Two recent Supreme Court decisions on Product-By-Process claim in Korea

The Korean Supreme Court rendered two decisions regarding Product-By-Process claims this year.

In the first Supreme Court decision that was rendered on January 22, 2015 (Supreme Court case No. 2011 Hu 927, en banc), the Supreme Court held that the patentability of product by process claims must be based on the product itself without considering the process recited in the claim. By the en banc decision, the standard of patentability of product by process claim was changed from the old practice that allowed some exceptions. The new standard does not allow any exception to product by process claims. Therefore, new process limitations can NOT save patents claiming known or obvious products.

Furthermore, in the second decision that the Supreme Court rendered on February 12, 2015, (Supreme Court case No. 2013 Hu 1726), the Court held that the same principles set forth in the first Supreme Court case No. 2011 Hu 927 shall be applied for constructing product by process claims; determining the claim scope of product-by-process claims and judging infringement of product-by-process claims. The process in claims shall not be any limitation and thus the product made by any different process may infringe the product by process claim.

However, the Supreme Court allowed an exception: in case the scope of claimed invention is clearly, overly broad and unreasonable (e.g., unduly exceeds the scope supported by the specification disclosure as a whole), the claim wordings of the process may be used as limitations to the scope of the product by process claim.

In summary, (1) the product itself in claims shall be a basis for the scope of claimed invention without considering the process limitations; but (2) the claim wordings of process may limiting the scope of claims in case the constructed scope of product by process claims is clearly and unreasonably broad considering the specification.

The old law is that always, without exception, every wording of clams shall be regarded as limitations of claimed inventions and thus the process recited in product by process claim must be considered to determine the scope of claims for infringement judgment. Under the old law, the same product made by any different process does not infringe the product by process claim. The recent Supreme Court decision changing the old law will benefit patent owners.

Patent and Drug Marketing Approval (MA) linkage in Korea

As of March 15, 2015, the new Pharmaceutical Act was implemented for the Korean version of HWA of patent drug market approval (MA) linkage. The key features are summarized below.


1. Listing Drug patents in Green List – the Korean version of Orange Book

When an drug application has obtained a drug market approval (MA) from KFDA, the NDA holder must list patent information in the patent list (“Green List”) of KFDA. The Green List is similar to the Orange Book in the U.S., but is not the same. The deadline to list is 30 days from the receipt date of MA.

Unlike the Orange Book in the U.S., a NDA holder must list patents with the claim-by-claim basis in the Green List. Therefore, an applicant must specify every claim that covers the approved drug product and further an applicant must submit detailed explanation between each claim and the approved drug to KFDA.


2. Submitting a Certification of ANDA Applicant regarding Listed Patents 

Like the HWA, an applicant of a generic drug application (ANDA) must submit a certification regarding listed patents of Green List to KFDA. The patent certification is similar to those of HWA. For example, an ANDA applicant must file a Para. IV certification if he wants to launch a generic drug before the expiry date of listed patents. In such a certification, the generic drug applicant must provide a detailed statement demonstrating that the listed patent is invalid or that the generic drug does not infringe the listed patent.


 3. Notice to an NDA holder and a Patentee

Like the HWA, an ANDA applicant with Para. IV certification must notify the fact that an application for generic drug approval has been filed and the filing date of the application to the product approval holder and patent owner within 20 days of the application filing date. The obligation to notice will apply to an ANDA applicant who will launch their product before the expiry date of term of the listed patent. Otherwise, this provision does not apply to generic applicants who intend to launch their drug after the expiration of the listed patent.

4. 9-Months Stay on Generic Drug Entry

Within 45 days from the receipt date of the notice, the patentee may file: a patent infringement action or a scope confirmation trial before the Korea Intellectual Property Tribunal (KIPT) against the generic drug. Further, the patentee/NDA holder may request KFDA to take an action stay generic drug entry for 9 months from the receipt date of the notice from an ANDA applicant. Such stay shall apply only once to each generic applicant.

5. First Generic's 9-Month Marketing Exclusivity

The first applicant may obtain first generic marketing exclusivity for 9 months over other generics. The first applicant for this marketing exclusivity means : (a) to be the first filer of ANDA application or skinny (paper) NDA applications that are similar to 505(b)(2) applications in USA; (b) to be the first filer of patent invalidity petition or non-infringement declaration action before the IPT, and (c) to be successful in obtaining an IPT decision or a court decision from challenging actions against listed patents including a scope confirmation trial or invalidation action. The actions must be filed before filing a generic approval application.

6. Forfeiture of 9-Month Marketing Exclusivity

The first generic's marketing exclusivity shall be forfeited if the ANDA applicant failed to obtain MA within 9 months from the filing date; or failed to launch generic within 2 months from the date that the generic may be marketed.