Korean IPTAB Issues Leading Decision on Patent Term Extension (PTE) - Enforceable Scope Related to Medicinal Use

Thanks to Sang Young LEE and Kevin Kyumin LEE of Kim & Chang for some news from Korea - reproduced below.  There is no published decision available yet, and we will post it once it appears. 

"In contrast to some foreign jurisdictions where the patent scope during PTE covers all types of use, Article 95 of the Korean Patent Act stipulates that PTE patent scope should be restricted to the specific use of the approved originator product.  It was generally considered that the use of medical inventions should refer to the target disease of the approved products but there has been no judicial precedent supporting how Article 95 should be interpreted on this issue.

This changed on July 1, 2020 when the Korean Intellectual Property Trial and Appeal Board (IPTAB) rendered a historic decision regarding the type of "use" that is considered within the enforceable patent scope during the PTE of a pharmaceutical compound patent.  Galvus® (API: vildagliptin), a type 2 anti-diabetic drug of Novartis, has five different types of dosage regimens (or efficacy and effect under the Korean translation).  Utilizing the fact that Novartis filed a PTE application based on only one approved efficacy and effect, three Korean generic companies filed scope confirmation actions claiming that their products did not fall within the patent scope because they had carved out the efficacy and effect first filed by Novartis as the basis for the PTE.  They argued that the patent scope during the PTE should be limited to the first approved efficacy and effect only, and that the later approved four efficacies and effects were not covered.

An expanded five-member panel of the IPTAB held that the use (and therapeutic effect) that is within the patent scope of the compound PTE is not limited to the first efficacy and effect, and that the generic's products were within the scope of the patent during PTE ruling in favor of Novartis.

The IPTAB's detailed reasoning was as follows:

l  If the scope of a patent during PTE is restricted to specific items of an approved product underlying the PTE (first approved effect and efficacy in this case), it becomes easy for generic companies to circumvent the patent during PTE when it relied on most of the approval data of the original products in gaining approval of its product.  This violates the purpose of the PTE system which is to compensate the non-practicing period of the patentees.

l  The Supreme Court held in a previous case ("Vesicare® case") that the patent right during the PTE should not be limited to the specific items as approved.  The Vesicare® case involved the issue of whether patent scope during the PTE for a compound patent is limited to specific salt forms of the approved product.  The Supreme Court held that the patent scope during the PTE should be determined based on the active ingredient, therapeutic effect, and use of an approved product underlying the PTE and not limited to the specific items as approved.

l  Compound patents during PTE should be more broadly protected than dosage regimen patents considering the different technical significances (meaning that a dosage regimen as approved as efficacy and effect should not limit the scope of compound patents).

l  The efficacy and effect in a marketing approval is governed by regulatory laws and is dependent on various factors including the type of disease and approval schedule, etc.  Thus, it is unreasonable to confine the scope of a patent based on efficacy and effect, which has a different legislative focus from patent law. 

The IPTAB decision can still be appealed to the Patent Court so is not yet the final say on this issue.  However, we believe this is a significant first step in improving understanding in the patent system of how the use of a medical invention should be defined during PTE, and has the potential to affect many originator pharmaceutical companies that rely on PTE to protect their products.  The IPTAB rejected the generic's efforts to unjustly narrow the PTE scope, and thereby laid the groundwork for originators to protect their legitimate interests from generic challenges as well as preserve the originator drug price after generic entry."

Santen ends Neurim-style SPCs

The wording of Article 3d of the SPC Regulation requires that the SPC application must rely on “the first authorisation to place the product on the market as a medicinal product”. This always suggested that a marketing authorisation granted for a new indication of a previously approved active ingredient could not be relied upon as the basis of an SPC for the patent directed to the new medical use.

However, based on a purposive construction of the Regulation, the CJEU decision in Neurim in 2012 opened the door to just that possibility.

Unusually, the CJEU has now reversed its own Neurim decision in the Santen decision C-673/18 issued on 9 July 2020. A later MA to a new indication cannot be used as the “first MA” supporting an SPC on a new medical use of the same active ingredient. The Santen decision states:

“Article 3(d) of [the SPC Regulation] must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.”

Neurim was always the problem child, out of step with earlier CJEU decisions, and national patent offices struggled to know how broadly to apply it. In Santen, the CJEU expressly now disapproves of the Neurim logic (see paragraph 53 of the decision).

In reaching its decision the CJEU (sitting in Grand Chamber with 13 judges) first concluded that the definition of an active ingredient under Article 1b of the SPC regulation does not import any use-limitation:

"the fact that an active ingredient, or a combination of active ingredients, is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product where the same active ingredient, or the same combination of active ingredients, has been used for the purposes of a different, already known, therapeutic application".

As a result, Article 3d of the regulation must then refer to the first MA for any use of that active ingredient as a medicinal product:

"In addition, in the light of the strict definition of the term ‘product’ within the meaning of Article 1(b) of Regulation No 469/2009, .. the analysis of the wording of Article 3(d) of that regulation presupposes that the first MA for the product as a medicinal product for the purpose of that provision means the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue (see, to that effect, judgment of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 34), irrespective of the therapeutic application of that active ingredient, or of that combination of active ingredients, in respect of which that MA was obtained."

So, the Neurim logic appears to be dead.

Crucially, any products protected only by SPCs based on second or further medical use patents, and relying on a second, or later, MA for that active, may now be vulnerable to immediate generic competition.