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Pharmaceuticals - copyright in PIs and indirect patent infringement

In the recent decision in Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3),1  Justice Jagot of the Federal Court found liability for indirect patent infringement in the context of supply of a pharmaceutical product.  Her Honour also held that copyright can subsist in product information documents for pharmaceutical products.

Sanofi-Aventis is the owner of a patent which claims a “method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of a pharmaceutical composition containing as an active ingredient [leflunomide]”.  Sanofi-Aventis alleged that Apotex threatened to infringe its patent by intending to supply and offer to supply its generic leflunomide products in Australia.  Apotex cross-claimed alleging that the patent in suit should be revoked, however it was not successful in establishing that the patent in suit was invalid.

Indirect patent infringement

Finding that Apotex’s intended conduct constituted a threatened infringement of the patent, Jagot J made various findings in relation to the operation of s 117 of the Patents Act 1990 (Cth) ("the Act") which provides statutory relief for indirect (or contributory) patent infringement.  In brief, s 117(1) provides that where “the use of a product by a person would infringe a patent, the supply of that product … is an infringement of the patent by the supplier”.  The reference to “the use of a product” is then clarified in s 117(2) of the Act. 

In examining each of the provisions of s 117(2), Jagot J first considered:

  • whether Apotex’s product information document instructed use of Apotex’s leflunomide product in accordance with the claims, as per s 117(2)(c) of the Act; or
  • whether, on the facts, Apotex had reason to believe that a person to whom the product is supplied will put it to a use that will infringe the patent, as per s 117(2)(b) of the Act. 

Apotex argued that since the indications in its product information documents referred to psoriatic arthritis, there was no clear instruction to use its leflunomide product to treat the skin disorder psoriasis, and therefore neither of these elements were established.  However, having regard to evidence that “almost all people with psoriatic arthritis have or will develop psoriasis” and therefore the administration of leflunomide to a person with psoriatic arthritis will also treat that person’s psoriasis, Jagot J found that the product information document contained instructions to use Apotex’s leflunomide product to treat psoriasis in accordance with the claims; and/or that Apotex would have a reason to believe that a person to whom the product is supplied would put it to use for the treatment of psoriasis.  With respect to Apotex’s “reason to believe”, Jagot J distinguished the present case from a situation where the product might treat psoriasis in only a percentage of patients with psoriatic arthritis. 

Staple commercial product

Second, Jagot J considered whether “the product” was a “staple commercial product”.  Briefly, s
117(2)(b) of the Act provides that where the product is not a staple commercial product, the reference to the use of a product is a reference to “any use of the product, if the supplier had reason to believe that the person would put it to that use”.  Accordingly, Apotex argued that the product is a staple commercial product, and therefore infringement should not be attributed on the basis that Apotex had a reason to believe that it would be put to a use that will infringe the patent.  This required her Honour to resolve the preliminary issue of the identity of “the product”.  Her Honour found that “the product” in question was not the active ingredient leflunomide generally, but rather Apotex’s leflunomide product “Apo-Leflunomide” as proposed to be supplied. 

Ultimately, Jagot J held that Apotex’s leflunomide product was not a staple commercial product, despite the fact that the product has more than one indication (rheumatoid arthritis and psoriatic arthritis).  Her Honour (applying reasoning from the High Court’s decision in Northern Territory v Collins (2008) 235 CLR 619) held that even if the range of indications does create two classes of use (here, oral administration for the treatment of rheumatoid arthritis and oral administration for the treatment of psoriatic arthritis), it cannot be said that Apotex’s leflunomide product is a product “that not only can be used in a variety of ways but also is traded for use in various ways”.

Her Honour found that when Apotex’s leflunomide product is administered for the treatment of psoriatic arthritis, the claimed method will be used because any concurrent psoriasis will be treated and any future psoriasis will be prevented.  Relevantly, Jagot J had construed the claim of the patent such that there was infringement where leflunomide was administered to a patient and that patient’s psoriasis was treated or prevented, and that it was irrelevant whether the purpose of the administration of leflunomide was to treat psoriasis.  Accordingly, Apotex’s intended conduct was held to infringe the patent.

Copyright

Sanofi-Aventis alleged that Apotex, by making and supplying to the Therapeutic Goods Administration (“TGA”) a product information document concerning its leflunomide product, infringed the copyright owned by Sanofi-Aventis in certain of their Arava (Sanofi-Aventis’ own leflunomide product) product information documents (“Arava PI”). 

Apotex acknowledged that in making its product information document it had reproduced the whole or a substantial part of the Arava PI, but submitted that it did not infringe copyright either because copyright did not subsist in the Arava PI, or because Apotex had an implied licence to reproduce the Arava PI.

Jagot J held that copyright subsisted in the Arava PI, which copyright was infringed by Apotex.  In finding that copyright subsisted in the Arava PI, Jagot J accepted that, as Sanofi-Aventis put it, “the preparation of a PI ... involves the exercise of considerable skill, judgment and knowledge by the author or authors”.  Her Honour also accepted that on their face, none of the versions of the Arava PI in evidence bore any resemblance to a mere compilation.

Jagot J did not accept that Apotex had the copyright owners’ implied licence to reproduce a substantial part of the works.  Apotex argued that Sanofi has previously “been aware of, participated in, benefited from and never complained about the practice of generic companies making close copies of originators’ PIs”.  Alternatively, Apotex argued that an implied licence arose from the circumstances surrounding the practices of the TGA with respect to generic products.  Both of these arguments were unsuccessful.

However, Jagot J acknowledged that the recent amendments to the Copyright Act 1968 (Cth) mean that certain acts in respect of product information occurring after 28 May 2011 do not amount to an infringement of copyright (our IP Whiteboard Post in relation to these amendments can be accessed here). 

We will keep you updated on any appeal.

Footnotes

[1] [2011] FCA 846

 

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