By Kevin E. Noonan --
In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz. In doing so, the Court limited the information available to biologic drug makers regarding a competitor's application for a biosimilar product (adopting Sandoz's argument). On the other hand, the decision extended the statutory exclusivity period enjoyed by innovator biologic drug makers relating to when the biosimilar applicant can enter the marketplace (as Amgen argued).
The BPCIA is a component of the healthcare law commonly termed "Obamacare" and provides for the first time in the U.S. an abbreviated pathway for FDA approval of so-called "biosimilar" drugs, generic versions of biologic drugs. The Act contains complicated litigation provisions that have come to be termed the "patent dance" that prescribe how the parties (termed the "reference product sponsor" and the "biosimilar applicant") decide which patents will be litigated during the time prior to FDA approval.
The case arose over Amgen's drug Neupogen® (filgrastim) that was the subject of a biosimilar application by Sandoz. At issue was Sandoz's decision not to comply with the first provision of the law, which states that the biosimilar applicant "shall" provide to the reference product sponsor a copy of its application and also manufacturing information (because it was recognized that patents related to manufacturing might be at issue between the parties). Sandoz contended that despite using the word "shall" Congress did not intend to make these disclosures mandatory, because the law also provided remedies for reference product sponsors faced with nondisclosure from the biosimilar applicant. The District Court sided with Sandoz in its interpretation of the law, that these remedy provisions indicate that, taken as a whole, the law does not force the biosimilar applicant to make these disclosures.
Also at issue was interpretation of another provision of the law, that the biosmilar applicant provide 180 day notice to the reference product sponsor that it intended to enter the marketplace. Sandoz provided this notice prior to obtaining FDA approval, and the Court agreed with Amgen that the law does not permit marketing notice until after a biosimilar applicant has received FDA approval. Sandoz's biosimilar, under the brand name Zarxio®, obtained FDA approval on March 5, 2015, and under this aspect of the decision will be available for marketing on September 2nd.
The decision was written by Judge Lourie, who was able to persuade Judge Chen to his point of view regarding the interpretation of whether disclosure of the biosimilar application was mandatory, and Judge Newman to his opinion that the law prevents a biosimilar applicant from giving marketing notice until after FDA approved the application. Each of these judges wrote separate opinions reflecting partial concurrence and partial dissent, which gives both parties a basis for en banc review and, if necessary petitions for certiorari.
Patent Docs will provide more information on this decision in subsequent posts.
Section (k) ‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL
PRODUCT.—Upon review of an application submitted under this
subsection relying on the same reference product for which
a prior biological product has received a determination of interchangeability
for any condition of use, the Secretary shall not
make a determination under paragraph (4) that the second
or subsequent biological product is interchangeable for any
condition of use until the earlier of—
‘‘(A) 1 year after the first commercial marketing of
the first interchangeable biosimilar biological product to
be approved as interchangeable for that reference product;
‘‘(B) 18 months after—
‘‘(i) a final court decision on all patents in suit
in an action instituted under subsection (l)(6) against
the applicant that submitted the application for the
first approved interchangeable biosimilar biological
product; or
‘‘(ii) the dismissal with or without prejudice of
an action instituted under subsection (l)(6) against the
applicant that submitted the application for the first
approved interchangeable biosimilar biological product;
or
‘‘(C)(i) 42 months after approval of the first interchangeable
biosimilar biological product if the applicant
that submitted such application has been sued under subsection
(l)(6) and such litigation is still ongoing within
such 42-month period; or
‘‘(ii) 18 months after approval of the first interchangeable
biosimilar biological product if the applicant that submitted
such application has not been sued under subsection
(l)(6).
Under the Court’s reading – the first mover (Sandoz), that opts not dance, gets either 18 months from approval or 1 year from first marketing (whichever is earlier) exclusivity from any second or subsequent mover because the patent owner can not sue under (l)(6). But because the majority read (l)(8) notice requirement as “must” with a 180 days commercial marketing hold- both (A) & (C)(ii) basically mean the same thing [18 months from approval, because the first mover will market if they can to maximize profit because second movers will follow quickly].*
My point I guess – why choose not to dance? If the patent owner has patents they are going to assert them, and you get up to 42 months from approval because the courts don’t resolve anything in near the same speed as the FDA approved this biosimilar [applied may 2014 – approved march 2015].**
the section (l) disclosure is all confidential (as in the patent owner must maintain the follow-on company’s info confidential and vice-versa) and sections detail how the district court action takes over to use protective orders – there is no difference in information because the patent owner is going to ask for all of those documents in discovery, the only difference is when the patent owner knows it; moreover, in this case amgen got ALL of that information in the discover portion of the suit – its not like they couldnt figure it out
My real issue: either go with Chen the full way (if you are inclined to read (l)(2) to be an optional trigger for the dance, (l)(8) should be as well; otherwise, the entire process should be mandatory like Newman (which then actually accomplishes what congress wanted – efficient litigation to resolve the issues)
* Assuming any district court and/or appellate court enjoin commercial marketing which otherwise would trigger (k)(6)(A)'s earliest date at 12 months from marketing date - again assuming the first mover (sandoz) markets at first opportunity
**Yes – if the patent suit happens to go quickly, then only 18 months from a final decision or dismissal
Posted by: anon | July 21, 2015 at 11:59 PM
The link to the decision does not work.
Posted by: Sri Melethil | July 27, 2015 at 10:59 AM
Sri:
It appears that the Federal Circuit has modified its opinions page. The link has been fixed. Thank you for alerting us to the issue.
Don
Posted by: Donald Zuhn | July 27, 2015 at 11:26 AM