A recent UK court ruling has broken new ground in ordering an official health body to issue guidelines on prescribing a generic drug. Could the same thing happen in Australia?
The Therapeutic Goods Administration (TGA) is the Australian regulatory body for therapeutic goods, including medicines. A generic medicine can only be supplied if the TGA considers there to be evidence showing that the generic medicine is bioequivalent to the original medicine. Before either an original or generic medicine can be registered in the Australian Register of Therapeutic Goods, the company seeking registration must supply and have approved by the TGA a summary of the scientific information relevant to the use of the medicine. This summary is known as a ‘product information document’, and it is intended that this information be available to assist doctors, pharmacists and other health professionals in prescribing and dispensing medicines.
In recent times, product information documents have become a focus in legal battles between originators of medicines and their generic counterparts. Notably, decisions issued by the High Court and Full Federal Court have provided guidance to generic pharmaceutical manufacturers for avoiding contributory patent infringement by amending product information documents.
An order issued recently by the UK High Court has gone a step further by compelling those who prescribe and dispense medicines to effectively enforce a patent owned by a pharmaceutical originator. This may prove to be a game changer as to how generic medicines are prescribed and dispensed which may have global implications.
Use of ‘skinny labelling’ to avoid patent infringement
When patent protection for a reference medicine expires, it can sometimes be the case that patent protection for new indications (i.e. new uses of the medicine) can be obtained independently. From the perspective of a generics manufacturer, the medicine per se can be made without the risk of infringement. However, when seeking registration of the medicine with the TGA, if it were mandatory to include every new indication in the product information document, the generics manufacturer would arguably be liable for patent infringement.
In reality, Australian law (as do equivalent laws in Europe and the US) provides generics manufacturers the option of varying product information documents to exclude indications covered by patents that are in force. Such practice is often referred to as ‘carving-out’ specific indications or ‘skinny labelling’.
Apotex v Sanofi (‘the Leflunomide case’)
In an earlier article (In dark times for biotech patents, Australian High Court provides a ray of light on methods of treatment), we reported on the significance of the decision issued by the Australian High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd  HCA 50 in relation to the patentability of methods of medical treatment in Australia.
The decision also deals with contributory patent infringement. Specifically, Apotex had proposed to supply generic Leflunomide for the treatment of psoriatic arthritis and rheumatoid arthritis. It had, however, carved out from the corresponding product information document the use of Leflunomide in treating psoriasis not associated with symptoms of arthritis. In the Court’s view, this was sufficient to avoid infringement of a claim directed to a method of treating or preventing psoriasis patented by Sanofi.
Warner-Lambert v Apotex (‘the Australian Lyrica case’)
One might assume, after the above High Court decision was issued, that adopting a ‘skinny labelling’ strategy might provide a clear path as to avoiding patent infringement. However, this turns out not to be the case as highlighted by the subsequent unanimous decision issued by the Australian Full Federal Court in Warner-Lambert Company LLC v Apotex Pty Ltd  FCAFC 59.
Warner-Lambert (a member of the Pfizer group of companies) owns an Australian patent for treating pain using the pharmaceutical pregabalin. Pfizer Inc, the parent of the Pfizer group, is a co-owner of an Australian patent which covers the use of pregabalin in the treatment of seizures. Pfizer promotes pregabalin in Australia under the trade mark Lyrica in relation to the pain indication.
Apotex registered many products containing generic pregabalin in the ARTG in respect of the treatment of neuropathic pain and seizures, and has sought to invalidate the above patents. While Apotex’s challenge to the patent covering the treatment of seizures was resolved through confidential negotiations, it continued to pursue revocation of the patent covering the pain indication. Apotex amended only some of its registrations for generic pregabalin and associated product information documents to exclude the pain indication. Other registrations and associated product information documents were not amended. This included registrations/documents linking generic pregabalin to products carrying the brand names of recognised Australian pharmacies (namely ‘Terry White Chemists’ and ‘ChemMart’). Further, Apotex intended to apply to list these other pregabalin-containing products in Australia’s Pharmaceutical Benefits Scheme (‘PBS’) such that the products could be available to consumers at a subsided price.
