Newsflash | Changes to Expedited Examination in Canada

Changes relating to Expedited Examination in Canada came into force on March 3, 2011. These changes include:

1. Under current provisions to request examination, the Commissioner may advance an application for examination upon payment of a fee if the Commissioner determines that failure to advance the application is likely to prejudice the requester’s rights. A new provision has been added which allows the Commissioner to expedite the prosecution of an application when the invention is related to green technology. Under this new provision no additional fee is required. Rather, a declaration stating that the application relates to technology the commercialization of which would help to resolve or mitigate environmental impacts or conserve the natural environment and resources along with the request for expedited examination must be submitted. As there is limited guidance with respect to what constitutes green technology, should you be uncertain whether your technology is a green technology we recommend filing the request for expedited examination under the other existing provision available in order to avoid making a false declaration and triggering the possible consequences that may flow from this.

2. A restriction on the eligibility for expedited examination has also been introduced. In particular, new Section 28(2) states:

With respect to a request made under subsection (1) by an applicant, the Commissioner shall not advance the examination of the application out of its routine order and shall return to its routine order any examination that has been advanced if, after April 30, 2011,

(a) the Commissioner extends, under subsection 26(1), the time fixed by these Rules or by the Commissioner under the Act for doing anything in respect of the application; or

(b) the application is deemed to be abandoned under subsection 73(1) of the Act whether or not it is reinstated under subsection 73(3) of the Act.

Given this new restriction, should expediting allowance of an application be a priority to you, requests for extension of time or the abandonment of the application should be avoided.

Sold in New Jersey = Sold in Canada

In its first decision of 2011 (see Celgene Corporation v. Attorney General of Canada, 2011 SCC 1), the Supreme Court of Canada (“SCC”) clarified the meaning of “sold in any market in Canada” in the relevant provisions of the Patent Act giving the Patented Medicine Prices Review Board (“PMPRB”) its jurisdiction to regulate the prices of patented medicines in Canada. The only issue addressed by the SCC was whether the concept of “sold in any market in Canada” should be interpreted strictly in accordance with commercial law principles, or whether its definition should be responsive to the surrounding legislative context and purpose.

The appellant, Celgene Corporation, is based in New Jersey and distributor of the pharmaceutical drug Thalomid® (thalidomide). Thalomid is not marketed in Canada under a Notice of Compliance, but has been selling Thalomid since 1995 under the Special Access Programme (“SAP”), a program administered by Health Canada allowing access to drugs not otherwise available in a particular market for the treatment of “serious or life-threatening conditions where conventional therapies have failed, are unsuitable, or are unavailable either as marketed products or through enrollment in clinical trials” (similar to FDA’s Expanded Access Program). When a Canadian doctor places an order for Thalomid under the SAP, the drug is packed in Celgene’s facilities in the U.S. and shipped Free on Board (“FOB”) to the doctor in Canada. An invoice is then prepared in New Jersey, mailed to Canada and the doctor is directed to make a payment in U.S. dollars and mailed back to New Jersey.

Celgene obtained a Canadian patent in relation to Thalomid on April 6, 2004 and the PMPRB subsequently asserted that it had jurisdiction to request pricing information from Celgene. Although it initially provided some pricing information, Celegene subsequently took the position that the PMPRB did not have jurisdiction over the sales of Thalomid as the medicine was, in accordance with ordinary commercial law principles, “sold” in New Jersey not in Canada as required by the relevant provisions of the Patent Act which, as noted above, require that the medicine be “sold in any market in Canada” (our emphasis).

While acknowledging that the expression “sold in any market in Canada” lends itself to different interpretations, the SCC agreed with the PMPRB’s position that the legislative context and the consumer protection purpose of the Patent Act in regard to pricing support a conclusion that it should have authority over Celgene’s sales of Thalomid to Canadians through the SAP. According to the SCC, the PMPRB did not misinterpret the words “sold” and “selling” in rejecting the technical commercial law definition. Instead the PMPRB was properly guided by the consumer protection goals of its mandate, which is to ensure that the monopoly that accompanies the granting of a patent is not abused to the financial detriment of Canadian patients and insurers.

By Catherine Lemay

Recent Developments in the Political Front Regarding Compulsory Licensing

Brand name pharmaceutical companies may want to keep themselves abreast of recent developments in respect of compulsory licensing of patented medicines for humanitarian aid. Bill C-393, a private member’s bill, is currently working before the House of Commons and appears, at least on paper, intended to ease the requirements under Canada’s Access to Medicines Regime (“CAMR”) in order to facilitate compulsory licensing of patented medicines for export to developing countries.

The CAMR authorizes compulsory licensing of patented medicines, under specific prescribed circumstances, to manufacturers who wish to export patented medicines to developing countries. The CAMR was successfully used once, when Apotex Inc. received a compulsory license to export their drug, TriAvir, to Rwanda. Under the CAMR, every potential order is taken on a case-by-case, drug order-by-drug order, country-by-country basis and a company seeking a compulsory license under the CAMR must have unsuccessfully sought a voluntary license on reasonable terms from the patentee. A product exported under the CAMR must meet the same requirements for safety, efficacy and quality as those intended for Canadians and, as an anti-diversionary measure, the products exported under the compulsory license must have specific marking features to make them distinguishable from the patented versions available on the Canadian market to ensure that the drugs are not being diverted to unintended markets.

