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 using 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 JA 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 JA 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 JA [86, Gauthier JA'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 JA [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 JA 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 JA, 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.

Wednesday, January 18, 2017

Claim-First or Disclosure-First in Claim Construction?

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

As discussed here, Barnes J's decision at first instance, holding that AstraZeneca’s ‘693 patent to be valid and infringed, turned primarily on the facts. Unsurprisingly, the FCA has upheld Barnes J. The FCA decision is nonetheless interesting for its approach to claim construction, particularly in contrast with Locke J’s decision in Mediatube Corp v Bell Canada 2017 FC 6 (blogged here on the costs issue). That aspect of the decision is the focus of this post.

By way over overview, while Apotex raised a number of issues on appeal, the most important related to claim construction [27]. On that issue, Apotex acknowledged that Barnes J had correctly stated the applicable principles, but argued that he had misapplied them [31]. This argument was rejected by Gauthier J, essentially on the basis that it took passages from Barnes J’s decision out of context, and when read as a whole, it was evident that Barnes J had indeed applied the claim construction principles he had articulated (see eg [43]).

The FCA did vary Barnes J’s decision on a limitations period point, which was governed by s 39 of the Federal Courts Act, as this case was decided under the old Act [8]. Section 39 provides that the provincial limitations period applies in respect of any cause of action arising entirely in one province, and a general six year period is otherwise applicable. The FCA held that on the facts, Barnes J had wrongly applied the six year period to all the infringing acts, even though some of them might have arisen entirely in one province [124]. Rather than remanding, the FCA held that the difficult issue of assessing the limitation period applicable in respect of each act could be undertaken in the damages portion of this bifurcated trial [126]. The legal error is of little significance going forward, as s 55.01 of the current Patent Act provides for a general six year limitation period, regardless of where the cause of action arose.

Claim Construction

There is an ongoing debate in Canadian law as to whether recourse to the disclosure as an aid to construing the claims is always permissible, or is permissible only if the claims are ambiguous on their face. The latter position seems to stem from Procter & Gamble Co v Beecham Canada Ltd (1982) 61 CPR(2d) 1 (FCA) at 11, where the FCA reviewed the cases and summarized by saying:

in construing the claims in a patent recourse to the remainder of the specification is (a) permissible only to assist in understanding terms used in the claims; (b) unnecessary where the words of the claim are plain and unambiguous; and (c) improper to vary the scope or ambit of the claims.

(See also Dableh v. Ontario Hydro [1996] 3 FC 751 (FCA), repeating this.) Now, “unnecessary” does not mean “impermissible,” but in Mylan v Eli Lilly (CIALIS) 2016 FCA 119 [39] the FCA took that next step and held that “the judge erred in referring to the specification when construing the claims of the ‘377 patent. The rules of patent construction preclude reference to the specification when the claims are clear, and improper if reference varies the scope of the claims” [sic] (my emphasis). On the other hand, in Whirlpool 2000 SCC 67 Binnie J, for the Court, said that:

"[t]erms must be read in context, and it is therefore unsafe in many instances to conclude that a term is plain and unambiguous without a careful review of the specification". In my view, it was perfectly permissible for the trial judge to look at the rest of the specification, including the drawing, to understand what was meant by the word “vane” in the claims, but not to enlarge or contract the scope of the claim as written and thus understood.

In his recent decision in Mediatube Corp v Bell Canada 2017 FC 6 Locke J had a very careful analysis of this “tension” [37] in the jurisprudence. On that point he quoted and agreed with Zinn J’s discussion in Janssen-Ortho 2010 FC 42, [115-116], [119], including this paragraph:

[115] In my view, the whole of the specification (including the disclosure and the claims) may be examined to ascertain the nature of the invention. Where the words of the claims are plain and unambiguous and capable of only one interpretation by a person skilled in the art, recourse to the disclosure is unnecessary. This is not to say that the interpreter should not examine the disclosure. In my view, one should do so, but with caution. Recourse may be had to the disclosure for the purpose of confirming the interpretation arrived at from examining the claims alone or to disclose an ambiguity in the language of the claims that was not otherwise evident. However, the patentee cannot expand the monopoly specifically expressed in the claims by borrowing phrases from the disclosure and placing them into the language of the claims.

