As 2016 fades into the rearview, we look back at our most-read blog posts of last year. The topics you were most interested in included a retrospective of the AIA’s first five years, guidance amidst the uncertainty preceding the Supreme Court’s Cuozzo decision (since squared away), and exploration of post-grant strategies for biotech patents. What would you like to see us write about in 2017? Let us know.
The Cabilly patent family (including Cabilly I, II and III) is likely the most famous patent family in biotechnology. With claims that cover basic steps in generating therapeutic antibodies, these patents are gatekeepers in an industry that has shown unprecedented growth—currently, half of the 10 top-selling drugs in the world by sales are therapeutic antibodies. Through licensing to antibody manufacturers, Genentech—one of the owners of the Cabilly patents—is expected to reach a billion dollars in royalties from this patent family by 2018. Not surprisingly, the Cabilly patents have been extensively challenged, through interference proceedings, reexamination, and multiple rounds of litigation, as far as the Supreme Court. These patents seemed untouchable, withstanding all of these challenges. Now, the “Cabilly II” patent (US Patent No. 6,331,415) faces a new and potentially more potent threat. Read more
The Supreme Court has agreed to hear its first case relating to AIA trials. When the Court renders its decision, it should definitively settle two issues that created consternation in the early days of AIA trials. Until then, accepting the case for review reopens two questions that were seemingly settled in the Federal Circuit’s decision in In re: Cuozzo Speed Technologies. The uncertainty is particularly acute, given the high rate at which the Supreme Court reverses the Federal Circuit. Read more
The AIA ushered in significant changes in the patent system. At the time, there was much consternation about the change to a first-inventor-to-file system. The prospect of enhanced post-grant challenges was an afterthought, dismissed as a variation in inter partes reexamination. Inter partes reexamination filings even spiked in 2012, as practitioners were reluctant to let go of the familiar process in favor of the new post-grant trial system. Five years on, the emphasis has flipped; first inventor to file is accepted as not much different than the patent systems in the rest of the world. Post-grant trials now get much more attention. Some see them as the only way to save American business; others call the system disastrous for innovation. However you classify the impact, AIA trials have been significant. Read more
Initially, biopharma represented a small percentage of post-grant proceedings; however, that percentage is increasing. In particular, generic and biosimilar manufacturers are recognizing advantages of this pathway. The high success rates achieved so far are compelling: For biopharma IPR petitions that have reached a final written decision, 66 percent have resulted in some or all of the challenged claims being invalidated. For biosimilar developers, post-grant proceedings represent a particularly promising strategy for clearing a path through competitive patents. Read more
The PTAB has invalidated three patents covering Copaxone®, a multiple sclerosis drug marketed by Teva with annual sales of over $3 billion. Challenged by generic manufacturers Mylan and Amneal, the patents specifically covered a long-acting form of Copaxone®, known as “3-times-a-week COPAXONE® 40 mg/ml,” which Teva developed when the original version of Copaxone® was coming off patent protection. These IPR decisions highlight the usefulness of post-grant proceedings for generic and biosimilar manufacturers, particularly for challenging follow-on patents, such as those covering specific dose regimens, as we discussed in earlier posts. Read more