If the company is not prepared to continue in-depth research and development, the more information disclosed in the prior application, the more beneficial it is to prevent others from further research and development. If the company plans to carry out product development and replacement, the information disclosed in the prior patent application is inappropriate, which often affects the patent protection of subsequent development results.
New drug development is a long-term process. From the massive screening, to the establishment of target compounds, it has to be continuously modified and continuously improved, and the patents of related new drugs will continue to increase with the progress of the experiment.
Almost every major new drug is protected by a large number of patents. First is the compound patent, a formula that protects hundreds of new compounds. Subsequently, from this hundreds of compounds, a structural precursor with potential therapeutic effects was screened. After the mother is structurally modified from various possible directions, the target compound with clear curative effect is screened. There are also researches on processes and preparations after zui. These research results can be protected by patents, thus forming a huge patent network.
If the patent network is large and strong, it must be considered when making patent applications, so as not to lose sight of it. When writing a patent application, you should consider the patent application for the relevant technical content that may be available in the future.
If the company is not prepared to continue in-depth research and development, the more information disclosed in the prior application, the more beneficial it is to prevent others from further research and development. If the company plans to carry out product development and replacement, the information disclosed in the prior patent application is inappropriate, which often affects the patent protection of subsequent development results.
To what extent is the prior patent application disclosed? First of all, the content of the disclosure must satisfy the novelty, creativity, and practicality of the patent law, so that the patent application can be authorized through examination. However, under the premise of satisfying novelty, creativity and practicality, it is necessary to carefully consider the details of the open technical content according to the company's research and development strategy. This problem is generally difficult for patent attorneys to take care of, and requires legal counsel within the company to check.
The patent dispute between Aventis Pharmaceuticals and Impax Experimental Co., Ltd. is described below. The focus of the case is whether the content disclosed in the prior patent is sufficient for the person skilled in the art to make the invention in the latter patent. If it is, then the latter patent does not have novelty and should be declared invalid; if not, the latter patent is novel and should be valid.
Aventis has US 5,527,814 (814) use patents for the treatment of amyotrophic lateral sclerosis (ALS) with riluzole. Impax submitted a generic drug application for riluzole to the US FDA, triggering the patent infringement of Aventis v. Impax and Impaq counterclaim Avent patent.
Impax intends to use the US 5,236,940 (940) patent filed by Aventis earlier to invalidate its 814 patent for subsequent applications as a defense against this alleged infringement.
In the lawsuit, Impax claimed that the patents listed in the Orange Book should be invalidated, especially the earlier 940 patent of Aventis disclosed the content of the later 814 patent. Therefore, the 940 patent is the 814 patent. The prior art, which makes the 814 patent lose its novelty. A group of compounds useful in the treatment of ALS diseases is disclosed in the '940 patent.
Patentee Aventis refutes Impax: The prior dose of the 940 patent has a wide range of doses and lacks sufficient instructions or guidance for treatment options. The 940 patent also contains examples that do not work. Nothing in the '940 patent will enable one of ordinary skill in the art to appreciate that riluzole can be used to treat ALS, and that a large number of experiments are required to determine the dosage of ALS for treatment of ALS according to the teachings of the '940 patent.
In the first instance, the court found that: (1) Formula I of the 940 patent includes hundreds of compounds that can treat several diseases; (2) there is no mention of riluzole in the treatment of conditions associated with glutamate (3) The 940 patent itself is "substantially uncertain" in terms of the inhibition of glutamate compounds in the treatment of ALS; (4) The discussion of glutamate in the 940 patent is speculative at best. The court of first instance also found that there was no dose information for the therapeutic effect in the 940 patent. In contrast, the court of first instance noted that the dosage guidance in this patent is broad and does not specify which of the hundreds of compounds in the claims or which diseases. Even, the 940 patent specifically excludes riluzole when the dose is in phase with the inventive compound. Therefore, the technical content disclosed in the 940 patent does not allow the ordinary person skilled in the art to treat ALS with riluzole, and thus does not undermine the novelty of claim 1-5 of Patent No. 814, and the right to decide the patent of No. 814 The request is valid.
