• Skip to main content
  • Skip to primary sidebar
  • Skip to footer
+49 (0) 69 / 606 278 – 0
[email protected]
Contact form
Patent- & Rechtsanwaltskanzlei

Patent- & Rechtsanwaltskanzlei

  • Deutsch

+49 (0) 69 / 606 278 – 0

  • Facebook
  • Twitter
  • Instagram
  • LinkedIn
  • xing
  • Email
MENUMENU
  • Services
    • Advice On Protective IP Rights
    • Patent Application /TM Registration
    • Enforcement Of IP Rights
    • Defence Against IP Rights Enforcement
    • Costs
  • Company
    • Fields of Law
      • Patent Law
      • Utility Model Law
      • Employees‘ Inventions
      • Trademark Law
      • Design Law
      • Trademark and Product Piracy
      • Expert Opinions
    • Our Law Firm
      • Dr. Karl-Hermann Meyer-Dulheuer
      • Dr. Tim Meyer-Dulheuer
      • Dr. Klaus Zimmermann
      • Zhichao Ying
      • Dr. Christoph Hölscher
    • Commitment
  • Contact
    • Where To Find Us
    • Write us!
    • Request call back
  • Blog

After CETA: What companies need to know about pharmaceutical patents

6. October 2017

Nearly unnoticed by the general public, Canada’s Economic and Trade Agreement (CETA) with the European Union and its Member States entered into force on 21 September 2017. This has far-reaching consequences, especially for pharmaceutical patents in Canada.

CETA not only leads to harmonization of standards in the participating countries, but it leads also to a fundamental reform of many Canadian intellectual property laws. Important amendments apply primarily to pharmaceutical patents in Canada. The regulations will initially apply provisionally until the final ratification of all EU countries.

In the field of pharmaceutical patents, therefore, the following important changes have been made:
I) a change in the rules for patented drugs (Notice of Compliance) (PM (NOC) regulations
a) which has the basic intention of eliminating dual litigation, and
b) has a major impact on the approval of generic medicines,
II) and new patent extensions for pharmaceutical patents, so-called “Certificates of Supplementary Protection”, to compensate for delays in the approval of new drugs.

Eliminating “Dual Litigation” of pharmaceutical patents

MedicineUp to now, Canada has been subject to a so-called “Dual Litigation”: At present, Canada has a system that allows for two legal proceedings between the same parties with respect to one and the same drug and patent:
(i) a fast-track procedure in accordance with the provisions of the Patent Notice of Compliance (PM), which links the patent regime to regulatory approval by Health Canada; and
(ii) a patent infringement or rescission action under the Patent Law.

The new regulations are intended to replace the existing fast-track proceedings with full patent infringement and validity proceedings. In detail, the new rules allow a patentee to appeal to the Federal Court and to ask the court for an order prohibiting the government from issuing an NOC to the generic manufacturer. The key issue here is that the ban should be imposed before generic drug manufacturers receive approval from Health Canada (the Canadian counterpart to the US FDA) to sell their products. The new NOCs are also known as “linkage schemes” because they link regulatory authorities.

Pharmaceutical patents under NOC rules must be registered

CETA CanadaIn order to assert his claim under the new NOC rules, the patentee must register his patents in the Health Canada Patent Register within strict time limits. If these deadlines are not met, or are not observed too late, the patentee cannot rely on the new regulations and must again only sue for a conventional patent infringement after the generic company is on the market.

There are a number of requirements for registering a patent in the Patent Register. There must be a substantive correspondence between the patents in the patent list and the drug submission so that a patent list can be approved for inclusion in the patent register. The time requirements are:

  • Patents that have already been granted before a drug was submitted to Health Canada must be accompanied by a patent list of the drug.
  • For patents granted after the filing of a patent application, you can file a patent list if two conditions are met: (1) the Canadian patent application date precedes the filing date of the drug application; and (2) the patent list is filed within 30 days of the grant of the patent. These deadlines are strict and cannot be extended.

Patent protection for pharmaceutical products extended

In the context of CETA, Canada has also introduced the term of up to two years if research or regulatory delays have taken up part of the 20-year term of a pharmaceutical patent. This reinstatement of patent protection is carried out by issuing a so-called “Certificates of Supplementary Protection (CSP)”.

The patent mentioned in the CSP application must consist of a drug component or a combination of all drug components, i. e. it applies to patents on human and veterinary drugs.
The patent must contain at least one claim relating to the following:
(i) the medicinal ingredient (or combination);
(ii) any use of the medicinal ingredient (or combination); or
(iii) the medicinal ingredient (or combination) produced by a defined process.
The CSP regulations prescribe several variations that would result in medicinal ingredients being considered equal, including esters, salts, chelated complexes, enantiomers and other chemical compounds.

