This Newsletter was originally posted to the articles section of the Harness Dickey website in March 2015. To receive the most up-to-date BioPharma news and tips, please visit www.hdp.com and subscribe to the BioPharma emails.
1) First U.S. Biosimilar Approved!
The FDA approved Sandoz’s biosimilar version of Amgen’s Neupogen® for sale in the U.S. on 6 March 2015. This is the first biosimilar to be approved under the provisions of the Biologics Price Competition and Innovation Act (BPCIA) of 2010. Sandoz will sell its biosimilar under the brand name Zarxio™. The drug is used to stimulate neutrophil production in patients undergoing chemotherapy. Note the FDA did not approve Zarxio™ as an interchangeable product, because, among other reasons, the agency has not yet developed standards for making this determination. Meanwhile, Amgen and Sandoz are still in pending litigation over whether Sandoz is required to participate in the litigation provisions of the BPCIA.
2) Applying the New “Reasonable Certainty” Definiteness Standard:
Two recent Federal Circuit cases apply the indefiniteness standard from Nautilus that changed the test from “insolubly ambiguous” to “reasonable certainty.”
- Indefinite: In Interval Licensing, the claim term “unobtrusive manner that does not distract a user” – in the context of an image display for a device – was indefinite. “Unobtrusive manner” was a highly subjective term of degree, without any definition provided. Further, the hazy relationship between the claim term and the application failed to provide the reasonable certainty needed to interpret the subjective language. However, the court noted that not all claim terms of degree are automatically indefinite.
- Definite: In DDR Holdings, the subjective claim term “look and feel” was definite. The term had a known, objective meaning in the art. Further, the application listed various “look and feel” examples consistent with the term’s established meaning. Thus, “look and feel” was not facially subjective, but rather definite because there was reasonable certainty of its meaning.
Avoid subjective claims terms where possible. Define claim terms in the application and provide examples. Provide quantifiable parameters, metrics, or test methods as to how certain claim terms can be objectively determined. If a claim term potentially has multiple interpretations, explicitly indicate which interpretation is intended. For example, the meaning of the claim term “molecular weight” of a copolymer active ingredient was not specified and is at issue in the recently decided Teva Pharmaceuticals case that was vacated and remanded to the Federal Circuit.
3) Eye on Obviousness: Fate of Post-Filing Date Evidence?
- Seeking Supreme Court Review: After the Federal Circuit invalidated Bristol-Myers Squibb’s (“BMS”) US 5,206,244 covering Baraclude® in June 20145, BMS petitioned the Supreme Court on 20 Jan 2015 to review the question: “Should courts consider post-filing date evidence showing the actual differences between a patented invention and the prior art?”
- Potential Consequences: If the Supreme Court answers that question in the negative, it may significantly change the way patents relate to the business models of most pharmaceutical innovators.
- BIO, PHaRMA, and the Bay Area Bioscience Association have all filed amicus briefs urging the Court to grant certiorari and reverse the Federal Circuit panel.
- The deadline for Teva to respond is 1 April 2015, so the Court cannot decide to review the question before then.
- Harness Dickey is monitoring this case closely and will keep you updated as developments emerge.
4) More on Patent Term Adjustment (PTA)!
Loss of PTA after Restriction Requirement: The Federal Circuit affirmed the USPTO’s interpretation of the PTA statute, namely that filing an IDS after response to a restriction requirement is properly considered as applicant delay thereby reducing PTA.6
- If possible, submit IDSs before or along with filing a response to an office action or restriction requirement to avoid losing PTA.
- If a response has already been filed, if applicable, submit necessary patent office communications and references cited therein from a related/counterpart application (foreign or U.S.) within 30 days of receipt with a § 1.704(d) statement to avoid a loss in PTA.