A Potpourri of AIPLA Legislative Comments — And Other Developments

potpourri

The American Intellectual Property Law Association has once again made its comments on proposed changes to Chinese IP legislation (laws, regulations, rules, examination guidelines,  judicial interpretations, etc. ) available to this blog.

Attached are the AIPLA’s response to the request for comments to revision of the trademark law in China (商标法修改公开征集意见) first published by SAIC.  SAIC is now a part of SAMR – the State Administration for Market Regulation. It had published a public solicitation of ideas for revising the trademark law on April 2, 2018, with a due date for comments of July 31, 2018.  AIPLA’s comments primarily focus on providing clarifying and strengthening legislation regarding bad faith trademark applications and registrations.

AIPLA has also commented on the proposed patent validity rules  of the SPC on administrative patent litigation (最高人民法院关于审理专利授权 确权行政案件若干问题的规定(公开征求意见稿)).  This judicial interpretation was previously discussed in this blog, with a translation by the Anjie law firm.  Additionally, here  is the Chinese version of these comments.

Finally, AIPLA has commented on the special approval procedure for innovative medica devices (创新医疗设备特别批准程序(修订稿)) which was first published for public comment on May 7, with a closing date of June 15.   Here is a text of the draft approval procedures in Chinese.

In a related legislative development, the recent dismissal of party secretary Bi Jinquan of the SAMR due the tainted vaccine scandal may also impact reforms that BI had spearheaded, which included pharma-related IP reforms (patent linkage, regulatory data protection, etc).   Commissioner Bi formerly served as the leader of China’s Food and Drug Administration.  An August 20, 2018 notice of the State Council  (no. 83) on deepening reform in China’s medical sector ominously omits any mention of patents or IP reform.  国务院办公厅关于印发深化医药卫生体制改革2018年下半年重点工作任务的通知, (国办发〔2018〕83号.  The next place where we might see the continued life in these reforms is in the proposed revisions to China’s patent law, which the National People’s Congress had tabled for completion by the end of 2018 as noted in its 2018 workplan  (全国人大常委会2018年工作要点).  A first draft of the revised patent law is needed as early as late August/early September 2018 in order to meet the NPC’s deadline.  One much anticipated pharma-related concern in the new draft, which would also support China’s efforts to develop both an innovative and high quality pharma sector, is incorporation of “artificial infringement” by which a request for regulatory approval would be deemed an infringing act in order to support a patent linkage regime.

 

Note: The above photo by Unknown Author is licensed under CC BY-NC-ND

CFDA’s New Policies to Promote IP and Innovation in the Pharma Sector

As noted previously in this blog, the death of patent linkage which had been heralded by draft Drug Registration Rules appears to be premature.  In fact, the China Food and Drug Administration has stated that it is interested in developing a more robust patent linkage system.  On May 12, 2017, the CFDA published a draft policy announcement soliciting public comment on developing a more  IP environment for innovative drugs, including more robust patent linkage and addressing other areas, such as data exclusivity.

Patent linkage provides a “linkage” between pharmaceutical regulatory approvals and patent infringement, whereby regulatory approval is denied until the relevant patent is expired or determined to be invalid or not infringed.  A linkage system for a country like China would provide greater stability in patent enforcement for both innovators and generics, by insuring that innovators are amply protected by their innovation, and generic companies are afforded opportunities to seek regulatory approval based on proof that a patent that might otherwise prevent their entry into market is invalid or not infringed by the generic companies’ product.  The US experience with Hatch Waxman, which established our patent linkage system is that it has, in the words of former USPTO Deputy Director Teresa Rea helped “ generics account[]for 75 percent of all prescribed drugs, saving consumers and society more than $1 trillion over the last 10 years”.

This draft policy also contemplates additional improvements on data exclusivity, protecting confidential information in its procedures and developing what appears to be an “Orange Book” type system for disclosing relevant patents, as well as the periods for data exclusivity in new pharmaceutical marketing approval applications.

Providing enhanced data exclusivity protection appears to be an effort to implement a 2012 JCCT commitment regarding what constitutes a “new chemical entity” for purposes of regulatory data protection.  Certain foreign countries, such as Chile, provide data exclusivity within a window of overseas product launch, which this draft appears to borrow from to the extent of a commensurate reduction of the period of data exclusivity based on delays in introducing novel pharmaceutical products beyond a one year window into China. The draft thereby forces the hand of innovators to introduce their product expeditiously into the Chinese market.

Additional protection of confidential information in government proceedings appear to be consistent with proposed amendments to China’s Anti Unfair Competition Law and JCCT commitments.   In addition, the enhanced protection for data exclusivity is also consistent with proposed changes in the AUCL that remove the “practical applicability” requirement which by law would deny trade secret protection to experimental failures.

The draft policy does not discuss how the courts might handle data exclusivity or infringement issues, including the role of patent administrative agencies, or other aspects related to determinations of infringement that affect marketing approvals. To fully implement these policies, changes would likely need to be made in a number of laws or regulations, as well as judicial practices.  As an example, China’s patent law made need to require that a request for marketing approval would need to constitute infringement of an innovator’s patents. It is also unclear to me what courts may have jurisdiction over these matters, and if there are administrative and/or civil remedies to be made available for the various obligations that these policies propose.

Attached is a  rough, draft translation of CFDA Bulletin No. 55.  Also attached is a translation by Allen & Overy. Comments on this policy document are due by May 25 although the deadline for consultations is June 10.

All told, the draft shows an increased interest by CFDA in IP issues  in one of the most important markets in the world.  Nonetheless, as David Shen and Yijun Ge of Allen & Overy’s Shanghai office point out in their recent posting, another trend balanced against improved patent protection is generic consistency in pharmaceutical approvals.  This is also part of the drug approval reform which now mandates adherence to bioequivalence with an innovator’s approved drug, rather than previous procedures which required conformity to a national standard.  Thus, according to these authors, while an effective patent linkage system would strengthen overall patent protection, changes in bioequivalence requirements could also result in lowering the price of off-patent drugs through  different means.  As they point out: “most people believe that they [generics] will directly compete with off-patent drugs during the tendering process, without the current protection of “patented” status for the latter”.

In another development, exactly one week before this important CFDA policy document was released, the World Health Organization released its report  “China Policies to Promote Local Production of Pharmaceutical Products and Protect Public Health” (May 5, 2017).  The IP chapter of this apparently unrelated report focuses on technology transfer (Bayh-Dole), genetic resources, compulsory licensing, data exclusivity, and the need to improve domestic patent policy.  The introduction views patents as efforts to “monopoliz[e]” medicine, rather than (in my view) of taking a more pro-competition stance of recognizing that patents provide incentives to innovation and not necessarily monopolies and policies such as patent linkage strike a balance between generics and innovative companies to insure stability and competition in the market place.   In this sense, the report does not appear to anticipate the important new CFDA policy discussed above.  The words “patent linkage” do not appear in the IP section of this report, although the report does reference in an introductory footnote the “Guiding Opinions for Promoting Healthy Development of the Pharmaceutical Industry” (March 11 2016) which has a goal that generics are launched for 90 percent of drugs with expired patents by 2020.  This could be read to infer that generics are not launched when infringement has been determined, such as according to these proposed CFDA linkage policies.   In addition, the report does not consider issues the importance of post filing supplementation of data for China’s innovative industries and the role of China’s innovative companies in promoting reforms that improve IP.

Please provide any comments or suggestions to improve the draft translation or these personal observations.

Updates: afternoon of May 14, 2017 and morning of May 17, 2017.