SPEEDIER INNOVATION FOR MEDICAL DEVICES

Cutting-edge medical devices will reach the hands of ophthalmic surgeons more quickly than ever with new “unitary patentsâ€. The patents, formally known as “European patents with unitary effect,†were approved as part of regulations adopted by the European Parliament, European Commission and European Council of Ministers in December.

The new patent regulations are expected to come into effect later this year – as soon as they are ratified by France, Germany, the UK and 10 other EU countries. The first unitary patents are expected to be granted as early as April of 2014.

EU leaders hope that the new unitary patents will attract more inventors and start-up companies to use Europe as their base for research and development and thus spur much-needed economic growth. According to the latest statistics, the EU is lagging far behind the US and China in the patent race. In 2011, for example, the US granted 224,000 patents; China granted 172,000 patients. By contrast, the European Patent Office granted only 62,000 patents in 2011.

Legal protection

“One of the reasons for this difference is without a doubt the prohibitive cost and the complexity of obtaining patent protection throughout the single market,†said internal market and services commissioner Michel Barnier. Under the current system, which was set up in 1973, inventors must expend significant sums and time to receive full legal protection of their inventions throughout EU and in non-EU countries. Although inventors already can receive a European patent from the European Patent Office, they must apply to each European country separately to validate the European patent in that country and thus come within the protection of that particular country’s patent laws. In that way, the traditional European patent is more a “bundle†of national patents rather than a single patent.

The traditional European patent validation process involves also huge delays and significant fees for translating and administrative costs. For example, an inventor who validates a patent in every EU country must spend more than €36,000, about two-thirds of which is for translators, according to EU statistics. By comparison, inventors spend the equivalent of about €2,000 for a patent in the US or about €600 for a patent in China.

There are further costs under the current system. For instance, inventors now have to pay renewal fees in each country in which they have a validated patent. And if an investor wants to purchase the rights to use a patent through a licensing agreement, that agreement, too, has to be registered country by country, again for a significant fee. To make matters even more complicated, an inventor who wants to protect his or her patent from infringement must hire teams of lawyers to bring multiple sets of legal proceedings in every affected country.

Streamlined application

In addition to a streamlined application and approval process, the new patent regulations provide from a new Unified Patent Court to oversee the unitary patent procedure. The new process and court will protect inventions in 25 of the EU’s 27 countries.

Italy and Spain have, for now, declined to adopt unitary patents. Instead, they will continue to rely on the current – and more cumbersome – patent system, which included the EU’s 27 member countries and 11 other non-EU European nations: Albania, Croatia, Serbia, Iceland, Switzerland, Monaco, San Marino, Lichtenstein, Norway, Turkey and Macedonia.

Under the new procedure, a “European patent with unitary effect†will cost about €5,000, including translation fees. An inventor will: *Apply for a unitary patent at the European Patent Office in Munich, Germany through one of three official languages – English, German or French;

*Translate the terms of the approved patent into the other two official languages;

*Receive patent protection for 20 years for their inventions in every EU country – except Italy and Spain – without the need to validate the patent in any country;

*Pay renewal fees to the European Patent Office;

*Bring one set of legal proceedings to protect the patent in the Unified Patent Court. That court will have the exclusive jurisdiction to deal with lawsuits involving the validity of a patent and any infringement of a patent. The court will sit in a number of cities throughout the EU, including London, Paris and Munich. Appeals of the decisions of those courts will be heard by a special appellate court, which will sit in Luxembourg.

Overcoming obstacles

The new patent procedure, which is decades in the making, has overcome numerous political and legal obstacles.

Only two years ago, the EU's highest court, the European Court of Justice, ruled that a European Patent Court – as originally proposed, to adjudicate patent disputes throughout the 38 EU and non- EU countries – would be illegal because it did not allow for Court of Justice to hear any appeals from the patent court. In that ruling, the Court of Justice stated that the creation of an independent patent court – without oversight by the Court of Justice – would deprive national courts and the Court of Justice itself from ensuring that EU law was correctly and uniformly interpreted throughout the EU.

Under the new regulations, the Court of Justice can hear appeals from the Unified Patent Court, thus addressing the previous objections.