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The Korean Supreme Court considerably softens the inventiveness standard for selection inventions
09/07/2021“Selection inventions” are inventions covering a claimed compound, species, or subgenus encompassed by a range or genus already known in the prior art. Before the Supreme Court rendered its decision in this case, South Korea had unusually strict inventiveness requirements for selection inventions. Selection inventions were found to be inventive only if the claimed species or subgenus (embraced by a prior art genus) possessed either qualitatively different effects or significantly different quantitative effects from that of the prior art genus. See e.g., Supreme Court, 2001Hu2740 (rendered April 25, 2003).
In the present case, the Supreme Court lowered the bar for determining inventiveness of a selection invention by requiring that the inventiveness determination of a selection invention be the same as any other type of patent claim. A selection invention will now be deemed inventive if it is difficult to organically combine the elements of the prior art to arrive at the selection invention as a whole or if the selection invention achieves any particular technical effect. In addition, the technical effects can be shown by experiments conducted after the filing date so long as the experiments strictly follow the information disclosed in the written description.
Case Background
The present case relates to Korean Patent No. 0908176 (“the ‘176 Patent”) titled “Lactam-Containing Compounds and Derivatives Thereof as Factor Xa Inhibitors.” The chemical compounds recited in claim 1 cover the active ingredient named Apixaban, which is used to prevent blood clotting and is commercially available as Eliquis from Bristo-Myers Squibb Korea.
Prior art reference WO00/39131 (“the ‘131 Patent”) also disclosed Apixaban through a general chemical formula. However, the skilled artisan needed to undergo the following steps using the general chemical formula to realize the compound covered by the ‘176 Patent: (i) select one parent compound among 66 different patent compounds disclosed in the ‘131 Patent; (ii) simultaneously select all the correct substituents; and (iii) combine the parent compound selected in (i) with all substituents selected in (ii).
Theoretically, the chemical formula disclosed in the ‘131 Patent encompassed hundreds of millions of compounds depending on the structure of a parent compound and combinations of substituents thereto.
The patent dispute at issue started with an invalidation trial of the ‘176 Patent before the Korean Intellectual Property Trial and Appeal Board (the “KIPTAB”). The KIPTAB found that the ‘176 Patent was a selection invention and lacked inventiveness, as the specification did not provide any qualitatively different or quantitatively significant effect. On appeal, the Patent Court sided with the KIPTAB. The patent owner then appealed the Patent Court’s decision (affirming the KIPTAB’s decision) to the Supreme Court.
In the meantime, the patent owner also filed a separate proceeding with a district court seeking a preliminary injunction enjoining the petitioners of the invalidation trial from infringing the ‘176 Patent. Interestingly, before the Patent Court affirmed the KIPTAB’s decision, the district court held that the ‘176 Patent did not lack inventiveness and was valid.
On April 8, 2021, the Supreme Court found that the ‘176 Patent did not lack inventiveness, as, among other grounds, it was difficult to organically combine the elements of the ‘176 Patent as a whole from the disclosure of the ‘131 Patent. Based on its finding, the Supreme Court vacated the lower court’s decision and remanded the case to the Patent Court.
| Invalidation Trial | Preliminary Injunction Proceeding |
Supreme Court | Supreme Court, 2019Hu10609, April 8, 2021
Vacating 2018Heo2717 |
|
Intermediate Court | Patent Court, 2018Heo2717, Mar. 29, 2019
Affirming 2015Dang1184-1186, 1774- 1775 |
|
KIPTAB / Trial Court | KIPTAB, 2015Dang1184-1186, 1774- 1775, Feb. 28, 2018
Holding the ‘176 Patent is invalid for lacking inventiveness | Seoul Central District Court, 2018Ka-Hab20119, June 27, 2018
Holding the ‘176 Patent is valid, as it does not lack inventiveness |
Holding
1.The Inventiveness Determination for a Selection Invention
The Supreme Court held that the requirement of inventiveness should be no different in selection invention cases compared to other categories of patentable inventions. Based on the foregoing, the Supreme Court found that even though the ‘176 Patent does not have any qualitatively different or quantitatively significant effect compared to the ‘131 Patent, the ‘176 Patent nonetheless did not lack inventiveness, because it is difficult to organically combine the elements of the ‘176 Patent as a whole from the disclosure provided by the ‘131 Patent.
