Life Sciences Patent Restrictions Depend on Meaning of Word ‘And’

May 8, 2009 – In The News
BNA, Inc., Vol. 3, No. 9

The United States Patent and Trademark Office has long held that the meaning of the phrase, "independent and distinct," meant "independent or distinct;" however, the Patent Act of 1952 suggests a different conclusion as to the phrase's meaning.

Janet McLeod told BNA that under the PTO’s interpretation of ‘‘independent and distinct,’’ an ‘‘undocumented example of an alternative process for making or using the product is sufficient to show that the inventions are distinct. Thus, a requirement for restriction between claims directed to a product and process of using the product may be supported by a simple allegation that, for example, ‘the product as claimed can be used in a materially different process such as a detection assay.’’’

But McLeod cautioned that a change in interpreting the phrase ‘‘independent and distinct’’ might not benefit applicants for life sciences-related patents because the reworked interpretation still would be contingent on the PTO’s definition of ‘‘independent.’’

As previously noted, in the 2005 Green Paper the PTO presented the possibility of differing definitions of ‘‘independent.’’ McLeod noted, ‘‘The MPEP describes independent inventions as ‘unconnected in design, operation, and effect.’ However, the 2005 Green Paper states that an examiner could establish that inventions are independent by showing that the inventions do not share a common feature, or that there is a common feature but it does not ‘define over the prior art and/or satisfy the enablement or written description requirements.’ If there is a common feature and the elected invention is found to be patentable, the examiner would then search a nonelected invention that requires the common feature, or the common feature itself. This proposed methodology for examination would significantly increase the time and cost of prosecution.’’

McLeod concluded, ‘‘In addition, an applicant could not be certain whether a requirement for restriction would be maintained or withdrawn until completion of prosecution of the initially elected invention. An applicant who is unwilling to risk loss of patent term on important embodiments of an invention would thus need to file divisional applications well before a determination that the requirement would be maintained or withdrawn.”

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