Application Of Unexpected Technical Effects In Drug Patent Identification

Long drug research and development cycles,high consumption costs,and high risks of failure.Some data show that the original research drug generally takes an average of more than 10-15 years and an average development cost of $ 1.8 billion.Compared with this,the 20-year patent protection period is It has become the core protection that pharmaceuticals can rely on.Therefore,the dependence of pharmaceuticals on patent protection ranks first in all technical fields.With the expiry of patents for original research drugs in recent years,generic drug companies have invested in the process of filing patent invalidation to speed up the launch of generic drugs.According to relevant statistics,during the patent re-examination stage in China,almost more than 75% of the original drug patents are considered invalid,and the probability of a compound patent being considered invalid is greater than 50%.Both have objectivity,so being creative or not has become the invalid reason for the highest proportion of patent challenges initiated by generic drug companies.As an experimental field,drugs are difficult to predict whether they are patents for pharmaceutical products or applications.Unlike simple replacements of parts,materials,or locations in machinery and other fields,it is more difficult for drugs to pass a simple "three-step process." Law "to make creative judgments.In the judgment of pharmaceutical patent creativity,it is generally believed that when the immutable skeleton structure is similar,the two structures are considered similar.At this time,the auxiliary judgment element to obtain creativity and obtain unexpected technicaleffects is in the creative judgment of pharmaceutical patent Occupies a very important position.At the same time,due to the experimental characteristics of drugs,experimental data has also become more objective and easy to compare and grasp in creative judgment.However,many original research drug companies did not release complete experimental data for various reasons during the initial stage of patent application.In the description,in order to better implement the "first application system" and not to violate the provisions of Article 26,paragraph 3 of the "Patent Law",China has always adopted a more conservative attitude in the adoption of supplementary experimental data in judicial practice.At present,there is much controversy in our country on how supplementary experimental data should be adopted,whether it can be used to influence and judge creativity.Therefore,in order to make the objective judgment of the creativeness of pharmaceutical patents more objective,what position should be judged on the unexpected technical effect and how to adopt the supplementary experimental data should be properly compared with foreign The regulations provide a certain reference for the creative judgment of pharmaceutical patents in China.In this article,the author draws on the United States,the European Union and other countries and regions for patent creativity,especially pharmaceutical patent creativity,and compares the consideration of "achieving unexpected technical effects".The technical effect should be placed in the position of the main judgement factor,combining it with the creative "three-step method",and then making a more objective judgment on the creativity of the medical chemical patent.If the unexpected technical effect is only a secondary auxiliary judgment factor based on the three-step method,obtaining the unexpected technical effect must be based on the distinguishing technical features closest to the existing technology.However,we compare the fundamental purpose of distinguishing technical features,namely It is to prove whether the patent has obtained corresponding technical inspiration in the existing patent,and when the "quality" unexpected technical effect is obtained,it can itself prove that it has not obtained corresponding technical inspiration in the existing patent.Therefore,the unexpected technical effect has its importance in creative judgment,and it should be used as the main judgment factor of patent creative judgment in the field of medical chemistry.Whether an invention achieves unexpected technical effects depends on rigorous judgment.When we consider unexpected technical effects as the main judgmentfactors in the creative judgment of pharmaceutical patents,first of all,it should be clear that it is not the main judgment factor Completely independent,but should be combined with the "three-step method".In fact,whether to obtain an unexpected technical effect is to judge whether the existing technology has given technical inspiration to those skilled in the art.Therefore,we should use the unexpected technical effect as the third in the three-step method.Step judgment conditions apply.In the application process of unexpected technical effects,because "qualitative change" can be used to directly determine the technical inspiration of patents,and "quantitative change" also needs to be judged by combining many factors,we should separate "qualitative change" from "quantitative change" discuss.At the same time,the unexpected technical effects should be commensurate with the scope of protection of the claims.Only when the claims can be deduced that the applicant has found the unexpected technical effects when applying for a patent,can the technology be The effect is included in the consideration of patent creativity judgment.As the unexpected technical effects in the field of medicinal chemistry rely more on experimental data to prove,when applying for a patent,a patent applicant should make a clear and complete description of the invention in the description and be reflected in the claims to ensure that the patent At the filing date,those skilled in the art can produce the expected technical effects according to the content described in the description.The experimental data supplemented afterwards can only make a supplementary explanation of the original technical solution disclosed on the application date and the effect that can be achieved to clarify the misunderstanding of the examiner,but it cannot increase any technical effect,let alone Aside from the record of the original application document,the supplementary technical effect is used as the basis for evaluating whether the patent right can be granted.