Nearly a year after the Federal Circuit set the record straight on calculating the length of patent extensions, the Patent and Trademark Office (PTO) is including that decision in a final rule that also could penalize those who request continued examinations (RCEs).

Slated for publication in Friday's Federal Register, the rule recognizes that the time consumed by a continued examination ends with the notice of allowance – unless the applicant submits another RCE after that allowance.

A second RCE could result in a reduction of the patent term adjustment under the new rule, as the PTO would consider it a failure on the applicant's part "to engage in reasonable efforts" to conclude the process or examination of the application.

The only exception will be for RCEs that are filed in a timely way and solely to submit information cited in a PTO communication in a counterpart application. The rule also clarifies what papers may be submitted after a notice of allowance without the applicant running afoul of the "reasonable efforts" provision.

The new rule could add to past criticisms that the PTO assumes RCE applicants, who must pay extra fees, are abusing the system. Patent attorneys have said in many cases, applicants have no alternative, especially when examiners look at claims in a vacuum, fail to read the entire application before making a decision and then fail to respond appropriately so the decision can be appealed. (See BioWorld Today, April 4, 2013.)

As of last November, the PTO had a backlog of 48,000 RCEs. Because of that backlog – and what some see as a lack of priority – the PTO takes about five years to work through an RCE. Once an RCE has been decided, another five months go by, on average, before further action is taken, according to the PTO.

Prior to the Federal Circuit's Jan. 15, 2014, decision in Novartis AG vs. Michelle Lee, the PTO basically stopped the clock on a patent when it received an RCE and never started it again – even though the time from allowance following an RCE to actual issuance tended to mount up.

Recognizing how delays at the PTO could chip away at the value of a patent, Congress offered a three-year guarantee in 1999 for patent processing. Any delays attributable to the PTO that took the process beyond three years were to be compensated through an extension, the U.S. Court of Appeals for the Federal Circuit noted in its opinion.

While RCEs are one of the few exceptions to the three-year rule, the court made it clear that delays occurring from allowance following an RCE to the issuance of the patent are still attributable to the PTO and must be compensated for through patent extensions.

Although the PTO is just now releasing the final rule, it said it has been deciding requests for reconsideration of a patent term adjustment in keeping with the circuit court decision since the day it was handed down. It also has modified its patent term adjustment computer program, so adjustment determinations in patents issued on or after Oct. 7, 2014, are consistent with the court decision and the new final rule.

BIOSIMILAR GUIDANCE NEEDED

Adcom meetings can't take the place of guidance, the Biotechnology Industry Organization (BIO) said in adding its voice to the clamor for the FDA to officially share its thoughts on the naming and labeling of biosimilars and to clarify its conditions for determining a biosimilar to be interchangeable.

Wednesday's adcom on what is likely to be the first biosimilar approved by the FDA provided an important discussion of the scientific approach of reviewing biosimilar applications, said Jim Greenwood, BIO president and CEO. (See BioWorld Today, Jan. 8, 2015.)

"However, we believe the appropriate way to develop policy on such a significant new approval pathway is through published guidance documents with the opportunity for public comment, rather than through single-application advisory committee meetings," he noted.

The FDA had hoped to issue draft guidances on interchangeability, biosimilar labeling and implementation of the Biologic Price Competition and Innovation Act last year, along with finalized versions of the first four biosimilar guidances issued in 2012 and 2013. Those guidances are now on the agency's agenda for 2015. (See BioWorld Today, Jan. 7, 2015.)

Although there has been considerable demand for guidance on naming, the agency has yet to say when that could be expected.

PART D REDUX REINTRODUCED

In the opening days of the 114th Congress, Sen. Amy Klobuchar (D-Minn.) reintroduced legislation that would allow Medicare to negotiate the price of drugs offered under the Part D prescription drug program.

The Medicare Prescription Drug Price Negotiation Act would eliminate the "non-interference" clause in the Medicare Modernization Act that currently bans Medicare from negotiating directly with drugmakers for the best possible prices.

Klobuchar and other lawmakers have been trying to clear the way for Medicare negotiations for several years, claiming that government could get better prices than other payers.