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« Daiichi Sankyo Co. v. Lee (Fed. Cir. 2015) | Main | Amgen v. Sandoz (Fed. Cir. 2015) »

July 21, 2015

Comments

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

The link to the decision does not work.

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

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