The Chinese Patent Law excludes patenting methods of diagnosing or treating a disease. More specifically, this refers to processes of identifying, determining, or eliminating the cause or focus of diseases which are practiced directly on living human or animal bodies. Please keep in mind that instruments used for implementing these methods are still patentable. So what constitutes a diagnostic method that would be excluded from patent protection? It must meet the following two criteria: It is practiced on a living human or animal body Its immediate purpose is to obtain the diagnostic result of a disease or health condition Living Human or Animal Body This first requirement means that, for…
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No % homology? How to craft allowable claim scope around sequences to comply with China’s strict written description requirements
Since 2010, the Patent Re-examination Board (PRB) has published the top 10 patent invalidation cases of the year in April of each year. The selection criteria are high social concern, significant impact on the related industry, or involve difficult legal issues and important examination criteria. Below is one of the top 10 cases that discusses what is considered allowable claim scope around sequences. It is well known that China has strict requirements when it comes to adequate written description and support in the specification. Chinese Patent Law Article 26(4) says that “all claims must be supported by the description and shall define the extent of the patent protection sought for…
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Is it Sufficient to Claim an Antibody only by Describing its Antigen?
Things may be brewing with respect to antibody inventions. Just how much description is sufficient? After losing in the Federal Circuit, Amgen has decided to ask the US Supreme Court to weigh in on a standard that could vastly influence the pharmaceutical and biotech industry. The story relates to Repatha™, an LDL-lowering drug from Amgen whose active ingredient is a monoclonal antibody called evolocumab. The monoclonal antibody binds to PCSK9 protein, preventing it from destroying LDL receptor protein (LDL-R), a protein that removes LDL from the bloodstream. Amgen sued Sanofi, who created its own PCSK9 antibody. Sanofi sued back, arguing that Amgen’s patents were invalid for failing to comply with,…
