The Importance of Product Specificity in the Listing Patents

by Bennett Jones LLP
Contact

[author: Martin P.J. Kratz]

The Patented Medicines (Notice of Compliance) Regulations (SOR/93-133) provides the framework for most of Canada's patent litigation. The Patent Act and the PM (NOC) Regulations seek to balance “effective patent enforcement” over new and innovative drugs with the “timely market entry” of lower priced generic versions once the patents have expired. The PM (NOC) Regulations provide innovators of pharmaceutical patents with an ability to list their patents on a Patent List. A generic drug maker who wishes to obtain consent from Health Canada to market a drug based on the same active ingredient (called a Notice of Compliance or NOC) must address the applicable patents on the Patent List. The generic drug maker may address such listed patents by accepting that its product will not receive an NOC until expiry of a listed patent, or may assert that its product would not infringe the claims of such listed patent or may challenge the validity of a listed patent.

The PM (NOC) Regulations further provide the innovator with an extraordinary remedy – if the generic makes assertions of non-infringement or invalidity, the application for judicial review of such assertions gives the innovator an automatic two-year stay of the decision of Health Canada to issue the NOC – without having to satisfy the normal requirements for injunctive relief otherwise provided by law. During that two-year period the parties litigate the issues raised by the generic's allegations.

One can see, therefore, that it is of extraordinary importance to determine whether or not a patent may be properly listed on the Patent List. There must be a rational connection between the patents so listed and the regulatory submissions of the innovator against which the patents are submitted. The PM (NOC) Regulations provide the rules for assessing what patents may be listed. Given that there is so much litigation under the PM (NOC) Regulations, it is important to have a clear understanding of the applicable rules.

The Federal Court of Appeal had a recent opportunity to consider and provide clarity to these rules in Gilead Sciences Canada Inc. v. Canada (Health) , 2012 FCA 254.

Gilead had sought to list Patent 2,512,475 ( ‘475 Patent) in respect of a New Drug Submission (NDS) (the process by which the innovator seeks to obtain an NOC for the applicable drug) seeking approval of a drug for the treatment of human immunodeficiency virus (HIV) infection. The NDS stated that the drug, known as Complera, contained the medicinal ingredients: tenofovir, emtricitabine, and rilpivirine. The '475 Patent claimed chemically stable characteristics of tenofovir and emtricitabine in combination and sometimes with a third medicinal ingredient. The '475 Patent did not claim rilpivirine.

The listing criteria require that to be eligible for listing the patent must contain, under section 4(2)(a), "a claim for the medicinal ingredient" or under section 4(2)(b) "a claim for the formulation that contains the medicinal ingredient", in either case where the medicinal agreement or formulation had been approved through the issuance of an NOC in respect of the Submission.

Gilead claimed listing of the '475 Patent under either section 4(2)(a) or 4(2)(b).

The Minister of Health refused to list the ‘475 Patent on the Patent Register as, in his view, it did not meet the requirements of section 4(2)(b) that require that, to be eligible for listing, the patent must contain "a claim for the formulation that contains the medicinal ingredient and the formulation has been approved through the issuance of a notice of compliance in respect of the Submission."

The Minister found that the medicinal ingredients claimed in the ‘475 Patent did not match up with those in the NDS. The Minister found that “a patent containing claims for a formulation cannot 'match' the approved formulation unless both formulations explicitly contain all of the same medicinal ingredients.” The Minister found that the '475 Patent did not meet the “matching requirement” for lack of product specificity. Gilead sought judicial review.

The test for judicial review of the Minister's decision required the Federal Court to assess: (1) the correct construction of the ‘475 Patent; (2) the proper interpretation of sections 4(2)(a) and (b) of the PM (NOC) Regulations; and, (3) whether the Minister’s decision to exclude the ‘475 Patent from the Register was reasonable.

The Federal Court accepted the Minister’s position and dismissed Gilead's application for judicial review. The Federal Court had found that the object of the invention was to take advantage of the chemically stable characteristics of tenofovir and emtricitabine in combination and sometimes with a third medicinal ingredient.

While there was no dispute with the construction of the claims, the Federal Court had jumped directly to describe these claims in comparison with the three ingredients contained in Complera, without interpreting both sections 4(2)(a) and (b) to assess whether the claims fell more appropriately under (a) or (b).

The FCA found that both the Minister and the Judge failed to give sufficient weight to the requirement that formulations, by definition, contain non-medicinal ingredients and set out a particular dosage form, which is administered to the patient. In the case of the '475 Patent it was clear that the relevant claims did not meet the definition of "formulation", because they did not contain non-medicinal ingredients. The FCA rejected the argument that claims to a combination of medicinal ingredients was a “formulation of the separate medicinal ingredients into the new combination product” as the definition of "formulation" in the PM (NOC) Regulations is clear and must contain both medicinal and non-medicinal ingredients.

Here, since the '475 Patent did not claim a formulation and only claimed medicinal ingredients, the '475 Patent should properly have been considered by the Minister or the Federal Court under section 4(2)(a) which deals with claims to medicinal ingredients.

Gilead argued for a low threshold of connection between the wording of the NDS and the patent claim and also that the PM (NOC) Regulations must be given a broad interpretation.

The FCA rejected these arguments noting that it had confirmed in Purdue Pharma v. Canada (Attorney General), 2011 FCA 132, dealing with another subsection of the PM (NOC) Regulations, that absent precise and specific matching between the patent claims and the approved NOC, the patent was not eligible for listing. The FCA noted that the wording of section 4 is consistent across the four subsections and requires a high degree of specificity between the wording of the claim and the NOC.

The FCA affirmed the Federal Court's reasoning on product specificity that “the claimed formulation and the approved formulation do not match precisely and the requirement of product specificity is not met” and then considered the '475 Patent under section 4(2)(a). In conclusion the FCA upheld the Judge’s conclusion that the patent claims fail the requirement for product specificity because they do not make specific reference to the medicinal ingredient rilpirivine, but only the broad class of compounds, but the FCA did so under section 4(2)(a) rather than 4(2)(b).

The Gilead decision reinforces the importance of strict compliance with the listing requirements under the PM (NOC) Regulations. This strict approach to addressing the listing requirements is consistent with the policy, set out in the RIAS underlying the 2006 amendments to the PM (NOC) Regulations, that where the patent fails to meet the listing requirements, policy considerations tip the balance in favour of the generic manufacturer, and the matter is better left to the alternative (and traditional) judicial recourse of an infringement action. It is worth remembering that the PM (NOC) Regulations are an exceptional process and provide unusual rights to the patent owner additional to the rights provided to all patent owners under patent law.

A version of this article will be published in SLAW.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Bennett Jones LLP | Attorney Advertising

Written by:

Bennett Jones LLP
Contact
more
less

Bennett Jones LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.