- NOA Found to be Deficient for Failing to Plead the Facts and Law Relating to the Manufacture and Importation of the Drug Product
- October 10, 2016 | Authors: Jillian Brenner; Adrian J. Howard; Beverley Moore; Chantal Saunders
- Law Firm: Borden Ladner Gervais LLP - Ottawa Office
- Bayer Inc. v. Fresenius Kabi Canada Ltd., 2016 FC 581
Drug: moxifloxacin hydrochloride
Bayer has obtained an order of prohibition against the Minister of Health from issuing a NOC to Fresenius for its proposed moxifloxacin hydrochloride product.
Bayer had alleged that Fresenius infringed their patent during the manufacturing process, at an intermediate step. Fresenius did not challenge the validity of the patent, instead claiming it did not infringe the patent. However, the Federal Court found that the Notice of Allegation (NOA) was defective because it does not contain the "detailed statement of legal and factual basis" for the alleged non-infringement.
The NOA alleged that it did not infringe because Fresenius' solution for injection will not contain moxifloxacin in crystalline form. Moreover, Fresenius alleged it would not use the monohydrate moxifloxacin specified by the patent in its manufacturing of Fresenius-moxifloxacin or in the manufacture of the active pharmaceutical ingredient used in the manufacture of Fresenius-moxifloxacin. Fresenius did not disclose in its NOA the fact that its proposed new drug is to be manufactured, processed and packaged offshore and imported into Canada.
Bayer conceded that the imported drug for which the NOC is sought does not contain Bayer's patented product. However, the Court noted that Fresenius did not directly plead non-infringement through exportation and the Saccharin Doctrine in its NOA, instead relying on what was termed "code words" such as "trivial and merely incidental use". Thus, the NOA was found to be defective.
Had the Court not found the NOA defective, the Court would have dismissed this application because Bayer failed to establish on a balance of probabilities that the allegations of non-infringement are not justified.
Bayer Inc. v. Fresenius Kabi Canada Ltd., 2016 FC 970
Fresenius has unsuccessfully sought to have the Court reconsider its judgment in 2016 FC 581, summarized above. Fresenius argued that the remedy of a prohibition order is inconsistent with the reasons, and the reasons overlook specific concessions made by Bayer in its argument.
The Court held that this motion was an attempt to reargue the application, and if the decision was made in error then it is for the Federal Court of Appeal to make such a determination on appeal.