Important for pharmaceutical companies: A patent that has already been granted can also be eligible for a CSP. But if an application for marketing approval has already been filed in

  1. the European Union or any member country,
  2. the United States of America,
  3. Australia,
  4. Switzerland, or
  5. Japan

, then the Canadian application for marketing approval must be made within a prescribed period of: 24 months (if the application for a CSP was filed no later than the first anniversary of the day on which the CSP provisions come into force) and 12 months, in any other case.

The term of a CSP is the difference between the filing date of the patent application and the date on which Health Canada first granted a marketing authorisation, less five years. In all cases, the maximum term of a CSP is limited to two years.

But caution is necessary: In order to be eligible for aid, the ingredient or combination must not be contained in a medicinal product previously authorised for sale in Canada and must not be the subject of another CSP. Accordingly, after a patent has been granted for a particular medicinal product, no further patent relating to the same product can be granted.

CETA is thus laying down rules for the restoration of patents and lodging appeals, which prolong patent protection for pharmaceutical products and may increase consumer prices and license outflow. And from a different angle: The innovation of pharmaceutical companies is more widely recognized. And incentives will be provided for the early launch of innovative medicines on the Canadian market.

 

Do you want to read more of our articles?

Then please register for our weekly Newsletter: We provide latest news on intellectual property rights.

Do you want to read more of such articles? Then enter your e-mail address and click on "Subscribe"

Facebook

Mit dem Laden des Beitrags akzeptieren Sie die Datenschutzerklärung von Facebook.
Mehr erfahren

Beitrag laden

You want to protect pharmaceutical patents?

Then please do not hesitate to contact us. We will help you protect your Intellectual Property rights.

CAT-call_en

 

Sources:

Patented Medicines (Notice of Compliance) Regulations (SOR/93-133)

pictures:

RonnyK / pixabay.com / CC0 License ||  Val_gb /pixabay.com / CCO License 

  • share  
  • share 
  • share 
  • tweet 
  • share 

Category iconUnkategorisiert

Primary Sidebar

More articles about: Unkategorisiert

All articles

Blog Menu

  • Design Law
  • Healthcare & Lifesciences
  • International Intellectual Property
  • Licenses
  • News from our law firm
  • Overall
  • Patent Law
  • Product- and Trademark piracy
  • Trademark Law

Recent Posts

  • BPatG: Patent claim of cancer drug on active substance as salt 7. March 2022
  • Grant for European IP Protection: SME Fund 2022 4. March 2022
  • CODE-X vs. Cody’s: Likelihood of confusion in drinks? 25. February 2022
  • EOS lip balm no 3D trademark – appeal before ECJ not admissible 24. February 2022

Fields of Law

  • Patent Law
  • Utility Model Law
  • Employees’ Inventions
  • Trademark Law
  • Design Law
  • Trademark and Product Piracy
  • Expert Opinions
  • Costs

Das könnte Sie auch interessieren:

28. August 2017
Intellectual property theft: Trump orders investigation against China

Intellectual property theft: Trump orders investigation against China

25. July 2017
WIPO: Goodbye Fee Irregularities – welcome Madrid e-Renewal

WIPO: Goodbye Fee Irregularities – welcome Madrid e-Renewal

14. July 2017
Global Innovation Index 2017: Switzerland #1, Netherlands strong growth

Global Innovation Index 2017: Switzerland #1, Netherlands strong growth

1. June 2017
Notice: From 1 October 2017 – New EU Trade Mark Regulation

Notice: From 1 October 2017 – New EU Trade Mark Regulation

28. April 2017
Brexit: United Kingdom to continue on ratification course for UPC

Brexit: United Kingdom to continue on ratification course for UPC

15. November 2016
EPO/EUIPO: New study shows intellectual property is good for the European economy

EPO/EUIPO: New study shows intellectual property is good for the European economy

Contact us or request a call back

+49 (0) 69 / 606 278 – 0
[email protected]
Request a call back

Footer

Contact

Torhaus Westhafen
Speicherstrasse 59
D – 60327 Frankfurt am Main
Deutschland
+49 (0) 69 / 606 278 – 0
+49 (0) 69 / 606 278 – 199
[email protected]

Office Hours
Moday – Friday:   08:00-18:00

Fields of Law

  • Patent Law
  • Utility Model Law
  • Employees’ Inventions
  • Trademark Law
  • Design Law
  • Trademark and Product Piracy
  • Expert Opinions
  • Costs

Law Firm

  • Request non-binding call back
  • Company
  • Our Law Firm
  • ISO Certificate
  • Privacy Policy
  • Data handling for clients
  • Imprint

Follow Us

  • Facebook
  • Twitter
  • LinkedIn
  • xing
  • Email

Newsletter Signup

© Patent- & Rechtsanwaltskanzlei Meyer-Dulheuer MD Legal Patentanwälte PartG mbB

Contact Form

 

Give us a call, send us an email or fill out the contact form.

+49 (0) 69 / 606 278 – 0
[email protected]

Kontaktformular

 

Rufen Sie uns an, schicken Sie uns eine Mail oder füllen Sie das Kontaktformular aus.

+49 (0) 69 / 606 278 – 0
[email protected]