Canada: Pharmacapsules @ Gowlings - December 3, 2009

Last Updated: December 21 2009

Edited by Jennifer Wilkie and Chantal Saunders

  • New Disclosure Requirements for Clinical Trials
  • U.S. FDA Contemplates New Rules for Internet-Delivered Health Information
  • Recent Cases

New Disclosure Requirements for Clinical Trials

By Scott Robertson

The International Federation of Pharmaceutical Manufactures and Associations (IFPMA) has released its latest Joint Position which will require member companies to disclose information on all clinical trials in patients. This new requirement will now extend to early-stage safety trials of medicines for life-threatening conditions. Member companies will still maintain discretion to disclose information from Phase I safety trials in health volunteers.

The Joint Position has already been approved by pharmaceutical associations from Japan, Europe and the United States respectively. Once the position comes into force, member companies will be responsible for posting details of new clinical trials in patients on a publicly accessible website within 21 days of the start of the patient enrolment. There will also be a requirement for member companies to publish summary result of the trials within one year of the relevant product being tested.

More detailed information can be accessed at the site below:
http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=13083



U.S. FDA Contemplates New Rules for Internet-Delivered Health Information

By Melissa Binns

In recognition of the increasing use of the Internet by consumers for health-related information, the FDA is seeking to determine whether it needs to regulate the promotion of drugs and medical devices on the Internet. The FDA recently convened a two-day public hearing on November 12-13, 2009 called "Promotion of Food and Drug Administration-Regulated Medicinal Products Using the Internet and Social Media". Presenters included pharmaceutical companies such as Pfizer and Eli Lilly as well as Internet companies such as Google and Yahoo.

The Pharmaceutical Research and Manufactures of American urged the FDA to adopt a standard safety logo for Web content which would link FDA-approved information regarding a particular drug or device. Other options being considered to prevent misleading information include modified rules based on the FDA's current regulations governing more traditional sources of health information such as television and magazine advertisements.

An archived copy of the two-day public hearing is available online as set out below:

http://www.capitolconnection.net/capcon/fda/111209/FDAarchive.htm until December 18, 2009



Recent Cases

By Beverley Moore

Pfizer v. ratiopharm, Motion to Intervene in Appeal of Infringement proceedings; November 19, 2009, amlodipine

The Court of Appeal denied BIOTEC Canada's and Eli Lilly's leave to intervene in Pfizer's appeal of the Court's decision to invalidate a patent for amlodipine.

Our summary of the trial level decision of Justice Hughes can be found here:

The Court of Appeal held that a jurisprudential interest is not sufficient to grant intervenor status. The proposed intervenors submitted that the Court below significantly changed established law relating to utility and section 53 of the Patent Act and that this change in law significantly lowered the threshold to demonstrate invalidity on these grounds. In addition, the proposed intervenors claimed to have specialized expertise in patent law and practices around the world that would provide the Court of Appeal with information on how the decision of the court changes Canada's patent law and practice when compared to the international stage.

The Court held that in order for this to be demonstrated, the intervenors must show a difference between patentability requirements in Canada and in foreign countries thus requiring evidence on foreign law. Yet the proposed intervenors explicitly stated that they did not seek to introduce evidence on the appeal (which is rarely ever permitted), thus undermining the prospect of adding a new perspective to the dispute. Thus, the motion to intervene was dismissed.

The full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2009/2009fca339/2009fca339.html

Pfizer v. ratiopharm Inc.; Interlocutory Motion on Appeal of Impeachment decision; November 19, 2009, amlodipine

Pfizer filed a motion to amend the contents of its appeal book, its notice of appeal and its memorandum of fact and law on the appeal to deal with the additional grounds. This motion was denied.

After the Trial Court found the patent at issue to be invalid (summary of decision here), ratiopharm brought a motion to set aside the original prohibition order on the patent so that it could also file a claim for section 8 damages. ratiopharm's motion was founded on Justice Hughes' finding that the patent was invalid due to section 53(1) of the Patent Act. The outcome of ratiopharm's motion is discussed in the next summary below.

Pfizer argued that the inclusion of ratiopharm's motion in the appeal book is material to the Court's understanding of why it is necessary to address Pfizer's appeal of the section 53 allegation regardless of the other grounds of appeal.

The Court of Appeal found that this was a bare assertion and there is no specificity as to what Pfizer intends to establish by inclusion of the document. The Court also found that an appellate court should not consider evidence that was not before the court below unless an order is made pursuant to Rule 351 of the Federal Court Rules and no such motion was brought in this case. Although amendments to a Notice of Appeal can be made at any stage of the proceeding, Pfizer must at least indicate that the amendment is necessary and will serve the interest of justice and it has not done so in this case. Thus, the motion was denied.

The full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2009/2009fca338/2009fca338.html

Pfizer v. ratiopharm, Motion to Amended a Previous Judgment on the Merits, November 16, 2009, amlodipine

ratiopharm was successful in the proceeding under the NOC Regulations at the trial level, but the decision was overturned on appeal. With the prohibition order in place, ratiopharm then brought a proceeding to impeach the patent at issue. It was successful in this proceeding (that decision is summarized here). ratiopharm then brought the within motion in the Trial Division to set aside the Court of Appeal decision issuing the prohibition order. The Court dismissed that motion.

