CJEU (C-179/16, Hoffman-La Roche): infringement of pharmacovigilance obligations may give rise to EU competition law liability

On 23 January 2018, the European Court of Justice (“CJEU”) issued its preliminary ruling in the Hoffman-La Roche case, where it had the chance to address some major issues regarding competition law in the pharmaceutical sector. The request for a preliminary ruling had been referred by the Italian Consiglio di Stato in relation to a cartel case where the Italian Competition Authority had fined Roche and Novartis for a total amount of 180 million euros.

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SEP licensing and competition law: DOJ and European Commission bless a new “patent-friendly” approach

Recently, the debate on the applicability of competition law to the licensing of standard-essential patents (SEPs) has come to a turning point. Indeed, both the US Department of Justice (DOJ) and the European Commission are making an attempt to provide a final answer to the following questions:

1) should the conduct of SEP-holders be subject to the application of competition law?

2) should standard-setting organisations (SSO) provide guidance on the meaning of “fair, reasonable and non-discriminatory” terms (FRAND), or would that guidance amount to a price-fixing cartel?

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Japan considers introducing a new ADR system with a compulsory license for SEPs

In April, 2017, Ministry of Economy, Trade and Industry (METI) in Japan revealed a report on a new design of an IP system taking the 4th industry revolution into consideration. The report discloses the possibility of introduction of a compulsory license on SEPs (Standard Essential Patents) in upcoming several years.

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Recent development in Japanese patent case law; the doctrine of equivalents and the Supreme Court judgment in the Maxacalcitol case

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In my previous post, I wrote about an IP High Court judgment (the Maxacalcitol case) regarding doctrine of equivalents in patent infringements in Japan. The defendants appealed against the IP High Court judgment and the Supreme Court handed down the final judgment on 24th March, 2017. Continue reading “Recent development in Japanese patent case law; the doctrine of equivalents and the Supreme Court judgment in the Maxacalcitol case”

Revised Patent Examination Guidelines in China welcome more patents on business models

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Last October, the State Intellectual Property Office of China (SIPO) released draft revisions to its Guidelines for Patent Examination for public consultation (see my earlier post). This month, SIPO published the final text of the revised Guidelines, which will enter into force on 1 April 2017. In comparison to the draft, the final version remains substantially unchanged. This may be a sign of support from the stakeholders. In fact, the proposed revisions received a quite good press immediately after their release, even when it comes to the part of revisions regarding patents on business models, which have been and probably are still one of the most controversial aspects of the IP system in many other countries such as the U.S.

As the SIPO explicitly stated, the planned revisions are aimed to strengthen the IP protection for innovation in emerging fields such as Internet, e-commerce, big data and to improve the IP protection system for business models. This emphasis reflects the state of innovation in China, where indigenous businesses have been so far quite successful in developing innovative services and products in these emerging fields. While it can be debated whether an expansion of patent protection into the arena of business models would indeed do more good than harm to the innovation, the objective of the Chinese policymakers is clear: to promote business model innovation through more IP protection.

While it remains to be seen in long term whether the above policy objective can be achieved, it is for individual inventors and businesses more interesting what immediate changes in practice will come out of the planned revisions. So, let’s first take a look at the revision itself. Continue reading “Revised Patent Examination Guidelines in China welcome more patents on business models”

The scope of patent with an extended term became clearer with three concrete standards provided by the IP High Court in Japan

A patent term may be extended if there is a period during which a patented invention is unable to be worked until a marketing authorization has been granted (For further information, see here). However, there was, until recently, no case law in Japan on the interpretation of the scope of patent with an extended term, and high uncertainty as to patent infringement by generic drugs was a big issue in the pharmaceutical industry. On 20th January, 2017, the IP High Court’s judgment (grand panel) was handed down, answering this issue by establishing three concrete standards. This judgment attracts great attention of generic companies and will boost their marketing of generic drugs because these standards contributed to clear away the uncertainty of patent infringement.

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Recent developments on the admissibility of patent term extension in Japan

Drugs are not allowed to be marketed without a marketing authorization. Taking into account the investment on R&D for a new drug and the necessity to recoup such investment, the patent term may be extended by a period not exceeding 5 years if there is a period during which the patented invention cannot be worked. Later in this post, I will discuss the judgment of the Japanese Supreme Court in 2015, which caused the guidelines on patent term extension to be significantly amended.

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Sad to CJEU Go? What Brexit Could Mean for Intellectual Property (part 1 of 2)

Guest post by William Wortley*

It is over six months since the United Kingdom (UK) decided to leave the European Union (EU). The uncertainty surrounding the timing and form of the exit remains undimmed and much remains unknown about how IP rights will be affected. This week’s statement on Brexit by Theresa May make it an excellent time to revisit what the referendum result could mean for IP rights.

Patent Rights

Immediately after the Brexit vote, questions were raised about the implications for the Unified Patent Court (UPC). To the surprise of some commentators, the UK announced its intention to ratify the UPC agreement on 28 November 2016, stating that the UK would continue to work with the preparatory committee to bring the UPC into force as soon as possible. Continue reading “Sad to CJEU Go? What Brexit Could Mean for Intellectual Property (part 1 of 2)”

Is the product-by-process claim “dead” in Japan?

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After the Supreme Court in Japan handed down a very important judgment in 2015 on the scope of the Product-by-Process (“PBP”) claim, and its doubtful validity concerning the clarity requirement (Pravastatin sodium case, a drug lowering the cholesterol in blood), the authorities commented that the PBP claim is “dead” because almost all PBP claims would be fairly likely to be invalidated according to the Supreme Court’s strict judgment on its patentability. However, very recently, the IP High Court handed down a relevant judgment on this issue, wherein it basically followed the Supreme Court judgment but limited the application of the Supreme Court’s judgment to the “true” PBP claim.

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The strategies for patent litigation under the double track system in Japan

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In my previous posting (here), I described advantages and problems in the two systems, i.e., the double track system and the bifurcation system in patent litigation. In this posting, I, as a Japanese patent litigator, would like to introduce several practical strategies for patent litigations under the double track system in Japan in the form of Q&A.

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