(By You Yunting) Recently, the Foshan Higher People’s Court in Guangdong province heard a case and determined that medical instruction manuals provided with pharmaceutical and other medical products do not receive copyright protection.
In my opinion, this viewpoint is worth discussing. Although it is probably reasonable to presume that the defendant, as a drug distributor, has less of an obligation to be vigilant about copyright infringement than that of the drug manufacturer, the overall scenario coupled with the court’s decision to find non-infringement seems correct. However, in regard to the question whether the copyright law should protect medical product instructions, we find ourselves in a rather difficult position; it is not that easy to come to a simple conclusion. In today’s post, we will introduce and share the aforementioned case, as follows:
Introduction to the Case:
The Plaintiff, Weierman Company, was the manufacturer of a new drug named Piperacillin Sodium and Subactm Sodium (the “disputed drug”) for Injection. The Plaintiff’s medical instructions were examined and approved by the China Food and Drug Administration (the “CFDA”). A non-involved party in the case, Erye Company, manufactured its own Piperacillin Sodium and Tazobactam Sodium for Injection, and its accompanying medical instructions were almost the same as those manufactured by the Plaintiff. After discovering that the Defendant, Hongxin Enterprise, sold Erye Company’s drugs, the Plaintiff Weierman Company filed a lawsuit alleging copyright infringement against Hongxin Enterprise, but not against Erye Company.
The defendant, Hongxin Enterprise, in its defense, argued that it had only acted in its role as an intermediary drug distributor; therefore, it would be nearly impossible for it to know whether said medical instructions infringed on another party’s copyright, and it would be incredibly inequitable for it to undertake full liability if infringement is found.
The court in its investigation discovered that Erye Company had previously applied for a registration with the CFDA for Piperacillin Sodium and Tazobactam Sodium for Injection in 2005, and that its medical instructions accompanying the drug at that time were different than the written instructions it allegedly took from the Plaintiff Weierman Company.
At that time, the CFDA decided that Erye Company’s medical instructions were in need of revision, and attached model instructions for it to use in making the necessary revisions. However, the content of model instructions provided was nearly identical with that of the Plaintiff’s, with variations in the order of descriptions and the deletion of several words. Based on this model provided to it, Erye Company revised its medical instructions accordingly, reapplied with the CFDA and received approval for its product.
In conclusion, the court held that, took together medical instructions’ writing styles, publication requirements, legal attributes, as well as the balance of public interests, medical instructions must not be considered a work protectable under the Copyright Law. If the medical instructions at hand constituted copyright infringement, and if the laws were imposed on the Defendant, Hongxin Enterprise, acting in its role as a distributor, it would possibly bear the burden of having an affirmative obligation to determine whether medical instructions contained within products it distributed infringed the copyright of another party. However, because the court determined that the law does not apply, Hongxin Enterprise was found to be completely without fault and did not bear any liability for the alleged infringement. Based on this reasoning, the court rejected Plaintiff Weierman Company’s claims.
The presiding judge, when being interviewed in regard to the findings (note: the link is in Chinese), stated that although medical instructions do contain the requisite originality in order to enjoy protection pursuant to the Copyright Law, and that relevant Chinese laws enforce strict writing standards for medical instructions, which shall be written in a specific legally-specified format for marketing approval, the current laws and regulations restricting medical instructions in actuality grant very little space for creative and original writing.
In addition, the facts showed that Erye Company revised the disputed medical instructions in accordance with the CFDA’s requirements, and subsequently received approval for its product when it did so. Therefore, it is reasonable to find that Erye Company had actually lawfully and reasonably. Finally, if one considers medical instructions for drugs independent from the drugs they refer to, any possible marketing value will be lost, and it would be considered quite different from that of a general creative work protected by the Copyright Law.
Finally, if medical product instructions can be protected pursuant to the Copyright Law, there will be an inevitable conflict with the corresponding patent rights – it is common knowledge that medical patents receive protection pursuant to the Patent Law for a far shorter period of time than that of copyright. There is also the possibility that this kind of protection will result in the Copyright Law undermining the Patent Law, and this disguised protection of medical instructions will harm the market. It is plausible that such tactics may result in a monopolization of the pharmaceutical market. This is why the court eventually suggested using the Patent Law to protect the disputed drug.
Lawyers’ Comments:
1. A key point as to why the plaintiff lost in this case is largely due to a failure of litigation strategy – the Plaintiff only sued the drug distributor and not the drug manufacturer. Generally, the major target in similar cases is the manufacturer that made the medical instruction. In the same way, the major target in this case was clearly Erye Company – taking the distributor to court was more likely due to jurisdictional reasons.
To our surprise, the Plaintiff did not sue the manufacturer as a co-defendant. Instead, the Plaintiff only sued the distributor. Thus, it could be expected that the Plaintiff would have lost this case. In order to consider protection of transactional security, in the sale of drugs, as a drug distributor, its main obligation is clearly to examine whether the drug sold receives approval from the CFDA instead of the copyright of its medical instruction.
2. The decision handed down by the court has not deeply analyzed the limitations of description in the Copyright Law. Due to not suing the manufacturer in this case, the distributor, acting in its role as the Defendant, had no obligation to disclose why the medical instruction was nearly identical to that of the Plaintiff’s. Instead, if the manufacturer were a co-defendant, the court could make a relatively thorough and detailed study on whether the medical instruction can be protected by the Copyright Law.
Back to the decision contained by the court, the vital question is clearly the following: why was the allegedly infringing medical instruction provided by the CFDA, which in fact is owned by the Plaintiff, used as a de facto requirement by the CFDA when it imposes such strict limitations in regard to the structure and writing style of such instructions? In the author’s opinion, as for the function and usage of a drug, if the manufacturer provides an independent statement, it would be unlikely that such descriptions would be identical. The conclusion is obvious – where two sets of instructions are the same, clearly infringement has occurred.
3. Copying model medical instructions tendered by the CFDA should not be considered an exemption from liability for copyright infringement. If Erye Company was also sued by the Plaintiff, acting in the role as a co-defendant, could Erye Company avoid liability by simply stating it was making use of the model instructions provided by the CFDA? Generally, the answer is “no”. Considering the fact that Erye Company was ordered to revise its medical instructions in accordance with the model one, the correct way to make use of this model would be to utilize a bit of intellectual originality, and allow the model instructions to act as a template rather than as a literal roadmap. From a commercial point of view, blatant copying is unjustifiable, and Erye Company should have been found liable for its actions.
Finally, in relation to whether the medical instruction can be protected by the Copyright Law, our website once did a detailed analysis in a post named Which Part of Medical Instruction Could be Protected by China Copyright Law for your reference.
Lawyer Contacts
You Yunting：86-21-52134918 youyunting@debund.com/yytbest@gmail.com
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