Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd &
Ors  HCA 50
The High Court of Australia yesterday issued its long awaited
decision in a dispute between Apotex Pty Ltd (Apotex) and
Sanofi-Aventis Australia Pty Ltd and related entities
(collectively, Sanofi) concerning Sanofi's Australian patent
no. 670491 entitled "Pharmaceutical for the treatment of skin
disorders" (Patent). In summary:
The majority (French CJ, Crennan, Keifel and Gageler JJ, Hayne
J dissenting) held that assuming all other requirements for
patentability are met, a method (or process) for medical treatment
of the human body can be a "manner of manufacture" and
therefore patentable for the purposes of section 18 of the
Patents Act 1990 (Cth) (Act).
The Court unanimously held that Apotex did not indirectly
infringe the Patent pursuant to section 117 of the Act by supplying
Apo-Leflunomide. It was not shown, nor could it be inferred, that
Apotex had reason to believe that Apo-Leflunomide would be used in
accordance with the patented method, and Apotex's approved
product information document did not instruct recipients to use
Apo-Leflunomide in accordance with the patented method.
The dispute concerned Leflunomide, a drug used to treat the skin
disorder psoriasis. The patent for the substance Leflunomide
expired in 2004. The Patent claims a method of using Leflunomide to
Apotex registered its generic, Apo-Leflunomide on the ARTG.
Apo-Leflunomide was indicated on the Australian Register of
Therapeutic Goods (ARTG) for treatment of rheumatoid arthritis and
psoriatic arthritis. Importantly, psoriasis and psoriatic arthritis
are separate conditions, but most people with psoriatic arthritis
will develop psoriasis. The product information for the product
expressly excluded use of the product to treat psoriasis.
Sanofi successfully restrained Apotex from supplying products
containing Leflunomide in the Federal Court of Australia. Justice
Jagot held that supplying Apo-Leflunomide would infringe the patent
for the purposes of section 117(2)(c) of the Act, on the basis that
using Leflunomide to treat psoriatic arthritis would inevitably
treat (or prevent) psoriasis as well, even if Leflunomide was only
prescribed for treating psoriatic arthritis.
The Full Federal Court upheld infringement, but on the basis
that Apotex had reason to believe that the product would be put to
the infringing use because it accepted that rheumatologists do
seek, and will seek, to treat both conditions when patients present
with psoriatic arthritis and psoriasis concurrently.
High Court Appeal – Manner of manufacture
The majority of the Court held that the Patent was valid.
This was the first time the High Court has considered whether a
method of treatment was inherently patentable subject matter, and
the majority's decision will have far reaching implications for
operators in the pharmaceutical industry.
Importantly, Justices Crennan and Kiefel JJ did draw a
distinction between a method of medical treatment which involves a
therapeutic use of a pharmaceutical substance, and the activities
of doctors or other medical staff when physically treating
patients. Such activities or procedures are unlikely to satisfy the
test for patentability because they are not capable of being
practically applied in commerce or industry, which is a necessary
prerequisite for a "manner of manufacture".
High Court Appeal – Indirect infringement
In its application for special leave (heard in December 2012),
Apotex also sought leave to appeal the Federal Court's decision
regarding whether, its conduct constituted contributory
infringement of the Patent pursuant to section 117(1) of the
The Court found that Apotex did not indirectly infringe the
Patent by its supply of Apo-Leflunomide. The Court found that
Apotex had no reason to believe Apo-Leflunomide would be used to
infringe the Patent and nor did it instruct those to whom it
supplied the product to do so. This was especially where the entry
for Apo-Leflunomide on the ARTG stated that it is a therapeutic
good registered for its indicated uses, which specifically excludes
use of the method disclosed in the Patent.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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