Search Team

Search by Last Name
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

Mylan Institutional LLC v. Aurobindo Pharma Ltd.

Review of “Function-Way-Result” Equivalence Test Raises Questions About Suitability for Some Cases

Mylan Institutional LLC v. Aurobindo Pharma Ltd.,  (Fed. Cir. May 19, 2017) (LOURIE, Moore, Reyna) (E.D. Tex.: Schroeder) (4 of 5 stars)

Fed Cir affirms grant of preliminary injunction barring Aurobindo from making or selling isosulfan blue (“ISB”), a dye used in the mapping of lymph nodes, but modifies the injunction so that it is premised only on a composition patent asserted by Mylan. The district court had erroneously also based the injunction on two process patents.

As to the process patents, the district court abused its discretion in concluding that Mylan was likely to prove infringement under the doctrine of equivalents. The opinion notes, “[T]he district court’s analysis of equivalence in this case was flawed, no doubt because of the sparse and confusing case law concerning equivalents, particularly the paucity of chemical equivalence case law, and the difficulty of applying the legal concepts to the facts.” Op. at 12. The opinion goes on to discuss in detail the function-way-result test. It concludes that Aurobindo had raised ““sufficient doubt” as to whether two compounds—silver oxide and magnanese oxide—oxidize isoleuco acid in the same way as the claimed invention as to make the district court’s finding abuse of discretion. The opinion notes that, at the full trial on the merits, the district court may wish to consider whether the “substantial differences” test for equivalents is better suited to chemical cases than the “function-way-result” test.

As to the composition patent, the district court did not abuse its discretion in finding Mylan likely to prevail on its claims. Aurobindo did not contest the likelihood of an infringement finding, and the district court did not clearly err in its rejection of Aurobindo’s invalidity defenses. Each of the errors Aurobindo alleged were factual in nature, and the opinion defers to the district court. It also notes that Mylan had raised evidence of secondary considerations to overcome Aurobindo’s obviousness attack.

As to irreparable harm, the district court did not err in rejecting Aurobindo’s arguments against causal nexus. The opinion rejects Aurobindo’s argument that the district court had based its finding of nexus solely on the fact that the FDA had approved Aurobindo’s ANDA. The record also included evidence of copying, and otherwise indicated that Aurobindo would not have been able to make the product described in its ANDA without infringement.

KEYWORDS: PRELIMINARY INJUNCTION (YES); DOCTRINE OF EQUIVALENTS; FUNCTION WAY RESULT