Lack of Likelihood of Success and Irreparable Harm Doomed Preliminary Injunction

In Takeda Pharmaceuticals USA, Inc. v. Mylan Pharmaceuticals Inc., [  2020-1407, 2020-1417] (July 31, 2020), the Federal Circuit affirmed the denial of a preliminary injunction on the grounds that Takeda failed to show that it was likely to succeed on the merits or that it would be irreparably harmed absent a preliminary injunction.

A plaintiff seeking a preliminary injunction must establish [1] that he is likely to succeed on the merits, [2] that he is likely to suffer irreparable harm in the absence of preliminary relief, [3] that the balance of equities tips in his favor, and [4] that an injunction is in the public interest.”

On the likelihood of success, the Federal Circuit agreed that the final judgment in the prior litigation likely triggered Section 1.2(d) of a License Agreement, permitting Mylan to market its generic colchicine product, and therefore Takeda was unlikely to succeed on the merits.

The Federal Circuit then considered the issue of irreparable harm. Takeda primarily relied on Section 1.10 of the License Agreement, which created a presumption of harm if the license agreement were breached, to prove irreparable harm. The Federal Circuit by its terms, Section 1.10 only offers Takeda a basis for establishing irreparable harm in the event Mylan breached Section 1.2.  However, because it concluded that it is unlikely Takeda can show that Mylan breached the License Agreement, the Federal Circuit further conclude that Section 1.10 is not useful for establishing irreparable harm.

Judge Newman in dissent argued that there was no accelerating event and thus Mylan breached the Agreement, entitling Takeda to a preliminary injunction.

Hindsight Cannot be the Thread that Stitches the Prior Art Patches into the Claimed Invention

In Metalcraft of Mayville, Inc., v. The Toro Company, [2016-2433, 2016-2514] (February 16, 2017), the Federal Circuit affirmed a modified preliminary injunction against Toro’s continued infringement of U.S. Patent No. 8,186,475 on platform suspension systems for lawnmowers.

The claims required “an operator platform that supports the seat and an entire body of an operator during use of the utility vehicle,” while Toro maintained that because part of the user’s body were supported by the controls, which were not mounted on the operator platform, its accused lawnmowers do not meet the limitation “an entire body of an operator.”

On appeal Toro argued that the district court’s construction of “an entire body of an operator” was improper because it excludes the operator’s hands and arms. The Federal Circuit disagreed, finding that nowhere did the district court conclude that “an entire body of an operator” excluded the operator’s arms and hands.  The Federal Circuit said that the patent makes clear that it is the suspended operator platform that supports “an entire body of an operator” and that the operator platform is a separate and distinct element from the steering controls. However this really did not address Toro’s argument that if the controls are connected to the platform, then the platform supports the users entire body, but when the controls are attached to something else, something else helps support the user’s body.

Toro also argued that if the steering controls are not mounted on
the operator platform, the operator’s hands will not be isolated from shock loads. However, the Federal Circuit rejected this argument as importing limitations into the claims.

On the question of validity, the district court rejected Toro’s obviousness contention because a patent composed of
several elements is not proved obvious merely by demonstrating
that each of its elements was, independently,
known in the prior art.  The district court said that Toro provided “no reason, and the Court cannot imagine one, that a person of ordinary skill in this field would combine a motorcycle shock with a suspended truck cab and come up with a suspended operator platform.”

The Federal Circuit agreed that Toro provided no explanation or reasoning for concluding that one of skill in the art would have combined these particular references to produce the claimed invention. Without any explanation as to how or why the references would be combined to arrive at the claimed invention, we are left with only hindsight bias that KSR warns against.  The Federal Circuit said that while it understands that the obviousness
analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, it also recognizes that it “cannot allow hindsight bias to be the thread that stitches together prior art patches into something that is the claimed invention.”

The Federal CIrcuit also agreed with the district court that there was irreparable harm, because “it is impossible to quantify the damages caused by the loss of a potentially lifelong customer.”

Finally, the Federal Circuit agreed with the scope of the injunction, rejecting Toro’s argument that that it was too broad.

Denial of Preliminary Injunction because of Stay Still Requires the Court to State Findings and Conclusions

In Murata Machinery USA v. Daifuku Co., Ltd., [2015-2094] (August 1, 2016), the Federal Circuit affirmed the district court’s refusal to lift a stay pending inter partes review, but vacated the denial of a preliminary injunction because the district court failed to state findings and conclusions supporting denial of a preliminary injunction as required by Rule 52(a)(2) of the Federal Rules of Civil Procedure.