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FDA Considers Abbreviated Approval Process for Biosimilars

By Benjamin Bergan

The FDA has begun the potentially long and complex task of creating a system for approving biosimilars. ‘Biosimilars’ are products highly similar to, or interchangeable with, currently approved biopharmaceutical products. At first glance, biosimilars may appear analogous to generic versions of brand-named drugs such as Tylenol or Advil; however, unlike generic drugs that share the exact same chemical compositions as the name brands, the exceptionally large and complex proteins that comprise biopharmaceutical products make exact replication very difficult. Further, slight differences of biosimilars that may arise in manufacturing process may result in drastically adverse effects on patients.

The FDA has a long-standing policy of allowing drug developers to rely on knowledge already known about a drug when creating replications or generic versions of the drug. The FDA has adopted this policy to limit unnecessary financial and time investments, and eliminate unnecessary human and animal testing. The reduced costs in developing these replications or generic versions results in savings to patients and health care providers

As part of the health care reform initiatives, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which allows for an abbreviated approval process for biological products highly similar to or interchangeable with a currently FDA-licensed biological product. Through this act, the FDA has to weigh its policy of allowing the reliance on knowledge already known against the inherent dangers of replicating biopharmaceutical products.
To help achieve this balance, the FDA held a two-day public hearing on November 2nd and 3rd of this year to obtain input on the implementation of the BPCI Act. The FDA heard testimony from biotechnology and pharmaceutical firms, physicians, patient groups, academic and research professors, and several other organizations. The presenters generally agreed on the benefits of less-expensive generic biopharmaceutical products, but disagreed on how abbreviated the FDA should make the approval process. The FDA welcomes written and electronic submissions of comments on the subject until December 31st, 2010.

New Patent Classification System in the Works

By Jacob Berger

Major changes may be coming to the patent system. On October 25th, the USPTO announced that it was going to work toward creating a joint patent classification system with the European Patent Office (EPO). This would be a major change to the current system and hopefully improve efficiency by making it easier to conduct patent searches across systems.

Currently, the classification that the USPTO uses differs from that of the International Patent Classification (IPC) system because it predates the IPC system. The IPC system is the basis for several major patent document classification systems, and it is hoped that this new system will be more detailed than that of the IPC; however, any move toward a system based off the IPC is likely to be beneficial.

The IPC system is administered by the World Intellectual Property Organization. It is hoped that, someday, a singular patent classification system will be created. This would make things much more efficient since many patent searches involve looking through various patent offices, each of which uses a slightly different classification system. If the USPTO and the EPO can create a system that both offices use, then this will be perhaps one of the first steps toward global standardization.

In the least, if both the USPTO and the EPO are using the same patent classification system, that should eliminate a great deal of duplication in the examination process. Currently, both offices conduct their own examination of a patent application; however, if they were to use the same system, then much of their work could simply be forwarded between the two offices, thereby increasing the efficiency of examinations and, hopefully, helping to alleviate the backlog at the USPTO.

USPTO Set to Break Record Amount of Patents Granted

By Roy G. Franks

On October 5th, the patent law blog Patentlyo.com announced that the USPTO had issued more utility patents to date this year than during the entire previous year. The blog’s author estimates that if the USPTO continues at its current rate, the record high set in 2006 will be surpassed this year.

On a possibly related note, the USPTO’s backlog of patents has remained fairly constant over the past few months, while the number of patent applications has doubled. USPTO Director David Kappos announced on September 20th that the USPTO is “poised to see the first significant reduction in the backlog in a decade”. These facts are even more amazing in light of the fact that the USPTO has fewer employees than a year ago. Perhaps one reason is the decreasing number of official actions taken on each patent prior to the resolution of the patent application, which have decreased from an average of 2.9 to 2.4 between 2008 and now. David Kappos has been at the helm of the USPTO for just over a year, and stakeholders are watching closely for improvements in the PTO's performance.