Typical case of non-application of the Bolar exception clause of the patent law: "Rivaroxaban" invention patent infringement administrative ruling.

BenCaseYesNanjing Hang Seng Pharmaceutical Co., Ltd. and itsWholly-ownedSubsidiary Nanjing Life Energy Technology Development Co., Ltd. (hereinafter referred to as Hang Seng Company and Life Energy Company)With Nanjing Intellectual Property Office, Bayer CorporationofPatent Administrative Adjudication Dispute.Selected in this case2022Chinese court in50Typical intellectual property cases and.2022Ten cases of judicial protection of intellectual property rights in Jiangsu courts.

basic case]

Bayer's patent number is00818966.8The patentee of the invention entitled "Substituted oxazolidinones and their use in the field of blood coagulation. The commonly used anticoagulant rivaroxaban is a compound within the scope of protection of this patent.Hang Seng Company/Life Energy Company displayed rivaroxaban preparations and bulk drugs marked with the registered trademark of Hang Seng Company on its official website and relevant exhibitions, suspected of promising to sell infringing products. Bayer then submitted a request to the Nanjing Intellectual Property Office for handling patent infringement disputes, which ruled that the two companies should stop infringement (Ning Zhi (2019) Correction of words5Administrative adjudication of patent infringement dispute cases). The two companies refused to accept and filed a lawsuit with the Intermediate People's Court of Nanjing City, Jiangsu Province. The court of first instance ruled to reject the claim ((2020) Sue01Line beginning261No.）。The two companies are still not satisfied and appeal.The Supreme People's Court held in the second instance that the two companies, without permission, expressed their intention to sell the products involved to unspecified objects through websites and exhibitions, which constituted an infringement of promise to sell. The promise of sales does not belong to the infringement exemption of the patent law on the administrative examination and approval of drugs and medical devices (Bolarexception). The appeal was rejected and the original judgment was upheld ((2021) The highest law knows the end of action451No./(2021) The highest law knows the end of action702No.).

【Casefocus of controversy]]

(1)Whether the behavior constitutes a promise to sell 

Regarding the definition of promised sales, Article 24 of the "Several Provisions of the Supreme People's Court on the Application of Laws in Hearing Patent Dispute Cases" stipulates that the promised sales referred to in Articles 11 and 69 of the Patent Law refer to the intention to sell goods by advertising, displaying them in shop windows or displaying them at trade fairs.

Two company views:

Publicity and display of the product in question should not be considered an indication of sale., does not constitute a promise to sell in tort,The reasons are as follows:

(1)Promise to sell should make the productInStatus of being able to sell,AndThe company does not have a product in a saleable state..

(2)PublicityofInvolved products, there is no content such as price and supply volume.,AlsoWithout the approval number, there will be no buyer at all.

(3)PublicityThe behavior belongs to directional delivery.

The Court's view:

The two companies displayed the involved products marked with product specifications, registered trademarks and manufacturer information on their official websites and relevant exhibitions. As an important symbol to distinguish the origin of goods and services, the trademark user shall be responsible for the quality of the goods using the trademark. From the use of trademarks by the two companies, information about the sale of the products involved was passed. The meaning of its sale of the products involved is clear and specific.

In addition, a promise of sale can be either an offer (an indication of a party's intention to conclude a contract with the other party) or an invitation to make an offer (meaning that a party invites the other party to make an offer to itself). Specific to this case, for the first (1) points,A promise to sell is by nature a unilateral expression of the seller's will and can be considered a promise to sell as long as there is a clear expression of the will to sell. AsTwoWhether the company has the corresponding qualifications and production capacity to produce and sell the patented products, as well as whether it has the actual products available for sale, is not a necessary condition for the determination of the promise of sale and cannot be changed.TwoThe nature of the company's actions.For the first (2) points,The purpose of the promised sale is to point to the sale, which is a statutory and independent form of tort, and its civil liability is not based on whether the sale actually occurred.For the first (3) point, the promised sales behavior can be targeted at both specific and non-specific objects.There is no evidence in this caseTwoThe company's propaganda behavior is aimed at a specific target,TwoThe products involved in the case publicized by the company on its website and exhibition are aimed at unspecified objects. Although they do not have the necessary terms of the contract, they are still promised sales.

