AbbVie Biotechnology Ltd v Canada (Attorney General), 2014 FC 1251

The Federal Court reversed a decision by the Commissioner of Patents that refused claims 1-12 and 27-51 of Canadian Patent Application No. 2,385,745 (“the Application”), owned by AbbVie Biotechnology Ltd., for being directed to methods of medical treatment. [1] The core of the Commissioner’s argument was that Janssen Inc v Mylan Pharmaceuticals ULC, 2010 FC 1123, broadened the prohibition against patents on methods of medical treatment to include generally claims which restrict the “how and when” a physician could administer a particular drug, [108] and that the claims at issue to a fixed dosage regimen fall under the restriction. [23-24] Reviewing a long line of jurisprudence, the Court found that the Commissioner had misread Janssen. [65]

The Court found that the case law consistently held that the prohibition is against claims that restrict a professional’s skill or judgment. [114] This includes claims to dosage ranges, which it distinguishes from vendible products which are patentable, [61] but claims that include fixed dosages do not necessarily restrict the “how and when” a physician could administer a particular drug. The physician must exercise skill and judgment to determine if the claimed use is appropriate for the patient, but prescribing practices are not restricted. [121] If prescribed, there would be no restriction on the exercise of skill or judgment. [121] As such, the claims at issue were found to be properly towards a vendible product and do not restrict a physician’s skill or judgment. [115] The question was decided on a correctness standard since the issue was the Commissioner’s interpretation of the prohibition against methods of medical treatment, which is essentially a question of jurisprudence, [44] involved policy considerations, [47] and has significant precedential value. [46]

The Application claims the use of Humira, a known drug that is already patent-protected, [9] in a fixed dosage amount (40 mg) on a fixed schedule (bi-weekly). [10] The invention was already determined to be a new, useful, and nonobvious improvement. [51] The claims are not analysed in the decision, but independent claim 1 is provided for convenience:

1. A preloaded syringe comprising a syringe, 40 mg of an isolated human anti-TNFa antibody wherein said antibody

(a) comprises a light chain variable region (LCVR) comprising a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7; and

(b) comprises a heavy chain variable region (HCVR) comprising a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 8; and at least one pharmaceutically acceptable carrier, for treating an arthritic disease or an inflammatory bowel disease in a human subject, said preloaded syringe being

(i) adapted for subcutaneous administration of its contents to the human subject in need thereof and

(ii) for use on a continuous schedule having an every other week dosing interval of 14 days. [CD 1362 at 83]

The Standard of Review is Correctness

The appeal of the Commissioner’s decision was determined on a correctness standard. [36]

The Commissioner had asked for the reasonableness standard to apply, as it framed the issue as being whether the particular claims at issue were methods of medical treatment. [33] The Court, however, sided with AbbVie, who argued that the question was one of the Commissioner’s interpretation of the prohibition against patenting methods of medical treatment, which is a question of law. [26, 36] Furthermore, the question was primarily one of jurisprudence [44-45] and could have significant precedential value, [46] which pushes towards the correctness standard.

Conflicting Views on the Prohibition against Methods of Medical Treatment

The second issue, and the only substantive issue on appeal, was whether the Commissioner’s decision that the claims were directed to a method of medical treatment was correct.

The appellant AbbVie’s view was essentially that the prohibition is against claims which restrict professional skill, such as claims which include a range of activities within which a professional (not only a physician) operates. [57] Fixed dosages and precise scheduling regimes, however, do not involve the exercise of discretion or skill on the part of the professional, and thus should be admissible. [107] Janssen does not change the law merely because the claims at issue in that case were to a fixed dosage and precise scheduling regime. The claims at issue in that case were rejected because the physician’s judgment was restricted because the claims related to a titration regime, which itself involved the physician’s skill and judgment, and because the physician was expected to monitor and make adjustments. [63] AbbVie argued that the Commissioner must have misread Janssen. [65]

AbbVie also argued that the Commissioner may have been implementing a new policy, as set out in a CIPO Practice Guideline (which remains posted), based on its reading of Janssen, [67] but that the Commissioner does not have discretion to refuse a patent based on policy grounds. [68]

The Commissioner’s view, as the Court describes, was essentially that the prohibition is against any patenting of the “how and when” in the administration of a drug. This broader prohibition would target all claims to dosage regimens, whether they are fixed or fall within a range, or whether they involve some professional judgment or none at all. [108] It argued that skill and judgment is still exercised in using a fixed dosage amount and fixed schedule. [76] The Humira drug was already known, so the claimed 40 mg fixed dosage at the bi-weekly interval adds the “how and when” which “fences in” the prescribing practice. [74] Thus, the claimed invention is not patentable. [73]

