Hidden Agendas? Teva v Pfizer

In May of 2011, the Supreme Court of Canada granted Teva Canada leave to appeal the Federal Court of Appeal’s decision, Teva v Pfizer, 2010 FCA 242. At issue is Patent ‘446 (July 2008; expires in 2014), which covers Pfizer’s sildenafil-based drug for treating erectile dysfunction (ED). Pfizer originally patented sildenafil in 1998 to treat hypertension, and only after a number of test patients reported spontaneous ‘reactions’ did they begin testing the compound for treating ED. The patent prevents pharmaceutical companies from marketing generic, low-cost alternatives.

Both parties are asking the Court to revise its position on sufficiency in patent applications. Teva suggests that the Court revise the test to identify if patents sufficiently disclose the elements or compounds required to make the invention operational. As the test currently stands, patent applications only need enough information to enable the reader to carry out experiments to make use of the invention under question. Pfizer is asking the Court to “clarify that there is no special disclosure regime applicable to patents for inventions whose utility turns on sound prediction.”

Teva’s claim is largely focused on what they interpret as an intentional, and “artfully worded” patent application for Viagra. They argue that the repeated use of the phrase “especially preferred compounds” (among 260 quintillian other untested compounds) by Pfizer in reference to sildenafil impedes the reader’s understanding, and prevents a sound prediction of utility of the invention – in this case, the purpose and use of sildenafil.

Teva wants the Court to follow preceding judgments (notably Noranda Mines v Minerals Separation Corp., [1950] SCR 36), and invalidate Pfizer’s Viagra patent on the common law grounds of “concealment and avoidable obscurity,” and for failing to act uberrima fide (with utmost good faith). In addition, Teva suggests that the FCA’s reliance on the test laid out in Consolboard Inc. v MacMillan Bloedel (Sask.) Ltd., [1981] 1 SCR 504 (“What is your invention? How does it work?”) was insufficient for assessing the validity of the patent. Finally, Teva asserts that its claims are not simply a “technical attack” to defeat the patent, and that the insufficiency itself is enough to invalidate.

Teva’s claims are not without merit, and are, at the very least, descriptive of the patent. The application judge found that “the patent obfuscated the reader and did not simply and distinctly describe the true invention for the skilled reader.” Despite this, he found it to be valid and restricted his criticism to Pfizer’s choice of wording to a section entitled “Obiter.” Unclear patents prevent others from knowing if their use of the invention is an infringement on the patent holder’s right to exclusivity.

Both sides remind the Court about the “proper” and “modern” approach to statutory interpretation, with which they assemble their opposing conclusions. Teva argues that s. 27(3) of the Patent Act, RSC 1985, c P-4 (to “correctly and fully describe the invention and its operation”) must be understood in line with the purpose of the statute, which is to disclose inventions clearly to the public. Pfizer argues that the objective of the Patent Act is “economic encouragement for research and development,” which is undermined when new rules are introduced and applied retroactively.

Pfizer suggests that Teva’s strategy implants s. 53 of the Patent Act, which covers “intention to mislead,” into the interpretation of s. 27(3). Invalidity does not arise out of common law principles, and can only be grounded under s. 53, which was never raised as a point of contention. Pfizer maintains that the issue is based in statute, and that Teva is seeking to change “long-standing rules for patent disclosure.” They couch Teva’s motion as “rhetoric” the Court should be skeptical of, and that Teva’s “name calling” and ethics judgments have no merit.

Teva is not the only generic drug company that has begun proceedings against Pfizer, and Canada is not the only jurisdiction hosting this legal battle. A U.S. federal judge upheld the Viagra patent in August 2011 (Pfizer v Teva, 10-cv-128, U.S. District Court, Eastern District of Virginia (Norfolk)), extending Pfizer’s control of the ED market until 2019. Teva had made similar claims regarding Pfizer’s allegedly bad faith conduct, and that it had withheld information regarding its related patent disputes in Canada.

Teva has done well to preface its factum with a dramatic quote from G.K. Chesterton, which both frames and sums their argument: “Where does a wise man hide a leaf? In the forest. But what does he do if there is no forest? He grows a forest to hide it in.” Even if Teva’s challenge against a number of the Supreme Court’s own decisions should fail, their counsel should be lauded for stimulating the legal arena with a pretty, if not erudite, literary reference.

The hearing is scheduled for April 20, 2012.