1. No more 10 sequences rule!

   Will we have to file a separate patent application for each sequence claimed?

   The “ten sequences” rule in MPEP §803.04, used to say that “in most cases, up to ten independent and distinct nucleotide sequences will be examined in a single application without restriction…” (emphasis added). The Oct 2015 MPEP now says that “[c]laims to polynucleotide molecules will be considered for independence, relatedness, distinction and burden in the same manner as claims to any other type of molecule.” In other words, the “ten sequences” rule is no more. The previous rule was enacted in 1996, and the PTO has explained that MPEP §803.04 was revised because today’s SEQ ID NOs are more complex than they were back in 1996. This is probably true, but today’s sequence search tools are also more sophisticated than those of 1996. It is not clear, therefore, that the reasoning behind the old “ten sequences” rule is actually obsolete. Meanwhile, the new §803.04 has the potential to do real harm to the biotechnology industry, which under the terms of the new rule could be required to file a separate application on each SEQ ID NO claimed. When and if the PTO solicits comments on the new MPEP revisions, interested stakeholders should urge the Director to reinstate the “ten sequences” rule.

2. Rehearing en banc denied!

   As reported in our Sept 2015 Newsletter, following Amgen v. Sandoz¹, Sandoz launched the first biosimilar licensed under the Biologics Price Competition and Innovation Act of 2009 on 3 Sept 2015. Sandoz’s ZARXIO (filgrastim-sndz) is a biosimilar version of Amgen’s NEUPOGEN (filgrastim) that the FDA licensed on 6 Mar 2015 under BLA 125553. The Federal Circuit denied Amgen’s and Sandoz’s petitions for rehearing en banc. Now, we will have to see if the parties pursue recourse to the U.S. Supreme Court.3. Dynamic Drinkware… a small but significant exception to this “earliest filed disclosure” rule.

3. Dynamic Drinkware… a small but significant exception to this “earliest filed disclosure” rule.

   A disclosure in a U.S. patent or a published U.S. application is part of the prior art from the date of filing. If a patent claims the benefit of a previous U.S. filing (often a provisional filing), then the art-effective date of the disclosure is the date of the earliest filing that contains the relevant disclosure. However, the Federal Circuit recently held² that there is a small but significant exception to this “earliest filed disclosure” rule. The earlier filing only becomes prior art if the later patent or published application is entitled to claim priority to the earlier filing under 35 U.S.C. §119. Therefore, a challenger trying to invalidate a patent claim based on a disclosure in a provisional patent application must not only show that the disclosure in the provisional anticipates the challenged claim or renders it obvious, the challenger must also show that the issued U.S. patent is entitled to claim the benefit of the provisional filing date. Even if the issued patent is entitled to the benefit of the provisional filing date, if the challenger does not show as much, then the challenge fails as a matter of law.

4. 1st 3D Printed Drug Approved in U.S.

   In August 2015, the U.S. FDA approved the first 3D printed drug, SPRITAM® (levetiracetram), developed by Aprecia Pharmaceuticals for epilepsy treatment. SPRITAM® uses “ZipDose” technology to produce “a porous formulation that rapidly disintegrates with a sip of liquid.” It is easy to imagine the implications of this new technology, such as personalized dosage formulations and access to medicine in the developing world. However, what are the safety and intellectual property implications? How will we identify infringing products and enforce patent laws if we cannot trace the source? How will the FDA regulate manufacturing away from the source? Further complicating this issue, the Federal Circuit recently ruled³ that U.S. customs has no authority to stop digital signals from crossing the border, because digital signals are not “articles” that infringe a U.S. patent under 19 U.S.C. §1337. There is, therefore, no recourse to stop someone from sending a signal from outside the U.S. to a 3D printer in the U.S., even if that signal directs the 3D printer to manufacture an infringing item. Existing laws may not be up to the challenges posed by 3D printing, and statutory revisions may be necessary.

[1] Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015)

[2] Dynamic Drinkware v. Nat’l Graphics, 116 U.S.P.Q.2d 1045 (Fed. Cir. 2015)

[3] ClearCorrect Operating v. ITC, No. 2014-1527 (Fed. Cir. Nov. 10, 2015)