Pankhuri Malik is an IPilogue Writer, IP Innovation Clinic Fellow, and an LLM Candidate at Osgoode Hall Law School.

On , the Federal Court of Appeal (“FCA”) the Federal Court’s decision, upholding the validity of two of Bristol-Myers Squibb (“BMS”) and Pfizer’s patents. The relevant patents concerned the active pharmaceutical ingredient Apixaban, used in thrombosis treatment. Apixaban is a selective inhibitor of the enzyme Factor Xa (“FXa”) which works by blocking certain blood-clotting proteins.

Through its lawsuit, and subsequent appeal, Pharmascience Inc. (“PMS”) challenged the validity of two of BMS’s patents, Canadian Patent Nos. 2,461,202 (“202”) and 2,791,171 (“171”) on different grounds.

The 202 patent describes the action of many FXa inhibitors, including Apixaban, in thrombosis treatment. This patent was challenged by citing BMS’s expired patent, Canadian Patent Number 2,349,330 (“330”) on the following grounds:

1. Lack of Status as a Selection Patent: Essentially, PMS alleged that the Federal Court did not identify the 202 patent as a selection patent and failed to appreciate that it does not disclose a special advantage over the 330 patent, which is essential for it to be recognized as a selection patent. The FCA, however, reaffirmed the lower court’s finding that a special advantage was disclosed by inference. FCA confirmed that Apixaban, under the 202 patent, was identified from the genus of compounds protected by the 330 patent because it was useful.
2. Anticipation and obviousness, falling within the broad ambit of double patenting: PMS also claimed that the 202 patent did not identify the inventive concept of the claims in issue. PMS claimed that since 202 does not disclose a special advantage, the patent is fatally flawed due to anticipation and obviousness. The FCA disagreed and reaffirmed Federal Court’s finding that apixaban’s inventive concept is that it is an effective FXa inhibitor useful in treatment of Thromboembolic disorders, as opposed to the 303 patent which only had the potential to be useful.
3. Insufficiency: Lastly, PMS challenged the 202 patent as Apixaban was not identified by the patentee at the date of publication of patent; PMS argued that this error constitutes insufficient of identification of the invention. The Court, however, disagreed PMS and held that the relevant specification for determination of sufficiency is the issued patent, and not the publicized patent.

The 171 patent relates directly Apixaban tablets’ formulation, particularly the particle size and dissolution rate of the medicine. The 171 patent describes the method of formulation such that it displays solution-like properties in the body, which optimize absorption.

The primary challenge was obviousness (as discussed ). The contention in this case pertained to a fifth additional component of the test, the “obvious to try” test. This component questions the validity of a patent on grounds that some inventions might be obvious to try due to their chemical structural similarity. PMS claimed that the Federal Court should have concluded that the claims in 171 are invalid because the invention was obvious to try.

However, FCA disagreed. The Court agreed with the lower court in that the formulations of the 171 patent are indeed inventive because a skilled person in the art would not have thought to reduce the particle size to improve absorption, or to target a lower dissolution rate. The FCA held that the lower court considered the correct and relevant factors in determining what would have been obvious to try to a person skilled in the art. The FCA confirmed that the lower court correctly held the patent valid.

Other jurisdictions

It is noteworthy that BMS and Pfizer’s patents for Apixaban have faced similar challenges outside of Canada as well. The companies have, so far, successfully enforced their patents in the . This Canadian decision adds another point to the companies’ win column.

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The validity of a patent can be challenged on the basis of double patenting. In , the Supreme Court noted that there were two branches of this doctrine. "Same invention"-type double patenting [4] asks whether the claims of the later patent are "identical or co-terminus" to an earlier patent, while "obviousness"-type double patenting asks whether a person skilled in the art would find the claims "patentably distinct". Earlier this year, two different federal court judges addressed allegations that Eli Lilly's was invalid due to double patenting of the invention in the earlier . ( [5] and [6]). While both justices ruled in favor of Eli Lilly, they disagreed on the “appropriate date” at which the common general knowledge of a person skilled in the art should be assessed in order to undertake an obviousness-type double patenting analysis.

Both the '377 patent and the '784 patent relate to the compound tadalafil, which is now marketed by Eli Lilly under the brand name CIALIS and used in the treatment of erectile dysfunction (ED). However, it was not always known that tadalafil had such interesting uses, and the compound was initially developed as a treatment for disorders such as hypertension. Both Justice Gleason (Apotex-Tadalafil) and Justice de Montigny (Mylan-Tadalafil) agreed on the construction of the relevant claims in the '377 Patent (a claim for one compound, tadalafil, as a PDE V inhibitor) and in the '784 Patent (a claim for tadalafil as a PDE V inhibitor to treat ED). PDE V is an enzyme which catalyzes a chemical reaction that consumes a chemical that is responsible for, among other things, maintaining an erection. Tadalafil blocks this enzyme from functioning and thereby prevents the loss of an erection.

If, as of the "appropriate date", a person skilled in the art would have known that a PDE V inhibitor could be used to treat ED, then the two inventions would not be patently distinct and the '784 patent would be invalid for obviousness-type double patenting. The Court therefore needed to answer the question of what "appropriate date" should be used in the assessment.

