The unenforceability of patent rights unique to the United States. In patent litigation in China, the defenses commonly used by accused infringers generally include: invalidity of the patent, no infringement, right of prior use, publicly known technology, etc. . However, in the United States, there is a unique form of defense that is not available in China, which is to claim that the patent right is unenforceable. The so-called unenforceability of patent rights means that although the legal status of the patent is valid, the court will no longer enforce it.

The defense of unenforceability of patent rights is not based on U.S. statutes, but on U.S. patent judicial precedents. Based on this defense, the accused patent infringer can claim that the patent right is unenforceable in patent litigation on the basis that the patentee has violated the principle of equity during the patent application process.

Relevant provisions on violations of the principle of equity

Since patent examination in the USPTO is a unilateral procedure, usually the examiner only conducts the previous case by himself within a limited time The information obtained is retrieved to determine the patentability of the patent application. In most cases, the inventor or applicant actually knows the relevant previous case information of the patent application best. Therefore, in order to protect the public interest, the USPTO has written the applicant’s obligation to disclose and the corresponding provisions of the ethical standards of candor and honesty into Chapters 600 and 2000 of the Compendium of Federal Administrative Regulations and the Guidelines for US Patent Examination.

Part of the excerpt from Article 56 of Part 37 of the Federal Administrative Regulations is translated as follows: “Every person involved in the patent application and examination process has the obligation to be frank and honest with the Patent Office, including "Obligation to disclose information he/she knows that is substantially relevant to patentability"; "Information that meets the following conditions will be considered to be substantially relevant to patentability: a) The information alone or in combination with other information can preliminarily determine the patentability Unpatentability of the claim b) The information refutes or is inconsistent with the applicant’s assertion of patentability, or the information refutes or is inconsistent with the applicant’s rebuttal of the patent office’s reasons for non-patentability”; "The so-called 'persons related to the patent application and examination process' include: a) every inventor of the patent application; b) every agent or lawyer who prepares or engages in the patent application; c) every other person who is substantially involved The person who prepared the patent application, as well as any person related to the inventor, the assignee, or any person who is obligated to assign the patent application."

Therefore, if the applicant fails to fulfill the above-mentioned disclosure obligation during the examination of the patent application and violates the ethical standards of straightforwardness and honesty, it may be regarded as violating the principle of equity. To determine whether there is a violation of the principle of equity, two factors usually need to be considered: whether the omitted information is information that is substantially relevant to patentability and whether the applicant's behavior was "intentional" to mislead the patent office.

1 Information related to the substance of patentability

Information related to the substance of patentability refers to information that may affect its patentability or reveal the examiner’s Features to focus on when reviewing a patent. Among them, the patent review process includes the review process of new applications, the re-examination process of patents and the re-publication review process. The disclosure obligation of a patent applicant is not limited to previous cases known to the applicant, but also includes all other information related to the patentability of the patent, including litigation information. According to the U.S. Patent Examination Guidelines, the lawsuits include lawsuits to invalidate the patent involved and lawsuits alleging deception or violation of the principles of equity by the patent applicant.

For example, in the case of Critikon vs. Becton Dickinson, because Critikon failed to fulfill its obligation to disclose invalid litigation information involving its patent during the re-examination process of its patent, its patent was ruled by the Federal Circuit Court as Not enforceable. After hearing the case, the Federal Circuit Court ruled that Critikon's patent was unenforceable because Critikon violated the principle of equity during the patent review process.

The violation of the principle of equity was that Critikon did not disclose the invalidity litigation related to the Lem-uex patent during the re-publication review process of its Lemiuex patent. The patent involved in the invalidation lawsuit (the Mcdonald patent) is essentially related to the patentability of the Lemiuex patent, and the non-disclosure can be inferred as intentional misleading.

The main point of dispute between the district court and the Federal Circuit Court in this case was whether the McdonaId patent involved in the lawsuit was information substantially related to the patentability of the Lamiuax patent. The district court held that the Mcdonald patent was not substantially relevant because it was substantially different from the patent at issue. However, the Federal Court held that the Mcdonald patent disclosed two important features, and these two important features were the features that the examiner focused on when examining the patent. Although the two features were applied in two completely different devices, they were also It cannot therefore be concluded that the Mcdonald patent is not information substantially relevant to patentability. According to MPEP §2001.06(c)(2005), during the review process of the Reissue case, if the patent is subject to invalidation review, the previous case used to invalidate the patent in the invalidation case can re-issue the patent for review. Information related to the substance of patentability.

