Monday, October 1, 2012

Infringement if Later ≠ Anticipation if Earlier

Bristol-Myers Squibb Co. v. Mylan / efavirenz (NOC) 2012 FC 1142 Barnes J
            2,101,572 – 2,279,198 – efavirenz – SUSTIVA

The traditional rule is that “what would infringe if later, anticipates if earlier”: Abbott Labs v Ratiopharm / clarithromycin (NOC) 2006 FCA 187 [25]; Lightning Fastener Co. v. Colonial Fastener Co.[1933] SCR 377 at 381. This is no longer true, since Sanofi 2008 SCC 61, following Synthon [2005] UKHL 59, held that anticipation requires enabling disclosure. This adage applies only to the disclosure prong of anticipation: Synthon [24]. If the prior use did not disclose the information necessary to enable the invention, it will not anticipate. It will still infringe if practiced later, since infringement does not require knowledge: Merrell Dow v HN Norton [1995] UKHL 14 [47]; Abbott / clarithromycin (NOC) [24]. The consequences is that if the prior use was not enabling, a later patent could confer a right to stop people from doing what they had done before. This is strikingly counter-intuitive: “Ever since the power of the Crown to grant monopolies was curbed by parliament and the courts at the beginning of the seventeenth century, it has been a fundamental principle of United Kingdom patent law that the Crown could not grant a patent which would enable the patentee to stop another trader from doing what he had done before”: Merrell Dow v HN Norton [17]. Nonetheless, that is the direct implication of the rule that anticipation requires enabling disclosure. So far the leading cases Canadian and UK cases have avoided this result on the facts, as in Merrell Dow, but this is not a satisfactory response. (US law has addressed the problem directly with the doctrine of inherent anticipation: “a prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference”Schering Corp v Geneva Pharmaceuticals 339 F.3d 1373, 1377 (Fed Cir 2003).) The problem will arise one day in a context in which it cannot be avoided, and the courts will face a choice between preventing a person from doing what she has been done before, and adhering strictly to the requirement of enabling disclosure.

That day may come in respect of the ‘198 patent at issue in Bristol-Myers Squibb Co v Mylan / efavirenz (NOC), though it is not yet here. Efavirenz exists in various crystal forms, several of which were previously known [99]. BMS’s ‘198 patent claims a particular crystalline form of efavirenz, Form I, and a process for producing it. Mylan used a different process to produce a different form, Form X (redacted). The process claims were not in issue and BMS’s infringement argument turned on the alleged fact that all forms of efavirenz, including Form X, will convert to Form I in a small but detectable amount under mild drying conditions [122]. It appears that this was not previously known, so that even though Form I would previously have been produced by drying of other forms, this would not constitute enabling disclosure for the purposes of anticipation. (The decision is not explicit on the lack of enabling disclosure; I am inferring from the fact that anticipation on this basis was not in issue.) The problem is that BMS’s argument, if successful on the facts, would prevent makers of prior forms of efavirenz from continuing to make those other forms, even by processes which they had previously used, if those processes involved mild drying conditions.

BMS could not establish this allegation on the evidence, so its infringement argument failed [134], and consequently the order for prohibition was dismissed. (Mylan’s validity attacks failed on the facts.) But the point is not entirely moot. Neither party led direct evidence on the issue in this proceeding, and the same issue will likely be raised again on a fuller evidentiary basis in the infringement action that will no doubt follow the expiry of BMS’s ‘572 patent. (I discuss the '572 patent in yesterday's post.)

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