In Mylan-Tadalafil the judge held that the "appropriate date" was the priority date of the earlier patent (January 21, 1994). At this point the evidence showed that the skilled person, although aware of the role of PDE V in cardiovascular disorders, would not have known about its role in erectile dysfunction. De Montigny rejected the priority date of the later patent (July 14, 1995) as the "appropriate date" for two reasons. First, such an analysis would simply become a question of whether the second patent was [7] without the patentee being able to rely on the one-year applicant disclosure grace period.[8] Second, when considering "obviousness"-type double patenting, the question is whether the later patent "disclose[s] novelty or ingenuity" over the earlier patent. If it does, then a second patent is justified.

However, in Apotex-Tadalafil justice Gleason found there was a "sound argument" for the selection of the priority date of the second patent (July 14, 1995) as the "appropriate date". Choosing the later date would guard against a patentee abusing the between filing a patent application and it becoming available to the public. If the common general knowledge were to develop in such a way as to suggest an additional use for the patented compound (in conjunction with the confidential information in the patent application) the patentee would have the advantage of filing a second patent that would have been obvious had the 18 month delay not been in place.

In the end, the issue became moot as the only piece of prior art published between the two dates (the '902 application above) turned out not to be relevant. However, if the issue were to be decided, I find the reasoning of Justice de Montigny more compelling. While the scenario described by Justice Gleason could occur, the patentee would run the risk of a competitor independently discovering the information in the first patent and filing an application for the new use themselves.

[1] Pioneer Hi-Bred Ltd v Canada (Commissioner of Patents), [1989] 1 SCR 1623.
[2] Patent Act, RSC, 1985, c P-4 s. 42.
[3] Whirlpool Corp v Camco Inc, 2000 SCC 67 at para 63. [Whirlpool]
[4] Whirlpool, at paras 64-65.
[5] Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC, 2015 FC 17. [Mylan-Tadalafil]
[6] Eli Lilly Canada Inc v Apotex Inc, 2015 FC 875. [Apotex-Tadalafil]             
[7] Patent Act, RSC, 1985, c P-4 s. 28.3. For the Supreme Court of Canada's approach to the non-obviousness requirement for a patent see Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61.
[8] Patent Act, RSC, 1985, c P-4 s. 28.3(a). For a summary of the one-year grace period for applicant disclosure see .

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A recent case, , came through the US Court of Appeals, Federal Circuit, which highlighted potential conflicts between findings of validity that arise from re-examination on the one hand and an invalidity action on the other. This case appeared to be rather odd: the Federal Circuit confirmed the validity of certain patent claims in a matter in 1998, and then under subsequent re-examination, found that the same claims were invalid due to issues of obviousness 9 years later. The re-examination was appealed to the Federal Circuit.

On first glance, this is problematic: the same issues seem to be re-litigated, with a different result – was this simply the re-litigation of an issue that was already litigated to finality in prior judicial proceedings? Would this be a situation where the PTO overstepped its authority during the re-examination and ignored a final judgement of the Court? If so, should the principles of res judicata or abuse of process prevent the reconsideration of these issues?

For those of us unfamiliar with re-examination proceedings (they are seldom applied in Canada, but the more popular ex parte re-examination in the United States is very similar to the Canadian re-examination), re-examination is a relatively summary and expedient proceeding whereby a party files a request to the USPTO to re-examine an already-granted patent. The re-examination is limited in focus, only considering anticipation and obviousness challenges based upon published documentation, patents and patent applications that should have been considered during the initial examination of the patent prior to granting. This is in contrast to determinations of patent validity in full-blown court actions, where parties may challenge patent claims on a broader range of grounds, undergo discovery and the Court conducts hearings where the evidence is subject to examination and cross-examination. The majority decision was very short and is silent about the prior invalidity action and the potential for an issue of res judicata or abuse of process, upholding the finding by the Board of Patent Appeals and Interferences (BPAI) that the patent claims were obvious.

However, a fiery dissent was lodged by Newman J. who considered the case to be one where the principles of res judicata and issue preclusion should have prevented Powerscreen from requesting re-examination. In her dissent, she considered the various policy reasons involved: the public interest in finality, the conservation of scarce judicial resources, and the ability of an administrative agency to override a judicial adjudication.

These are all valid concerns – but let’s look carefully to see whether this situation should trigger these principles. Here, the same prior art is cited against the same patent, and the challenge is also on obviousness grounds. However, there is a key difference: The prior art, while considered previously, was applied in a different way than in the previous litigation in an obviousness challenge. In light of these circumstances, it may be interpreted as Newman J. proposing that, in the interests of finality, where prior art has been raised in prior proceedings, it should not be open to re-litigation. As Professer Vaver notes in his book, this line of thinking is similar to the current English rule and thus, similarly fails to take into consideration the countervailing public interest in intellectual property litigation.

As such, instead of applying a res judicata in this situation, it may be better to consider the abuse of process doctrine when determining when an issue is open to reconsideration. The abuse of process doctrine is, similar to res judicata, designed to provide finality in litigation and is a broader remedy where a court will preclude re-consideration of an issue where not only is there re-litigation but also an additional serious element where it is shown that the process which is to serve justice is being abused to work an injustice.