AsPromotional PicturesThe original research company, the trade name of the original research drug, and the relevant provisions of the U.S. Code of Federal Regulations marked with the product involved are instructions for the product involved, and its essence is to serve the adoption ofTwoThe purchase of the product by another person who is aware of the company's promise to sell the product does not affect the fact that it constitutes an infringement of the promise to sell..IfTherefore, to exempt its infringement, it may lead to the patent law's promised sales system is overhead.

(2)Whether the act is an exception to the provisions of Article 69 (5) of the Patent Law 

patent lawBolarThe exception is:In the Patent Law, the import, manufacture and use of patented drugs by others without the consent of the patentee before the expiration of the drug patent shall be regarded as an exception to the non-infringement of patent rights.

TheThe rule originated in the United States, and its main purpose is to solve the problem that the administrative examination and approval time of drugs and medical devices is usually long, and it is difficult for generic drug manufacturers to obtain the administrative examination and approval of generic drugs and generic medical devices and market them in time after the expiration of others' patents, which leads to the objective extension of patents, its purpose is to allow generic drug manufacturers to engage in certain specific acts of patent enforcement without the permission of the patentee in order to provide the information required for administrative approval.

China's Patent Law2008At the time of revision,BolarThe exceptional rule is set out in article 69, paragraph 5., its contents are:In order to provide the information required for administrative examination and approval, the manufacture, use or import of patented drugs or patented medical devices, as well as the manufacture or import of patented drugs or patented medical devices specially for them, shall not be regarded as infringement of patent rights.

Two company views:

Even if it is determined that the company has a sales intention,AlsoAn act of targeted delivery rather than advertising..CompanyofThe publicity target is enterprises preparing to apply for registration of new drugs of rivaroxaban,PublicityYesSpecificallyThese generic drug companiesPromised sales by providing information required for administrative approval.

The Court's view:

FromBolarException clauseofSubject conditions.,BolarThe exception clause contains two types of subjects, the first type of subject is to apply for administrative approval for themselves, and the second type of subject is to help the first type of subject apply for administrative approval. The latter subject claimsBolarException defenseWhen, should be based on the actual existence of the first type of subject as a prerequisite..In this case, two.CompanyObjectively, the intention of selling the products involved to unspecified objects was expressed through official website and exhibition publicity., andNo evidence of the existence of an administrative approval applicant for the production of rivaroxaban drugs was submitted., I .e.There is no fact that it has been promoted only to the first category of subjects..Companyitself does not belongCategory I Subjects.Therefore,The alleged tort in this case is an expression of intent to sell the products involved to an unspecified object.,The accused tortfeasor in this case does not conformBolarThe body condition of the exception rule.

FromBolarThe scope of the exception clause is seen.,BolarException clauseIt is only applicable to those implemented for their own application for administrative examination and approval.The act of "manufacturing, using and importing" and the act of "manufacturing and importing" carried out specifically for the administrative examination and approval of the previous subject. Therefore, the exceptionThe scope of conduct involved does not include"Promised Sales".

[CaseMeaning]]

The judgment on whether the establishment of the promised sales behavior must be based on the premise that the product is in a saleable state, whether the actor does not have the qualification to produce the product involved will affect the establishment of the promised sales behavior, and the actor marks a disclaimer in the exhibition publicity materials (Disclaimer) Whether it affects the establishment of promised sales behavior is discussed in detail.And more importantly,This case makes it clear that the promise of sale does not apply to patent law.BolarExceptions,of this provision.The applicationconditions are given.Clear justiceExplain. The judgment in this case is a final characterization of the infringing nature of such marketing, reflectingRight.Interests between patentees, generic drug companies, and the publicPrudent balance.ForEncourage inventions in the field of medicine,Maintaining the pharmaceutical marketOrderhas a positive effect.