The object of medical patent protection in the United States and its comparison with China

Introduction: when you enter the United States Patent and Trademark Office, you will see the words "the patent systems add the fuel of interest to the fire of" engraved on the front door "Genius" vividly reflects the relationship between invention and innovation and patent system, and fully shows that the United States attaches great importance to patent system With the continuous improvement of R & D capabilities, more and more domestic pharmaceutical enterprises begin to focus on and layout the U.S market Recently, China officially joined ICH, which further improves the possibility of domestic pharmaceutical enterprises to explore the U.S market Patent plays an important role in many aspects, whether in the research and development of innovative drugs or generic drugs Based on the comparative study and typical cases of pharmaceutical patent system (published by intellectual property press in 2012), which was compiled by Ms Zhang Xiaodong, and combined with relevant literature, this paper introduces the object of protection of American pharmaceutical patent system, and compares its similarities and differences with Chinese pharmaceutical patent system, in order to provide reference for domestic pharmaceutical enterprises 1、 Article 1, paragraph 8, of the Constitution for the United States of America (approved in 1788), provides that Congress has the right to In order to promote the development of science and practical technology, the authors and inventors should have exclusive rights to their works and inventions within a limited period of time The Congress shall have Power… To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their perspective writings and discoveries The first patent law in American history, the an act to promote the progress of practical arts, was signed by President Washington on April 10, 1790 The current patent law in the modern sense, i.e 35 U.S.C (hereinafter referred to as "the U.S Patent Law"), was enacted in 1952 and underwent four major modifications in 1984, 1994, 1999 and 2001 Article 101 of the U.S Patent Law provides that any person who invents or discovers any novel and practical process, machinery, product, or compound, or any improvement of the above novel and practical products, which meets the conditions and requirements of this law, may obtain a patent right Who events or distributors any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent there for, subject to the conditions and requirements of this title New utilization of known processes, machinery, products, compounds or substances The term“process”means process,art,or method,and includes a new use of a known process,machine,manufacture,composition of matter, For example, the Supreme Court of the United States pointed out in the "Chakrabarti case" in 1980 that: natural laws, physical phenomena and abstract concepts have been judged not to be patentable, 42 U.S.C 2181 pointed out that: nuclear materials or atomic energy used in atomic weapons cannot be patentable Comparison: Article 2 of the patent law of the people's Republic of China first provides a relatively clear definition of the object protected by the Patent Law (technical scheme and Design), that is, "invention refers to a new technical scheme proposed for a product, method or improvement thereof" The review guide further explains "technical solution" as "technical solution is a collection of technical means that utilize natural laws to solve technical problems Technical means are usually embodied by technical characteristics " Articles 5 and 25 of the patent law further clarify a series of exclusions and exceptions The specific terms are as follows: Article 5 of the Patent Law (2008): no patent right shall be granted for inventions and creations that violate laws, social morality or public interests No patent right shall be granted for an invention or creation that is obtained or utilized in violation of the provisions of laws and administrative regulations and is completed by relying on such genetic resources Article 25 of the patent law of the people's Republic of China (2008): no patent right shall be granted for the following items: ① scientific discovery; ② rules and methods of intellectual activities; ③ diagnosis and treatment of diseases; ④ animal and plant varieties; ⑤ substances obtained by nuclear transformation; ⑥ designs that are mainly used to mark the pattern, color or combination of the two of plane printed products A patent right may be granted in accordance with the provisions of this Law for the method of production of the products listed in Item (4) of the preceding paragraph 2、 The patentability of medical methods article 25 of the patent law of China explicitly excludes the diagnosis and treatment of diseases from the object of patent protection, while the current patent system of the United States recognizes the status of medical methods as the object of patent, which is one of the biggest differences between the Chinese and American Medical patent systems in terms of protecting objects However, the recognition of the object status of medical method patent in the U.S patent system has gone through a long process, and there are great disputes 1 Watershed event - Becton Dickinson v Schere case (1952, 106fed Supp.665) before 1952, the case law of the United States clearly refused to grant patent protection to medical methods The main reason is that the court