This threads the needle between the two approaches, though rightly favouring the SCC position that reference to the disclosure is permissible even when the claims are unambiguous. Nonetheless, Locke J was very careful to first read the words of the claims alone to determine whether they were ambiguous. He did have recourse to the specification in interpreting each disputed terms, but in almost every case, this was only after expressly concluding the claim alone was ambiguous. See eg his discussion of “audio/video signals,” concluding examination of the claim alone “certainly gives rise to enough ambiguity in this term to justify recourse to the disclosure in order to assist in understanding its scope” [49]. This implies that recourse to the disclosure, if not strictly impermissible, would not be “justified” absent the ambiguity. See similarly [58], [74], [81]. (The only exception was in considering the term “server,” where he adverted to the disclosure without expressly holding the claim was ambiguous on its own [66]).

Contrast Locke J’s analysis with Gauthier J’s approach in this case:

[41] As the issue of construction of the patent is to be reviewed on the correctness standard, I have performed my own analysis of the 693 Patent. I have thus considered, as proposed by Apotex, what the invention is by reading the full specification.

The first sentence is explicit that Gauthier J is performing her own analysis, which means the approach she takes would be also appropriate for a judge at first instance. The second sentence indicates that Gauthier J very first step in construing the claims is to read the disclosure, without a word as to whether there is any ambiguity in the claims themselves. She also stated (my emphasis) that

[48] It is trite law that a court will consider the disclosure when it construes the claims. I considered the disclosure as it may help to determine if the inventor gave a particular meaning to an expression or word in the claim by adopting a special lexicon. However, the disclosure cannot be used “to enlarge or contract the scope of the claim as written and thus understood” (Whirlpool at para. 52 in fine; see also Justice Rothstein’s comment in the seminal decision of Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 at para. 77 in fine, [2008] 3 S.C.R. 265).

This was not merely a statement of principle; Gauthier J’s analysis of the claims at hand began with a twelve paragraph discussion of the disclosure [49]-[60], before turning to the claims themselves.

The two approaches are not strictly inconsistent in principle, in that Locke J did acknowledge that it is permissible to look to the disclosure. Nonetheless, there is a striking contrast between Locke J’s claims-first approach and Gauthier J’s disclosure-first approach.

How can this tension be resolved? First, all of the cases agree on one fundamental principle: use of the disclosure is “improper to vary the scope or ambit of the claims,” and “improper if reference varies the scope of the claims”; “the patentee cannot expand the monopoly specifically expressed in the claims by borrowing phrases from the disclosure and placing them into the language of the claims”; “the disclosure cannot be used ‘to enlarge or contract the scope of the claim as written’”; and, from Sanofi [77] “Of course, it is not permissible to read the specification in order to construe the claims more narrowly or widely than the text will allow.” I am not aware of any case holding to the contrary.

In light of this principle, it is easy enough to see why recourse to the disclosure is unnecessary when the words of the claim are plain and unambiguous; it is unlikely to change anything. Even if reading the disclosure suggests a meaning that was inconsistent with the claims, the court would say, in effect, “I see what you should have said, but you didn’t say it, and I won’t redraft the claim for you.” If that’s right, whether one starts with the claims, or starts with the disclosure, should make no difference in the end. The point made by the SCC in Whirlpool is that there may be cases where the claims appear clear when read on their own, but the disclosure clarifies the true meaning. An example might be Catnic, where the word “vertical” in the claim might be taken to mean “90 degrees”, but reading the disclosure makes it apparent that it really means “sufficiently vertical to carry out the load bearing function.”* In that case, reading the disclosure changes our understanding of the claim, but does not read limitations from the disclosure into the claim. Rather the disclosure makes it apparent that the initial reading of the claim alone was wrong, because a word that appeared clear was in fact ambiguous. In such a case, it would be wrong to avoid recourse to the disclosure on the basis that the claims were unambiguous.

The really difficult case is when the claim says “up” and the disclosure defines “up” to mean “down.” I don’t have a ready answer for that case, except to say that would be a very poorly drafted patent. It would be better to address the such a case on its facts, in light of the underlying principles that claim defines the monopoly, but the skilled person reads the patent, rather than debating whether it is permissible or not to read the disclosure.

Finally, what about  the statement in CIALIS that "[t]he rules of patent construction preclude reference to the specification when the claims are clear," and also "as there was no ambiguity in the claims here, there could be no recourse to the specification" [43]? I acknowledge that these statements of principle are inconsistent with a disclosure-first approach, but there is no inconsistency on the facts, because in CIALIS the real problem was that the trial judge had indeed read in a limitation from the disclosure into the claim: see [40]. Thus the holding would have been the same on a disclosure-first approach

*This oversimplifies Catnic, where the claim construction at trial was not merely “a purely literal one derived from applying to it the kind of meticulous verbal analysis,” as suggested by the HL.

