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May 4, 2009 - Volume 8, Number 5 | |
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PMPRB Lacks Jurisdiction over Foreign Sales of Medicines Made Available to Canadians
In a recent decision, the Federal Court held that the Patented Medicine Price Review Board ("the Board") does not have jurisdiction to regulate sales of medicines made available to Canadians under a Special Access Program ("SAP") if the sale of the medicine occurs outside Canada. In this case, the U.S. company that sold the medicine did not have a Notice of Compliance to market the medicine in Canada. It was, however, permitted to sell the medicine to people living in Canada under SAP. In this case, the Board accepted that the sale of the medicine itself occurred in the U.S. The Board, nevertheless, seized jurisdiction over the sale price of this medicine because it was being marketed in Canada. The Court rejected this argument finding that even though the drug in question is sold to Canadians, the medicine is not being sold in "any market in Canada"; it is sold in the U.S. and thus is outside of the jurisdiction of the Board. For more information, please see:
Anti-Rebate Provisions in Bill 102 Used by Ontario
On April 27, 2009, Ontario announced that it was taking action against a number of pharmacies, generic drug manufacturers and wholesalers under the anti-rebate provisions enacted under Bill 102. Audits done by the Ministry of Health and Long-Term Care's Ontario Public Drug Program uncovered discrepancies in the reporting of professional allowances. Upon investigation, it was determined that the pharmacies in question had been purchasing a greater amount of drug than required, collecting professional allowances on these amounts and returning a portion of the drugs to the manufacturer. The product would then be resold, triggering a second professional allowance. Rebate penalty orders were issued in the amount of $33.8 million against 7 generic drug companies, 4 wholesalers and 1 pharmacy. 20 provincial offence charges have also been laid. Investigations are ongoing, with additional parties being implicated and possible further sanctions by the Ontario College of Pharmacists. For more information, please see:
Sandoz Canada Receives Approval for First Subsequent Entry Biologic in Canada
Sandoz Canada announced this week that it received market authorization for recombinant human-growth hormone marketed as OmnitropeTM in Canada. This approval is the first version of a previously approved recombinant biotechnology drug to be approved by Health Canada under the regulatory term "Subsequent Entry Biologic" (SEB - also known as "biosimilars" in Europe and "follow-on proteins" in the U.S.). OmnitropeTM, a somatropin (rDNA orign) for injection, is approved for long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone. It is also approved for long-term replacement therapy in adults with growth hormone deficiency due to an underlying hypothalamic or pituitary disease or who were growth deficient during childhood. OmnitropeTM Pen 5 and 10 provides a new convenient delivery system because the liquid is already dissolved in a ready-to-use cartridge that can be loaded into the pen for injection. For more information, please see:
Clinical Trial On Gene Therapy For Blindness Yields Promising Results
On April 28, 2009, researchers from the Institute of Ophthalmology at University College London and Moorfields in the UK published the results from the world's first clinical trial to test the use of gene therapy to treat inherited blindness. The research was particularly focused on Leber's congenital amaurosis - a group of inherited rod-cone dystrophies in the retina caused in part by mutations of one of several genes including RPE65. In the study, three young adult patients were administered subretinal injections of recombinant adeno-associated virus vector 2/2 expressing RPE65 protein complementary DNA under the control of a human RPE65 promoter. The results were published in the New England Journal of Medicine, and the authors suggest that the subretinal administration of recombinant adeno-associated virus vector is not associated with immediate adverse events in patients with severe retinal dystrophy and that adeno-associated virus-mediated RPE65 gene therapy can lead to modest improvements in visual function, even in patients with advanced degeneration. The authors further concluded that these findings provide support for the development of further clinical studies in children with RPE65 deficiency as these children are more likely to benefit than adults. For more information, please see:
Recent Cases
