Newsletter

IP Practice: “Update of Patent Linkage System for Pharmaceutical Products in Taiwan”

We are pleased to announce the February 2018 issue of Sonderhoff & Einsel Taiwan IP Newsletter.

The Legislative Yuan (equivalent to the Japanese national Diet) passed a proposal for the partial revision of the Pharmaceutical Affairs Law on December 29, 2017. The revision and newly established articles are 26 in all, and data protection for new indications and a patent linkage system were introduced in accordance with this revision proposal. Patent linkage is a system whereby a country links drug marketing approval of a generic drug to the status of the patents related to the originator’s product.
The newly established patent linkage system in Taiwan is positioned to be a part of Taiwan’s Trade and Investment Framework Agreement (TIFA) and the Trans-Pacific Partnership (TPP), and involves the disclosure and registration of patent information on new drugs, declaration and announcement by generic drug applicants, challenges to patent rights and related correspondence, temporary suspension of the issuance of generic drug licences, and market exclusivity of generic drug manufacturers who first obtained a drug license.

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IP Practice: “Update of Patent Linkage System for Pharmaceutical Products in China”

We are pleased to announce the December 2017 issue of Sonderhoff & Einsel China IP Newsletter.

 

Patent linkage is a system where a country links drug marketing approval of a generic drug to the status of the patents related to the originator’s product. In China, there have been a series of regulations that have been released for public comment which indicate that China will soon be introducing a patent linkage system: on May 12,2017, the China Food and Drug Administration (CFDA) announced for public comment “Policies regarding the Promotion and Protection of Innovators’ Rights in Pharmaceutical Products and Medical Devices” (“Announcement No. 55”); 2) on October 8, the General Office of the CPC (Central Committee) and the General Office of the State Council of the People’s Republic of China published an “Opinion on the Promotion of Reformation regarding Examination and Approval System as well as Innovation of Pharmaceutical Products and Medical Devices” (“Opinion”) for extensive implementation of reforms; and 3) on October 23, the CFDA released for public comment “Administration Regulations for Registered Pharmaceutical Products” (“Proposal for Revision”).
This system hopes to ensure a stable supply of pharmaceutical products by taking the patent term of an original drug into consideration by, for example, negotiating with the original drug manufacturers prior to the approval of generic drugs. Since 2007, generic drug applicants are obliged to declare that their generic drug products do not infringe the patent right of the original drug. However, there is no mention of the punishment or penalty for non-conformance with this obligation. Since the CFDA is not capable of examining whether the generic drug infringes a patent right in response to the approval application for generic drugs, it is highly probable that the CFDA will approve the generic drug without clarifying the possibility of patent infringement. The linkage system will attempt to resolve these issues, but as commented below, the new set of regulations will still be insufficient and advantageous for generics as a whole. Therefore, generic drug manufacturers are expected to mount a more vigorous challenge to original drug manufacturers’ patent rights and original drug manufacturers are expected to file lawsuits in response to these challenges. Thus, disputes regarding patent rights are likely to increase further after introduction of the patent linkage system.

 

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IP Practice: “Revision of Administrative Regulations of Prioritized Examination”

We are pleased to announce the October 2017 issue of Sonderhoff & Einsel China IP Newsletter.

 

The average time period for a patent examination is currently 22 months in China, which is not necessarily long. However, considering the serious risk of patent infringement by copied products, there is a stronger need to ensure that patents are granted quickly. In addition to the PPH (Patent Prosecution Highway), the “Administrative Regulations of Prioritized Examination”, which was revised in 2017, has been used, mainly by Chinese applicants.

 

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IP Practice: “Announces White Paper on Judicial Protection of IP Rights in 2016”

We are pleased to announce the August 2017 issue of Sonderhoff & Einsel China IP Newsletter.

 

On April 27, 2017, the China Supreme People’s Court announced in the “Current Situation of Judicial Protection of IP Rights by the Supreme People’s Court (2016)” (“White Paper”), ten court decisions and 50 other representative court decisions regarding the judicial protection of IP rights. The Court’s White Paper provides an overview of the current judicial protection of IP rights in China, and hints at how such protection will be apportioned in the future.
Our newsletter focuses on four key Court decisions which deals with the patent production process, product manuals and instructions for maintenance as publication of prior art, disclosure of use and/or effect for chemical product patent applications, and specifications for gene sequence inventions.

 

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[IP Newsletter] New Types of Trademarks – First Registration of a Color Mark in Japan

We are pleased to announce the March 2017 issue of Sonderhoff & Einsel IP Newsletter.

 

New types of trademarks involving sound, movement, position, holograms, and color have been eligible for registration in Japan since the revision of the Trademark Law in 2015. As of February 20, 2017 a total of 1494 applications have been made, resulting in the registration of 207 of these new types of trademarks. On the other hand, none of the applications for color marks consisting solely of colors had been registered so far.
The Japan Patent Office (JPO), however, recently granted registration of two color marks on March 1, 2017 for the first time.

 

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[IP Newsletter] Decision by the IP High Court regarding average molecular weight and the clarity of claims requirement

We are pleased to announce the February 2017 issue of Sonderhoff & Einsel IP Newsletter.

 

The plaintiff, X, filed an invalidation trial against a patent held by defendant ROHTO Pharmaceutical
Co. Ltd. which claimed a violation of the clarity of claims requirement based on the lack of clarity of
the “average molecular weight” in the claims. The JPO, however, made a decision to maintain the
patent.
The plaintiff was not satisfied with the decision by the JPO and appealed to the Intellectual Property
High Court, which led to the JPO’s decision being denied.
The subject matter of the present patent was a “refreshing composition for ophthalmology”
containing chondroitin sulfate or a salt thereof which has a specific average molecular weight. The
defendant filed a patent application in 2005, and the establishment of the patent right was
registered in 2013.

 

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[IP Newsletter] Decision by the Grand Panel of Intellectual Property High Court (January 20, 2017) Regarding Scope of Extended Patent Right

We are pleased to announce the January 2017 issue of Sonderhoff & Einsel IP Newsletter.

 

The plaintiff, a Swiss pharmaceutical company called Debiopharm, requested an injunction against defendant Towa Pharmaceutical Co. Ltd. (a generic pharmaceutical drug manufacturer) and removal from the market of Towa’s alleged infringing product based on Debiopharm’s extended patent right.
The Tokyo District Court rejected the request for an injunction by the plaintiff, and the plaintiff appealed the court’s decision to the Intellectual Property High Court. The High Court affirmed the District Court’s decision that the effect of the patent right does not extend to the alleged product.
The subject matter of the dispute was “oxaliplatin,” an infusion drug used to fight colon cancer and other related cancers. The plaintiff filed a patent application in 1995 for the drug, and the production and distribution of the drug was started by a Japanese company, Yakult, in 2005. Later, more than ten companies including Towa started selling the generic drug after they had obtained approval from the Ministry of Health, Labor and Welfare. The plaintiff filed a lawsuit against Towa because the extended patent term had not expired at the time Towa began selling the product.

 

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Please click here for the judgment of Grand Panel Case announced on the website by the Intellectual Property High Court.

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[Law Newsletter] January 2017 Issue: 2017 Revision of Childcare and Family Care Leave Law and Implications for Employers

On January 1 of this year, amendments to Japan’s childcare and family care leave act became effective, and although the amendments are not substantial and more incremental in nature, it is important that employers implement these detailed changes into their company’s existing work rules so that the company will be in compliance with the act.  Please see article below for more details.
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