AIPPI World Congress 2019: SPC and PTEs around the world

This week at the AIPPI World Congress 2019, counsel discussed how supplementary protection certificates (SPC) and patent term extension (PTE) regulations differ across jurisdictions.

Speaking on a panel yesterday, September 16, James Horgan, assistant managing counsel at Merck Sharp & Dohme, said that while the SPC regulation in the EU has been very successful, the law is not always clear.

One of the problems is that the Court of Justice of the European Union, which is the final arbitrar for SPC disputes, is not a specialised IP court.

“The result of this is that you have decisions which are made by people that are not specialist IP lawyers. They don’t know about patents, therefore the way they come to their conclusions is by using concepts and ideas, which can result in confusing case law for IP lawyers.

“It’s like getting two jigsaw pieces from two sets of puzzles that don’t quite fit,” he said.

Under Article 3 of the EU SPC regulation, the key requirement for obtaining an SPC is a patent which is valid and enforceable. The patent must cover an active ingredient, i.e the ingredient inside the product that does the therapeutic work.

Aside from this, the patent holder must also have a marketing authorisation for the product in the relevant jurisdictions.

In order for a product to qualify for supplementary protection it must not have previously been granted an SPC.

One issue which comes up in court is in the scenario when a product contains multiple active ingredients and the patent doesn’t mention them all, Horgan said,

He referred to a July 2018 decision, Teva v Gilead, in which Teva challenged the validity of an SPC granted to Gilead. Gilead’s patent claimed a drug composed of mixing tenofovir disoproxil “and another active ingredient”.

“This was extremely broad. So much so, that following this, similar claims were often referred to as ‘a Gilead claim’”, he said.

In the Gilead decision, the CJEU essentially said that patent  must “expressly or specifically” refer to the product it claims.

“I would argue that open language like ‘another active ingredient’ is not an express or specific reference,” he said.

Failing this, the CJEU said each of the active ingredients must be specifically identifiable by the information in the patent by a person skilled in the art.

In the US, a PTE regime exists. This differs from SPC regulation, as the extension compensates the patent owner for time lost during the regulatory review period that most drugs are subject to.

For example, if a patent has been granted but the product hasn’t come to market because it is still being reviewed by the US Food and Drug Administration (FDA), the patentee may be eligible for a PTE.

This is calculated by looking at the regulatory review period and subtracting time where the applicant didn’t practice due diligence, i.e not submitting documents on time.

Scott Burwell, a partner at Finnegan in Virginia, said these PTEs are subject to caps.

“The PTE can’t last for more than five years after the patent expiration date, or for more than 14 years after the approval from the FDA,” he said.

“It also differs from the EU SPC protection as products other than pharmaceuticals can obtain extension, such as medical devices and food additives,” he said.

It is similar to the EU regulation in that each product can only be subject to one PTE.

In Japan, patent extension laws also exist.

The law in Japan is similar to the US PTE in that an extension is granted to compensate for the period in which it was “not possible for a person to work the patent invention due to the need to ensure safety”, Takeshi Komatani, a patent attorney at Shusaku Yamamoto in Japan said.

However, while pharmaceuticals and agricultural chemicals are included, medical devices are excluded from extended protection.

There are also laws covering who can apply for an extension.

Only the patent owner can be granted a PTE. Even in the pharma industry, where licencing is common practice, licensees are prohibited from filing for an extension.

In a scenario where a licensee obtained regulatory approval to sell the product in Japan, it is still the patent owner who must file for an extensinsion based on the approval.

Restrictions on the number of PTEs do not exist, so applicants may file for as many PTE’s as they like for the same product, but a cap of 5 years of patent protection from the date of expiry applies.

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