Thursday, June 18, 2015

Surfs up for Glatopa ( glatiramer acetate injection for relapsing MS )?

Of the decision in Teva v. Sandoz related to Copaxone,
as to legal matters:

To the extent that Teva argues that the meaning of
“molecular weight” in the context of patents-in-suit is
itself a question of fact, it is wrong. See Teva, 135 S. Ct.
at 841–42. A party cannot transform into a factual matter
the internal coherence and context assessment of the
patent simply by having an expert offer an opinion on it.
The internal coherence and context assessment of the
patent, and whether it conveys claim meaning with
reasonable certainty, are questions of law. The meaning
one of skill in the art would attribute to the term molecular
weight in light of its use in the claims, the disclosure
in the specification, and the discussion of this term in the
prosecution history is a question of law. The district court
should not defer to Dr. Grant’s ultimate conclusion about
claim meaning in the context of this patent nor do we
defer to the district court on this legal question. To the
extent that Teva argues that this ultimate determination
deserves deference, it is in error. To the extent that Teva
or the dissent suggests that the specification’s disclosure
of SEC would “infer” that this claim term, molecular
weight, in this patent refers to Mp, such an inference is
part of the legal analysis, not a fact finding to be given

Determining the meaning or significance to
ascribe to the legal writings which constitute the intrinsic
record is legal analysis. The Supreme Court made clear
that the factual components include “the background
science or the meaning of a term in the relevant art
during the relevant time period.” Id. at 841. Teva cannot
transform legal analysis about the meaning or signifi-
cance of the intrinsic evidence into a factual question
simply by having an expert testify on it. Id. at 841 (“experts
may be examined to explain terms of art, and the
state of the art, at any given time, but they cannot be
used to prove the proper or legal construction of any
instrument of writing” (citation omitted)). Determining
the significance of disclosures in the specification or
prosecution history is also part of the legal analysis.
Understandings that lie outside the patent documents
about the meaning of terms to one of skill in the art or the
science or state of the knowledge of one of skill in the art
are factual issues. Even accepting as correct the district
court’s factual determinations about SEC and the transfer
of chromatogram data to create Figure 1, these facts do
not resolve the ambiguity in the Group I claim about the
intended molecular weight measure

**Of average molecular weight

The district
court found credible Dr. Grant’s testimony that Mp is
the only type of average molecular weight that can be
directly obtained from a chromatogram and calibration
curve obtained by the analytical method described in
Example 1 (Size Exclusion Chromatography or SEC). Id.
at 588, 590. It noted that experts testified that Mn and
Mw can be obtained from the chromatogram and calibration
curve, but doing so would require additional data
manipulation and calculations not disclosed in the specification.
Id. It therefore credited Dr. Grant’s opinion that
Example 1 implies the use of Mp.

One has the text about other cases:

In the prosecution of both patents, the
examiner rejected the claims as indefinite because the
term average molecular weight was meaningless without
specifying whether Mp, Mn, or Mw should be used. S

One notes that Mp is not an average.

**Of the commercial significance-->

from :

About GlatopaTMOnce daily Glatopa (glatiramer acetate injection), developed in collaboration with Sandoz, is the first FDA-approved generic version of daily COPAXONE® 20 mg for patients with relapsing forms of multiple sclerosis. Produced entirely in the United States, once daily Glatopa has been determined by the FDA to be therapeutically equivalent to daily COPAXONE 20 mg, and is an "AP" rated, fully-substitutable product. As a therapeutically equivalent generic product, once daily Glatopa contains the same active ingredients, route of administration, strength, and dosage form, and can be substituted with the full expectation that Glatopa will produce the same clinical effect and safety profile as daily COPAXONE 20 mg. Daily COPAXONE 20 mg is one of the leading products marketed to treat multiple sclerosis, and is frequently prescribed as a first-line therapy in newly diagnosed patients.


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