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 post filing data in China patents. Post Filing Data in China Can post-filing data showing unexpected technical effect be used to overcome inventive step if the specification contains no data but asserts the unexpected technical effect? In short, the answer is no, post-filing data cannot be used to overcome inventive step even if the idea…
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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,…
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New Policies to Promote Importation of Innovative Drugs
At the April 12, 2018 executive meeting of the State Council in China, Premier Mr. Li Keqiang indicated the government’s desire to increase China’s access to innovative drugs. To achieve this, the government would encourage importation of innovative drugs into China by streamlining the regulatory pathway, enhancing IP protection, and lowering the cost of medicine. Shortly thereafter, the Chinese Food and Drug Administration (CFDA) published draft guidelines on May 12, 2018 and asked for comments. Below is a summary of where things stand today.
