First Canadian Antibody Decision of Federal Court Significant for What It Does Not Say

It has been 15 years since the last brand v brand challenge of a biologic patent in Canada. In 2000, Amgen’s recombinant EPO patent (for EPREX, which stimulates red blood cells to treat anaemia) was found valid and infringed by Hoffman’s RECORMON product.[1] In January 2014 the Federal Court once again upheld the validity of certain claims of Abbott’s psoriasis antibody patent that were challenged by Janssen[2].

The Abbott v Janssen decision (“Decision”) provides a somewhat typical patent validity analysis. Mr. Justice Hughes favoured certain Abbott experts who found that Abbott’s discovery of a “very sticky” antibody that bound to interleukin 12 (a protein involved in the immune system) was a “transformative moment”. The discovery provided “a proof of concept” that such an antibody is indeed useful to treat psoriasis. The court found the two claims in issue were not obvious. It was not self-evident to find an antibody “that actually worked and cured a disease” – this was a rare “lucky hit”.

The court characterized claims broader as “the most substantial issue in this case. … The issue has been couched in many ways by Counsel during argument; including utility, sound prediction, overbreadth, sufficiency and ambiguity”. The court quickly found it was acceptable to claim any antibody (having any structure, as made in any way), having regard to (1) the “great detail” provided in the patent to make one antibody, and (2) that neutralization of interleukin 12 (which was claimed) was the critical parameter. Abbott’s evidence was that a person skilled in the art was “well aware that antibodies did not need to be identical to bind to the same cytokine or treat the same disease”. The court concluded that Janssen has “not satisfied me that there are parameters beyond those set out in claims 143 and 222 that are essential for the functioning of the antibody to treat psoriasis.”

Notable Points From Decision

On the substantive side, there are a few interesting points:

• The court recognized there was “marginal” relevance that Janssen had independently developed its STELARA product. If anything the earlier isolation of its product indicates that Janssen should have filed a patent earlier (the court did not comment on this latter point).
• The timing of Abbott’s development clearly showed the critical “Example 9 patient test” in the patent was only added after the priority date, and before the filing date. It was “recorded that, by luck, one of the persons being clinically studied was given the [antibody]… called J695 and was, in so doing, treated for psoriasis. Some patent agent, presumably, was astute enough to record this event as Example 9 in the patent application filed”. The Decision provides another illustrative example of the problem with evaluating sufficiency as of the filing date (when Abbott had actually added its Example 9), and yet obviousness is evaluated as of the priority date (when the inventors themselves only could have hoped that its antibody would treat psoriasis) (para. 133. 135-136).

On the procedural side, there are also a few significant points:

