Claims Involving the Skills of the Physician Fall under Method of Treatment Claims and therefore Unpatentable Subject Matter

In most of the Jurisdictions, claims related to method of treatment and allied human surgical processes are not patentable including Europe, Canada, India etc. Lots of debate is going on what actually the scope of these treatments, what areas come under treatment scope and how claims should be drafted to avoid objection of unpatentable subject matter.

Last month, Federal court-Canada handed down interesting decision in Novartis Vs Cobalt case. Federal court rejected the obviousness ground but dismissed the patent on basis of unpatentable subject matter asserted by Cobalt. This particular case is related to Zoledronic acid and product covered therein. Cobalt seeks approval by way of a Notice of Compliance from the Minister of Health to market a generic version of Novartis ACLASTA drug in Canada. Novartis brought an application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Company for its drug containing zoledronic acid until the expiry of Canadian Patent No. 2,410,201.

As to validity, Cobalt asserted mainly two grounds for the revocation of patent:

1. Obviousness; and

2. Is the subject matter ineligible for patent protection – is it a method of medical treatment?

I would summarize mainly on later part as court rejected the cobalt’s former allegation as to obviousness.

THE CLAIMS OF THE '201 PATENT 

The claims at issue - claims 1 to 36 - can be considered as being in different groups; each with a general claim, followed by more specific claims.

There are 5 types of claims in the Patent:

a. Claims 1-9 are Swiss-type claims, in that they relate to the use of ZA in the manufacture of a medicament;

b. Claims 10-18 are use claims, in that they relate to the use of ZA;

c. Claims 19-27 are claims to a compound (i.e. ZA);

d. Claims 28-36 are claims to a pharmaceutical composition containing ZA; and

e. Claims 37-39 are claims to a kit containing ZA.

Claim construction related to the claims 10 to 18 particularly, together with a rewritten claim 16 are considered to determine whether they fall under medical treatment claims or not?

Claim features were –

      Claim 10: -use of zoledronic acid

-to treat abnormal bone turnover

-intermittent administration of about at least one year

Claim 11: - administration about one year

Claim 12: - intravenous administration

Claim 13: - dosage from about 2 mg to about 10 mg

Claim 14: - dosage of about 5 mg

Claim 15: - condition is osteoporosis

Claim 16 - once-a-year administration intravenously, 5 mg dose, for osteoporosis

Main arguments were whether such claims were directed to a method of medical treatment or for a vendible product having real economic value. According to the previous case laws vendible product claims are patentable subject matter if they are directed to product having economic value.

But federal court rejected Novartis argument regarding vendible product claims and said these claims are actually directed to method of medical treatment because patent claiming a dosage range within which the physician is to exercise skill and judgment was not a vendible product; and thus, not patentable. Claims where actual involvement of physician comes are directed to treatment claims as it is the physician who has to apply his skills to decide the dose, dosage frequency, route of administration depending on the condition of patient.

The '201 patent specifically states that the mode of administration and dosage “may be selected by the attending physician taking into account the particulars of the patient, especially age, weight, life style, activity level, hormonal status (e.g. postmenopausal) and bone mineral density as appropriate”. (page 11, emphasis added)

Further at page 11, the '201 patent states that the “dose mentioned above is typically administered intermittently, with a period of at least 6 months between doses. The period between bisphosphonate administrations may be longer, e.g. conveniently once per year, once per 18 months, or once every 2 years, or even longer, or any period in between.”

Page 12 of the '201 patent describes dosages that depend on the potency of the bisphosphonates and that dosages may be administered in a divided manner, such as 4 mg one day, and a further 1 mg a few days later.

Finally court held that it is in reality, however contrived the wording of the claim may be, a method of medical treatment under Canadian law, unpatentable.

Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company et al., 2013 FC 985