In this case, the Federal Court finally ruled that the patent was valid, that is, the McdoRald patent was not sufficient to invalidate the Lemiuex patent, but was considered to be information substantially related to the patentability of the Lemiuex patent. It can be seen that the criteria for judging whether information is substantially relevant in US patent law are relatively broad. Simply because the information will not affect the patentability of the patent, it cannot be arbitrarily considered that the information is not substantially relevant.

2 Intentionality

Although violation of the principle of equity does not require strict evidence to prove the relevance of the previous village and the subjective intention of the applicant like fraud, it only proves that the applicant has simple negligence. Accidental oversight and misjudgment are not enough to render a patent unenforceable. However, whether the applicant's behavior was "intentional" or an unintentional simple negligence or accidental oversight, how should the standard of judgment be determined?

"Intentional" is usually determined by evidence and reasoning, and Admission by the inventor or attorney is not required. But there must be evidence related to "intention", although this evidence does not have to be direct evidence, it can be inferred from the behavior of the patentee, for example, reckless neglect, obvious negligence. However, "intentional" misleading cannot be determined solely from the finding of negligence. The subjective honesty of the patentee is a factor that can be considered. "In the Kinsdown case, the judge held that the inference of "intention" depends on the overall circumstances of the case, including the nature and extent of (the patentee's) negligence, and whether there is subjective good faith. In the Allen Archery case, the inventor and his patent attorney argued , purely out of good faith, they believed that the previous case was not related to the novelty and inventiveness of the patent involved, and therefore, they did not submit it to the Patent Office. However, the judgment of whether the previous case was related to the novelty or inventive step of the patent involved should be based on the maximum scope. Interpret claims to avoid miscarriage of justice.

"Substantial relevance" and "intentionality" are not completely separate: the higher the relevance, the lower the degree of "intentionality" required to determine a violation of the principle of equity. When the patentee is faced with a very relevant previous case, and there is clear evidence that the patentee knew or should have known the relevance of the previous case, the ground of "bona fide misjudgment" is difficult to prevent "intentional" misleading. Therefore, it is useless to simply deny “intentional” in this case.

Generally speaking, withholding or concealment is used to refute the corresponding foreign application (referring to the non-U.S. application). ) is an important factual factor for being determined to be "intentional". Therefore, if a corresponding Chinese patent is rejected by the Chinese Patent Office during the examination process, the applicant should submit the relevant prior case to the US Patent Office in a timely manner. case to avoid the U.S. patent application being judged to be unenforceable in the subsequent process.

In addition, if the inventor has previously sold a product and failed to truthfully disclose the product to the patent office, although the product is not exactly the same as the patent application, it reveals that the patent is different from the previous case. Important technical features will also result in the consequences of “deliberately” misleading the patent office.

Of course, falsification is easier to judge as "intentional" than hiding information. When a patent applicant submits non-English previous cases or literature information, only the less relevant part is translated, which may mislead the examiner into thinking that the previous case is less relevant, which will result in "inferred concealment".

Discussion on whether to abolish the defense that patent rights cannot be enforced

Considering the positive significance of the U.S. system for restraining behavior that violates the principle of equity, some scholars in China also call for following the example of the United States and establishing Relevant applicant disclosure notification system. In fact, during the current discussion on the reform proposals of the US patent law, the US patent industry is also having a heated discussion on whether the defense for claiming that patent rights are unenforceable due to violations of the principle of equity should be abolished. The U.S. National Academy of Sciences has also written on proposals for reforming U.S. patent laws, suggesting the abolition of the defense to claim that a patent right is unenforceable based on the patentee's violation of the principle of equity during the patent application process.

The main reasons for the proposed abolition are: (1) There is no clear objective standard to define which behaviors violate the principle of equity. The judgment of behavior that violates the principle of equity is a personal subjective judgment based on specific facts. ; (2) The court’s requirement for the applicant’s disclosure obligation is the highest level of frankness and honesty that is difficult to achieve; (3) There is no clear and clear definition of the two elements “information substantially relevant to patentability” and “intentional”. ; (4) The U.S. Federal Circuit Court also pointed out that the unenforceable defense has been over-abused like the plague, which not only increases the cost of litigation but also reduces litigation efficiency.

However, the Intellectual Property Section of the American Bar Association recently wrote to the Senate Judiciary Committee on reform proposals for U.S. patent law: the defense system for claiming that patent rights are unenforceable due to violations of the principle of equity should be Further revisions improved and retained.