The Federal Court Upholds Consistent Jurisprudence and Allows the Claims

The Court ultimately decided that Commissioner had erred in interpreting the case law and incorrectly rejected the Application. [125]

The Court reviewed a long line of jurisprudence in which claims to fixed dosages and dosage ranges were challenged as methods of medical treatment, [85-106] and concluded that the jurisprudence was consistent and that Janssen did not change the law. [114]

The rule is that a claim directed to the exercise of professional skill or judgment is not patentable. [114]  However, a physician may exercise their skill and judgment to decide whether the claimed invention should be used as claimed, but once that is determined, there may be no further need to exercise skill and judgment to vary the claimed way to use the invention. [110]

In the present case, the physician’s skill is not expected to be exercised within the claim. [121, emphasis added] The physician must exercise skill and judgment to determine if the claimed use is appropriate for the patient, but prescribing practices are not restricted. [121, emphasis added] If prescribed, there would be no restriction on the exercise of skill or judgment. [121] It would not be needed or expected because the fixed dosage does not require adjustments. [122]

The present claim is for a vendible product. [115] It does not restrict the physician’s choice or skill that would be relied on at the outside to determine whether that vendible product should or should not be prescribed. [115]

The Court determined that the Commissioner must have misread Janssen by overlooking its specific facts and agreed with AbbVie that the reason the claims in Janssen were rejected because the physician’s skill and judgment required for the titration. [116, 118] To the extent that the Commissioner was implementing a new policy direction on its reading of Janssen – if it did – it went too far. [125] The Commissioner has no discretion independent of the Patent Act to consider the public interest when granting or denying a patent. [126]

The Court was careful to note that just because a claim includes a fixed dosage regimen does not mean it is automatically patentable. [113] The evidence may indicate that such a fixed dosage regimen may require adjustments which require skill and judgment. [113] A physician’s skill or judgment is not only restricted only where dosage ranges are used. Also where the physician “would still be expected to be alert and responsive to a patient’s profile and to the patient’s reaction to the compound”. [118]

In the result, since the claims were already determined to be new, useful, and nonobvious, and there are no other issues on appeal, the Commissioner was directed to allow the claims at issue. [134-135]

Commentary

This decision affirms that the case law on the prohibition against patents on methods of medical treatment is consistent. The rule appears to be that any claim directed to the exercise of professional skill or judgment is not patentable. A claim to a dosage range would typically fall into this category since selecting a dosage from within the range would engage the physician’s skill and judgment. On the other hand, a claim to a specific dose could be performed without a physician’s skill or judgment. One should note, however, that a claim to a specific dose could still be prohibited if it restricts a physician’s skill and judgment in other ways. [118] Nevertheless, the claims at issue in this case did not meet any such prohibition.

One view of the Commissioner’s argument is that it is targeted towards how the prohibition should be interpreted, in order to give physicians the greatest freedom to treat the ill, rather than fitting the rule within the body of jurisprudence which the Federal Court has now affirmed to be consistent. However, the jurisprudence is binding, and the path that the jurisprudence has chosen to take is not to prohibit any claim that restricts a physician’s treatment, but only to prohibit claims which call upon on the physician’s skill or judgment. A broader statement of the rule based on policy grounds would be outside the Commissioner’s purview.

The Commissioner understandably may have felt justified in its interpretation of the law because of the peculiar way in which the prohibition against patenting dosage ranges is justified. Although it was not discussed in the case, the current statement of the law leads to the unsettling anomaly that a claim to the use of a 10-12mg dose of a particular drug would be unpatentable, but three separate claims to the use of a 10 mg dose, an 11 mg dose, and a 12 mg dose would be patentable – but would seem to restrict the physician in the same way. Accepting the Commissioner’s view of the law would have done away with this difference, rendering both sets of claims unpatentable.

There is different justification that courts could have used that would have been simpler and would not have been at odds with the Commissioner’s view. Consider if claims to dosage ranges were unpatentable not for the reason that they restrict a physician’s skill or judgment, but instead for the reason that such claims are ambiguous. A claim to a dosage range might not adequately uphold the “teaching” end of the patent bargain. It would then be an injustice to give a monopoly to the patentee if the patentee was largely piggybacking on the physician’s skill and judgment to ensure that the claimed invention works.

In this alternative scenario, the method of medical treatment prohibition would still carry weight, as it would still apply to medical techniques that draw on a physician’s skill or judgment such as surgical incisions, [92] but courts would not have to run the argument that administering a dosage from within a range invokes a physician’s skill or judgment, whereas administering a specific dose does not (at odds with the Commissioner’s view), and the anomaly that a claim to a 10-12mg dose is unpatentable while three claims to 10, 11, and 12mg doses are patentable, would have an answer.