Late last year in the landmark decision of Apotex Pty Ltd v
Sanofi-Aventis Australia Pty Ltd  HCA 30, the High Court
found that methods of medical treatment of human beings including
surgery and the administration of therapeutic drugs can be the
subject of patents.
Prior to this decision, the Federal Court had in two relatively
recent decisions expressed the view that methods of medical
treatment of the human body should be capable of protection by
patent. However, these statements were in contrast to a substantial
history of case law which excluded methods of medical treatment
from being patentable based on a variety of ethical, precedential
and public policy reasons.
Sanofi-Aventis was the registered owner of a patent which
claimed to protect a method of treating or preventing the skin
disorder psoriasis by administering an effective amount of a drug,
a compound of which was Leflunomide.
Leflunomide itself was not protected by a patent (as a separate
patent in relation to Leflunomide had expired).
Apotex obtained registration of generic versions of Leflunomide
on the Australian Register of Therapeutic Goods, with the intention
to supply products containing Leflunomide in Australia as
treatments for psoriatic arthritis and rheumatoid arthritis.
Sanofi-Aventis alleged that Apotex's proposed supply would
infringe Sanofi-Aventis' patent.
The Federal Court at first instance, and the Full Federal Court
on appeal, found that Sanofi-Aventis had a valid patent which
Apotex had threatened to infringe.
Apotex then appealed to the High Court in relation to the
validity of Sanofi-Aventis' patent and whether, if the patent
was valid, Apotex had infringed the patent.
The High Court found that, despite the body of case law to the
contrary, if the requirements for patentability were met, a method
for medical treatment of human beings could be considered a
'manner of manufacture' which would be a patentable
invention within the meaning of section 18 of the Patents Act
Chief Justice French commented that "The history of the
exclusion of medical treatments from patentability does not
disclose a stable, logical or normative foundation and seems to
depend on nice distinctions for its maintenance"
The High Court then considered whether Apotex had infringed
Sanofi-Aventis' patent. This decision turned on the
interpretation of the patent. The High Court found that
Sanofi-Aventis' patent would not be infringed unless the
purpose, object or aim of administering Leflunomide was to treat
the skin disorder psoriasis. This was in contrast to the opposing
view that if the actual effect of administering Leflunomide would
be to treat psoriasis then Sanofi-Aventis' patent would be
Because Apotex's product information document gave
instructions to restrict the use of Apex's Leflunomide products
to the treatment of psoriatic arthritis and rheumatoid arthritis
and not the skin disorder psoriasis, the High Court found that
Sanofi-Aventis' patent had not been infringed.
Some might see this decision as simply closing an anachronistic
loophole, giving force to earlier comments made in recent Federal
Court decisions. Others might regard it as an undesirable
development of intellectual property rights. Whatever your view,
the decision is likely to have a significant effect on the
development of new medical procedures.
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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