Sanofi Aventis v. Apotex; interlocutory motion; 2009 FC 294; ramipril; March 19, 2009 Two days after the completion of the evidentiary phase of a trial on the merits, Apotex brought a motion to admit approximately 3,000 pages of evidence consisting of affidavits sworn in other Federal Court proceedings, transcripts from U.S. depositions and file history information for certain Canadian and U.S. patents. The Court assumed, without deciding, that for the purposes of the motion the new evidence would be relevant to the issues in the case. However, the Court found that Apotex had delayed in seeking avenues to introduce this evidence orally in Court. The Court held that Apotex, as a matter of strategy, chose to try to split its case. In addition, the Court found that the documents were not reliable, as there was no evidence that the truth of the affidavits had been tested. Furthermore, the Court was not persuaded that the plaintiffs had had meaningful rights to participate in the depositions which Apotex was seeking to introduce. Thus, the Court found that there would be prejudice to the plaintiffs and declined to admit all documents other than the file histories of two patents. The file histories were admitted as they demonstrate when documents were placed on file at the Patent Office. However, the Court noted that they do not speak to the truth of any matter contained in the documents in the file history. Apotex had also asked the Court to issue a Commission to take the evidence of four additional witnesses in the U.S. This request was denied for a number of reasons including its timing, and the Court's holding that Apotex did not do everything in its power to persuade the witnesses to testify in person at the trial. The full text of the decision can be found at: Eli Lilly v. Novopharm; merits of a 55.2 proceeding; 2009 FC 235; raloxifene; March 19, 2009 The Court dismissed the proceeding, finding the allegation of non-infringement justified, as well as the allegation as to invalidity based on utility justified. The patent at issue related to claims for particles of raloxifene having a particular size. Both parties submitted testing results to determine the size of the particles in the product. However, on a balance of probabilities, the Court found the allegation of non-infringement to be justified. Allegations were made as to both obviousness and inutility. The Court found that if the requirement of utility is satisfied then the claims can be said to be inventive. However, the Court found that the allegation with respect to sound prediction of utility was justified. The full text of the decision can be found at: Eli Lilly v. Apotex; merits of a 55.2 proceeding; 2009 FC 320; raloxifene; March 26, 2009 The Court dismissed the application for prohibition on the basis that the allegations of anticipation, obviousness, claims broader and Gillette defence are justified. The allegation as to non-infringement was not justified, however, that did not effect the outcome of the proceeding. A preliminary motion was brought to strike the evidence of one of the witnesses for Apotex as when he drafted his affidavit, he was an employee of a company related to Apotex, and when he was cross-examined on his affidavit he was an employee of Apotex' counsel of record. This motion was dismissed for a number of reasons, including that there was no evidence that any of his connections caused him to be biased or influenced the results of his testing. Furthermore, the motion was brought just before hearing, with no reservation of rights to do so. The Court found that the evidence was in the record and nobody was taken by surprise. The Court found that there had been no abuse in continuing with the Apotex proceeding when a Novopharm proceeding was pending as the decision in the Novopharm proceeding was not rendered until after the hearing in the Apotex proceeding. However, the Court did consider that comity should apply and found that there was no reason to arrive at a result different from that in the Novopharm proceeding. Thus, the allegations as to invalidity based on anticipation and obviousness were justified. The Court then considered additional allegations made by Apotex and found the allegation as to be overbreadth to be justified. Furthermore, the Court found that on a balance of probabilities, Apotex' process is not different than the process of one of the prior art patents found to anticipate the patent at issue. Thus, although a simple allegation of non-infringement would fail, Apotex' Gillette defence is justified. The full text of the decision can be found at: Apotex v. Servier; interlocutory motion to strike in a s.8 proceeding; 2009 FC 319; Gliclazide; March 25, 2009 The defendant brought a motion to strike portions of the generic company's claim for s. 8 damages. Specifically, Servier sought to remove Apotex' claim for unjust enrichment. The Court agreed that, as a consequence of both the amendments to the PM(NOC) Regulations and Justice Hughes' decision in T-1144-05, a claim for unjust enrichment could no longer be advanced under the PM(NOC) Regulations. However, Apotex argued that this claim could still be advanced under s. 20(2) of the Federal Courts Act. The Court found that reading Apotex' pleading as it currently stands, the claim is framed under the