Case facts

For medical use patent, Paragraph 2, Articles 48-20 of Taiwan Pharmaceutical Affairs Act stipulates carve-out mechanism which allows generic drug license applicants who exclude the indication protected by medical use patent and are thereby inapplicable to the stipulation regarding the stay of drug permit issuance to be granted license after examination by the Central Competent Health Authority¹.

However, would amending the indications on package insert definitely avoid patent infringement successfully? Taiwan Intellectual Property and Commercial Court (IPCC) had determined that, despite TSH Biopharm had amended the package insert to exclude related indications, based on clinical practice for treatment, the amended package insert was not “medically logical” and therefore the drug of TSH Biopharm had infringed the patent right of ASTRAZENECA in the case ASTRAZENECA AB v. TSH Biopharm Corporation Ltd. (2021 Min Zhuan Su Zi No.9 Judgment).

Recently, the patent linkage case AstraZeneca AB v. TTY Biopharm Company Limited (2023 Min Zhuan Su Zi No.38 Judgment) also relates to the issue regarding description of package insert. The court rendered a judgment in favor of the generic drug maker, TTY Biopharm. In this case, the court considered not only the indications described on package insert of the generic drug but also the data of clinical trials combined with clinical practice for treatment and the requirement of being “medically logical” and therefore determined that “Gynsav solution for injection 50mg/ml (Fulvestrant)” (hereinafter referred to as the “disputed generic drug”) for which TTY Biopharm apply drug license did not fall within the approved and extended scope of Taiwan Invention Patent No. I259086 entitled “PHARMACEUTICAL FORMULATION ADAPTED FOR INTRA-MUSCULAR INJECTION” of AZ (hereinafter referred to as ‘086 patent).

Key points of judgment

We would introduce several key points of the court opinion in this case in the follows.

1. The indication of disputed generic drug is medication for second-line or subsequent treatment, which corresponds to the indications of patented drug before package insert amendment, and not the indications of first-line treatment for which the patented drug requesting for patent term extension (PTE).

The patented drug of AZ obtained drug license with new indications after supplemented by new data of clinical trials and was granted PTE based on said license, wherein the use is for first-line treatment. By contrast, the indication of disputed generic drug is medication for second-line or subsequent treatment, which corresponds to the indications of patented drug before the package insert amendment. Accordingly, since the new data of clinical trials was for first-line treatment, the scope of ‘086 patent during extended patent term shall not cover the indications of patented drug before the package insert amendment. Also, the data of clinical trials which second-line or subsequent treatment based on were distinct with that which first-line treatment based on. Therefore, the two subjects can be easily distinguished in terms of both clinical practice for treatment and clinical trials for medicine and therefore belong to different scope.

2. First-line, second-line or subsequent treatment can be clearly distinguished and the script of package insert of disputed generic drug did not refer to the clinical trials results of new indication described in the package insert of patented drug, which leaves no concern that it may imply that the disputed generic drug may be used for new indications for medical personnel.

Furthermore, the data of clinical trials referred in the script of package insert of disputed generic drug only supported the therapeutic efficacy of second-line or subsequent treatment and the script did not refer to the clinical trials results of new indication described in the package insert of patented drug, which leaves no concern that it may imply that the disputed generic drug may be used for new indications for medical personnel. The scope of patent right during extended patent term of patented drug was limited to First-line treatment. First-line, second-line or subsequent treatment can be clearly distinguished in terms of both clinical practice for treatment and clinical trials for medicine without needs to conduct specific diagnosis or specific tests. Therefore, there is no such thing as being unable to identify patients with indications, being hard to apply in treatment for patients practically, and therefore failing to be medically logical and inconsistency with clinical practice for treatment as in the case AZ v. TSH as AZ claimed in this case. 

3. “Off-Label Use” is the physician's personal behavior.

The court considered that “Off-Label Use” is the physician's personal behavior. TTY did not refer to the clinical trials results of the indication in the scope of extended patent right of ‘086 patent in the script of package insert of disputed generic drug and therefore did not suggest the medical personnel to use the disputed generic drug for the indication in the scope of extended patent right of disputed patent in the script of package insert. Also, there is no evidence demonstrating that TTY would publicize or promote disputed generic drugs for the indication in the scope of extended patent right of disputed patent. It is hard to determine that the disputed generic drug of TTY infringe the scope of extended patent right of ‘086 patent merely based on the physician's personal behavior of “Off-Label Use” or drug purchasing options or principles for partial medical institutions.

[1]Paragraph 2, Article 48-20 of Taiwan Pharmaceutical Affairs Act: the provisions related to the stay of drug permit issuance and the marketing exclusivity period under Articles 48-13 to 48-18 are not applicable to the application for a generic drug permit set forth in Article 48-12 if the following circumstances are met: