Federal Court shows generics how to avoid infringement of Swiss-style claims

Under Australian practice, both method of treatment and Swiss-style claims, in the format use of [compound X] in the manufacture of a medicament for the treatment of [condition Y]” are permitted. As reported previously, method of treatment and Swiss-style claims are directed to different infringing acts in Australia. This highlights the importance of pursuing both these claim types in Australian pharmaceutical patents.

 

The construction of Swiss-style claims was recently considered again in Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28. The Federal Court confirmed that infringement of a Swiss-style claim requires the patentee to establish that the manufacturer has made (or will make) the relevant medicament with the “objective intention” that it be used to treat the condition defined in the Swiss-style claim.

In this case, the applicants’ product, fenofibrate (marketed under the name Lipidil), was indicated for the treatment of retinopathy, in particular diabetic retinopathy, and covered by Swiss-style claims of Australian Patent No. 2006313711. The allegedly infringing products, collectively referred to as “the Ranbaxy Products” were originally approved for the same indication as the applicants’ product. However, the product information (PI) for the Ranbaxy Products was subsequently amended to remove reference to diabetic retinopathy.

The infringement case submitted by the applicants relied on the following points at [105]:

(a)    the amended PI for the Ranbaxy Products asserts that the Ranbaxy Products are bioequivalent to Lipidil;

(b)    the PI for Lipidil expressly states that Lipidl is indicated for the reduction in the progression of diabetic retinopathy and includes details of the FIELD and ACCORD trials relevant to that indication; and

(c)    the PI for the Ranbaxy Products does not assert that the Ranbaxy Products are not indicated for diabetic retinopathy or that it is somehow not relevantly bioequivalent for that purpose.

Nicolas J acknowledged that the Ranbaxy Products are suitable to be administered for the therapeutic use designated in the Swiss-style claims yet he rejected the submissions above and said at [106]:

“[i]n my view the evidence does not support a finding that the Ranbaxy products will be manufactured with the intention that they be used for the prevention or treatment of diabetic retinopathy. The infringement case based on the Swiss-style claims must fail.” (emphasis added)

In reaching the decision, Justice Nicolas was guided and accepted the observations of the UK Supreme Court in Warner Lambert Company LLC v Generics (UK) Ltd [2018], including:

  • that a Swiss-style claim is “purpose limited” and that the monopoly claimed is for the preparation or manufacture of a medicament for the treatment of a particular medical condition; and
  • as a matter of construction, a Swiss-style claim required a “mental element” involving an “objective intent” or a “subjective intent” of the manufacturer.

The test of “subjective intent” questions whether the manufacturer made the product with the intention of targeting the patent-protected market while “objective intent” asks whether the alleged infringer knew or could foresee that at least some of the prescriptions for the claimed drug for the claimed indication would actually be fulfilled by their own product. While Nicolas J did not find it necessary to decide in the present case whether the Swiss-style claims are concerned with the objective or subjective intention of the manufacturer, he found the reasons given by the UK Supreme Court who favoured the “objective intention” more persuasive and evidently, he stated at [103]:

“[o]f course, it is for the applicants to establish that the manufacturer has made (or will make) the relevant medicament with the objective intention that it be used to treat the condition designated in the Swiss-style claims. The fact that it may be reasonably foreseeable or even likely that a substantial portion of the product manufactured will be used to treat that condition is certainly not determinative at least not where the product is also used extensively in the treatment of other non-designated conditions.” (emphasis added)

The Court’s decision suggests that establishing the “intention” of a potentially infringing manufacturer may be difficult particularly when the product has a wide range of indications. Importantly, simply because the products are bioequivalents does not establish an intention nor does a lack of disclosure excluding the claimed indication on the PI. As such, innovators should include all possible medical indications of a product in a Swiss-style claim as sufficiently supported and enabled by the specification.