Novartis Pharmaceuticals Canada Inc. v Cobalt Pharmaceuticals Company [2013 FC 985]
Affirmed on Appeal [2014 FCA 17]
Background
This is an application under the NOC regulations relating to Patent 2,410,201. Generally the patent is for a semi-annual or annual dosage schedule for bisphosphonates. The most preferred bisphosphonate for semi-annual or annual dosages is zoledronic acid.
There are five types of claims contained in the patent:
- Swiss-type claims – they relate to the use of zoledronate to manufacture a medicament
- Use claims of zoledronate
- Claims to a compound (zoledronate)
- Claims to a pharmaceutical composition containing zoledronate
- Claims to a kit containing zoledronate
Novartis sought a prohibition order to keep Cobalt off of the market. The issues at trial were Obviousness, and whether the patent was valid due to ineligible subject matter (is it a claim for a method of medical treatment). A third issue that arose was whether the patent could be listed under the NOC Regulations.
Several studies are included in Examples one to five of the patent culminating in a Zoledronate specific study that indicates efficacy when a person is given a dosage every six to twelve months.
Insufficiency and Utility
Since Cobalt did not challenge the ‘201 patent for insufficiency or lack of utility it is presumed that on these issues Novartis would succeed.[32]
Obviousness
Obviousness is addressed from the perspective of the person of skill in the art. If the public does not receive a new invention in exchange for the granting of a monopoly then the public has paid something for nothing. This is the foundation of the patent bargain.
The person of skill is either a medical doctor who treats patients with abnormal bone mechanism disorders or bone disorders or a person with experience in chemistry, biopharmaceuticals and experience designing and interpreting chemical trials with knowledge of osteoporosis. Both were accepted as interchangeable at trial.
The common general knowledge at the time is construed by examining what the person of skill at the time would have obtained by a reasonably diligent search. [66] The Court then went on to apply the ‘Obvious to Try’ test.
The utilization of a less frequent dosage regimen was not self-evident. The dosing annually was not something that was tried or even expected to work. The process was costly and time consuming. It does not follow that because the means were available that they were obvious.[67] Consequently claims 7, 16, 25 and 34 of the ‘201 patent were not obvious.
Statutory Subject Matter
Patent protection is not available where the subject matter is directed to the skill of a professional, such as surgical procedures. Protection is available for vendible products in the area of medical treatment such as new substances to be used to treat disease or old substances that unexpectedly treat another disease.[78] Claims such as substance X for the treatment of Y or substance X in the form Y for the treatment of Z are all patentable subject matter.[91]
Improper subject matter includes:
The closure of a surgical incision by using adhesive X
The use of substance X in a dosage range between A and B for the treatment of X[93]
Every claim of the ‘201 patent includes directions that the substance is to be used to treat bone conditions. In the present circumstance the court should disregard the artificial nature of a Swiss claim and look at what the real subject matter of the claim is.[101] Here the invention is the recognition that zoledronate can be administered infrequently (ie. annually) and still provide effective treatment. It is, regardless of how contrived the wording may be, a method of medical treatment. It is therefore not patentable subject matter.[101]
The Court took great care to distinguish the present case from that of Shell Oil.
Qualifying for NOC listing
Novartis argued that the ‘201 patent does not contain a claim for use of a medicinal ingredient. The use claims (claims 10 – 18) fit squarely within the definition of a claim for the use of a medicinal ingredient.[106]
The proper procedure for challenging a listing is not by a ‘white knight’ seeking to cleanse a listing under the NOC Regulations.[107] Cobalt’s argument was dismissed.
Commentary
In some respects, this case is helpful since it provides clear examples of what the Court considers to be patentable subject matter. Marketable treatment claims such as X for the treatment of Y or X in dosage form Y for the treatment of Z are both acceptable method claims. Where the subject matter is directed to the skill of a professional it is not patentable. While the distinction may seem arbitrary the intention is to prevent medical procedures from being patented. On the other hand engineers are long considered professionals and one wonders how many mechanical patents are likewise invalid since the subject matter of those patents may well be considered directed to the professional skill of an engineer.