfate)
 Prohibtion order granted
 Upheld on appeal