December 2013
Practice Group(s):
IP Litigation
IP Procurement and
Portfolio
Management
Breaking News - High Court of Australia Confirms
That Methods of Medical Treatment are Patentable
By Jane Owen, Shalini Jayaweera and Alex Dunlop
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors [2013] 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:
1. 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).
2. 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 ApoLeflunomide 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.
Background
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 treat psoriasis.
Apotex registered its generic, Apo-Leflunomide on the Australian Register of Therapeutic
Goods (ARTG). Apo-Leflunomide was indicated on the 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.
Breaking News - High Court of Australia Confirms That Methods of Medical
Treatment are Patentable
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 Act.
The Court found that Apotex did not indirectly infringe the Patent by its supply of ApoLeflunomide. 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.
Authors:
Jane Owen
jane.owen@klgates.com
+61.2.9513.2327
Alex Dunlop
alex.dunlop@klgates.com
+61.3.9205.2062
Shalini Jayaweera
shalini.jayaweera@klgates.com
+61.3.9205.2095
2
Breaking News - High Court of Australia Confirms That Methods of Medical
Treatment are Patentable
Anchorage Austin Beijing Berlin Boston Brisbane Brussels Charleston Charlotte Chicago Dallas Doha Dubai Fort Worth Frankfurt
Harrisburg Hong Kong Houston London Los Angeles Melbourne Miami Milan Moscow Newark New York Orange County Palo Alto
Paris Perth Pittsburgh Portland Raleigh Research Triangle Park San Diego San Francisco São Paulo Seattle Seoul Shanghai
Singapore Spokane Sydney Taipei Tokyo Warsaw Washington, D.C. Wilmington
K&L Gates practices out of 48 fully integrated offices located in the United States, Asia, Australia, Europe, the Middle East and
South America and represents leading global corporations, growth and middle-market companies, capital markets participants and
entrepreneurs in every major industry group as well as public sector entities, educational institutions, philanthropic organizations
and individuals. For more information about K&L Gates or its locations, practices and registrations, visit www.klgates.com.
This publication is for informational purposes and does not contain or convey legal advice. The information herein should not be used or relied upon
in regard to any particular facts or circumstances without first consulting a lawyer.
©2013 K&L Gates LLP. All Rights Reserved.
3