IP Law Bulletin

As patent practitioners are well aware, U.S. patent examiners will issue a first action on the merits of a patent application as non-final and typically issue a second action on the merits as final. The finality of second actions is so universal that the finality of an action may be accepted as proper by a patent applicant when, in fact, the action was improperly deemed final. It therefore behooves applicants to always evaluate whether a final action on the merits was properly made final to have improper final actions withdrawn before the applicant incurs unnecessary costs and/or delays in prosecution.

Our last article in Nutter’s How-to Series on Branding contemplated various territorial considerations that go into deciding where to file a trademark application. Even when a trademark applicant desires protection in multiple countries, or one or more states, most often our readers in this situation will want to first start by filing a United States trademark application. To that end, in our next two articles we address eight of the most commonly asked questions that arise when completing a U.S. trademark application filing.

On May 15, 2014, the U.S. Patent and Trademark Office (USPTO) published rules to implement the patent term adjustment (PTA) provisions of the Leahy-Smith America Invents Act (AIA) and the AIA Technical Corrections Act, the latter of which was summarized in the January 2013 issue of the Nutter IP Bulletin. Under the new rules, the fourteen (14) month PTA period and the three (3) year PTA period are measured from the same date: the date on which an application was filed under 35 U.S.C. § 111(a) in an application under 35 U.S.C. § 111; or the date of commencement of the national stage under 35 U.S.C. § 371 in an international application. The rules also revised the provisions for notifying applicants of PTA determinations and the time period for requesting reconsideration (now by the date of issuance of the patent, and by seven months from the date of notification, respectively) and judicial review of the USPTO’s PTA determinations and decisions (now 180 days from the date of the USPTO’s decision on the patentee’s request for reconsideration). The new rules do not come as a surprise—rather, they adopt the interim rule published April 1, 2013, which are discussed in greater detail in an article from the May 2013 issue of the Nutter IP Bulletin.

New draft guidance released by the FDA on May 13, 2014 will assist drug companies in determining whether a proposed therapeutic biological product is “biosimilar” to its reference product. “Biosimilarity” under Section 351(k) of the Public Health Service Act is defined as “highly similar to the reference product notwithstanding minor differences in clinically inactive components” with ”no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” A biosimilar’s applicant must demonstrate to the FDA that the biological product is biosimilar based on analytical studies, animal studies, and clinical studies, including the assessment of immunogenicity and pharmacokinetics (PK)/pharmacodynamics (PD).