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How Does the IP Court Determine if an Example in the Specification Should Be Excluded from the Patent Scope?

Hsiu-Ru Chien/Elina Yu


During patent infringement litigation, the literal interpretation of a patent claim can be a major focus of conflict among the parties.  A number of principles regarding the interpretation of patent claims are clearly stipulated in Paragraphs 4 and 5 of Article 58 of the Patent Act.  For example, “The protection scope of an invention patent shall be determined by the claim(s), and the description and drawing(s) may be considered a reference when construing the claim(s).” However, whether the specification, in particular, the examples provided therein, can always be deemed to fall within the scope when construing the scope of the claims, is thus far in dispute under current practice.  The IP Court's judgment, 2018 Min Zhuan Shang Zi No. 26 judgment, ruled on 6 February 2020, considered that it can be seen from to the description of the specifications and the applicant’s response of the subject patent during the prosecution process that the patentee intentionally subtracted the specific example from the construes of patent claims.  Therefore, the judgment considered that the accused infringing products do not fall within the scope of the subject patent.  The facts of the case and the reasoning are summarized as follows:
 
Pharma A, who is the patentee of the subject patent “Solid Dosage of Combination Medicine for Treating Cardiovascular Disorders,” filed litigation to claim that the Drug C (the subject drug), manufactured by Pharma B, fell within the scope of Pharma A’s patent.  Claim 1 of the subject patent is directed to a solid dosage of combination medicine for treating cardiovascular disorders comprising as active ingredients combination of benazepril or its pharmacologically acceptable salt and amlodipine or its pharmacologically acceptable salt, wherein the active ingredients are homogenously mixed.  Pharma B argued that there is an obvious layer between the two aforementioned active ingredients (i.e., benazepril and amlodipine), and thus it cannot be considered "homogenously mixed."  In this regard, Pharma A contended that since the Example 4 set forth in the specification of the subject patent was also a double-layered tablet, it can be understood that the description of “the active ingredients are homogenously mixed” in claim 1 shall be interpreted as that of the active ingredients contacting each other (i.e., mixed completely or partially) with no separation between the same.  Pharma A also argued that they have never excluded or waived the form as described in Example 4, showing the mutual contact of the double-layered tablet.  Therefore, if there is a “partially mixed structure" between the double-layered tablet, the subject drug shall still fall within the context of the scope of the claims.
 
After reviewing the specifications and the file history of the subject patent, the IP Court considered that, based on the content of the patent specifications, it was evident that the "homogenously mixed" state of the active ingredients reveals an identical composition and not any inhomogeneous distribution, separation or layering, in a random sampling analysis.  Moreover, according to the file history, it can be understood that the applicant (patentee) of the subject patent discloses that the subject invention should be considered different from the prior art (Citation 1, which is a double-layered tablet), and also that the subject patent brought up a completely different technical solution, which did not require a designed mutual separation between the aforementioned active ingredients.  In addition, in the response, the patentee contended only that the stability of the subject solid dosage can be evident from Examples 1 to 3, and nowhere contended that the Example 4 also belongs to the "homogenously mixed" solid dosage.  It can be seen that the solid dosage does not include the double layer form described in Example 4.  Accordingly, the IP Court dismissed the argument of Pharma A and considered that the subject drug, forming two different layers each of two active ingredients, is obviously different from the construed technical characteristic and accordingly does not infringe.
 
In view of the judgment, it can be seen that even though the patentee was simply “passively not arguing for a specific example to be included as the subject invention’s implementation forms” during the patent application process, it is still a possibility that the IP Court can consider this point a basis for interpreting the scope of the claims.



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