Impax refused to accept the first-instance judgment and appealed to the Federal Circuit Court of Appeals. On October 3, 2008, the Court of Appeals for the Federal Circuit upheld the judgment of the first instance court.
New drug development is a long-term process. From the massive screening, to the establishment of target compounds, it has to be continuously modified and continuously improved, and the patents of related new drugs will continue to increase with the progress of the experiment.
Almost every major new drug is protected by a large number of patents. First is the compound patent, a formula that protects hundreds of new compounds. Subsequently, from this hundreds of compounds, a structural precursor with potential therapeutic effects was screened. After the mother is structurally modified from various possible directions, the target compound with clear curative effect is screened. There are also researches on processes and preparations after zui. These research results can be protected by patents, thus forming a huge patent network.
If the patent network is large and strong, it must be considered when making patent applications, so as not to lose sight of it. When writing a patent application, you should consider the patent application for the relevant technical content that may be available in the future.
If the company is not prepared to continue in-depth research and development, the more information disclosed in the prior application, the more beneficial it is to prevent others from further research and development. If the company plans to carry out product development and replacement, the information disclosed in the prior patent application is inappropriate, which often affects the patent protection of subsequent development results.
To what extent is the prior patent application disclosed? First of all, the content of the disclosure must satisfy the novelty, creativity, and practicality of the patent law, so that the patent application can be authorized through examination. However, under the premise of satisfying novelty, creativity and practicality, it is necessary to carefully consider the details of the open technical content according to the company's research and development strategy. This problem is generally difficult for patent attorneys to take care of, and requires legal counsel within the company to check.
The patent dispute between Aventis Pharmaceuticals and Impax Experimental Co., Ltd. is described below. The focus of the case is whether the content disclosed in the prior patent is sufficient for the person skilled in the art to make the invention in the latter patent. If it is, then the latter patent does not have novelty and should be declared invalid; if not, the latter patent is novel and should be valid.
Aventis has US 5,527,814 (814) use patents for the treatment of amyotrophic lateral sclerosis (ALS) with riluzole. Impax submitted a generic drug application for riluzole to the US FDA, triggering the patent infringement of Aventis v. Impax and Impaq counterclaim Avent patent.
Impax intends to use the US 5,236,940 (940) patent filed by Aventis earlier to invalidate its 814 patent for subsequent applications as a defense against this alleged infringement.
In the lawsuit, Impax claimed that the patents listed in the Orange Book should be invalidated, especially the earlier 940 patent of Aventis disclosed the content of the later 814 patent. Therefore, the 940 patent is the 814 patent. The prior art, which makes the 814 patent lose its novelty. A group of compounds useful in the treatment of ALS diseases is disclosed in the '940 patent.
Patentee Aventis refutes Impax: The prior dose of the 940 patent has a wide range of doses and lacks sufficient instructions or guidance for treatment options. The 940 patent also contains examples that do not work. Nothing in the '940 patent will enable one of ordinary skill in the art to appreciate that riluzole can be used to treat ALS, and that a large number of experiments are required to determine the dosage of ALS for treatment of ALS according to the teachings of the '940 patent.
In the first instance, the court found that: (1) Formula I of the 940 patent includes hundreds of compounds that can treat several diseases; (2) there is no mention of riluzole in the treatment of conditions associated with glutamate (3) The 940 patent itself is "substantially uncertain" in terms of the inhibition of glutamate compounds in the treatment of ALS; (4) The discussion of glutamate in the 940 patent is speculative at best. The court of first instance also found that there was no dose information for the therapeutic effect in the 940 patent. In contrast, the court of first instance noted that the dosage guidance in this patent is broad and does not specify which of the hundreds of compounds in the claims or which diseases. Even, the 940 patent specifically excludes riluzole when the dose is in phase with the inventive compound. Therefore, the technical content disclosed in the 940 patent does not allow the ordinary person skilled in the art to treat ALS with riluzole, and thus does not undermine the novelty of claim 1-5 of Patent No. 814, and the right to decide the patent of No. 814 The request is valid.
Impax refused to accept the first-instance judgment and appealed to the Federal Circuit Court of Appeals. On October 3, 2008, the Court of Appeals for the Federal Circuit upheld the judgment of the first instance court.
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