Monday, September 19, 2016

Broad Experimental Use Exception to Anticipation

Bayer Inc v Apotex Inc 2016 FC 1013 Fothergill J
            2,382,426 / micronized drospirenone / YAZ YASMIN / action

Bayer’s ‘426 patent covers an oral contraceptive comprising drospirenone and ethinylestradiol, where the drospirenone is in the form of fast dissolving particles. In this consolidated infringement action, Fothergill J found claims 31, 48 and 49 to be valid and infringed by Apotex’s Zamine and Mya tablets and Cobalt’s Zarah tablets. The conclusions on validity and infringement turned on almost entirely the facts. With that said, it is significant that that Fothergill J accepted the broad experimental use exception to anticipation set out by Hughes J in his NOC decision concerning the same patent. Fothergill J’s remarks on blinding of expert witnesses, as well as on comity and the binding effect of prior FCA decisions on claim construction, are also of interest. This post deals with experimental use and blinding, while tomorrow’s post will deal with comity.

More than one year before the filing date, Schering, Bayer’s predecessor in title [19], conducted Phase III clinical studies in Europe and the United States involving oral contraceptive tablets containing the claimed amounts of drospirenone and ethinylestradiol [145]. (It is not clear to me whether it was admitted that these tablets also fit the claimed formulation profile, but for the purposes of Fothergill J’s reasoning, we may assume they did.)

Participants were given a large number of the tablets, which were to be self-administered over several months outside of a clinical setting. In all three trials, participants were told what the tablets contained, and knew that the tablets were intended to be used as oral contraceptives. No restriction was imposed on participants regarding the disclosure of information concerning the tablets. The participants did not sign confidentiality agreements. [145-46].

Apotex alleged these trials anticipated the ‘426 patent. Fothergill J held they did not. He pointed out that anticipation requires enabling disclosure, and he held that even if some of the tablets had made their way into the hands of a person skilled in the art, such a person would not have been able to reverse engineer the tablets to discover the particular formulation which constituted the invention without the exercise of inventive ingenuity [154-55]. That finding turned on the facts and the law he applied is not controversial.

More interesting is the “alternative” basis for Fothergill J’s holding that the trial did not anticipate [156]. In Bayer v Apotex 2014 FC 436 a prior NOC case involving the ‘426 patent, the same argument was raised that these same clinical trial were anticipatory. Hughes J held that they were not, on the primary basis that Bayer benefited from an experimental use exception to anticipation. The following key passage from Hughes J's decision was quoted by Fothergill J [159]:

[121] In the present case clinical studies were necessary to prove that the drug was safe and effective and, thereby, gain government approval for sale. Until this had been demonstrated, no commercial sale of the drug could have been made. Bayer took reasonable steps to ensure the confidentiality of the relevant documents and to ensure that unused tablets were returned. The theoretical possibility that some tablets were retained and analyzed is just that, theoretical. This theoretical possibility does not preclude the fact that the studies were experimental, and of necessity, conducted by the provision of tablets to members of the public. Thus these clinical studies are exempted from public use.

As I said in my blog post on Hughes J’s decision, this seemingly establishes a broad experimental use exception to what would otherwise be anticipating disclosure, which applies to any clinical trial, so long as reasonable steps are taken to ensure that the unused tablets are returned. Fothergill J agreed with Hughes J both as to this statement of the law and its application to the facts of this case [156], [159]. Fothergill J also clarified that the fact that these trials had been conducted for the purpose of gaining regulatory approval did not take them outside of the experimental use exception [162].

In my post on Hughes J’s decision, I suggested that his decision was notable because, while there was some case law supporting such a broad exception, it was not well-established. Fothergill J’s holding is therefore significant as reinforcing the law stated by Hughes J.

Blinding Expert Witnesses
Apotex argued that the evidence of its expert witnesses should be preferred to those of Bayer’s witnesses because its experts had been “blinded.” Like Brown J in the recent VIREAD decision, 2016 FC 857 (blogged here), Fothergill J was unimpressed by the arguments in favour of blinding. Fothergill J noted that “[t]he fact that expert witnesses were blinded may be persuasive and helpful in weighing their evidence where credibility concerns arise” [65], but, citing Locke J in Shire 2016 FC 382, [45] (blogged here), he continued to say that “if an expert’s opinion is well supported, then there may be no reason to place less weight on the expert’s evidence merely because he or she was not blinded to certain facts when forming that opinion” [66]. In this case, “I have not found the blinding of expert witnesses to be a significant factor in deciding the legal and factual issues raised by this case” [66]. It is still too early to be sure, but the tide may be turning against “blinding.”

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