Canada: Pharmacapsules @ Gowlings: January 20, 2010

Last Updated: January 22 2010

Edited by Jennifer Wilkie and Chantal Saunders


  • U.S. Senate Votes Against Bill Allowing Americans to Import Prescription Drugs
  • Obama Moving To Renegotiate Biologics Exclusivity Period
  • U.S. Drug Prices Challenged
  • Recent Cases

U.S. Senate Votes Against Bill Allowing Americans to Import Prescription Drugs
By Natalie de Paulsen

In December, the Senate rejected an amendment by Senator Dorgan to allow American pharmacies and drug wholesalers to import federally approved drugs from abroad. Under U.S. federal law, only pharmaceutical companies are permitted to import prescription drugs approved by the FDA. The FDA had raised concerns with the amendment noting that it would be "logistically challenging and resource intensive" and that there were significant safety concerns.

More detailed information can be accessed at the links below:
( prescription_drugs_091210/20091210 (

Obama Moving To Renegotiate Biologics Exclusivity Period
By Roger Tam

In the United States, biologics are not regulated under the Hatch-Waxman Act, which governs approval of conventional generic "small molecule" pharmaceuticals. Current U.S. health care reform bills include provisions intended to introduce a mechanism to regulate approval of subsequent entry biologics. Current House and Senate bills provide the innovator biologic drug with 12 years of exclusivity, even absent patent protection. This 12 year period received broad bipartisan support in both chambers. President Obama is now signaling that he would like to see this exclusivity period truncated to a rumored range from seven to ten years, presumably as another means of containing costs in his plan for health care reform. The pharmaceutical industry has reiterated the need for the 12 year exclusivity period to recoup development costs and fund further research.

More detailed information can be accessed at the link below:

U.S. Drug Prices Challenged
By Roger Tam

In December, brand pharmaceutical companies defended themselves before the House Energy and Commerce health panel against complaints over reports, including one by the AARP (which represents 40 million older Americans), that drug prices continued to outstrip inflation in 2009. It is alleged that drug companies are profiteering in advance of anticipated health care reforms. These reforms are anticipated to include government rebates from drug makers and decreased drug prices, which were the subject of earlier negotiations between the pharmaceutical industry and the Obama administration. Many other options still remain under debate, including legalizing the re-importation of medications from overseas.

More detailed information can be accessed at the link below: (

Recent Cases
By: Beverley Moore

Sanofi-Aventis v. Apotex / Novopharm / Riva, Interlocutory Motion to Consolidate Actions, December 17, 2009, ramipril

Sanofi brought a motion to consolidate three actions pertaining to damages pursuant to section 8 of the NOC Regulations. The actions were brought by Novopharm, Riva and Apotex. Apotex agreed with the consolidation while Novopharm and Riva strongly opposed consolidation. The Court refused to order a joint hearing or a formal consolidation, however, did order that the 3 actions be managed by the same case management prothonotary and heard consecutively by a single judge.

The Court found that each generic claim for damages would have to be evaluated separately. While there may be common evidence relating to the operation of the market for ramipril and while actions of a generic who is not party to one action may impact on the assessment of damages in a different action, these are evidentiary matters that can be dealt with in the context of each action without consolidation.

The Court further found that there would be prejudice to Novopharm and Riva if consolidation occurs. Furthermore, it is Sanofi's burden to prove that it would suffer prejudice without a consolidation and it did not do so.

Finally, the Court found that the possibility of inconsistent findings in the three cases could be effectively managed by having the cases heard separately but consecutively by one judge, and case managed by the same case management prothonotary or judge. However, as these cases relate to damages, it is likely that issues of admissibility and confidentiality will be complex and the interests of the parties will not always be aligned at each procedural step. Thus, the motion was dismissed.

The full text of the decision can be found at: ( )

Schering v. Pharmascience, Merits of NOC proceeding, December 22, 2009, desloratadine

The application under the NOC Regulations was dismissed. The Court found that Pharmascience's allegations of non-infringement, anticipation, obviousness and overbreadth of one patent and non-infringement of a second patent were justified.

When considering the test for obviousness, the Judge looked at whether it was obvious to try to obtain the invention rather than whether the invention itself was something that would be obvious to try.

Furthermore, in considering the allegation of overbreadth, the Judge looked at this legal concept in the context of a functional claim. The Judge held that if the claim is to be construed as catching every stable composition no matter how or why it is stable, this is over-broad claiming.

The full text of this decision can be found at: ( )

Pfizer v. Pharmascience, Merits of NOC proceeding, December 18, 2009, latanoprost

The Court granted prohibition to Pfizer and found that Pharmascience's allegations of invalidity were not justified. Pharmascience also raised the Gillette defence and the Court held that the availability of such a defence depends upon the determination of the allegations of invalidity that were raised; meaning that if the allegations of anticipation and obviousness failed, then the Gillette defence must also fail. In this case, all three allegations were held to fail.

The Court also considered the allegation of insufficiency and found that the patent sufficiently disclosed what the invention is and how it works. Thus, the allegation of insufficiency failed. The Court further found that the patent offered the public a useful choice from what was offered as the state of the art. Thus, the allegations of inutility failed. Finally, the Court considered and rejected the lack of sound prediction and overbreadth allegations. This decision has been appealed.

The full text of the decision can be found at: ( )

Canada (Attorney General) v. Celgene Corporation, Appeal of a PMPRB decision, December 23, 2009, thalidomide

The Court of Appeal overturned the decision of the Trial Judge and restored the decision of the PMPRB providing jurisdiction to the PMPRB over medicines imported under the Special Access Program.

The Court of Appeal held that the only question before the Board was whether the medicine was being sold in any market in Canada. If so, then the Board could require the patentee to provide pricing information about the medicine and make a remedial order regarding the pricing.

The Court of Appeal concluded that the phrase should not be interpreted with reference to common law commercial legal principles for determining the location of a sale, as the price regulation provisions of the Patent Act are for the protection of consumers. The Court of Appeal held that the legislation is part of a regulatory scheme administered by a specialized tribunal to prevent the abuse of the monopolistic market power created by a patent through the charging of excessive prices for medicines used to treat patients in Canada. This must be used to guide the meaning of the phrase in question. Thus, the Court of Appeal agreed with the PMPRB's interpretation of the phrase as enabling the Board to oversee the prices of medicines in Canada either generally or in specific markets, including purchasers receiving medicines through the Special Access Program.

The full text of the decision can be found at: ( )

Eli Lilly v. Hospira, Interlocutory motion regarding further and better Affidavit of Documents, December 31, 2009, gemcitabine

In a case of patent infringement, the Case Management Prothonotary had ordered Hospira to produce a further and better Affidavit of Documents pursuant to an earlier motion by the Plaintiffs. Hospira's appeal of this order was dismissed.

One focus of the motion was batch production records and both parties conceded that those records would be the direct evidence of the process actually used by Hospira's supplier for the manufacture of its product and thus, the direct evidence of whether there is infringement. However, Hospira argued that its ANDS documents should be presumed to be true, thus the batch records need not be produced. The Court rejected this argument.

The Court held that the Prothonotary focused on the correct test regarding relevance of documents. In particular, whether it was reasonable to suppose that the documents sought would undermine Hospira's case, advance Lilly's case, or would fairly lead to a train of inquiry which would have either of those consequences. The Motions Judge found that there was sufficient evidence to support the findings made by the Prothonotary and upheld the production of further documents.

The full text of the decision can be found at: ( )

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