Pfizer also brought a motion to quash ratiopharm's motion arguing that ratiopharm's motion is premature as the impeachment decision is under appeal. The Court dismissed Pfizer's motion as ratiopharm's motion had been fully argued and the Court found many reasons to dismiss it. Thus, the best use of resources was to dispose of ratiopharm's motion.

The Court dismissed ratiopharm's motion on three grounds. First, it found that it had no jurisdiction to set aside the Order of the Federal Court of Appeal granting prohibition. It is for the Court of Appeal to deal with such a motion.

Second, the Court held that the matter is moot. The NOC, which was prohibited by the Order of the Federal Court of Appeal, has now been issued to ratiopharm. Thus, there is no live controversy in these proceedings. ratiopharm argued that if the prohibition order is overturned, it could sue for damages pursuant to section 8 of the NOC Regulations. However, the Court distinguished the jurisprudence set out by ratiopharm and held that in this case, the Court of Appeal heard the case on its merits and made a decision to order prohibition. Thus, the matter was finally determined and there is no longer any live controversy in respect of section 8.

Third, the Court held that the prohibition order has come to an end because the patent has expired. A prohibition order can be vacated if, in an action, the patent is held to be invalid or not infringed. However, this is not the same as the prohibition subsequently being dismissed. As the NOC proceedings are not in rem proceedings as to the validity of the patent, they are based on a determination by the Court as to whether the allegations made by the company in its Notice of Allegation are justified or not. In this case, ratiopharm had its day in court and raised the issues it believed to be important, adduced the evidence it chose and made the argument that it wished in the NOC proceedings. These allegations were found to be not justified and thus the prohibition order issued. The impeachment proceeding is a different proceeding causing a patent to expire, but having no relevance on the "dismissal" of NOC proceedings.

ratiopharm also argued that as the patent was found invalid pursuant to section 53 of the Patent Act in the impeachment proceeding, the prohibition order was obtained as a result of fraud. However, ratiopharm did not raise the allegation pursuant to section 53 of the Patent Act in its NOA. Thus, this allegation cannot be considered in the context of ratiopharm's motion at this stage. Thus, the motion was dismissed.

The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2009/2009fc1165/2009fc1165.html

Bayer Inc. v. Canada (Health), Listing Decision, November 17, 2009, drospirenone/ethinyl estradiol

The Court dismissed a judicial review of the Minister's decision refusing to list a formulation patent on the Patent Register.

The patent at issue contains formulation claims, but only specifically referred to one of the medicinal ingredients in the approved combination product. The Court focused on the question of interpretation of the NOC Regulations, holding that it must look at the plain and ordinary meaning of the full phrase "a claim for the formulation that contains the medicinal ingredient".

The Court then held that a formulation is essentially a physical mixture of medicinal and non-medicinal ingredients and that a mixture containing two medicinal ingredients is different from a mixture that contains only one. The drug with one medicinal ingredient will have a different effect from a drug with two medicinal ingredients where two medicinal ingredients are combined to have a desired effect.

The Court considered Bayer's argument that the interpretation of this section is different than the interpretation of a claim to the medicinal ingredient section of the Regulations but disagreed. The Court held that there is a fundamental difference between a compound patent and a formulation patent. A compound patent containing a single medicinal ingredient will necessarily be early-worked if a generic company tries to copy the product as the essence of a compound patent is the medicinal ingredient. But the essence of a formulation patent is the mixture of all ingredients. This distinction requires a different approach when matching of specificity is being considered. A formulation patent eligible for listing must contain a claim for the approved mixture of medicinal and non-medicinal ingredients that are actually administered to the patient.

The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2009/2009fc1171/2009fc1171.html

Sanofi v. Hospira, Merits of a 55.2 proceeding, October 22, 2009, docetaxel

The Court refused to grant an Order of Prohibition against Hospira regarding its docetaxel product.

After the NOA had been filed, but prior to the filing of the Application, Sanofi had disclaimed part of the claims of the patent at issue. The proceeding continued on the basis of the disclaimed claims until just before the hearing when Hospira raised the issue of whether it had to address them. Motions were brought before the Court resulting in the application being allowed to proceed. Sanofi and Hospira were also permitted to file further evidence on the disclaimer.

At the hearing, the Court held that previous jurisprudence in NOC proceedings regarding disclaimers had not considered the Supreme Court of Canada's decision in Merck where it was held that the relevant date for assessing the justification of a NOA is the date of the hearing. The Court held that allowing a generic company to obtain a NOC despite a disclaimed patent does not meet the purpose of the NOC Regulations as the Court is not issuing a decision that prevents infringement when it ignores the reality of a disclaimed patent.

The Court then found that the disclaimer was not valid as once it was challenged, Sanofi failed to establish that through mistake or accidental inadvertence, its patent was overly broad. Thus, it failed to establish the disclaimer meets the prerequisites of section 46(1) of the Patent Act.

The Court held that the application would have to be dismissed based on the findings as to the invalidity of the disclaimer. However, in the event of appeal, the Court considered the remainder of the allegations in the NOA. The Court found that the claims would be infringed by Hospira's formulation. The Court also found that the claims were not overly broad due to a failure to list every additional non-essential ingredient of the formulation in the claims. Furthermore, the allegations as to anticipation were not justified. The allegations as to material misstatement were found not to be justified as Hospira did not meet its evidential burden. The allegation as to insufficiency and non-patentable subject matter were also dismissed. However, the allegation to obviousness was justified on the basis of an obvious-to-try test.

The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2009/2009fc1077/2009fc1077.html

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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