Bio-Science Law Review - Volume 13 - Issue 6
MEETING THE NEEDS OF PATIENTS: EARLY ACCESS AND ADAPTIVE LICENSING
REVERSE PAYMENT SETTLEMENT AGREEMENTS IN THE PHARMACEUTICAL INDUSTRY: SETTLING THE DEBATE BETWEEN THE PRO-EXCLUSIVITY PRINCIPLES OF PATENT LAW AND THE PRO-COMPETITION PRINCIPLES OF ANTITRUST LAW
JULIANNE O'LEARY AND JOSEPH DEL-GRECO
Stephenson Harwood LLP, London
The EU and the US recently confirmed that reverse payment settlement agreements concluded in the context of patent disputes in the pharmaceutical industry are open to antitrust challenge, even if the reverse payment settlement agreement contains terms which are within the scope of the patents at issue. Whilst the European Commission’s approach in Lundbeckwas to hold that such agreements can be infringements of competition law by object, the Supreme Court’s approach in Actaviswas to hold that reverse payment settlement agreements should be assessed under a structured rule of reason test.
This article: (1) defines the concept of a reverse payment settlement agreement; (2) provides an overview of the regulatory contexts in which reverse payment settlement agreements are reached in the US and the EU; (3) considers why parties to patent litigation choose to enter into settlement agreements rather than fully litigate the patents to judgment; (4) provides an overview of the Actavis decision and subsequent case law; (5) provides an overview of the Lundbeck decision and subsequent case law; and (6) considers how the US and EU treatment of reverse payment settlements may evolve, and the potential impact of these approaches on future settlement agreements in the pharmaceutical industry.
TRANSPARENCY OF CLINICAL TRIAL DATA: CURRENT STATE OF PLAY
IAN DODDS-SMITH AND JACKIE MULRYNE
Arnold & Porter (UK) LLP
EU institutions have been promoting increased disclosure of pre-clinical and clinical trial data for some time, and the European Medicines Agency (EMA) seems determined to release as much data as possible after a marketing authorisation has been granted. The authorities claim to be responding to widespread public pressure for greater transparency, and, at times, it has seemed that there is little companies can do to stem the tide. Industry and intellectual property associations are objecting tothe EMA’s increasingly unqualified policy in favour of disclosure, whereas researchers and national competent authorities have supported the EMA’s position. Against this background, there are a number of new initiatives and developments that will determine how data from clinical trials and within marketing authorisation dossiers will be released in the future. This article sets out a summary of the current position in relation to disclosure of clinical trial data, and highlights some of these areas of development.
THE UK PHARMACEUTICAL PRICE REGULATION SCHEME (PPRS) AND THE STATUTORY REGULATIONS: AN OVERVIEW AND OUTLINE OF HOW THE SCHEMES MAY IMPACT THE LIFE SCIENCES INDUSTRY
CHRISTIAN HILL, PAUL RANSON AND HELEN CLINE
Pinsent Masons LLP
There are clearly short-term financial benefits for the UK in these new pricing deals, but these benefits may have consequences for health and UK finances in the longer term. Only time will tell how UK pricing policy interrelates with, and impacts on the Government’s commitments in its UK life sciences strategy. However, these new arrangements could stifle inward investment into the UK as companies find it increasingly difficult to justify investment decisions based on lower net prices in the UK when compared with other global markets. One, no doubt unintended, consequence, maybe to limit UK patients’ access to new innovative medicines, as companies delay launch in the UK while they negotiate more a favourable unit price elsewhere in Europe.
UNIFIED PATENT COURT: THE 16TH DRAFT RULES OF PROCEDURE: TEN KEY DEVELOPMENTS
Taylor Wessing LLP, London
THE HIGHEST ITALIAN ADMINISTRATIVE COURT HAS THE FINAL WORD ON THE XALATAN CASE AND REINSTATES THE ORIGINAL INFRINGEMENT DECISION OF THE ITALIAN COMPETITION AUTHORITY
Desogus Law Office, Italy
The Xalatan case recently adjudicated by the Italian Council of State well illustrates the complex interaction between patent and competition laws. A conduct, while lawful under patent laws, may, nevertheless, amount to a competition infringement. Drawing on the 2009 Pharmaceutical Sector Inquiry Report of the European Commission, the Italian Competition Authority found Pfizer to have infringed Article 102 TFEU as with a divisional patent and the ensuing supplementary protection certificate sought to extend the length of patent protection for its blockbuster drug Xalatan. The Council of State upheld all the findings of the competition authority, which is not good news for drug originators. Indeed, what the judgment said is that drug originators, when exercising the exclusive rights conferred on by patent laws to patent holders, may also commit abusive conducts banned by competition law. Unfortunately, the judgment did not clearly set out when that may happen.