held that human beings themselves are unpredictable, and the effects of treatment methods applied to human beings are inconsistent, so it is unpredictable and difficult to reproduce In the 1952 bectondickinson v Schere case, the court held that "methods are patentable, even if they consist of medical or surgical methods" Since then, the U.S patent and Trademark Office believes that medical method patents can be protected as long as they meet the definition of the method and meet the conditions of practicality, novelty and non obvious 2 Milestone event - the first case of patent infringement of medical method in the history of the United States Although the judgment of bectondickinson v Schere in 1952 affirmed the status of medical method as the object of patent protection, the granting of patent protection for medical method was controversial However, the case occurred in Palin v singer in 1994, which was the first patent infringement of medical method in the history of the United States The patent involved in the case (US 5080111) protects a pure medical method for ophthalmic surgery, which does not need to sew the incision, not only reduces the pain of the patient, but also saves the treatment cost for the patient Patent owner Palin claims a royalty of $3 to $4 per operation in the suit Although Palin only seeks compensation in his statement, not injunctive relief, his claim has been widely criticized by the American medical community The American Medical Association, for example, unanimously condemned patents on medical and surgical methods at its 1994 annual meeting The association claims that: medical method patents will damage the integrity of the medical profession, reduce the professionalism of doctors, and encourage doctors to focus on the economic interests of patients' health In particular, the association pointed out that allowing patentees on medical method inventions to set barriers to medical method access through bans and damages would have a devastating impact on the prevailing moral standards in the medical community As counterparties, private organizations such as the American Bar Association, the American Intellectual Property Law Association, and the American biotechnology industry association need to protect medical method patents In their view, there is no law in the United States that prohibits the granting of patent rights for medical method inventions [Wei Yanliang Patent protection of medical method in the case law of the United States and its reference significance for China [J] Application of law, 2003, z1:133-137] On May 1, 1995, the District Court refused to give a summary judgment on the defendant's patent invalidation request On March 28, 1996, the court of final appeal abrogated four claims in Palin's patent and prohibited Palin from enforcing any claims of the patent against the defendant The verdict is actually a compromise between the two opposing factions 3 Amendment of the patent law in September 1996 - exceptions to liability in September 1996, the U.S Congress amended the patent law by adding the provisions of section 287 (c), in which section 287 (c) (1) of the U.S Patent Law provides that medical practitioners are engaged in medical activities Activity) constitutes an infringement in accordance with Article 271 (a) (direct infringement) or (b) (inducement infringement) of the U.S patent law, article 281 (civil remedy by civil action for infringement of a patent), article 283 (injunctive remedy for patent infringement The provisions of article 284 (compensation for damages) and article 285 (attorney fees in patent litigation) shall not be used to confront professional medical personnel or health care activities related to the medical institution Articles 287 (c) (2) (a) to 287 (c) (2) (g) respectively explain the relevant terms, among which the pharmaceutical enterprises should pay attention to articles 287 (c) (2) (a) and 287 (c) (2) (f) related to the composition Article 287 (c) (2) (a): in article 287 (c), "medical activity" means "the performance of medical or surgical procedure on a But it does not include: "the use of patented machine, Manufacture or composition of matter in violation of such patent ";" the practice of a patented use of agreement of matter in violation of such patent ";" the practice of a process in violation of biotechnology patent According to article 287 (c) (2) (f), "patentable use of the composition" does not include a claim for a method of performing a medical or surgical procedure on the body The claim refers to the use of the composition, but the use of the composition does not directly help the realization of the goal of the method claimed in the claim Article 287 (c) (3): does not apply to the activities of the following persons, or their employees or agents, who are engaged in the commercial development, production, sale, import, distribution of machines, products, compositions, or the provision of drugs, clinical trial use (excluding clinical trial services provided in the doctor's office) It can be seen from the above clauses that although the U.S Patent Law granted a patent right for medical use, it exempted the professional medical personnel from the liability for infringement of the medical method patent when they engaged in medical activities, but the exemption was only limited to the professional medical personnel and did not include the use of the composition In addition, using the patent of diagnosis method can not exempt the tort liability