Proponents of Bill C-393 argue that the CAMR is filled with red tape making the process for generic manufactures unnecessarily cumbersome, expensive, and time-consuming, thereby needlessly restricting the ability of humanitarian groups and generic pharmaceutical companies to respond to the needs of developing countries. They argue that Bill C-393 will remove some of the red tape by introducing a one-license approach, thereby allowing applicants to obtain a compulsory license first, and that license would allow a company to supply drugs to any of the countries already covered by the existing legislation. The one-license approach would not allow countries to be disclosed in advance.

Opponents of Bill C-393, however, argue that it is unnecessary given that the CAMR has been successfully used and works. There is concern that the proposed changes under Bill C-393 will remove the necessary safeguards to mitigate the potential for corruption. There is also a concern that if Canada passes legislation that attempts to circumvent the brand name pharmaceutical industry’s control in the issuance of compulsory licensing relating to its patented products, in effect circumventing its patent protection, Canada will be viewed as a less desirable place to do business. There is also a concern that if brand name companies feel they are losing revenue through loosened requirements on the issuance of compulsory licensing, they might transfer that loss to the cost of their drugs.

Whether Bill C-393 has any teeth and passes into law is yet to be seen. One thing is, however, clear. The CAMR was developed in view of the delicate balance between having brand name pharmaceutical companies investing in research and development of new drugs and supporting humanitarian efforts through the accessibility to vital drugs at reasonable prices in developing countries. Similar to the development of the CAMR, Bill C-393 is likely to be hotly debated.

By Tanya Weston

Another Strong Win By MBM - Empresa Cubana Del Tabaco Trading Also As Cubatabaco v. Shapiro Cohen and The Registrar Of Trade-marks

This was an appeal from two decisions of the Registrar of Trade-Marks expunging two Cohiba cigars trade-marks.

The Court concludes that:

1. The new evidence submitted by MBM would have materially affected the Registrar’s decision with respect to whether the use of the COHIBA trade-mark for the sale of cigars and cigarillos constitutes use of “manufactured tobacco for smoking and chewing” as listed in the COHIBA trade-mark statement of wares;

2. Cigars and cigarillos are “manufactured tobacco for smoking or chewing” and therefore fall within this general class in the statement of wares for the COHIBA trade-mark registration;

3. The new evidence before the Court would have materially affected the Registrar’s decision with respect to whether the COHIBA and COHIBA & DESIGN trademarks were used by the applicant; and

4. The applicant demonstrated to the Court its control over the character and quality of the cigars and cigarillos sold in Canada so as to constitute use by the applicant of the COHIBA and COHIBA & DESIGN trade-marks in Canada.

Decision: 

For these reasons, the Court allows the appeals with respect to the Registrar’s decisions to expunge the COHIBA & DESIGN trade-mark with regard to “cigars and cigarillos”, and the COHIBA trade-mark with regard to “manufactured tobacco for smoking and chewing”.

Read the full decision here.

MBM Wins Before the Federal Court - Repligen Corporation v. Attorney General Of Canada

The central argument in this judicial review of a patent decision – that was accepted by the Court – is below:

B. The Applicant’s Oral Argument at the Hearing 

[24] In oral argument, he argued the Commissioner failed to properly interpret section 46 of the Act resulting in asking herself the wrong question when analyzing Repligen’s correction request. [25] He argues section 46 of the Act is clear. It obliges the owner of a patent i.e. the patentee of a patent; in French “le titulaire d’un brevet” to pay prescribed fees and it is only if and when such fees payable are not paid within the prescribed time that the term of the patent shall be deemed to have expired at the end of the prescribed time for payment.
 

[26] He argues the Commissioner was wrong to say the maintenance fees were not paid by Repligen on the ‘486 patent. CPA’s payment which the Commission does not deny receiving were specifically made on behalf of the named owner Repligen. Moreover in its request for correction Counsel specifically so stated. In the circumstances of this case there was no discretion for the Commissioner to exercise, Counsel argued.
 

[27] In addition, he argues there is nothing in section 46 of the Act which requires maintenance fee payments to be made by reference to the number under which the patent was issued nor is that requirement found in section 182 of the Rules. He buttressed this argument by a reference to section 7 of the Rules which provides that communications addressed to the Commissioner in relation to an application shall include the application number, if one has been assigned. He contrasted this requirement with a reference to section 182 of the Rules dealing with Maintenance Fees which does not contain a similar requirement in respect of issued patents.

Decision: 

THIS COURT'S JUDGMENT is that this judicial review application is granted with costs, the Commissioner's decision is set aside and the Applicant's correction request shall be reconsidered by a different official in the Patent Office taking into account these reasons.

Read the full decision here.