In this scenario, there is a strong public interest in ensuring that patentees are not granted exclusive rights against the public where their patent claims were either obvious or anticipated. If we accept the reasoning in Newman J.’s dissent, in the interests of finality, the patent system could reward unworthy claimants and penalize defendants who did not or could not exhaustively investigate their assertions. As such, while Newman J. does have some strong policy concerns, a more nuanced approach should be taken rather than instituting a complete bar on re-litigating on already-considered prior art.

There are certain situations where the courts should refuse to re-litigate, but these should only apply where there is a clear abuse of process, for example, where the parties are attempting to re-litigate on exactly the same issues, with arguments that do not provide any more merit than those already argued. While this may open the doors to some overlapping arguments in litigation, a less mechanistic approach to re-litigation would nonetheless help ensure that strong invalidity arguments are not unnecessarily barred simply because the prior art had already been considered in another light. Given the facts of this case, it appears that the balance is in favour of re-considering these issues.

Details of the Case

The original invalidity action and subsequent re-examination proceedings concerned US patent 5,234,564, a patent owned by the Construction Equipment Company (CEC) concerning a vehicle for screening rocks and plant matter (among other things).

In 1998, CEC sued Powerscreen for infringement. The Federal Circuit court confirmed the validity and corresponding willful infringement of certain claims in the ‘564 patent.

In 2007, a third party requester (possibly Powerscreen) requested an ex parte re-examination of the ‘564 patent, raising questions of patentability based upon previously considered prior art from the 1998 decision, applying the prior art in a different way than was alleged in 1998 (citing the same references and additional references, but placing strongest reliance on the same references that had been cited in the litigation). The PTO began a re-examination, finding that the request raised a substantial new question and in spite of amendments and submissions by CEC, the examiner rejected all the claims as obvious. CEC then appealed to the BPAI, who upheld the decision of the PTO. CEC then appealed to the Federal Circuit.

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The suit concerned a patent held by over a crystalline cefdinir (a broad-spectrum antibiotic) marketed under the name “Omnicef.” Abbott Laboratories argued that claims 2 through 5 of its patent (US Patent No. 4,935,507) should not have characterized the product-by-process claims as requiring performance of all of the process steps in order to find infringement of the patent. Claims 2 through 5 are as follows:

2.  Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by acidifying a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) at room temperature or under warming.

3.  Crystalline substance of claim 2, wherein a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) is an aqueous solution of an alkali metal salt of said compound.

4.  Crystalline substance of claim 3, wherein the acidifying of the solution is carried out at the temperature from room temperature to 40°C. at the pH from 1 to 4.

5.  Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by dissolving 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) in an alcohol, continuing to stir the solution slowly under warming, then cooling the solution to room temperature and allowing the solution to stand.

Essentially, Abbott argued that the above “process” claims should not have been interpreted to mean that these chemical steps need to be performed for infringement to occur, but rather the fact that the compound possesses these chemical properties – that is, the ability of the compound to crystallize out of the specifically named acidified solution, for example – is evidence of infringement. The court cited different courts of appeal in the United States, including the 3^rd Circuit in the case , “A patent granted on a product claim described one process grants no monopoly as to identical products manufactured by a different process." was also cited: “Unless it is shown that the process of [the patent] was followed to produce the defendant’s article, or unless it is shown that the article could not be produced by any other process, the defendant’s article cannot be identified as the product of the process of [the patent].” The court expressly overruled Scripps Clinic and concluded:

In sum, it is both unnecessary and logically unsound to create a rule that the process limitations of a product-by-process claim should not be enforced in some exceptional instance when the structure of the claimed product is unknown and the product can be defined only by reference to a process by which it can be made. Such a rule would expand the protection of the patent beyond the subject matter that the inventor has particularly point[ed] out and distinctly claim[ed].

The dissent by Judge Newman, who was in the majority for the Scripps decision, stated that Abbott Laboratories violated the well-accepted notion that patent claims are to be interpreted the same way for both validity and infringement cases. Abbott Laboratories essentially states that patent validity cases must prove both the process and product, whereas infringement cases now only have to prove the process was violated. Judge Newman states, “According to the majority, a patentee can continue to obtain a product claim using process descriptors, but such product claims are treated as process claims for infringement.”

The majority does not seem concerned with this apparent contradiction: “For this reason, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.” This idea is referenced in the (MPEP), which states that “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps,” which seems to coincide with Abbott’s argument regarding claims 2 through 5. However, as Judge Newman pointed out, the fact that the majority did not find infringement in this case clearly shows that there are different standards for patent applications and for infringement.

The distinction that Abbott Laboratories creates between validity and infringement may not pose a problem for many patent infringement cases, but it may create problems for manufacturers of complex chemicals and pharmaceuticals which can only be described through product-by-process claims. If a patent applicant cannot describe an innovation under the rules for “pure” product claims, should the applicant suffer the (potential) consequences?  One of the problems with describing many chemical mixtures such as in the case at hand by their "properties" is that the properties in actuality are products-by-process.

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