Friday, January 20, 2017

"One Method is Enough"

Apotex Inc v AstraZeneca Canada Inc 2017 FCA 9 Gauthier JA: Pelletier, Scott JJA var’g 2015 FC 322 as amended by 2015 FC 671 Barnes J
            1,292,693 / omeprazole formulation / LOSEC

Barnes J’s holding that the ‘693 patent valid and infringed turned primarily on the facts, as did the FCA affirmation, but the FCA decision shed interesting light on the proper approach to claim construction. That was subject of yesterday’s post. Today's post turns to the FCA's discussion of Biogen v Medeva.

The ‘693 patent pertains to pharmaceutical preparations containing omeprazole. Omeprazole was a known to be useful in treating gastric and duodenal ulcers, but it turned out to be a particularly difficult compound to formulate. It had to be enteric coated to prevent contact with acidic gastric juice, but a conventional enteric coating would react with omeprazole and cause degradation, particularly in storage. The claimed invention solved this problem with an inert subcoating between the omeprazole core and the enteric coating. The disclosure of the 693 patent contemplated that the subcoating would be applied “by conventional coating procedures in a suitable coating pan or in a fluidized bed apparatus using water and/or conventional organic solvents for the coating solution” (p6). In Apotex’s product, in contrast, the putative subcoating was the end product of an in situ chemical reaction that occurs when the enteric coat is applied by Apotex to the pellet cores. The main issue at trial was claim construction: Apotex argued that the claims did not cover a subcoat which forms in situ. Barnes J rejected this argument as a matter of claim construction. (See my post on the FC decision for details.) This holding was affirmed on appeal.

But Apotex had another arrow in its quiver. The ‘693 patent did disclose how to make the claimed invention using conventional coating procedures, but it did not disclose how to make the claimed invention use the in situ process, for the simple reason that the in situ process was developed several years after the patent was issued [80]. Apotex argued that the disclosure was therefore insufficient [80], [81], relying on Teva (VIAGRA) 2012 SCC 60, and Biogen v Medeva [1996] UKHL 18, [1997] RPC 1.

Gauthier J easily distinguished Teva [80], but the Biogen discussion was more interesting. She distinguished Biogen as follows:

[81] [I]n [Biogen], the reason Lord Hoffman held that the disclosure was insufficient was because of the hybrid nature of the claim and the nature of the invention. In that case, the inventor could not claim a product because the DNA molecule (Dane particle) he had made was not new. He could not claim the process because the process itself was also known; thus, he had to draft the claim to describe the product he was trying to monopolize partly through the way it worked and partly through how it was made.

[82] As indicated above, the 693 Patent is a product claim describing the essential elements of the final structure of the product, thus the nature of the claims in the 693 Patent are not at all similar to the one dealt with in Biogen.

This is not entirely convincing. It is true that the nature of the claims is different, but that in itself does not provide a distinguishing principle. The claim at issue in Biogen was to “A recombinant DNA molecule characterized by a DNA sequence coding for a polypeptide or a fragment thereof displaying HBV antigen specificity. . .” There is no doubt that the disclosure did enable a skilled person to make such a DNA molecule (Biogen, 50), but Lord Hoffmann went on to say (51, my emphasis):

there is more than one way in which the breadth of a claim may exceed the technical contribution to the art embodied in the invention. The patent may claim results which it does not enable, such as making a wide class of products when it enables only one of those products and discloses no principle which would enable others to be made. Or it may claim every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which make no use of the invention.

It was on this second branch, now known as “Biogen insufficiency,” that the claim failed: “Its excessive breadth is due, not to the inability of the teaching to produce all the promised results, but to the fact that the same results could be produced by different means” (51-52). The defendant Medeva’s method used a different means to produce the same result (52).

With that said, I intend no criticism of Gauthier J in so distinguishing Biogen, because she was simply adopting Lord Hoffmann’s own subsequent explanation in Lundbeck CA aff’g [2008] EWCA Civ 311 aff’d [2009] UKHL 12, [2009] RPC 13, which she then went on to cite and discuss. In that case Lord Hoffmann said, in a passage quoted by Gauthier J [86, Gauthier J's emphasis]:

[27] In an ordinary product claim, the product is the invention. It is sufficiently enabled if the specification and common general knowledge enables the skilled person to make it. One method is enough.

Lord Justice Jacob agreed, in a passage also relied on by Gauthier J [89]:

[52] I turn to sufficiency. There is a very short answer to this point. The claim is to the (+) enantiomer. That is novel and non-obvious. If one asks the straightforward question "Does the patent enable the skilled man to make it?" the answer is an equally straightforward: "Yes."

Gauthier J is more than justified in adopting the explanation of Lord Hoffmann’s decision in Biogen provided by Lord Hoffmann himself. But I must say that I don’t find Lord Hoffmann’s distinction based on the form of the claim to be persuasive. The real point of Lord Hoffmann’s Biogen opinion, it seems to me, was to draw a distinction based on the inventive concept, or “technical contribution” as he called it. As stated in the passage quoted above, he was concerned that “the breadth of a claim may exceed the technical contribution to the art embodied in the invention,” and he focused on “the technical contribution to the art which [the inventor] made in 1978 and disclosed in [the patent application]” (51). He concluded by noting that the defendant’s methods “owe nothing” to the invention (52).

But if that is right, then “one method” of enabling the invention is not necessarily enough; it might be, or it might not be, depending on the nature of the inventive concept. Now, on the facts of this particular case, as I understand them, Apotex would have lost even on Biogen insufficiency, because the inventive contribution was not a method of depositing an inert subcoating, but the idea of using an inert subcoating, regardless of the method of deposition. But that conclusion would have required an investigation of the inventive concept, rather than merely an assessment of the nature of the claim.

As I see it, the problem with Biogen insufficiency is that it is not really a sufficiency objection at all, but rather an objection of overbreadth (see eg see Sandvik v Kennametal [2011] EWHC 3311 (Pat) Arnold J at [106]-[124] describing three types of insufficiency in modern UK law as being classical insufficiency, ambiguity and excessive breadth, with the latter corresponding to Biogen insufficiency). As the High Court of Australia perceptively noted in Lockwood (No 1) [2004] HCA 58, [67] the House of Lords' reasoning in Biogen boils down “to the following Voltairean aphorism: ‘Since the fair basis doctrine no longer exists, it is necessary to invent it.’” In Canada, the overbreadth objection is reflected in the principle that an inventor cannot claim more than he has invented: see eg Farbwerke Hoechst AG v. Commissioner of Patents, [1966] ExCR 91, 106; Radio Corp v Raytheon (1957) [1956-60] Ex CR 98, 117; Lovell Manufacturing Co v Beatty Bros (1962), 41 CPR 18, 66 (Ex Ct). The difficulty is that this principle, while very well established, does not have a clear basis in the Act. (The nearest thing is perhaps Rule 84, requiring that the claims be supported by the disclosure, but this is not a particularly clear statement of a prohibition on overbroad claims, and it is in any event discomfiting to have such a fundamental principle found only in the regulations, rather than the Act itself). Nonetheless, in my view, it is probably best to recognize overbreadth as an independent objection, rather than trying to shoehorn it into sufficiency, with the confusing fallout that we have seen from Biogen. So, in my view, the correct approach to sufficiency is indeed that articulated by Gauthier J, following Lord Hoffmann and Lord Justice Jacob in Lundbeck CA, but I would suggest it should apply regardless of the nature of the claim. This is not to say that Biogen is a dead letter, but rather than the problem it raised should be addressed, in Canadian law at least, as a matter of overbreadth.

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