In a recent Decision, Warner-Lambert Company LLC v Apotex Pty Ltd [2014], the Federal Court of Australia granted a Patentee of an ARTG-registered pharmaceutical an interlocutory injunction against a potential infringer. However, the injunction was limited only to exploitation of products indicated for the ARTG registration. The balance of convenience was held to favour the potential infringer.

The Patent sought to be enforced

Warner-Lambert Company LLC (“Warner-Lambert”), a member of the Pfizer group of companies, is the Patentee of Australian Patent No. 714980 (“the Pain Patent”) which relates, inter alia, to the use of pregabalin for the treatment of pain in general.

Claim 1 of the Pain Patent is directed to:

A method for treating pain comprising administering a therapeutically effective amount of a compound of Formula I… [which includes pregabalin].

Claim 5 of the Pain Patent is directed to:

A method according to Claim 1 wherein the pain treated is neuropathic pain.

Pfizer Inc., another company in the Pfizer group of companies, co-owns Australian Patent No. 677008 (“the Seizure Patent”) which relates to the treatment of seizure disorders.

Warner-Lambert, together with four other Applicants (“the Applicants”) filed an interlocutory application seeking to restrain Apotex’s launch of products that would allegedly infringe the Pain Patent. The Seizure Patent was not enforced.

Potential of infringement by Apotex

The Pain Patent covers “Lyrica,” a product containing pregabalin, which is the Pfizer group’s second biggest product by revenue in Australia. Pfizer’s Lyrica is registered on the Australian Register of Therapeutic Goods (“ARTG”) for:

  1. the treatment of neuropathic pain in adults” (neuropathic pain indication), and
  2. as adjunctive therapy in adults with partial seizures with or without secondary generalisation” (seizure indication).

In September 2012, Apotex Pty Ltd (“Apotex”) obtained regulatory approval to supply a number of pharmaceutical products containing pregabalin. In October 2013, Apotex amended the registered indications on the ARTG to delete the indication relating to neuropathic pain and to retain only the seizure indication.

The ARTG approved product information document relating to the Apotex Products relevantly states:

  1. Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.”

In mid-2013, Apotex commenced revocation proceedings of both the Pain Patent and the Seizure Patent. By consent, the part of the proceedings dealing with the Seizure Patent was discontinued. The part of the proceedings dealing with the Pain Patent continues.

On 14 February 2014, in line with a prior undertaking, Apotex gave notice to Warner-Lambert of Apotex’s intention to launch some products containing pregabalin. Apotex announced the launch of the products on 14 March 2014.

On 25 February 2014, Warner-Lambert, together with four other Applicants (“the Applicants”) sought interlocutory relief against Apotex. The Court dismissed the application for an interlocutory injunction on 14 March 2014, in respect to the supply of products by Apotex containing pregabalin for the treatment of seizures.

On 18 March 2014, the Court ordered that until the final hearing and determination of the infringement proceeding, Apotex will not exploit any product containing pregabalin in Australia, which is indicated for “the treatment of neuropathic pain in adults.

Thus, the scope of the injunction was limited to the wording of the ARTG registration of Pfizer’s Lyrica and it did not include the full scope of Claim 1 of the Pain Patent.

Summary of Arguments and Evidence

The Applicants argued that even though Apotex’s products were marked for seizure prescriptions, the products would be given as pain medication in any event, thereby infringing the Pain Patent.

The Applicants argued that pharmacists typically substitute original brand pharmaceuticals with generic brand pharmaceuticals on the Commonwealth Pharmaceutical Benefits Scheme (“PBS”), and that generic suppliers encourage this by providing pharmacists with a financial incentive, usually in the form of a discount or rebate. It was asserted that while a prescription for pregabalin could be given for seizures, there was no seizure market for pregabalin in Australia, and it is more likely that pregabalin would be given for off-label uses, such as pain. Significant funds were asserted to be expended by Pfizer in neuropathic pain education and awareness and in the promotion of Lyrica to prescribers and Pfizer would suffer loss in this regard if Apotex were permitted to sell its products.

Apotex argued that its products were only indicated as seizure medication and would not be given for off-label uses such as pain.

Apotex argued inter alia that a pharmacist would not risk his or her professional standing by dispensing a substituted product for the treatment of an off-label indication and that there would be no profit incentive to do so. Emphasis was placed on the marketing material sent by Apotex to prescribers and pharmacists, which included statements to the effect that the products are not indicated for the treatment of neuropathic pain. Evidence was submitted as to the extensive and complex damages inquiry that may result should Apotex seek to enforce the usual undertaking as to damages in circumstances where it had been restrained by an interlocutory injunction, but had succeeded in its revocation application.

Summary

The Court accepted Apotex’s arguments and considered the balance of convenience to favour Apotex. Public interest considerations were also considered to be relevant with regard to the supply of a choice of products to seizure patients at a potentially cheaper price.

It is clear in this case that the scope of Claim 1 of the Pain Patent for “a method for treating pain” is broader than the ARTG-registration of Lyrica for “the treatment of neuropathic pain in adults.” It is therefore possible that the activities of Apotex may still fall within the scope of the broad Claim 1 of the Pain Patent.

Nevertheless, the Court limited the injunction to the wording of the ARTG registration, such that Apotex is restrained from exploiting products for “the treatment of neuropathic pain in adults.

Take Home Message

Although the details of registration of a pharmaceutical on the ARTG are generally not considered to be directly relevant to the issue of potential infringement, Australian Courts may take such evidence into account.

Any injunction against an infringer may ultimately be limited to the narrower wording of the ARTG registration, rather than the broader scope of the Patent Claims.

Patentees may wish to consider ensuring that any Patent Claims to be enforced are aligned with the wording of all ARTG Registration before seeking injunctive relief. The filing of Divisional Applications having Claims of narrower scope, which mirror the wording of relevant ARTG Registrations, could support interlocutory injunctions to restrain potential infringers from selling products with the potential of off-label use.