Compound Patent Found Valid In Face Of Allegations Of Lack Of Utility/Sound Prediction And Insufficiency - Intellectual Property Weekly Abstracts - Week Of February 25, 2013

Edited by Chantal Saunders and Beverley Moore

Patent Actions and NOC Cases

Compound Patent found Valid in face of Allegations of Lack of Utility/Sound Prediction and Insufficiency

Teva v. Novartis.
Novartis v. Apotex.
Drug: imatinib

Apotex and Novopharm started actions to impeach Novartis' patent covering the compound imatinib, sold under the brand name GLEEVEC®. They then sent Notices of Allegation to Novartis in respect of the same patent. As a result, 4 proceedings were started and later consolidated. The Court heard the cases and although several of the claims in the patent were found to be invalid, the validity of a number of other claims was upheld. Thus, Apotex' and Novopharm's actions were dismissed. In addition, the Notices of Allegation were found to be not justified.

The patent at issue claimed a novel genus of compounds, as well as pharmaceutical compositions, uses and processes to make the compounds. Sound prediction of utility and sufficiency of disclosure were the only two validity issues raised at the hearing.

When assessing utility, the Court held that utility is determined based on the state of the art and information available at the filing date. The Court confirmed that utility can be either demonstrated or met through sound prediction. With respect to sound prediction, the Court stated that "[i]ts introduction into Canadian law was not ... to give a crushing hammer to those who challenge patents." (para 164)

The Court held that determining the promise of the patent, in a purposive manner, is the first step in a utility analysis. It is hoped that this guidance, provided by the Court, will serve to reduce the unpredictability of decisions on this issue in the future. The Court held that different types of claims have different promises. The compound claims were held to promise selective inhibition of certain enzymes. The use claims were held to promise in vivo utility.

The generic companies conceded during the trial that the in vitro activity of imatinib was demonstrated or soundly predicted. Despite this concession, the Court considered the utility of the compound claims. Selective inhibition of certain enzymes was agreed to be a valuable pharmacological property. The Court also held that demonstrated utility does not mean that all in vitro tests need to be carried out on all of the compounds. The Court then considered the evidence and held that utility of the compounds for some of the claims had been demonstrated, and for some of the claims had been soundly predicted. However, for several of the genus claims, the Court held that utility had neither been demonstrated nor soundly predicted. In considering the use claims, the Court also found them to be soundly predicted.

Regarding the allegations that the patent's disclosure is insufficient, the Court held interpreted the Supreme Court's recent decision regarding sufficiency and held that three questions must be answered: 1) what is your invention; 2) how does it work; and 3) having only the specification, can the person of ordinary skill in the art produce the invention using only the instructions contained in the disclosure? (para 344) The Court then held that the patent was not invalid for insufficiency.

Finally, the Court considered allegations of infringement against Apotex. Apotex acknowledged that it had in its possession bulk imatinib. However, the Court held that most of it had been used for regulatory purposes and the remainder had expired. Furthermore, Apotex' chairman undertook that the imatinib it had would not be used for commercial purposes. Thus, an order to deliver it up was not made.

Court of Appeal Permits Sampling of Apotex's Products

Apotex Inc. v. Eli Lilly Canada Inc.
Apotex Inc. v. H. Lundbeck A/S
Apotex Inc. v. Astrazeneca Canada Inc.

The Court of Appeal is permitting several innovator pharmaceutical companies to obtain samples of Apotex's drug products for destructive testing. There were a total of three drugs in play across the five appeals, and in all cases the Court permitted the sampling requested. The innovator companies may sample bulk active ingredient, blends, tablet cores, finished tablets or other related materials as necessary for their respective cases.

In each appeal, the normal discovery process was considered to be insufficient to assist the innovator in making its case. It was considered to be necessary and expedient for the innovator companies to request the samples as there was a reasonable possibility that the proposed testing would reveal something useful for the trier of fact. Rule 249 was interpreted to give a broad discretion to the Court, and on the facts in these appeals it was appropriate to grant the relief sought.

Other Cases of Interest

Motion to Strike Pleading Mostly Denied, but Granted in Part

Apotex v. Canada (Health) et al..

The Defendants brought a motion striking portions of the Statement of Claim under three different headings. Furthermore, particulars were sought. The Claim alleges that the Plaintiff incurred damages as a result of the Defendants' conduct in dealing with new drug submissions filed by the Plaintiff under the Food and Drugs Act and the Food and Drug Regulations.

The Defendants sought to strike the allegations of breach of statutory duty, bad faith and unlawful discrimination on the basis that there is no independent cause of action in tort for these allegations. The Court held that the references to bad faith are proper, as they are for the purpose of supporting the allegation of misfeasance in public office and the claim for punitive damages. However, the Court held that the claim of discrimination could not succeed, and struck it from the pleading. However, references to discrimination in the pleading were permitted to remain as they also support the claim for misfeasance in public office.

Furthermore, the Defendants sought to strike the claims as they relate to 4 of 11 drug products on the basis of res judicata and failure to disclose a reasonable cause of action. These claims were not struck as the Court held that the claims before the Federal Court were different than the claims in this case. Thus, res judicata did not apply.

Finally, the Defendants sough to strike claims for damages based on section 8 of the Patented Medicines (Notice of Compliance) Regulations. The Plaintiffs argued that their claim was for the loss of the benefit of section 8. The Court accepted this argument and refused to strike the claim. The Court also held that further particulars were not needed. Several paragraphs that pled evidence rather than facts were struck as they were held to offend the rules of pleading.

Other Industry News

Health Canada has released a Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance: M7 - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. The consultation is open for comment until April 26, 2013.

Health Canada has published a number of documents in relation to a Label Safety Assessment Update.

Health Canada has published a Notice to Stakeholders - Release of draft Guidance document for consultation: Submission and Information Requirements for Extraordinary Use New Drugs (EUNDS).

The Canadian Intellectual Property Office is conducting roundtable sessions with Canadian small and medium-sized enterprises that have filed at least one patent and/or trade-mark application in Canada.

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