Warner-Lambert subsequently commenced infringement proceedings and sought interlocutory relief restraining Apotex from listing its generic pregabalin in the PBS or supplying its pregabalin-containing products. At first instance (Warner-Lambert Company LLC v Apotex Pty Ltd  FCA 241), the Federal Court granted an interlocutory injunction restraining Apotex from supplying products containing pregabalin indicated for the treatment of neuropathic pain. However, the primary judge was not satisfied that Warner-Lambert had demonstrated a case for additional interlocutory relief restraining Apotex from supplying any product containing pregabalin.
Warner-Lambert appealed to the Full Federal Court. In brief, the Full Federal Court found in Warner-Lambert’s favour as it had reason to believe that Apotex’s generic pregabalin would be used to treat pain based on the size of the ‘pain market’ compared to the ‘seizure market’ even though the pain indication had been carved out. Apotex submitted that it intended to advise doctors and pharmacists not to use generic pregabalin to treat pain, however this was not persuasive. Consequently, the Full Court extended the injunction to cover all of Apotex’s products containing generic pregabalin.
Warner-Lambert v Actavis (‘the UK Lyrica case’)
Similarly to Apotex, Actavis is a generics manufacturer that sought to make generic pregabalin. Actavis also sought to revoke Warner-Lambert’s European patent for pregabalin which covers the treatment of pain (albeit indirectly, because claims directed to methods of treatment are not patentable in Europe). Initially, Actavis planned to market its generic pregabalin under a skinny label in respect of seizures and anxiety disorders (not pain) while it challenged the validity of Warner-Lambert’s European patent.
Warner-Lambert subsequently applied to the High Court of England and Wales for an interim injunction to ensure that Actavis’ generic pregabalin would not be prescribed for pain. Evidence was presented showing that the UK market for pregabalin in respect of pain treatment was substantial compared to other indications. The Judge recognised that Actavis had taken steps to avoid having its generic pregabalin prescribed for pain, including restricting its marketing to non-pain indications, and by offering to write to prescribing and dispensing authorities to provide instructions that generic pregabalin is not to be prescribed for pain.
Ultimately, the Judge in that case (Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Ors  EWHC 72 (Pat)) refused the application for an injunction based on the steps taken by Actavis to avoid infringement. However, Warner-Lambert was still concerned that generic pregabalin would be ultimately prescribed for pain. In this regard, the Judge noted that the best solution was for the National Health Service (NHS) to issue appropriate guidance to doctors to prescribe Warner-Lambert’s Lyrica for pain. The NHS is a publically funded healthcare system which is administered by the UK Department of Health.
Warner-Lambert then subsequently sought, and was successful in obtaining, a court order to compel the NHS to issue guidance to doctors and pharmacies that pregabalin should only be prescribed for the treatment of neuropathic pain under the trade mark Lyrica: Warner-Lambert Company, LLC v Actavis Group PTC EHF & Ors  EWHC 485 (Pat). This effectively places the doctors and pharmacists in the position of enforcing Warner-Lambert’s patent.
Could Australian doctors and pharmacists be compelled to enforce patents?
The Judge in the UK Lyrica case also made the point that, under current UK prescribing and dispensing practices, pharmaceuticals are almost always prescribed according to their generic name. The situation is likely the same in Australia. Further, pharmaceuticals are almost always prescribed without reference to the indication for which it is being prescribed (see, e.g., the basic legislative requirements associated with writing prescriptions in the State of Victoria, Australia [234kb, .docx]). Thus, while Australian Courts might see skinny labelling as being sufficient to avoid infringement, the reality is that generics are likely to continue to be prescribed for patented indications.
Given the outcome of the UK Lyrica case, the question arises as to whether pharmaceutical originators will now seek court orders in Australia to have the Department of Health (the Australian equivalent of the NHS) issue guidance to prescribing and dispensing authorities to ensure that generics are not to be prescribed or issued to treat patented indications.
The author acknowledges the article High Court orders NHS to give guidance on the prescribing of pregabalin in Warner-Lambert v Actavis by Christofer Freeth of Wragge Lawrence Graham & Co LLP, UK for information on the UK Lyrica case.