EU Courts Uphold Entresto SPC on Different Grounds

• Courts in Greece (an EU member state) and the UK (a former EU member state) have upheld the SPC for Entresto on different grounds of attack.
• The decisions demonstrate that the courts are willing to uphold SPCs, even when challenged on different grounds.
• The precedent set by these rulings may impact companies' intellectual property strategies in the EU, particularly with regards to the compounding exemption.

The decisions demonstrate that the courts are willing to uphold SPCs, even when challenged on different grounds.

The European Union's courts have made significant decisions regarding the Supplementary Protection Certificate (SPC) for Entresto, a heart failure medication. In recent weeks, courts in Greece (an EU member state) and the UK (a former EU member state) have upheld the SPC for Entresto on different grounds of attack. This development has left many in the legal community wondering about the implications of these rulings.

The decisions in the UK and Greece demonstrate that the courts are willing to uphold the SPC for Entresto, despite challenges from various parties. The fact that the grounds of attack were different in each jurisdiction highlights the complexity of the issue and the need for careful consideration of the legal framework surrounding SPCs.

The Supplementary Protection Certificate (SPC) is a type of intellectual property right that provides extended protection for pharmaceutical products. In the EU, SPCs are governed by Regulation 469/2009, which sets out the conditions under which an SPC can be granted. The regulation also includes provisions related to the compounding exemption, which allows pharmacies to compound certain medications without infringing on patent rights.

The recent decisions in the UK and Greece have implications for the interpretation of these regulations. Lawyers should pay close attention to the precedent set by these rulings, as they may impact their clients' intellectual property strategies in the EU. The compounding exemption, in particular, is a critical aspect of the SPC framework that requires careful consideration.

The upholding of the Entresto SPC in two separate jurisdictions has significant implications for the pharmaceutical industry and intellectual property lawyers. The decisions demonstrate that the courts are willing to uphold SPCs, even when challenged on different grounds. This sets a precedent that may impact the way companies approach patent protection and compounding exemptions in the EU.

Lawyers should take note of these developments and consider how they may affect their clients' strategies. The compounding exemption, in particular, is an area where companies must be careful to navigate the complex regulatory landscape. As the pharmaceutical industry continues to evolve, it is essential that lawyers stay up-to-date on the latest case law and regulatory developments.

Lawyers should watch for the precedent set by these decisions, which may impact their clients' intellectual property strategies in the EU, particularly with regards to the compounding exemption.

Source: Original reporting via Sunday Surprises