PM(NOC) Regulations and not under the Federal Courts Act. Indeed, Servier was not even aware of this legal basis for the claim until it received Apotex' written submissions on this motion. As a result, Apotex' pleadings in relation to unjust enrichment pursuant to the PM(NOC) Regulations were struck, without prejudice, to Apotex' rights to amend the claim to plead pursuant to the Federal Courts Act. Apotex had also made a number of pleadings regarding its interpretation of the legal effect of the PM(NOC) Regulations. However, these were not struck as the Court found them to properly provide background to the claim, and not prejudice the defendant. The full text of the decision can be found at: Eli Lilly v. Apotex; appeal of 55.2 proceeding; 2009 FCA 97; raloxifene; March 25, 2009 In the underlying decision on the merits, the Federal Court dismissed the application on the basis that the allegation as to a lack of sound prediction because the patent lacks adequate disclosure was justified. The Court of Appeal upheld that decision. The Court reiterated the test articulated by the Supreme Court in AZT, namely that when an invention had not yet been reduced to practice, the disclosure must give both the underlying facts and the sound line of reasoning to justify the prediction. The Court of Appeal then stated that "[i]n sound prediction cases there is a heightened obligation to disclose the underlying facts and the line of reasoning for inventions that comprise the prediction." In this case, the Court found that neither of those elements were present in the disclosure. The Court of Appeal found that whether a prediction is sound is a factual question which cannot be overturned without a palpable and overriding error. The Court of Appeal held that on the relevant evidence, it was open to the Federal Court judge to conclude that patent at issue disclosed no more than the prior art. The full text of the decision can be found at: Canadian Pharmaceutical Technologies International v. Canada; judicial review of a decision by Health Canada under the Food and Drugs Act; 2009 FC 244; vancomycin; April 7, 2009 The Court upheld the decision of Health Canada that the applicant's product was indeed a "drug in dosage form" and thus was subject to the provisions of the Food and Drugs Act and Regulations. The Court further held that there was no denial of procedural fairness in the process. The applicant, CPTI, makes vancomycin hydrochloride in a powder form which it sells in fixed, premeasured, standardized package units to pharmacies and hospitals in Canada. It is not sold directly to consumers but rather was alleged to be an active pharmaceutical ingredient intended for use by licensed pharmacists in compounding. CPTI had previously succeeded in an application that Health Canada had breached the duty of fairness it was owed in a classification proceeding, by not providing it with the opportunity to respond with evidence to a position taken by Health Canada regarding this product. As a result of that decision, Health Canada needed to provide CPTI with an opportunity to respond. CPTI took the position in starting this application that Health Canada still had not met the requirements of procedural fairness in the steps it had taken after the finding in the previous application. The Court found that procedural fairness was not violated and that there was no discrimination against CPTI on the basis that other companies in Canada are selling vancomycin products to pharmacists without being required to obtain a DIN. The Court then considered the merits of the hearing finding that the statutory definition of drug is very broad and that vancomycin fits within that definition. A drug in dosage form is defined as being a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing. CPTI argued that the further steps taken by pharmacists before its product is patients amounts to further manufacturing or transformation of the product. Health Canada identified the degree of control exercised by manufacturers versus pharmacists over the dosage of the drug that was ultimately administered to the patient as key to his analysis as to whether this was drug and dosage form. In this case, as the product contains a premeasured amount of drug substance that corresponds to a standard dosage of vancomycin hydrochloride normally administered to the patient, it is CPTI's actions that determine the amount of drug substance received by the patient. The intervening actions of the pharmacists in adding excipients or diluents do not change the fact that the total delivered dosage of the product was determined by the manufacturer. As Health Canada should be afforded considerable deference due to the considerable fact finding and level of similarity which the Court does not share, the conclusion drawn was reasonably open to Health Canada. Thus, the application for judicial review was dismissed. The full text of the decision can be found at: |
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