Monday, January 16, 2017

Methylphenidate Dosage Form Patent Valid and Infringed on the Facts

Janssen Inc v Actavis Pharma Company 2016 FC 1361 O’Reilly J
            2,264,852 / methylphenidate dosage form / CONCERTA / NOC

In this brief decision O’Reilly J granted Janssen’s application for an order prohibiting the Minister of Health from issuing an NOC to Actavis in respect of its generic version of CONCERTA, a drug used to threat ADHD [1]. Actavis’ invalidity and non-infringement arguments failed on the facts and on claim construction.

The active ingredient in CONCERTA is methylphenidate (“MP”), but the ‘852 patent does not cover MP itself, which was long used in the treatment of ADHD, particularly in the well-known drug Ritalin [7]. Rather, it covers a formulation which provides a “sustained-ascending dose over time,” for regulation of tolerance to MP. While Ritalin was widely prescribed, the original immediate release formulation had to be taken either two or three times a day, which led to compliance problems with school age children [8]. A subsequent slow-release formulation was puzzlingly ineffective, as it too worked only for a few hours. The insight which was the basis of the ‘852 patent is that the reason for the short duration of effectiveness, even for the slow release formulation, might be “acute tolerance,” where a patient becomes tolerant to a drug within a single dosing period [14]. This would explain the failure of the slow-release formulation; while the plasma concentration was stable over the dosing period, it became less effective because the patient developed tolerance over the same period. This hypothesis turned out to be correct [18]-[19]. This discovery led to the development of the ‘852 formulation, which provides a dosage that increases over time, so as to provide a stable response once balanced against the tolerance that would develop over the same period.

Actavis’ main invalidity attack was based on obviousness. Actavis argued that all the inventors had done was to confirm the hypothesis that the problem with slow-release Ritalin was acute tolerance to MP [44]. However, on the facts, while acute tolerance was one of the conceivable reasons for the problem, is was not at all obvious that it was actually the cause; indeed, most researchers at the time doubted that acute tolerance was the reason for the problems with slow-release Ritalin [47]. In light of this, the fact that it was easy to actually make a sustained-ascending dosage form is beside the point [48]. As was said long ago, in Canadian Gypsum [1931] Ex CR 180, 187, “[T]he inventive ingenuity necessary to support a valid patent may be found in the underlying idea, or in the practical application of that idea, or in both. It may happen that the idea or conception is a meritorious one, but that once suggested, its application is very simple,” but that is no bar to obtaining a patent.

On claim construction, Actavis argued that the phrase “sustained-ascending dose over time” meant “over an entire dosing period”. This was rejected by O’Reilly J, in favour of an interpretation that the dosage would have to rise for a sufficient duration to provide effective treatment over the dosage period [33]. This is different, given that the drug continues to be effective for at least a couple of hours after it stops releasing into the plasma [34].

While Actavis lost on claim construction, it had another non-infringement argument, namely that the release profile of its product was not good enough to make it effective at compensating for acute tolerance [57]. O’Reilly J rejected this argument on the facts, including the fact that Actavis’ product monograph confirmed both that the tablets will release MP at an ascending rate for 6 to 10 hours, and that the Actavis product was essentially equivalent to CONCERTA.

Friday, January 13, 2017

A Costs Cornucopia

Mediatube Corp v Bell Canada 2017 FC 6 Locke J
            2,339,447 / Internet Protocol Television / Fibe TV, FibreOp

In his decision, Locke J held that the plaintiff NorthVu’s ‘447 patent (Mediatube is the exclusive licensee), was valid but not infringed by Bell’s products. However, the infringement action fell apart halfway through the discovery process, if not sooner, with the result that the main thrust of the decision was more about allocation of costs rather than about patent infringement [7]. While no new principles of law were applied, the decision is important on costs simply because it is unusual to see so many requests for elevated costs considered, and several actually granted. This post focuses on a few of the more interesting costs issues. These turned generally on Rule 400(3) and particularly Rules 400(3)(i), which relates to conduct which tend to “unnecessarily lengthen the duration of the proceeding,” and (k) which relates to steps which are “improper, vexatious or unnecessary,” or “taken through negligence, mistake or excessive caution.” The overall message is that there will be costs consequences against a patentee for proceeding with a claim that it should have known was without merit.

Friday, January 6, 2017

No New Cases for the Week of 2 January

No new patent / NOC / data protection cases were released for the week of 2 January 2017.