Publications

Fall 2006

Biotechnology & Pharmaceutical
Group Newsletter

Generic Company Can’t Use File History Statements in Canadian Litigation

There is no file history (wrapper) estoppel in Canada. Therefore, when claims are interpreted, statements or admissions made by the patent owner during patent prosecution cannot be used by a court to assist with interpreting the claims. Such statements are not relevant and not admissible to determine the scope of the claims and validity of the patent. Statements can only be used for very limited purposes unrelated to claim interpretation.

In a recent case involving the drug atorvastatin, a motions judge stopped an attempt by a generic drug company to sneak file history in the back door. The judge struck out portions of a generic company’s affidavit which referred to statements made by the patent owner during prosecution of the Canadian and foreign applications. The Court also ordered that the file histories of the foreign patents be struck from the Court’s record.

The generic company argued on appeal that the affidavit paragraphs and the file histories did not go to claim construction, but that it was merely an admission about the chemical content of atorvastatin.

The appeal Court upheld the motions judge’s decision on the basis that the reference to file history was for the improper purpose of claim construction.

Pfizer Canada Inc. et al. v. Ranbaxy Laboratories Limited, [2006] FC 790

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Inventorship: Making a List? Check it Twice.

A recent case illustrates the importance of correctly determining Canadian inventorship prior to patent issuance. While an application is pending, the Patent Office has the discretion to join an inventor, if satisfied that the inventor should be joined, and the omission of the inventor was by inadvertence or mistake and was not for the purpose of delay.

After the patent issues, the Patent Office has no discretion to amend inventorship. In this case, the patent owner had to apply for a Federal Court order to add an inventor to Canadian patent no. 2,192,915. The omission of the inventor was through inadvertence during a period of corporate restructuring. The error was discovered during an internal review of the corresponding U.S. patent, which occurred after the Canadian patent issued. A court proceeding was required even though the current inventor consented to the addition of a second inventor, there was no legal dispute with a competitor, and there was no known party that would be directly affected by adding the inventor. The Court issued the order to amend inventorship.

Micromass UK Limited v. The Commissioner of Patents, [2006] FC 117.

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Court Takes Practical Approach to Double Patenting

A generic company unsuccessfully argued that a patent was invalid on the basis of the owner allegedly engaging in double patenting. The generic company asserted double patenting even though i) the patents had different inventors and ii) the patent that was alleged to be invalid (‘206 patent) had been filed before the other patents but issued later due to a protracted prosecution in the patent office.

The Court held that the doctrine of double patenting will not typically apply unless there are multiple patents issued to the same inventor. In this case, the inventor of the attacked patent is not the same as the inventor of the earlier patents. The doctrine of double patenting should also not be applied where it would be inconsistent with the Patent Act. To apply double patenting would mean that Patent Office delays in the issuance of the ‘206 Patent would unfairly deprive the patent owner of the patent rights to which it was entitled.

Pharmascience Inc. v. Sanofi-Aventis Canada Inc., [2006] FCA 229.

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No U.S. Presumption That Victorious Patent Owner Gets Injunction

In May 2006, the U.S. Supreme Court determined that a finding of patent infringement does not as a general rule entitle a patent owner to an injunction. Historically, victorious US patent owners have received an injunction in most cases. The Supreme Court reviewed a lower court decision in which eBay had been found guilty of infringing a patent for an electronic marketplace to promote the sale of goods between individuals by having a central authority that promotes trust. The lower court gave a $25 million damage award and also applied what it called a “general rule that courts will issue permanent injunctions against patent infringement absent exceptional circumstances.” The Supreme Court set aside this ruling in favour of a more flexible approach. A lower court will now reconsider whether the patent owner will receive an injunction.

eBay, Inc. v. MercExchange, U.S., No. 05-130, 5/15/06.

In a decision in a different case in June 2006, a court denied Z4 Technologies Inc. an injunction that would have prevented Microsoft using the patented software in its Windows and Office products. The court awarded Z4 approx. $140 million in damages.

z4 v. Microsoft (E.D. Tex. 2006).

In the biotech and pharma area, these decisions are likely to be very helpful to defendants where the patent relates to only a small component of the defendant’s method or product. Without a presumptive injunction, patent owners have less power to use the threat of an injunction simply for leverage in negotiations.

Edited by Noel Courage. Please send feedback and suggestions to Noel at ncourage@ bereskinparr. com.

The contents of this update are informational only, and do not constitute legal or professional advice.

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