The Supreme Court distinguished this case from the 2001Hu2740 case by explaining that the 2001Hu2740 case did not analyze whether or not it was difficult to organically combine the elements of a claimed invention, because the analysis was simply unnecessary under the relevant facts. The Court clarified that this does not mean an inventiveness determination of a selection invention can be rendered without analyzing whether or not it would be difficult to organically combine the elements of such selection invention.
2.of Effects of an Invention during the Inventiveness Determination
The Supreme Court also noted that it is important to consider improved effects of a selection invention when determining inventiveness.
For example, an invention may lack inventiveness if selecting one option from multiple options is done in an arbitrary manner without any technical significance, and improved effects of the invention can be an important indicator of whether a particular selection was arbitrary or based on technical significance. Moreover, significant improved effects of an invention may suggest or show difficulty in combining the elements of the invention as a whole from the prior art. Lastly, even if it is determined to be easy to combine the elements of an invention as a whole, the invention may still have inventiveness if it has qualitatively different effects or significant differences in quantitative effects.
In regard to the method of identifying improved effects, the Supreme Court explained that improved effects should be determined based on what a person of ordinary skill in the art (“POSITA”) can understand or reasonably infer from the description disclosed in the specification. If, however, improved effects described in a specification appear unclear or questionable, the effects may be proven by conducting experiments after the filing date strictly in accordance with the written description.
3.Application to the Case at Hand
In light of the foregoing, the Supreme Court found that the ‘176 Patent does not lack inventiveness, because (i) it is difficult to organically combine the elements of claim 1 of the ‘176 Patent as a whole from the prior art, and (ii) the ‘176 Patent has improved effects according to the patent specification and experiment data, which were obtained from experiments conducted after the filing date of the ‘176 Patent. Particularly, in regard to its improved effects, the Court found that the ‘176 Patent improved the Xa inhibitory activity and selectivity, the pharmacodynamic effects on drug absorption, and the effects of combined treatment.
Implications of the Supreme Court Decision
1.Changed Standard for Determining Inventiveness of a Selection Invention
Prior to this decision, a selection invention had been deemed unpatentable since it is already disclosed in a prior art genus, unless it passed a stricter standard of patentability. In other words, a selection invention had been deemed patentable only if it provided a qualitatively different effect or quantitatively significant effect. However, after this decision, a selection invention will be able to receive patent protection if it is difficult to organically combine the elements of the selection invention as a whole from the prior art.
The decision of this case was not issued by an en banc court, which suggests that the Supreme Court is of view that this case did not overruled its prior decisions but merely clarified the holding of its prior decisions. However, regardless of the Supreme Court’s view, this case has certainly changed common practices in making an inventiveness determination for selection inventions.
More specifically, this case followed similar standards provided in the USPTO Manual of Patent Examining Procedure. According to MPEP 2144.08 II.A.4. and the case at hand, the following factors can be considered in making an inventiveness determination: (i) the size of the genus, (ii) the express teachings to support the selection of the species or subgenus, and (iii) the teachings of structural similarity.
