Federal Court clarifies validity and evidence-related legal principles, and declines to grant injunction for infringed patent in HUMIRA decision

In this review, we summarize key points from the Federal Court's lengthy decision in AbbVie Corporation and Abbvie Biotechnology Ltd v JAMP Pharma Corporation, 2023 FC 1520 ("HUMIRA").

JAMP Pharma Corporation's ("JAMP")'s SIMLANDI biosimilar relates to AbbVie Corporation and Abbvie Biotechnology's ("AbbVie") HUMIRA biologic, the monoclonal antibody ("mAb") adalimumab, for treating autoimmune diseases. Examples of targeted diseases include rheumatoid arthritis, inflammatory bowel disease ("IBD") such as Crohn's disease, and ulcerative colitis and dermatological conditions such as hidradenitis suppurativa ("HS").

AbbVie's three HUMIRA patents in dispute were CA 2,504,868 (the "868 Patent"); CA 2,801,917 (the "917 Patent"); and CA No 2,904,458 (the "458 Patent"). The Court disposed only of the impeachment actions pursuant to section 60 of the Patent Act, and did not address the infringement actions pursuant to section 6 of the PM(NOC) Regulations, as there is a pending appeal of a related judicial review before the Federal Court of Appeal.^[1]

The 868 and 917 Patents disclose multi-variable dosing methods for treating TNF-α disorders, including Crohn's disease and ulcerative colitis (868 Patent), and HS (917 Patent). JAMP challenged the 868 and 917 Patents for obviousness, and lack of patentable subject matter (as a method of medical treatment). It also challenged the 917 Patent for anticipation, and for containing a claim that cannot be reasonably inferred from the specification and drawings, pursuant to 38.2(2) of the Patent Act.

JAMP challenged the 458 Patent, which discloses protein formulation, protein stability, and the shelf-life of proteins, for anticipation, obviousness, overbreadth and obviousness-type double patenting.

The Court invalidated both the 868 and 917 Patents for obviousness, and declared the 458 Patent valid. In its validity analyses, which came down to "legal conceptual differences," the Court made some valuable legal clarifications which we discuss below. Notably, the Court did not grant AbbVie a permanent injunction against JAMP, despite JAMP conceding to infringement of the 458 Patent. The Court found that the public interest in forced bioswitching to another (less ideal) biosimilar is indeed a valid reason not to grant a permanent injunction for infringing a patent.  

A dosing range can be anticipatory of a specific dose, but it depends on the evidence

Anticipation law, with respect to the 917 Patent, was "central to this dispute." The parties disagreed on whether prior art which leaves open choices for the skilled person, or which broadly encompasses the claimed invention, is sufficient to invalidate the patents based on anticipation.^[2] The Court specifically addressed whether prior art that discloses a dosing range (e.g. 0.2-400 mg) can anticipate a point within a range or embodiment (e.g. 10 mg) or a narrower range (e.g. 0.10-100 mg).

The Court accepted a "middle ground" position which relied on, inter alia, Justice Rennie's analysis in Apotex Inc v Shire LLC, 2021 FCA 52 ("Shire")^[3] with respect to selection patents: "ranges do not necessarily anticipate points. But they may ."^[4] As such, the Court determined that the application of the law in this context will depend on the facts. Whether the inventor "planted a flag" at the compound is " driven by the specific evidence in each case ."^[5] Namely:

[W]here the evidence presented at trial shows that the range is narrow enough, such that a flag can be planted based on the context and examples given, then it is anticipated. If the evidence shows a very broad range that the Judge, with the experts' assistance (if needed), does not see it as a precise enough to plant the flag before proceeding to the enablement stage, then it fails at the disclosure stage.^[6]

With respect to the 917 Patent, the Court found that there is no teaching in the prior art that would direct the POSITA to arrive at the specific dosing regimen. The asserted claims of the 458 Patent were also not anticipated, as the adalimumab concentration range (20-150 mg/mL) in the prior art did not "plant a flag at the specific concentration of 100 mg/mL, especially where specific examples of formulations given do not include the relevant protein."^[7] Furthermore, the preferred pH range of 4-5.5 in the prior art was a broad range based on the evidence, and therefore not anticipatory of the specific pH of adalimumab disclosed in the 458 Patent.^[8]

With respect to enablement of the 458 Patent claims, the Court found that based on the "sheer number of proteins disclosed, it is not clear that a POSITA would know to select adalimumab" and that adalimumab has "self-buffering capacity at a concentration of 100 mg/mL and a pH of 5.2."^[9] The same types of conclusions were drawn with respect to the conductivity of adalimumab.^[10]

Claim term not described is a proper basis of invalidity in Canada

The Court affirmed that subsection 38.2(2) is not to be narrowly interpreted and can serve as an independent ground of invalidity, even if it is considered a procedural requirement under the Patent Act. The Federal Court and FCA both previously relied on procedural requirements in the Patent Act and Patent Rules, SOR/96-423 ("Patent Rules") to invalidate patents. For example, the FCA in Dutch Industries Ltd v Canada (Commissioner of Patents), 2003 FCA 121 ("Dutch") upheld the invalidation of a patent application because of the failure of to pay patent application maintenance fees. The Court also recognized the fundamental unfairness in expanding an applicant's monopoly that originally filed by allowing "an applicant to successfully broaden or enlarge the patent through amendment to specifications or drawings."^[11]

Despite the Patent Act not containing independent statutory ground of revocation, the Court also drew similarities between the purposes of subsection 76(3) of the UK's Patents Act 1977 (UK), 1977, c 37 and subsection 38.2(2) of the Patent Act, concluding that these operate similarly in that they both "stop patentees from inserting information after filing which enlarges or changes the scope of the claims from when originally filed.^"[12]

