If There is No Quid Then There Can Be No Quo - Pfizer's Viagra patent invalidated by Supreme Court of Canada

By Suzanne Hof - November 2012

Today, in a unanimous decision, the Supreme Court of Canada sided with Teva Canada Limited in its bid to invalidate Pfizer Canada Inc.’s Canadian Patent No. 2,163,446 (the ‘446 patent), thereby clearing the way for generic companies to manufacture and sell a generic version of the multi-million dollar erectile dysfunction (ED) drug, Viagra.

This decision hinged on the finding that the ‘446 patent did not satisfy the disclosure requirements under Section 27(3) of the Patent Act. In this regard, the Supreme Court overturned the findings of both the Federal Court and the Federal Court of Appeal that the ‘446 patent did, in fact, provide sufficient disclosure.

The question of sufficiency was raised around whether the specification would have enabled the public “to make the same successful use of the invention as the inventor could at the time of his application” because it does not indicate that sildenafil (the active compound in Viagra) is the effective compound. Although the ‘446 patent does state that “one of the especially preferred compounds induces penile erection in impotent males,” there is no indication which of the several specific compounds identified throughout the description of the patent is this “especially preferred” compound, i.e., sildenafil. Nor does the specification state that the remaining compounds identified in the ‘446 patent were found not to be effective in treating ED.

Furthermore, although claims 6 and 7 are each directed to specific single compounds, there is no indication in the specification that claim 7 relates to sildenafil. By omitting any clear statement that the sildenafil is the active compound, the Supreme Court found that:

There was no basis for a skilled person to determine which of Claim 6 and Claim 7 contained the useful compound, further testing would have been required to determine which of those two compounds was actually effective in treating ED.

According to fundamental principles underlying the patent system, adequate disclosure of the invention in the specification is a precondition for the granting of a monopoly to an invention. It is this “bargain”, or quid pro quo, that the Court references (“[i]f there is no quid – proper disclosure – then there can be no quo – exclusive monopoly rights”) in its finding that the patent be deemed invalid.

http://scc.lexum.org/decisia-scc-csc/scc-csc/scc-csc/en/item/12679/index.do

If you have any questions please contact Suzanne Hof

Please read the UPDATE on this in our on Nov 16, 2012 NEWSFLASH - Supreme Court Asked to Reconsider Decision to Invalidate Viagra Patent

Supreme Court Asked to Reconsider Decision to Invalidate Viagra Patent

By Suzanne Hof - November 16 2012

Pfizer Canada Inc. (Pfizer) has asked the Supreme Court of Canada to reconsider its decision to invalidate their Canadian Patent No. 2,163,446, the patent that provided Pfizer with a monopoly for its multi-million dollar erectile dysfunction drug, Viagra.

Pfizer has taken the position that the Court “accidentally granted a remedy in this appeal that exceeds its jurisdiction.”  The proceedings in question were initiated as an application under the Patented Medicines (Notice of Compliance) Regulations, the outcome of which is typically not to determine invalidity or infringement, but rather to determine whether a notice of compliance should or should not be granted.  

In the present case, the present proceedings were initiated as an application for an order prohibiting Teva Canada Limited from obtaining a notice of compliance for its generic version of Viagra.  Pfizer has therefore taken the position that the Supreme Court was acting outside its jurisdiction in its finding of invalidity.  

In particular, Pfizer has applied for an order to amend the Supreme Court’s recent judgment “by replacing the words ‘and Patent 2,153,446 is declared void’ with the words ‘the application below is dismissed and the Order of the Federal Court dated June 18, 2009, prohibiting the Minister from issuing notice of compliance to the appellant is hereby set aside’.”  In the alternative, Pfizer has applied for a re-hearing on the issue of remedy.

We will, of course, be following these proceedings and posting updates.

The read the previous article on this please visit: If There is No Quid Then There Can Be No Quo - Pfizer's Viagra patent invalidated by Supreme Court of Canada

If you have any questions please contact Suzanne Hof

Industrial Designs - Why Should You Protect Your Unique Designs?

By Scott Miller and Grace Wang, June 15, 2021

Industrial designs (“ID”) protect a product’s unique appearance such as shape, configuration, pattern and/or ornamental features. The protection can be obtained for the design of the entire finished article or just a part of it. Examples of industrial designs can be found everywhere, ranging from your cellphone’s overall shape and graphic user interface to the colour patterns of your clothes.

