Clinical & Regulatory

Clinical & Regulatory

Who owns what? Opposing medtech patents before they get to the courts



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European patent attorneys Dr Florian Bazant-Hegemark and Thomas Somervell from legal firm Marks & Clerk talk to Kathryn Reilly about the work of the European Patent Office (EPO) and their expertise in the complicated field of medtech patenting

European Patent Office

Like it or not, the medical technology sector is increasingly likely to feature as an arena for patent disputes. This stems from the huge number of patent applications filed for medtech devices. In the European Patent Office’s annual reports, medtech consistently ranks at the top of the scoreboard of technologies with most patent applications filed, ahead even of other high-growth areas such as digital communications, computer technology and the energy sector. In 2015, 12,474 patent applications for medical technology were filed at the EPO – an increase of 11 per cent over the previous year. With higher patenting activity, more disputes are likely to follow.

Challenges and revoking patents

It may come as a surprise, but even though all patent applications will be carefully examined by a patent office before being granted, third parties can still challenge the validity after the patent is approved. After a patent application is filed at an office, a search is conducted to find relevant prior art documents that might invalidate patent claims. Patent offices typically provide an applicant with an opportunity to amend their application in these cases, to disclaim parts of the application that are invalid. If no document remains prejudicial to the claimed part of the patent, the patent may be granted. Sometimes, however, relevant prior art is not known to the patent office as no prior art search is guaranteed to be completely exhaustive, leading to a potentially invalid patent.

European Patent Office

Florian Bazant-Hegemark

In most countries, invalid patents can be revoked. However, a revocation action involves court procedures that can be both costly and time-consuming, particularly if the patent is defended by the patent proprietor. In Europe, the situation is exacerbated as patents applied for and examined at the EPO are granted as a ‘bundle’ of national patents valid in the countries chosen by the applicant – up to 38, including many non-EU countries such as Switzerland, Norway and Turkey. Revocation through the courts therefore requires actions in multiple jurisdictions, in different languages, and is subject to different countries’ legal procedures. Challenging a potentially invalid patent can be a considerable burden when trying to clear the market for a product, particularly in the medical devices sector where there can be significant lead times before the launch of a product.

However, the European Patent Office offers several mechanisms to help ensure the validity of the patents it grants, including ‘oppositions’, which allow anyone to seek full or partial revocation of a patent centrally at the EPO, without having to go through the courts in each individual jurisdiction. An opposing party can initiate this within nine months of a European patent being granted, and revocation can be sought on several grounds.

Differences between the EPO’s opposition procedure and national court-based revocation procedures can be exploited as part of a strategy to complement or avoid litigation in national courts. In terms of cost, the EPO opposition procedure is likely to require a considerably lower budget than litigation. Oppositions can be conducted in any one of the official languages of the EPO (English, French or German). The case management may be less rigid than in national courts, and amendments to a case may even be made on the day of a hearing.

Working with the experts

One advantage of EPO oppositions is that they are heard by trained examiners experienced in patent matters as part of their day-to-day practice, whereas this cannot be necessarily be assumed for national courts which may only occasionally have to deal with patent disputes. Furthermore, the EPO is notoriously strict in its assessment of novelty and ‘inventive step’, and its findings are often regarded as having persuasive character even in other jurisdictions. If an opposition fails, the validity of the patent is confirmed, and the opponent would then only be able to seek revocation in separate national court proceedings. A patent that survived an opposition, even in amended form, usually enjoys a presumption of validity, which increases the legal certainty for the parties involved.

The state of application in 2015

In 2015, more patent applications (12,474) were filed for medical devices than for any other type of technology. We look at figures from the European Patent Office to identify upcoming trends in medtech innovation

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European Patent Office

Thomas Somervell

From the perspective of a patent owner, an opposition raises the prospect of having patents in several countries in Europe revoked in a single procedure. However, a patent proprietor is permitted to defend their patent against the opposition and take advantage of the more flexible options for amending a patent offered by the opposition procedure (compared to litigation in national courts).

In 2014, European patent EP2242464 owned by the University of Southern California for an implantable device for independently delivering multiple drugs to patients (believed to be particularly useful for treating eye conditions) was opposed by Sanofi Aventis on various grounds, of which each single ground, if successful, would have resulted in the patent being revoked in its entirety – and throughout Europe. The case was decided at a hearing in which the Opposition Division of the EPO ruled that the patent is valid and maintained with only a minor amendment, clarifying that the device is for implantation in a patient’s eye. It is noteworthy that this result was achieved in a single forum with effect in all EPO member states, while providing both sides with legal certainty about the validity of the patent.

In 2015, of the 3,713 oppositions decided at the European Patent Office, in 31 per cent of cases, the opposition was rejected outright, with the patent being maintained as granted. In 38 per cent of cases, the patent was upheld in amended form, and in the other 31 per cent, the patent was revoked altogether.

Did you know? Fascinating patent facts from the Engine Room

  • A patent can be invalidated by something as simple as sharing your idea with one person who isn’t under an obligation to keep it confidential.
  • To be regarded as an invention, an idea needs to include an ‘inventive step’. An inventive step must be non-obvious, meaning that it would not readily occur to an expert.
  • Once the application text has been approved for the grant, the patent claims must be translated into the two other official languages in order to complete the grant formalities.
  • A large part of the cost of validation comes from the need for highly accurate translations.
  • Europe is the second largest medical technology market in the world, worth an estimated €100 billion ($138 billion).
  • Medtech products usually only have a lifecycle of 18 to 24 months before they are replaced by an improved device.

Discover the Seven Deadly Sins of the inventor.

About the author

Journalist and editor Kathryn Reilly has worked in consumer, contract and medical writing for more than 20 years.

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