Patent Protection of Medical Use Inventions in Taiwan

Though regulations of intellectual property rights in different countries tend to harmonise, each country has its own story and Taiwan is included. Similar to many other countries, Taiwan provides patent protection to medical uses. However, since “diagnostic, therapeutic or surgical operation methods for the treatment of humans or animals” are not patentable subject matter according to the Taiwan Patent Act, medical use inventions could only be claimed as kits or pharmaceutical compositions/combinations, or by Swiss-type claims as “Use of compound X in the manufacture of a medicament, wherein the medicament is for treating….”
 
First Medical Use
 
With respect to pharmaceutical composition claims, the patent authority of Taiwan used to require that all pharmaceutical compositions be limited by medical use(s) in claims, even if the claims are directed to first medical use. Such practices changed because Taiwan adopts All-Element-Rule in patent infringement assessment and the use indicated in the preamble of a claim, if any, is deemed as a limitation and an essential element for comparison. For instance, in Senetek PLC v. De-Sheng Pharmaceutical Co., Ltd. (Taipei District Court Case No. 93 Zhuan 3), the Taipei District Court stressed that the scope of the patent-at-issue (i.e., TW Invention Patent No. 076376) was limited to “pharmaceutical composition” for use in “treating a mammal to ameliorate the makeup appearance thereof” and did not cover any other uses, because the preamble of the claims of the patent read “A pharmaceutical composition for treating a mammal to ameliorate the makeup appearance thereof.” Accordingly, at present, a claim reading “a pharmaceutical composition comprising a therapeutically effective amount of compound X” is accepted by the patent authority of Taiwan (currently, Taiwan Intellectual Property Office, TIPO) for the first medical use.
 
Second Medical Use
 
As for the second medical use inventions, the TIPO used to accept such inventions to be claimed as “a pharmaceutical composition for use in treating (…description of the second medical use) comprising a therapeutically effective amount of compound X and a pharmaceutically acceptable carrier.” However, such subject matter is no longer accepted for second medical use inventions because, under current practices of the TIPO, the patentability of a substance would be determine by the substance itself, and the use(s) defined in the substance claims would not be considered. Accordingly, it is advisable to claim second medical use inventions by Swiss-type claims.
 
Medical Use for two or more active ingredients
 
However, if the medical use is directed to two or more active ingredients being administered simultaneously or separately, in addition to pharmaceutical composition claims, pharmaceutical combination claims, and kit claims, Swiss-type claims should not be forgotten and this could be reflected by such as Takeda Pharmaceutical Company Limited v. China Chemical & Pharmaceutical Co., Ltd. (Intellectual Property Court Case No. 97 Min-Zhuan-Shang 20).
 
In Takeda Pharmaceutical Company Limited v. China Chemical & Pharmaceutical Co., Ltd., the patent-at-issue (i.e., TW Invention Patent No. 135500, ‘500) relates to a pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics different from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes. The claims of ‘500 are directed to a pharmaceutical composition comprising two active ingredients, wherein the first active ingredient can be pioglitazone or its pharmaceutically acceptable salt, and the second active ingredient can be a biguanide, an insulin secretion enhancer or insulin. China Chemical & Pharmaceutical Co., Ltd. manufactured and sold medicine “Glitos” whose active ingredient was pioglitazone hydrochloride, a pharmaceutically acceptable salt of pioglitazone and the insert of “Glitos” recommended a physician or diabetic to use “Glitos” in combination with a biguanide, an insulin secretion enhancer or insulin. The Intellectual Property Court (IP Court, a specialised court established in 2008 for handling patent litigation) stressed that “Glitos” was not within the scope of ‘500 because it contained only one active ingredient and did not meet All-Element-Rule. Furthermore, though the insert of “Glitos” recommended the use of “Glitos” in combination with a biguanide, an insulin secretion enhancer or insulin, such recommendation did not infringe the patent rights of Takeda Pharmaceutical Company Limited because there was (and is) no indirect infringement or contributory infringement in Taiwan. Therefore, for a medical use involving two or more active ingredients being administered simultaneously or separately, it is advisable that, among others, a modified Swiss-type claim reading as follows be considered “Use of compound X in the manufacture of a medicament for use in combination with compound Y for …. (describing the medical use).”
 
Patent Term Extension
 
Taiwan Patent Act also includes patent term extension (PTE) system for medical use invention. PTE system was introduced to Taiwan Patent Act in 1994 and amendments were made in 2011 (2011 Amendments) and effected in 2013, and “Regulations for Ratifying Extension of Patent Term” (Regulations of PTE) stipulate the documents required for PTE and the calculation of the period to be granted extension.
 
According to the Taiwan Patent Act, where a regulatory approval shall be obtained in accordance with other laws and regulations for the exploitation of an invention patent involving a pharmaceutical or the manufacturing process thereof, if such regulatory approval is obtained after the publication of the concerned invention patent, the patentee may apply for one and only one extension of the patent term of said invention patent based on the first regulatory approval and the application for patent term extension shall be filed with the TIPO within three months following the date of receiving the first approval. Furthermore, under Regulations of PTE, the patent term to be extended includes (i) the period of domestic and/or foreign clinical trials conducted for obtaining a pharmaceutical approval from the central competent authority in charge of the business and (ii) the examining period for the domestic regulatory approval; however, the time period attributable to the requester’s omission of act, the overlapping time period between domestic and foreign clinical trials, and the overlapping period between the clinical trials and the examining period for the regulatory approval should be deducted from the period to be granted extension. In this respect, according to 1994 Patent Act, no period should be granted for extension if the total time for obtaining a pharmaceutical approval based on the aforementioned calculations was less than two years, while such two-year minimum requirement was abolished by the 2011 Amendments.
 