2.The Written Description Support for Effects of Selection Inventions
To date, the Supreme Court has rendered two main decisions relating to the written description support relating to the effects of selection inventions. The first decision is Supreme Court, 2001Hu2740 (rendered April 25, 2003), which held that the general rule requires the description of a selection invention to provide a clear and unambiguous disclosure of qualitatively different effects or significant quantitative effects. However, the alleged effects may be proven by conducting experiments after the filing date if the description is unclear or questionable. The second decision is Supreme Court, 2008Hu736, 743 (rendered Oct. 15, 2009), which held that the written description support for effects of inventions is met when there is a detailed description showing a qualitative difference or significant quantitative difference. Between the two decisions, the first decision was considered to be setting a relatively lower bar for the written description support relating to effects of inventions. As the Supreme Court in this case expressly cited the first decision but not the second decision, it can be reasonably inferred that the Supreme Court decided to shift toward a relatively less demanding written description support for effects of selection inventions. Also, instead of requiring the effects to be described in a clear and unambiguous manner, the Supreme Court held in the current case that effects should be determined based on what a POSITA can understand or reasonably infer from the description.
However, the above holding may be narrowly interpreted and only allow selection inventions with the elements that cannot be easily combined as a whole to be analyzed under the less demanding written description support for effects. If the elements of a selection invention can be easily combined as a whole, then the selection invention may be subject to the stricter written description support for effects.
3.The Novelty Requirement
Prior to the case at hand, the Supreme Court has held that a selection invention lacks novelty if a prior art genus specifically discloses the claimed species or subgenus. Supreme Court, 2008Hu736, 734.
In the case at hand, the Supreme Court decided not to review the novelty issue, because the issue was not at dispute. Accordingly, a determination of novelty will continue to follow the decision of the 2008Hu736, 734 case.
4.Implications
The case at hand essentially clarified that the patentability of a claim to a specific compound or subgenus embraced by a prior art genus should be analyzed no differently than any other claim for purposes of inventiveness and the written description support relating to effects of inventions. The common practice and strategy for patent owners prior to this case was to argue that their patent at issue was not a selection invention so that they may show the patentability of their patents based on less stricter standards. On the other hand, petitioners for invalidation trials argued otherwise so that the patent would be subject to a stricter standard for determining patentability. Those common practices are likely to decrease after the case at hand. There will be less of a need to dispute whether or not a patent at issue is a selection invention, as patentability of selection inventions will now be analyzed no differently from other inventions.
While the Supreme Court clarified inventiveness issues relating to selection inventions, it also introduced at least a couple of new questions.
In making an inventiveness determination, the Supreme Court held that claim 1 of the ‘176 Patent does not lack inventiveness, as (i) it is difficult to organically combine all elements of claim 1 as a whole from the prior art, and (ii) the ‘176 Patent has achieved improved effects. The Supreme Court, however, did not specifically define the term “improved effect.” The Court merely explained that improved effects may be an important indicator for distinguishing between an arbitrary selection (that lacks inventiveness) and a selection with technical significance (that is inventive). This may mean that an invention involves an arbitrary selection if the invention does not have any improved effects. In light of this interpretation, it can be reasonably concluded that one should show improved effects as evidence or indicator of difficulty in combining elements as a whole particularly with respect to selection inventions or any other inventions in the chemistry sector.
In addition, the Court added that improved effects could be proven by conducting experiments after the filing date strictly in accordance with the description of the specification without elaborating on the meaning of “strictly in accordance with the description.” While we expect that the exact meaning would be established by the courts in future cases, petitioners of an invalidation trial may consider arguing that the patent owner’s experiment was not “strictly in accordance with the description.
Lastly, there were, to date, only three Supreme Court cases where selection inventions were held to be patentable (i.e., Supreme Court, 2002Hu1935 (rendered Oct. 24, 2003), Supreme Court, 2010Hu3424 (rendered Aug. 23, 2012), and Supreme Court, 2014Hu1631 (rendered May 11, 2017)), but this landscape is likely to change. This case is likely to support patentability of selection inventions and likely encourage an increase in patent filings for selection inventions, especially where a prior art genus encompasses a high number of options for the selection of species or subgenus.
By Yulchon, Korea, a Transatlantic Law International Affiliated Firm.
For further information or for any assistance please contact korea@transatlanticlaw.com
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