Obtaining and enforcing Supplementary Protection Certificates (SPCs) for medicinal products in the European Union is a fertile ground for challenge and the law is still unclear in a number of key areas. Given their commercial significance, the application procedures and policies with respect to SPCs have attracted the attention of EU competition authorities. The Court of Justice of the European Union (ECJ) has also recently restated the application of rules of privilege in investigations of alleged breaches of competition law. These various factors suggest that now may be a good time for life science companies to reassess their strategies and procedures relating to SPCs.
The European SPC System
Delays caused by the need for lengthy and rigorous clinical testing of medicinal products have prompted many legislative systems around the world to operate a regime of patent term extension. The European Union introduced its solution in the form of the SPC in 1990 by way of Regulation 1768/92/EEC (the Regulation). Unfortunately, the simplicity of the legislation on its face has led to widespread uncertainty in its practical application.
At the core of the Regulation are the concepts of: i) a medicinal “product”, ii) a “first marketing authorisation” (to place the product on the market in the European Community), and iii) a patent that “protects the product” that has not previously been granted an SPC. Unfortunately, each of these concepts have been beset by uncertainty in the case law.
What is a “product”?
Although a “product” is defined as the active ingredient or combination of active ingredients of a medicine, numerous cases have highlighted areas of uncertainty. For example, can a “product” be limited to a single active ingredient (that is protected by a patent) in a medicine that includes several other active ingredients?
Another uncertainty arises in that the particular use to which a product is intended to be put does not form part of the concept of the “product” itself, so raising questions about the viability of certain SPCs based on second medical uses.
What is the “first marketing authorisation” for the product?
This question has arisen when considering medicines made up of several components, e.g., when an earlier marketing authorisation includes a combination of active ingredients and an SPC is granted in relation to a later authorisation for one of the components on its own. As discussed below, the practical meaning of the term has also come under scrutiny.
In addition, the geographic scope of this provision has led to uncertainty, e.g., how the rules apply to marketing authorisations in Switzerland/Liechtenstein and new accession states of the European Union.
When does a patent “protect a product”?
Perhaps most fundamentally, the meaning of this apparently simple phrase is open to debate. It is thus not clear if it is sufficient that an authorised product would infringe a patent or whether the claim (or specification) of the patent must disclose the particular product/combination in question and, if so, to what extent. Different courts in Europe have repeatedly reached conflicting decisions on this question.
A duty of candour for SPC and other applications?
How applicants address this legal ambiguity in their dealings with patent offices can have signif icant implications from a competition law perspective. A widely reported breach of competition law arising from alleged abuse of the SPC system has recently been confirmed by the Advocate General of the Court of Justice. At the time of the SPC application in question, it was unclear as a matter of law whether a “first marketing authorisation” referred to the actual grant of a marketing authorisation or to the practical ability to place the medicine on the market, which could be delayed several years. The applicant adopted the most favourable position. By doing so, it was alleged that it unlawfully abused its dominant position and materially misled patent offices, resulting in an extended monopoly to which the company ultimately was not entitled.
Importantly, the Court indicated that, insofar as a company is wrongful ly granted an exclusive right, it has a “special responsibility” not to impair genuine undistorted competition that requires it “at the very least” to inform the patent office of any errors made in its communications.
In the field of SPCs, this potential duty to highlight to patent offices alternative interpretations of the law presents particular challenges, given the state of the law as a whole.
Restrictions on Privilege
Of course, in order to assess the prospects of whether an alternative interpretation should be presented, applicants will normally take advice from specialist legal counsel and/ or patent attorneys, both internal and external. Another recent case from the ECJ underlines the fact that, in stark contrast to the position in the United States, many such communications will not attract privilege from disclosure in European investigations under competition laws.
That case focused on whether communications with in-house legal counsel admitted to the relevant national bar were immune from disclosure on the grounds of legal professional privilege. The debate centred on whether in-house lawyers are suff iciently independent to justify their communications being protected by privileged. The Court held that, since an in-house lawyer is bound economically to his or her employer and is more closely linked to its commercial policy, mere membership of a bar does not ensure sufficient independence to give rise to privilege.
It was noted in the course of the decision that this differs from the position under the national laws of certain Member States where privilege does extend to communications with in-house counsel. The ECJ nevertheless held there is no requirement for EU law and national law to apply the same standards.
Although not binding, the Advocate General’s opinion in this case took a clear position that privilege does not apply to communications with individuals who are not admitted to the bar of an EU Member State. Significantly, this rationale would also appear to apply to communications with external US counsel and to external European patent attorneys. The reason is that the privilege is said to attach only to communications that affect the right of defence of the client to the investigation in question. Whilst communications with European patent attorneys “in their capacity as such” are afforded privilege under recent amendments to the European Patent Convention, it is debatable whether that privilege will protect documents from disclosure in Commission investigations. First, it is not clear whether it is possible for a European patent lawyer’s remit “as such” to extend to questions of European competition law. Further, it should be remembered that the European Patent Convention does not form part of the legal structure of the European Community or any EU Member State.
It is almost unprecedented that the law concerning SPCs, having such commercial significance, should create such uncertainty. Moreover, it is unfortunate that disputes uncovering such uncertainties should coincide with an increased scrutiny of patent protection from a European competition perspective and the apparent erosion of attorney-client privileges.
Nevertheless, any organisation considering taking advantage of the patent term extension provided by SPCs should take careful note of these developments, and take steps to ensure appropriate strategies are adopted and suitable processes for their execution are implemented.