For medicaments such as Viagra, playing an important role on the finance of Pfizer, a clear understanding of the stipulations regarding the calculations of time period could be extended is important. The judgments made by the IP Court in 2015-2016 for the disputes between Pfizer and several local companies illustrate this matter.
 
In Pfizer, Inc. v. Nang Kuang Pharmaceutical Co., Ltd. (IP Court Case No. 103 Min-Zhuan-Su 55), Pfizer Ireland Pharmaceuticals v. Min-Yao Pharmaceutical Co. (IP Court Case No. 102 Min-Zhuan-Su 119), Pfizer Ireland Pharmaceuticals v. Nang Kuang Pharmaceutical Co., Ltd. (IP Court Case No. 102 Min-Zhuan-Shang 64), and Pfizer Ireland Pharmaceuticals v. Guang-Sheng-Tang Pharmacy (IP Court Case No. 101 Min-Zhuan-Su 112), the patent-at-issue was TW Invention Patent No. 083372 (‘372) and its patent term was extended in 2003 (i.e., earlier than 2011 Amendments) for two years and 50 days till 2 July 2016, however, all defendants alleged that the time period extended to ‘372 should be revoked because the period of time for obtaining the first approval was less than two years. In this respect, when calculating the period of time to be extended, the TIPO deemed the total time for conducting Australian clinical trials and obtaining a pharmaceutical approval from the central competent authority in Australia as “the period of foreign clinical trials conducted for obtaining a pharmaceutical approval from the central competent authority in charge of the business.” The aforementioned judgments confirmed that “period of foreign clinical trials conducted for obtaining a pharmaceutical approval from the central competent authority in charge of the business” referred to the period of the said foreign clinical trials, and the time period for obtaining a pharmaceutical approval in the said foreign country should not be included. Given that, the IP Court decided that the time period extended to ‘377 should be revoked because the total time period for obtaining the first approval for Viagra in Taiwan was less than two years. Accordingly, Pfizer’s claims of the removal of infringement or the prevention of threat of infringement were dismissed by the IP Court because the original patent term of ‘372 expired on 12 May 2014 already.
 
Exclusive License
 
Another issue to be highlighted for medical use patents is the royalty of an exclusive license agreement. According to the regulations of Taiwan Patent Act, an exclusive licensee may claim for damages and demand the removal of the infringement and the prevention of any threat of infringement on a patent, unless otherwise provided for in an agreement. For a medical use invention patent, if the patent owner is a foreign company, it is not unusual that the patent owner exclusively licenses its patent to a local company belonging to the same group. In this case, it is advisable that a proper royalty be indicated in the license agreement and this could be illustrated by Pfizer Ireland Pharmaceuticals v. Guang-Sheng-Tang Pharmacy (IP Court Case No. 101 Min-Zhuan-Su 112).
 
Taiwan courts currently adopt “no damage, no compensation” principle. That is, no compensation would be awarded by the courts if no actual damage could be proven. In Pfizer Ireland Pharmaceuticals v. Guang-Sheng-Tang Pharmacy (IP Court Case No. 101 Min-Zhuan-Su 112), Pfizer Ireland Pharmaceuticals alleged that the medicaments sold by Guang-Sheng-Tang Pharmacy as of 7 February 2012 fell within the scope of their TW Invention Patent No. 083372 (‘372) and such activity infringed on ‘372, Pfizer Ireland Pharmaceuticals thus claimed damage compensation for the time period as of 7 February 2012. The IP Court, however, considered no actual damage suffered by Pfizer Ireland Pharmaceuticals and dismissed such damage claims for the following reasons: Pfizer Ireland Pharmaceuticals exclusively licensed ‘372 to Pfizer Limited as of 1 January 2012, no royalty was shown in the license agreement between Pfizer Ireland Pharmaceuticals and Pfizer Limited, and Pfizer Ireland Pharmaceuticals admitted that no royalty was paid by Pfizer Limited for the exclusive license.
 
Therefore, for a patent involving exclusive license, a careful review of the license agreement should be made prior to bringing a patent infringement lawsuit. If no proper royalty is included in the license agreement, the licensee, if appropriate, could serve as the party to bring the lawsuit and claim damages.

Clarice T. H. Chen, Executive Partner of Rich IP & Co.
 
Conclusions
 
Biotechnology is one of the industries targeted by the new government of Taiwan as of 2016, with local companies are increasingly investing capital in this field. Hence, it is believed that significantly more patent applications would be filed by not only local companies but also foreign companies in Taiwan to protect the related R&D results. Nevertheless, to pursue proper protection of the R&D results and ensure the benefits of the parties, you need experts in Taiwan to have a clear picture of local regulations and practices.

Specialism:
Chemical-Related Patent (Including Pharmaceutical and Agrochemical Patent) Prosecution, Trademark Registration, Infringement Analysis, Portfolio Management, Transactions and Litigation

Education:
National Taiwan University, (MS and BS in Chemical Engineering)
Franklin Pierce Law Center, Research in Intellectual Property (IPSI & ALI)
Shih Hsin University (MS in Law)

Professional Positions:
Patent Attorney (1997～)
Trademark Attorney (2005 ~)

Editor for Taiwan area of Manual for the Handling of Applications for Patents, Designs and Trademarks throughout the World (The Brown Book (2005～))

Patent Counselor Assigned by Taiwan Intellectual Property Office for providing pro bono patent services (1998～)

+886-2-2713-1060
clarice.chen@richip.com