The U.S. patent industry is still reviewing the legal significance and practical effects of establishing the obligation to disclose and notify, and is at odds with further revising and improving the standards for identifying violations of the principle of equity. Therefore, it is unclear whether we should follow the example of the United States in establishing our own relevant system. The author believes that we should think twice before taking action. Moreover, there are obvious differences and gaps in the judicial systems, litigation procedures, judicial concepts, and current development status of the rule of law between our country and the United States. For example, China does not have the pre-trial investigation and evidence collection procedures of the United States, and it is difficult for the accused infringer in China to obtain evidence of the patentee's violation of the principle of equity. In the United States, the party accused of infringement can use this investigation and evidence collection procedure to investigate the patentee’s witnesses, physical evidence and other information. This will provide evidence of whether the patentee violated the principle of equity during the process of obtaining the patent.

Some issues that Chinese patent practitioners should pay attention to when handling U.S. patent applications

The author below briefly introduces how Chinese patent practitioners handle U.S. patent applications. When doing so, there are some issues that should be paid attention to in order to avoid violating the principle of equity.

1. All relevant persons have the obligation to disclose.

Except for the inventor, any individual involved in the preparation, submission and defense of U.S. patent application documents has the above disclosure. obligation. For example, writers, reviewers, and submitting patent attorneys of U.S. applications must disclose any relevant publications, patents, patent application publications, and other public uses or sales activities of the invention in the United States that they are aware of. Inform the examiner.

2 Confirm that all inventors are true inventors

In the following two cases, errors in the identity of the inventor may lead to the unenforceability of the patent: (1) At least one of the inventors in the list of inventors one is not the true inventor, or (2) if there is at least one true inventor who does not appear in the list of inventors.

3. Pay attention to changes in business status

If the business status is a small business when filing a patent application with the US Patent and Trademark Office, if it is subsequently reviewed or after the patent is granted, When an enterprise has developed into a large enterprise, it should pay various fees according to the large enterprise in a timely manner.

4. Avoid any false statements

During the review process, sometimes the inventor may present some evidence or make a sworn statement to overcome the rejection, but avoid any false statements. Certification or misrepresentation.

5 Confirm with the inventor whether the best embodiment has been disclosed in the U.S. patent application

Intentional concealment of the best embodiment in the U.S. patent application may also result in a patent Unable to implement.

6. Inform the USPTO of other related applications that are under review at the same time

If the applicant has other applications related to the invention in the United States at the same time, and these applications If the contents are substantially related to the patentability of the application, the inventor is also obliged to inform the examiner of the information of these applications.

7. The inventor's affidavit should be signed after confirmation.

The inventor should read, understand and approve the affidavit before signing. If the inventor cannot read or understand English, the inventor's corresponding Chinese version should be provided to explain the contents of the English version of the affidavit.

8 Disclosure of previous cases cited by Chinese examiners during patent examination

If a Chinese examiner cites some previous cases when examining a Chinese patent application corresponding to a U.S. application case. Then, these prior cases should also be informed to the US examiner. Note: Regardless of whether the U.S. application claims priority to the corresponding Chinese application, as long as the content of the Chinese application affects the patentability of the U.S. application, the inventor has the above notification obligation. Similarly, if there are patent applications from other countries corresponding to the U.S. application, such as Japanese patent applications and Korean patent applications, then the U.S. examiner should also be notified of the previous cases cited by the examiners of these other countries during the examination.

9. Non-English prior cases need to be translated or a brief explanation of relevance

If the prior case notified to the US examiner is in non-English, for example, the Chinese examiner is examining the corresponding If the Chinese patent application cites a Chinese previous case, then either provide a brief explanation of the relevance of the previous case to the U.S. patent application, or provide an English translation of the Chinese previous case, or provide the equivalent application in other countries. English version of the patent application.

10 The obligation to notify runs throughout the entire review period of the U.S. patent

In the period before the U.S. patent application is abandoned and granted, people related to the U.S. application have always been obliged to promptly notify Inform the examiner of any prior cases that are known to have an impact on the patentability of the U.S. application.

11. It is recommended to use the minimum relevance standard when submitting a previous case, and do not use the substantive relevance standard.

As long as it is discovered or suspected that a certain former village is related to the US application, the US should be notified in a timely manner. censor. Try not to disclose only previous cases that you judge to have an important impact on the patentability of the U.S. application. Some previous cases that the applicant considers not substantially relevant may later be found to be substantially relevant to patentability during the litigation process.