In Apotex v Sanofi-Aventis [2013] HCA 50 the High Court finally confirmed (what was fairly well understood all along) that methods of medical treatment are patentable subject matter in Australia. However, it remains uncertain whether medical/surgical procedures are patentable. The High Court’s approach to the infringement by supply provisions in the Patents Act is a welcome surprise for generic pharmaceutical companies.

This case concerned Sanofi’s patent to a method of using leflunomide to treat psoriasis. Apotex wished to introduce a generic version of leflunomide and its product information did not include psoriasis as an approved indication (rather its product was indicated for the treatment of psoriatic arthritis and rheumatoid arthritis).

The case before the High Court had two aspects:

  1. Apotex’s challenge to validity arguing that methods of medical treatment are not patentable subject matter; and
  2. Sanofi’s argument that Apotex was liable under the infringement by supply provisions (s117) as it had “reason to believe” that its product would be put to an infringing use (i.e. used to treat psoriasis).

METHOD OF TREATMENT PATENTS IN AUSTRALIA

While the High Court had not previously considered the issue, it was fairly well understood that methods of treatment were patentable under Australian law.

In 1994 the Full Court of the Federal Court in Rescare v Anaesthetic Supplies upheld a decision of a single judge rejecting a revocation claim made on the basis that a method of treatment claim could not be an “invention”. In that case the patent claimed a method for treating sleep apnoea. This decision was subsequently followed by another Full Court inBristol-Myers Squibb which concerned a method for administering an anti-cancer drug.

Further, as Justices Crennan and Kiefel identified in their joint judgment, the practice of the Patent Office has been, for many years prior toRescare (and continues to be), to grant patents in respect of methods of medical treatment.

METHOD OF TREATMENT PATENTS IN OTHER JURISDICTIONS

The European (and UK) position is that methods for the treatment of the human body by surgery or therapy are excluded from patentability. However, new uses of known substances for a therapeutic treatment are patentable.

The United States’ Act (Patents Act 1952, s101) permits patents to be granted for a broad range of inventions and does not expressly exclude methods of medical treatment.  Medical use patents are granted (including for surgical procedures), however the patentee is barred from taking action against medical practitioners performing patented surgical procedures.

In Canada, methods of medical treatment that involve a “medical or surgical step” (i.e. call for physician’s skill) are not patentable whereas a new therapeutic of a known compound is likely to be patentable.

Finally, despite a long line of judicial authority in New Zealand rejecting the patentability of methods of medical treatment, the New Zealand Court of Appeal has found “Swiss style” claims to be patentable (i.e. claims in the form “the use of compound X in the manufacture of a medicament for a new therapeutic use Y”).

THE HIGH COURT’S FINDING THAT METHODS OF TREATMENT ARE PATENTABLE

In finding that methods of treatment are patentable subject matter, the High Court was influenced by:

  1. the absence of any express exclusion to the patentability of methods of medical treatment in the Patents Act;
  2. the anomaly that would exist if pharmaceutical products were capable of being patentable but methods of treatment were not;
  3. the recognition that methods of medical treatment satisfy the test for patentable subject matter set down by the High Court in theNRDC case (i.e. they are capable of producing an “artificially created state of affairs” and have economic utility); and
  4. the lack of any basis to distinguish between methods of treatment that are medical and those that are “cosmetic” (the latter were found to be patentable in a previous case).

In addition, it might be wondered whether the fact that the Patent Office has been granting patents for methods of medical treatment for many years may have been taken into account.

While Justices Crennan and Kiefel acknowledged that they did not need to address the issue in the context of this case, they observed that the activities or procedures of doctors may not be patentable subject matter in Australia.

Therefore, as a result of the High Court’s decision, Australia is probably most closely aligned to the position in Europe and the UK. The US position appears to be more liberal (from a patentee’s perspective) whereas the New Zealand and Canadian approaches appear to be more conservative.

THE HIGH COURT’S FINDING ON INFRINGEMENT

In relation to the question of infringement, the Court identified that direct infringement could only be established if the product (leflunomide) is applied to treat the condition of psoriatic arthritis.

The High Court found that the method of treatment claim was “confined to” the “specific purpose” being the “unknown therapeutic use of leflunomide”. This suggests that the purpose of the administration will be regarded as an essential feature of the claim and, it follows, that the where there is an intention to use of the known product for another therapeutic purpose (not claimed), infringement will not be made out.

Sanofi, therefore, relied on the infringement by supply provisions in the Act (s117). It needed to show that Apotex had “reason to believe” that its product would be put to an infringing use.

The High Court held that because Apotex’s product information expressly stated that its product was not indicated for the condition described in the patent, Apotex did not infringe.

READING THE TEA LEAVES

First, it is likely that those challenging patents will seek to rely on the observations of Justices Crennan and Kiefel in relation to the patentability of procedures performed by doctors.

Secondly, the decision in relation to the infringement by supply provisions are likely to have a greater impact on future patent cases that the aspect of the decision relating to the patentability of methods of medical treatment.

The High Court’s finding that the practice of “disclaiming” a claimed medical use in product information and when obtaining regulatory approval is sufficient to prevent the supply of that product constituting an infringement, is inconsistent with the decision below and the position judges have taken in other cases. The counter-argument, which had enjoyed success (including in many interlocutory decisions), was based on an acceptance that the instructions or “carve out” in the product information would be ignored by prescribing doctors and pharmacists.

It is likely that future cases will test whether the High Court’s approach in relation to infringement is limited to the facts of this case.  Patentees will need to tender better evidence showing that irrespective of the generic company’s product disclaimers, the generic company has “reason to believe” that the product will be put to an infringing use.

On balance, the decision seems to endorse the practice of disclaiming conditions that are covered by method of treatment claims (which has been referred to as “skinny labelling”). This will clearly be a source of frustration for patentees and of comfort for generic pharmaceutical companies keen to market new generic drugs for non-patented indications/uses whilst carving out any remaining patented indications/uses.

Further, this aspect of the case has broader application because the infringement by supply provisions apply to all patents for the use of a product in an infringing process (whether a method of medical treatment or not).