• Perhaps in recognition of the highly complex area of antibody development (there were 22 listed inventors), the parties jointly provided the court with a 1 hour DVD lecture and diagrams. Although this was not evidence at trial, Justice Hughes stated the talk provided background information and vocabulary which “greatly assisted” the court.
• On claims broader, following a review of Canadian case law, the court found the functional claim parameters were “readily understandable” by a skilled person and there was no indication that those parameters would not treat psoriasis. The court requested submissions on foreign jurisprudence. Mr. Justice Hughes commented briefly on the US approach to determine “whether the patent simply presented a problem to be solved and not a solution”. A review of recent trends in UK jurisprudence followed, where there was a focus on the nature of the invention – and whether it was “an invention of broad application”. In finding the UK approach, like Canada’s, was to consider a patent on “a case-by-case” basis, the court concluded there was no universal rule that by disclosing only one antibody “you cannot claim all that will do the particular trick that you have in mind”.
• Only 2 claims (out of 223 claims) were asserted by Abbott, and at trial Janssen agreed to restrict its invalidity challenge to these 2 claims. As such, the validity finding was only “as between the parties”. (As to why Janssen would concede the validity of the other 221 claims is unclear; and may reflect the complexity of these types of biologic patents, or some unstated agreement by the parties.)
• Although the case dealt with Abbott’s patent, in fact Abbott does not have an applicable product approved in the US or Canada. Abbott’s ABT-874 Ozespa briakinumab was also withdrawn in Europe.
• According to an earlier “very broad order” obtained by Janssen, several matters had been bifurcated in the action, leaving only validity and infringement to be decided by Justice Hughes. Damages or profits were bifurcated (as is often the case). In addition, Abbott’s entitlement to an injunction was to be determined at a second trial (which is unusual and may be related to Abbott not working its invention). As a result, the Judgment only provides that either party may apply for a second trial for the bifurcated issues. (On the injunction issue, the Prothonotary’s recent written directions as to scheduling and hearing Abbott’s motion for a post trial injunction in May 2014 were recently “converted” to an Order and appealed by Janssen to be heard by Justice Hughes.) Abbott has also requested a trial date for damages.
• The parties had originally adjourned their Canadian case for over a year pending the corresponding US case. Justice Hughes briefly commented on the existence of US decisions that were under appeal, and simply stated they were not taken into consideration in his decision. In the US jury trial, Centocor (related to Janssen) only argued invalidity. The jury found the impugned claims were invalid based on written description, enablement, and obviousness. Abbott’s motion to overturn the jury verdict was denied in March 2013. In the Canadian case, Janssen also essentially conceded at trial that its product infringed if the claims were construed to cover antibody made by any method. Janssen did not conduct any tests of its own product and failed to cross-examine one of Abbott’s experts who conducted tests (despite having sought Letters Rogatory, which the court was critical of). Instead Janssen only challenged the methodology of Abbott’s tests.
• The court made the unusual decision of granting no costs to Abbott. The Decision stated that the parties engaged in various unnecessary steps and failed to properly narrow the issues with the use of Case Management. The court concluded “We expect better.”

Biologic Litigation in Canada

Abbott v Janssen is significant as the first Canadian case dealing with the validity of an antibody patent in Canada. (Previously the Patent Appeal Board had frequently commented on the absence of any Canadian jurisprudence.)

The Decision is both a continuation of the Janssen/Abbott biologic battle, and a good example of the “blurring” lines between brand and generic in biologic litigation.

Janssen has its own antibody patents that it has asserted against Abbott. Its US arthritis antibody patent (infliximab/ REMICADE) was invalidated in the US in 2011 where the USCA found Janssen’s patent was simply a “wish or plan” to obtain the claimed special/specific antibody. Centocor’s expert said the antibody-antigen relationship is like “a key in a lock”, but accepted the special human/human antibody required finding “a ring with a million keys on it.” The initial jury award in the lower court of $1.67 billion damages against Abbott (including a finding of wilful infringement) underscores the value of the biologic market.

Whether there will be a “trend” of antibody patents being upheld in Canada and found insufficient in the US remains to be seen. Of course, direct comparisons are difficult – judges consistently comment on the difference in evidence and law as between different jurisdictions.

There are two other pending biologic cases in Canada:

(1) Teva’s filgrastim Subsequent Biologic Entry (“SEB”) case against Amgen was discontinued on consent in August 2013 (the parties had earlier settled in the US). Apotex’s case is proceeding, with an October 2015 hearing. (Apotex has agreed to an extension of over 1 year past the statutory 24 month limit for SEB NOC cases.) Apotex relies on hundreds of prior art documents. Several other generics are expected to have filed SEBs for filgrastim (recombinant proteins for stimulating the immune system/white blood cell production).

(2) Hospira has brought an impeachment action and a declaration of non-infringement against an infliximab patent (which is listed in respect of Janssen’s REMICADE). CA 2261630 was only recently granted (in December 2012).

At the same time, in January 2014 two Celltrion (Hospira) SEBs relying on REMICADE were approved in Canada (another significant development given these are only the 2nd and 3rd approved SEBs in Canada). There were no patents listed against REMICADE between March and December 2012 (Janssen’s basic patent (CA 2,106,299) and divisional (CA 2,324,853) expired March 18, 2012). It will be interesting to see whether Janssen asserts any of its many TNF related patents against Hospira’s two new SEBs (in addition to CA 630 that Hospira is currently trying to impeach).