The exclusive right conferred by the Industrial Design Act does not extend to what the design is made of, how it is made, or how it works. These types of considerations are protectable through patents or trade secrets. However, too often, companies focus primarily on patent protection to the exclusion of other intellectual property rights. Simply put, industrial design protection should not be neglected where shape and configuration assist in a product’s marketability. ID protection can be used alone or in conjunction with other forms of intellectual property as a less expensive means to stop infringing activity.

How the Registration System Works in Canada

Canada employs a first-to-file system which means it is not necessarily who designed first that is entitled to an ID registration but rather it is a race of who files it first at the Canadian Intellectual Property Office (“CIPO”). To obtain an ID registration, it is necessary that the design be novel, which means that no identical or substantially similar design has ever been registered or disclosed. Therefore, if designer ‘1’ created a novel design before designer ‘2’ but designer ‘1’ did not file an application or publicly disclose the novel design (i.e., left the design prototype in their garage or computer) and designer ‘2’ independently created a substantially similar design and filed for the design within 12 months from designer ‘2’s’ public disclosure, then designer ‘2’ will be entitled to the industrial design registration. Notably, an applicant (i.e., designer ‘2’) is given a 12-month window (grace period) to file from its public disclosure or the public disclosure by a person who obtained knowledge of the ID directly or indirectly from the applicant (designer ‘2’).

Before filing, you should conduct a thorough search, preferably with professional assistance from an intellectual property lawyer, to ensure your design is novel and has not been previously registered or disclosed.

Applications are kept confidential until the earlier of either the registration date or 30 months after the application filing date or priority date. Therefore, the design disclosed in the application will become available to the public following the expiry of the confidentiality period. As such, if an applicant does not wish to disclose a design prior to a product launch, careful consideration should be given to the approximate time it typically takes from application to registration of an ID (12 to 18 months).

After registration, you only have to pay a one-time maintenance fee at the 5-year mark. The application process for an industrial design is much faster than that of a patent application. The exclusive right granted by the CIPO registration begins on the registration date and ends on the later of the end of 10 years after the registration date or the end of 15 years after the filing date. Therefore, an ID registration exclusivity is anywhere from 10 to 15 years.

Converting an Industrial Design into a “Perpetual” Trademark Right which can be used to Enforce Copyright

Through proactive and strategic planning, ID’s can be used as an effective tool to ultimately result in perpetual protection for a design.

Designs such as three-dimensional shapes can be registered as non-traditional trademarks under the Trademarks Act. However, in order to obtain a shape trademark registration, unlike a regular trademark, it is necessary to provide proof (evidence) of distinctiveness of the trademark at the date of filing of the shape trademark application. To overcome the hurdle of distinctiveness, a meaningful strategy is to first secure an industrial design registration, build up distinctiveness through the monopoly granted by the industrial design registration, and at some point, during the term of the ID registration, file an application for the shape trademark. Once registered, the shape trademark is valid for 10 years and can be renewed indefinitely every 10 years. In other words, a shape trademark can exist in perpetuity with use.

The Canadian Copyright Act permits the reverse engineering of an article if more than 50 articles are made. However, if the article (i.e., shape) is itself a trademark, then it is prohibited to reverse engineer the article without infringing copyright. Therefore, the ID can be used to support a distinctiveness claim for trademark rights and ultimately lead to enforcement through copyright.

International Protection by the Hague System     

To avoid submitting individual applications in each country of interest, the Hague System for the International Registration of Industrial Designs provides an option to register an industrial design in multiple countries by filing a single international application (Hague application) with the International Bureau (IB) of World Intellectual Property Organization (WIPO).

The IB of WIPO verifies compliance with formal requirements only, without any examination for novelty. A Hague application that complies with the formal requirements is recorded in the International Register and published in the International Designs Bulletin, followed by a substantial examination by each country identified in your application under its domestic law.

In respect of Canada, the international registration is valid for the first 5 years from the date of the international registration and may be renewed twice, namely, at the 5-year mark and the 10-year mark.

Summary

A valid ID registration provides the exclusive right to prevent others from making, selling or importing an article that embodies or is substantially similar to the registered ID.

Always try to think outside the box as part of your business strategy as it is important to identify all aspects of your IP assets. For example:

• a unique design may be protected by an ID registration;
• the new, inventive and useful functionality of the product may be covered by a patent;
• the logo of the product may be registered as a trademark;
• the advertising campaign video to promote your product may be protected by copyright.

In conclusion, you should always utilize a combination of IP assets to maximize your IP protection, depending on your budget and your new product development plan.

If you have any intellectual property questions, please feel free to reach out to MBM for a free consultation.