Medical devices

Meril Life Sciences denied compulsory licenses in heart valve dispute

In Germany, Meril Life Sciences has failed in its attempt to obtain compulsory licences from its US-based competitor, Edwards Lifescience. The latest Federal Patent Court decision follows on from autumn, where the Regional Court Munich banned Meril Life Sciences from marketing its heart valve prosthesis. Meril is also advancing a public interest defence in the UK.

26 April 2021 by Konstanze Richter

Edwards Lifescience, Meril Lifesciences All patents owned by Edwards Lifescience cover minimally invasive heart valves ©Damian/ADOBE STOCK

The dispute between Edwards Lifescience and Meril Life Sciences spans numerous jurisdictions and numerous patents. All patents relate to minimally-invasive heart valve technology. Now, the Federal Patent Court in Germany has denied Meril a compulsory licence.

Edwards Lifescience owns several patents and utility models for this technology, including EP 3 593 762 B1, EP 3 498 226 B1, EP 2 628 464 B1, EP 3 494 928 B1, EP 3 494 930 B1 and EP 3 590 471 B1. These patents protect minimally-invasive heart valves and accessories. A further patent, EP 3 494 929, relates to a delivery system for transcatheter heart valves.

US company Edwards Lifescience provides the heart valves in four sizes which can be individually adapted to patients’ physical conditions. However, Meril offers its product in a larger variation of sizes.

Court bans Meril in Germany

According to Edwards Lifescience, Meril’s heart valve MyVal and its delivery system technology Navigator infringes several of Edwards patents. Therefore, the US company sued Meril at the Regional Courts Düsseldorf (case IDs: 4a O 24/20, 4a O 71-72/20 and 4a O 41-42/21), Munich (case IDs:  21 O 8878/20 and 21 O 9466/20) and Mannheim (case IDs.: 2 O 9/21 and 2 O 36/20).

In autumn 2020, the Regional Court Munich used a preliminary injunction to prohibit Meril from marketing its products in Germany (case ID: 21 O 8913/20).

In return, Meril Life Sciences requested the granting of compulsory licenses for five of the disputed patents at the Federal Patent Court (case IDs 6 Li 1-5/20). The German Patent Act allows a compulsory licence if there is a public interest, and if the licence seeker has previously made unsuccessful efforts to obtain a licence from the patentee on reasonable terms.

Meril argued that Edwards Lifescience’s heart valve did not cover the oversized and undersized products. Therefore, according to the Indian manufacturer, there is a public interest in its products. For certain sizes, Federal Patent Court judges granted that such interest might exist.

However, the court ultimately ruled that Meril had not made sufficient efforts to obtain licences. The judges dismissed the application for compulsory licences.

Public interest defence

Compulsory licenses in patent use are exceedingly rare. Throughout its over 50-year history, the Federal Patent Court has ordered such a licence just once. This was for a pharmaceutical patent, in the case of the HIV active ingredient raltegravir. For the first time, a company is now demanding a compulsory licences for medical device patents.

However, Germany is not the only country in which Meril is advancing a public interest defence. For example, in the UK, the High Court has scheduled the public interest issue for autumn 2021.

In the infringement proceedings, in autumn 2020 the UK High Court found EP 753 infringed in one claim. However, the court also declared the same claim as invalid for obviousness. Regarding EP 929, presiding judge Colin Birss declared that Meril infringed the patent in some patent claims.

Edwards issues cease and desist declaration

In Germany, Edwards Lifescience has since withdrawn all infringement claims, after Meril signed cease and desist declarations. However, if Meril Life Sciences will appeal the decision of the Federal Patent Court regarding the compulsory licenses is unknown.

In addition, Meril has filed oppositions against the granting of EP 226, EP 464, EP 928, EP 929 and EP 930 at the EPO.

The dispute spans numerous European countries, including France, Italy, the Netherlands, Spain, Austria, Sweden, Denmark, Hungary and Poland. This is in addition to proceedings in Germany and the UK.

Bird & Bird highly visible

Edwards Lifescience has long relied on Bird & Bird. Previously, a team led by Munich partner Boris Kreye has acted for Edwards Lifescience in the heart valve dispute against Boston Scientific, until the two parties reached an agreement in early 2019.

Currently, national Bird & Bird teams advise Edwards Lifesciences in most markets. In France, the Paris team around Anne-Charlotte le Bihan organized a seizure of Meril’s products at a trade show. The company hired go-to firm Powell Gilbert in the UK, which represents the US medical technology company in various patent disputes.

In Denmark, the US company is represented by full-service firm Bech Bruun.

First time with Hogan Lovells

For its first patent dispute in Europe, Meril Life Sciences relied on a team around Hogan Lovells partner Andreas von Falck. The law firm also advises the Indian medical technology company in the proceedings against Edwards Lifescience in Spain and Italy.

In the UK, Meril hired a team led by Kirkland & Ellis partners Katie Coltart and Daniel Lim. Kirkland & Ellis won the work through a pitch. Other law firms involved for Meril are Gide Loyrette Nouel in France and Gorrissen Federspiel in Denmark.

For Edwards Lifescience
Bird& Bird (Munich): Boris Kreye (lead), Marc Grunwald, Anna Wolters-Höhne (Hamburg), Annika Lückermann (Düsseldorf); associates: Simon Reuter, Katharina Pehle, Elsa Tzschoppe, Anika Boche
Wuesthoff & Wuesthoff (Munich): Bernard Thum; associate: Jonas Weickert (both patent attorneys)

For Meril Life Sciences
Hogan Lovells (Düsseldorf): Andreas von Falck, Alexander Klicznik (both lead), Felipe Zilly (both patent attorneys); associates: Caroline Bley (patent attorney), Kerstin Jonen, Roman Würtenberger, Lukas Wollenschlaeger, Maximiliane Häusling, Chia Ching Chuong, Caroline Horstmann

Federal Patent Court, 6th Senate
Karin Friehe (presiding judge), Sabine Werner (judge reporteur), Blanka Zimmerer, Thomas Flaschke, Werner Veit

Regional Court Munich, 21st Civil Chamber (case ID: 21 O 8913/20)
Tobias Pichlmaier (presiding judge)