Allergan fails to demonstrate to FC that Apotex’s allegations of invalidity are not justified

Allergan fails to demonstrate to FC that Apotex’s allegations of invalidity are not justified

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Allergan Inc v Apotex Inc, 2016 FC 344

Not adequately distinguishing between mere goals and promises of utility in the claims of a patent could spell out disaster for patentees.

In this Federal Court (“FC”) decision, Allergan Inc. (“Allergan”) sought an order pursuant to the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) prohibiting the Minister of Health (“the Minister”) from issuing a Notice of Compliance to Apotex Inc. (“Apotex”) for it’s gatifloxacin ophthalmic product until after the expiry of Canadian Patent No. 2,307,632 (“the ‘632 Patent”). [1] Entitled “Aqueous Liquid Pharmaceutical Composition,” the ‘632 Patent claims eye drops, ear drops or nasal drops containing gatifloxacin and disodium edetate (“EDTA”). [2]

Apotex alleged in its Notice of Allegation (“NOA”) and submissions that the ‘632 Patent was invalid because it was obvious and lacked utility. [7] The FC found that the allegation was justified. [8]

The Claims and the Evidence

The main Claim at issue in this decision was Claim 10, as it read on Claims 1, 2, 3 and 9. [5] These Claims read as follows:

  1. An aqueous liquid pharmaceutical composition which comprises Gatifloxacin or its salt and disodium edetate.
  2. The aqueous liquid pharmaceutical composition according to claim 1, wherein pH of the composition is within the range of 5 to 8.
  3. The aqueous liquid pharmaceutical composition according to claim 1 or 2, where the composition is in the form of eye drops.
  4. The aqueous liquid composition according to any one of claims 1 to 5, wherein Gatifloxacin or its pharmaceutically acceptable salt is contained in an amount of 0.1 to 1.0 w/v% and disodium edetate is contained in an amount of 0.001 to 0.2 w/v%.
  5. The aqueous liquid composition according to claim 9, wherein the amount of disodium edetate is 0.01 to 0.1 w/v%. [5]

In considering the evidence, the FC was satisfied that the evidence of one of Apotex’s expert witnesses was preferred and to be given more weight than other expert witnesses. [12] The FC was of this view because opinions of experts who had not seen the patent nor been exposed to the positions of the litigants ought to be given greater weight on issues going to obviousness and patent construction than experts who had full disclosure of the ‘632 Patent and knowledge of the positions of the parties. [13]

Obviousness

Allergan’s objection that Apotex’s experts took 49 references cited in the NOA without doing their own prior art search [20] was found to be without merit. [21] The FC agreed with Apotex’s expert that the 49 references accurately represented the common general knowledge of a person of skill in the art (“POSITA”). The FC held that the POSITA would have a fair and reasonable expectation that combining gatifloxacin with EDTA would produce an effective ophthalmic compound that would have the three advantages set out in the ‘632 Patent. [39]

Utility

The FC also agreed with the three advantages that Apotex’s expert described as promises, and which Allergan had submitted were merely goals:

The promised utility is clearly and unequivocally described in the 632 Patent.  The skilled person would understand that the patent explicitly states that the gatifloxacin and EDTA compositions of the invention are useful as follows:  to increased or raise corneal permeability of gatifloxacin compared to an aqueous solution that does not contain EDTA; to prevent precipitation of gatifloxacin crystals compared to an aqueous solution that does not contain EDTA; and to prevent colorization of gatifloxacin compared to an aqueous solution that does not contain EDTA. [46]

Furthermore, the FC found that the many compositions covered by Claim 10, coupled with the very limited testing performed by the inventors, Allergan’s expert had correctly conceded that the utility was neither demonstrated, [50] nor soundly predicted. [60]

Prohibition Order Dismissed

The FC found that Allergan failed to both establish the utility of ‘632 Patent [61] and to disprove the allegations of Apotex with respect to Claim 10 of the ‘632 Patent, specifically that it was obvious and lacked utility. [62]

The application was dismissed with costs. [62]

Commentary

This decision deals with what has come to be known as the so-called “promise doctrine.” The doctrine holds that if a patent promises a certain type of utility, but fails to deliver upon it, then that patent is void. This decision emphasizes  that a patentee should be careful to clearly distinguish objectives that are merely goals from promises of utility in a patent application, lest the patent is found void for lacking the utility it promised. It is unclear, however, what the distinguishing feature is between something that is a general objective and something that is a promise of utility, though one presumes it is a matter of context and purposive construction within a given fact situation. This means that Canadian patentees and patent practitioners alike will have to wait for the courts to provide guidance on this nuance.