Physicians deviating from claimed dosing regimens does not make claims unpatentable

JAMP challenged both the 868 and 917 Patents for lacking patentable subject-matter on the basis that the asserted claims were methods of medical treatment.^[13] JAMP asserted that where there is evidence that the dose would be changed over time in response to a patient's needs, this requires the exercise of a physician's skill and judgement. The Court rejected this argument and applied AbbVie's reasoning that followed Janssen Inc v Pharmascience Inc, 2022 FC 1218, such that the relevant question to ask is whether the "invention as claimed" requires professional skill and judgement to practice.^[14] If a treating physician was to stop treatment or deviate from the claimed regimen that "takes the conduct outside of the scope of the patents" and does not make the claims unpatentable.^[15]

Double patenting allegation saved by dedication to the public

AbbVie's dedication to the public appears to have saved the 458 Patent on the double patenting grounds. JAMP alleged that AbbVie's Canadian Patent No 2,815,687 ("689 Patent"), and its dependent claims share the same inventive concept and essential elements as the 458 Patent, and as a result, there is no inventive ingenuity.^[16] AbbVie argued that a later filed patent cannot be used to invalidate an earlier filed patent on the basis of double patenting, and that in any event, it dedicated the 689 Patent to the public two months before trial.^[17]

Going back to first principles, the Court affirmed that double patenting is a means to "prevent patentees from securing more advantage than they are entitled to from their inventions"; in effect, the purpose is to prevent "evergreening." As was established in Bayer Inc v Cobalt Pharmaceuticals Company, 2013 FC 1061, aff'd 2015 FCA 116, a consequence of the evergreen problem is that a later expiring patent can be invalidated in light of an earlier expiring one, but the earlier expiring patent cannot be invalidated in light of the later expiring one.^[18]

Ultimately, since the 689 Patent was filed after the 485 Patent (and would expire later), but AbbVie subsequently dedicated the 689 Patent to the public, the 485 Patent did not extend AbbVie's monopoly on the subject matter disclosed in the 689 Patent, and "there would be no evergreen problem." However, the Court cautioned that were the filing dates reversed, the dedication would not necessarily save the 485 Patent from a double patenting analysi^s.[19]

The Court also considered the unfairness of the additional advantages of dedicating patents to the public, and the potential unfairness pursuant of patentees using the 24-month stay under the PM(NOC) Regulations with each additional patent listed under a relevant drug once an Notice of Allegation is filed.

JAMP vaguely argued that the presence of the 689 Patent on the Register "was an attempt 'to require biosimilars to address both patents under the PM(NOC) Regulations."^[20] The Court seemed to entertain this argument, but without a "clearer description of the actual unfair advantage conferred by the double patenting," it was insufficient to establish that AbbVie's dedication has extended its monopoly in time.^[21]

No permanent injunction granted for public interest in non-medical, potentially harmful, bio-switching

Despite conceding infringement of the valid 458 Patent, JAMP argued that, inter alia, the public interest would be disserved if SIMLANDI was removed from the Canadian market, as it is the only citrate-free, lower volume 80 mg/0.8 mL formulation of adalimumab. As such, patients would likely need to switch to a biosimilar with a higher injection volume and possible citrate, which has been shown to increase injection site pain in some patients ("ISP").

AbbVie pointed out it sells adalimumab for the treatment of IBD and HS in Canada, and sells its 100 mg/mL concentration citrate-free formulation for pediatric patients, and that generally SIMLANDI is not better or preferable to other adalimumab biosimilars. AbbVie argued that "JAMP's harm theory is not scientifically supported, as there is no evidence that patients will be harmed if they no longer have access to SIMLANDI.^"[22]

Nonetheless, the Court accepted JAMP's expert evidence that non-medical switching could negatively impact patients through the "nocebo effect," and can result in actual harm to patients because of the patients' perception of increased ISP. Some limited evidence was brought that an ISP can affect a patient's quality of life, as well as their adherence to a prescription.^[23] While the Court recognized that the risk is low to any patients forced to switch to another biosimilar, it nevertheless found the low risk was in the public interest, and a reasonable running royalty on future sales of SIMLANDI for any loss can compensate AbbVie.^[24]

Non-blinded expert statement and fact witness statement copying both reduce credibility

While the Court generally found the expert witness to be high calibre, some notable credibility issues were addressed. JAMP's pharmaceutical scientist expert claimed that she had not reviewed the claims of the 868 Patent or dosing regimen before providing her opinion. However, it became evident during cross-examination that she was indeed aware of the dosing regimen when she was an expert in a US proceeding against AbbVie for the same patent. AbbVie argued that this is a massive failing that destroyed the value of her evidence, as the premise was for her to blind create the dosing regimens in her simple PK models^.[25]

While the Court was skeptical with respect to blinding witnesses, the expert's evidence was still reliable for the reasoning and the substance of the opinion on PK/PD modelling of the 868 Patent, despite the Court agreeing with AbbVie that the failure of the expert to remember that she gave evidence on the same patent did "cause some pause for concern."^[26]

Notably, the Court affirmed that the principles from dTechs EPM Ltd v British Columbia Hydro and Power Authority, 2023 FCA 115 ("dTechs") also apply to fact witness statements. During cross-examination, the fact witness provided a "nearly identical" or "word-for-word the same witness statement"^[27] as an expert report from a litigation in the US. The similarity between the fact witness's statement and previous expert report was "well beyond the appropriate limits" of previous involvement,^[28] and "[while] this is not, in and of itself, hugely problematic, his responses on cross-examination reduced his credibility."^[29]