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Biotech Response to Proposed USPTO changes

Written by on Monday, February 27th, 2006

Peter Zura’s Two-Seventy-One Patent Blog recently examined the Biotech Community’s response to the USPTO’s proposed changes to US patent practice, including the proposed change aimed at curtailing the number of continuations that could be filed from a disclosure.

According to Zura, the response from the patent community was “befuddled outrage.” Zura writes:

The USPTO has no overt authority to limit continuations, yet is requiring applicants to explain why amendments, arguments, or evidence could not have been previously submitted? Aside from the fact that such a requirement injects subjective elements to an apparently objective process, this heavy-handed approach unduly restricts a valuable procedure for practitioners.

Zura reports that biotech companies are complaining that the proposed continuation rules are the wrong approach, since

[i]n this industry, product development timelines can reach 10 to 15 years and can cost upwards of $500 million. Accordingly, continuing applications are needed to protect technologies that can take more than a decade to bring to market. The biotech patent process not only covers product itself but also the process to make the product. As the 12 to 15 year cycle continues, different matters about the product, process, and its ultimate application are learned. All of this would require applicants to revisit applications and provide updates on any new developments.

Thus, restricting continuing applications will result in overly broad biotech patents, according to Todd Gillenwater, vice president of public policy at the California Healthcare Institute, a life sciences trade group in La Jolla, California.

Of course, from very early in the debate, the biotech community has been vocal on its views regarding the proposed patent reform rules. The Biotechnology Industry Organization (“BIO”) testified before the U.S. House of Representatives on September 15, 2005 on the proposed patent reforms, and has posted a transcript. An earlier letter to the U.S. House of Representatives is also posted on the website.

Likewise, in his recent President’s Desk column, the BayBio President wrote about the many flaws in the USPTO’s proposed direction, which was intended to address and remedy the existing three to five year USPTO backlog, highlighting the following:

First and foremost, the 2005 hiring trend at USPTO suggests that the agency of the Department of Commerce is aware of its human resource problems. Among the primary elements of reform that will not be proposed in the present comment period is the addition of hundreds – or thousands – of new examiner positions. Retention of new hires may also be an issue, but not in these proposed reforms.

Second, this collaborative approach asserts a fundamentally flawed view of governance in the public interest. Can John Q. Public realistically expect that Corporation X will act in the public’s interest in previewing materials and attachments filed by Corporation X in a working relationship with the Patent Office?

Third, the approach misses the mark on the responsibility of the USPTO. The backlog in the system is not the shared responsibility of innovators and the Government. The responsibility of innovators is to innovate – and in our industry, to continue the work of discovering life-saving products that shape and change people’s lives every day. It is the responsibility of the Patent Office to receive and review patent filings.

Finally, presuming that this proposition: Innovator: Control Thyself became USPTO policy, this reform does not accurately imagine the lawsuits that may result in the system – lawsuits by both innovators who face the unintended consequences of the priority of brevity, as well as by challengers who will have less material by which one discovery may be differentiated from another.

The BayBio President writes that the comment period will soon begin on these reforms and encourages members to participate in that debate and voice their views on the proposed reforms.

Clearly, this is sound advice to all of us in the biotech community.

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