The same legislation also provides for the granting
of supplementary protection certificates (SPCs), which give additional patent protection of up to five years where there has been a regulatory delay in allowing patented medicines to be sold on the EU market.
With the implementation of the CETA, as of September 21, 2017, Canadian law now provides for certificates
of supplementary protection that extend the term of certain pharmaceutical patents for up to two years.
He has extensive experience of patent prosecution in countries outside Europe and has pan-European expertise in the filing and prosecution
of supplementary protection certificates nationally, as well as considerable experience and success before the European Court of Justice, including the widely cited Queensland (C - 630 / 10) and Neurim (C - 130 / 11) referrals.
CETA Implementation: Guidance Documents and Notices Released to Address Amendments to the PM (NOC) Regulations and Certificate
of Supplementary Protection for Pharmaceutical Patents
Under the latter, Canada will, first, provide up to two years
of supplementary protection to pharmaceutical patents due to delays in excess of five years between patent filing and market approval.
These CSPs are listed on Health Canada's new Register of Certificates
of Supplementary Protection and Applications, along with a number of pending CSP applications.
It will also have competence over actions concerning infringement and validity
of Supplementary Protection Certificates, for pharmaceutical and plant protection products, based on European bundle patents and unitary patents.
The legislation provided key reforms to the Patent Act affecting the pharmaceutical industry, including up to two years of patent term restoration for patented pharmaceuticals under the Certificate
of Supplementary Protection Regulations (CSP).
Health Canada's online Register of Certificates
of Supplementary Protection and Applications indicates that the first CSP has issued in relation to TrumenbaTM, a meningococcal group B vaccine.
An exception is that the a Certificate
of Supplementary Protection does not prohibit the making, constructing, using or selling of the medicinal ingredient or combination of medicinal ingredients for the purpose of export from Canada.
Europe has used «Supplementary Protection Certificates» since the early 1990s in similar circumstances as the new Certificates
of Supplementary Protection in Canada, although there are some implementation differences, including a maximum five year term in Europe.
It will likely be some time before the impact of the Certificates
of Supplementary Protection are felt in Canada.
Comparison are also likely going to be made between the Canadian Certificates
of Supplementary Protection and patent term adjustments in the United States.
115 (1) The issuance of a certificate
of supplementary protection grants the certificate's holder and their legal representatives, during the certificate's term, the same rights, privileges and liberties that are granted by the patent set out in the certificate, but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients, set out in the certificate, by itself or in addition to any other medicinal ingredient.
The term
of the supplementary protection is a maximum of two years, based on the date that the authorization for sale set out in the certificate is issued but may be discounted by any «period of unjustified delay» caused by the applicant's failure to act.
There are important filing deadlines for any application for a Certificate
of Supplementary Protection based on both the grant of the underlying patent but also the timing of market approval in Canada and in other jurisdictions.
See the Register of Certificates
of Supplementary Protection (link) maintained by Health Canada for the latest status.
The Certificates
of Supplementary Protection are available for both human use and veterinary use medicinal ingredients but as of this time, no applications have been filed for veterinary use.
In parallel with the consultation on the Patent Rules, the CETA Implementation Act will also affect patents by introducing patent term extensions through certificates
of supplementary protection (CSPs) for certain pharmaceutical inventions, and an overhauled the patent linkage system.
new NOC Regulations will also relate to infringement regarding a SPC that could result from «making, construction, use or sale of a patented invention or invention protected by a certificate
of supplementary protection»
Not exact matches
For example, a
Supplementary Protection Certificate in Europe may be applied for approval to recover some
of the time lost between the patent application filing date and the date
of first marketing authorization.
One surprising gap in the EPO's information database covers the European Community's
Supplementary Protection Certificate scheme, which is among the most significant patent developments
of recent years in Europe.
These
supplementary policies will increase your home insurance premiums, but they'll also provide critical
protection if one
of the hazards they cover were to damage your home.
Many rewards cards offer a variety
of supplementary perks like price
protection, rental car insurance and discounts with travel providers.
While there are some types
of insurance that are required by law (e.g. worker's compensation), many policies are
supplementary but provide your business with vital
protection.
certificates
of supplementary patent
protection («SPC»)
of up to 2 years will be available to compensate for regulatory approval delay
Franco has many years» experience throughout the world, in the Renewal
of Patents
of Invention, Designs, Utility Models,
Supplementary Protection of Certificates, Textile Designs, Plant Varieties and Trademarks.
The Driver and Family
Protection Act establishes that the amount
of supplementary uninsured / underinsured motorist (SUM) coverage for any new auto insurance policy must be the same as the amount
of bodily injury coverage selected by the policyholder.
It added, that «before such measures are adopted, there is no provision
of EU law which requires that a category
of persons who already benefit from
supplementary social
protection, such as that at issue in the main proceedings, should be deprived
of it» (ibid.)
A maximum two years
of additional patent rights for an approved drug will be available by a
Supplementary Protection Certificate.
These
supplementary policies will increase your home insurance premiums, but they'll also provide critical
protection if one
of the hazards they cover were to damage your home.
Medical payments coverage is valuable
supplementary protection that helps to fill out the totality
of your auto and medical insurance coverage.
Supplementary UMBI: this provides extra UMBI
protection on top
of the mandatory 25/50 minimum through higher coverage limits.
This life insurance endowment plan allows you to choose a guaranteed tax free
supplementary income for future, while ensuring a strong financial
protection for your family in case
of uncertainties.
Supplementary insurance can be a good way to take advantage
of some additional
protection for your family.
Moreover, its scratch - free microfiber interior provides extra comfort and a
supplementary layer
of protection.
About Blog A niche blog dedicated to the issues that arise when
supplementary protection certificates (SPCs) extend patents beyond their normal life — and to the respective positions
of patent owners, investors, competitors and consumers.
In the case
of supplementary welfare allowance, you should contact the Department
of Social
Protection's representative (fomerly known as the Community Welfare Officer) in your local office.
In the case
of supplementary welfare allowance, you should contact the Department
of Social
Protection's representative (formerly known as the Community Welfare Officer) in your local Health Centre or local social welfare office.