Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_01-cv-02214/USCOURTS-cand-3_01-cv-02214-7/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:271 Patent Infringement

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United States District Court

For the Northern District of California

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United States District Court

For the Northern District of California

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

SYNTEX (USA) LLC, and ALLERGAN, INC.,

 Plaintiffs,

 v.

APOTEX INC, APOTEX CORP., and NOVEX

PHARMA,

Defendants. /

No. C 01-02214 MJJ

Related Case:

No. C 05-02116 MJJ

ORDER GRANTING TEMPORARY

RESTRAINING ORDER

Pending before the Court is Plaintiffs Syntex (USA) LLC, and Allergan, Inc.’s Ex Parte Motion

for Temporary Restraining Order and Order to Show Cause re Preliminary Injunction (Doc. #487). On

December 29, 2005, the Court entered a Temporary Restraining Order enjoining Defendants from

commercially manufacturing, using, offering to sell, selling or importing into the United States any drug

product the approval for which is sought through Abbreviated New Drug Application 76-109, pending

this Court’s decision as to whether a preliminary injunction should issue. Subsequently, on February 23,

2006, the Court entered an Order extending the TRO until the Court ruled on Plaintiffs’ request for a

preliminary injunction and Defendants’ related obviousness challenge to Plaintiffs’ ‘493 patent.

Construing the extension of the TRO as a preliminary injunction, on May 1, 2006, the Federal Circuit

issued an order vacating this Court’s Order extending the TRO for lack of factual findings necessary to

support a preliminary injunction under Federal Rule of Civil Procedure 52(a). (Doc. #487, ex. A..) In

light of the Federal Circuit’s ruling, and for the reasons articulated below, the Court GRANTS

Plaintiffs’ Motion as provided in this Order. 

Case 3:01-cv-02214-MJJ Document 491 Filed 05/18/06 Page 1 of 5
United States District Court

For the Northern District of California

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I. Legal Standard

In ruling on a motion for a temporary restraining order, the Court evaluates the following factors:

(1) the probability that the movant will succeed on the merits; (2) the threat of irreparable harm to the

movant should a preliminary injunction be denied; (3) the balance between this harm and the harm that

granting the injunction will cause to the other parties; and (4) the public interest. Anton/Bauer, Inc. v.

PAG, Ltd., 329 F.3d 1343, 1348 (Fed. Cir. 2003). 

II. Discussion

A. Likelihood of Success on the Merits

Defendants attack the validity of the ‘493 patent on the ground that it is obvious. Thus, the Court

must assess Plaintiffs’ request for injunctive relief in the context of Defendants’ obviousness challenge.

Section 103(a) of the Patent Act states that “[a] patent may not be obtained . . . if the differences

between the subject matter sought to be patented and the prior art are such that the subject matter as a

whole would have been obvious at the time the invention was made to a person having ordinary skill

in the art.” See KAO Corp. v. Unilever U.S., Inc., 441 F.3d 963, 968 (Fed. Cir. 2006). Obviousness is

a legal determination based on factual determinations, including: what a prior art reference teaches;

whether a reference provides a motivation to combine its teachings with others; whether the invention

experienced commercial success; and whether it satisfied a long-felt, but unmet need. Tec Air, Inc. v.

Denso Mfg. Mich., Inc., 192 F.3d 1353, 1359 (Fed. Cir. 1999). Assessing the factual questions, the

Court finds that Plaintiffs have sufficiently demonstrated a likelihood of success on the merits in

defending against Defendants’ obviousness attack. 

First, the Court finds that Plaintiffs have presented persuasive evidence that none of the prior art

references suggest a motivation to combine to form the patented invention. The Waterbury, Gilbert, and

Han patents do not discuss long-term stability or anti-microbial effectiveness and do not address any

problems relating to the interaction of BAC and ketorolac tromethamine. (R.T. 1158:1-6, 1159:25-

1160:3; 1707:25-1710:6; Trial Ex. WJ; Trial Ex. AK.) With respect to McCutcheon’s, while it identifies

Octoxynol 40 as an “emulsifier, stabilizer,” it does not disclose the use of Octoxynol 40 in a

pharmaceutical. (Trial Ex. AL.) Further, there is no evidence that anything in McCutcheon’s suggests

that Octoxynol 40 could be used on a pharmaceutical product or in an ophthalmic formulation, or that

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it would preserve the anti-microbial effectiveness of a preservative. (Id.) Further, none of the prior art

references disclose a functional equivalence between Octoxynol 40 and any of the surfactants disclosed

in the prior art references. 

Second, Plaintiffs have presented sufficient evidence to rebut Defendants’ argument that a

motivation to combine existed. In support of their argument that there was a motivation to substitute

Octoxynol 40 for the surfactants disclosed in the Waterbury, Gilbert, and Han patents, Defendants

primarily rely on Dr. Mitra’s testimony that Octoxynol 40 was well-known in the cosmetic industry and

that it would be easy to substitute an octoxynol like Octoxynol 40 for another non-ionic surfactant such

as Polysorbate 80. (Record Transcript 1143-1144.) Notably, Dr. Mitra never opined that it would have

been obvious to one skilled in the art at the time Plaintiffs’ applied for their patent to use a non-ionic

surfactant as a stabilizer in an ophthalmic formulation containing an NSAID. (Id.) Additionally,

Defendants cite Dr. Mitra’s testimony that all water-soluble non-ionic surfactants would have worked

equally well in the patented formulations. Plaintiffs, however, have presented testimony from their

expert, Dr. Stella, calling into question the validity of Dr. Mitra’s theory regarding the substitutabiliy

of surfactants. (R.T. 1717.) Particularly, Dr. Stella criticized Dr. Mitra’s theory on the basis that it

failed to take into account structural variations among surfactants and the effect of other variations, such

as differences in BAC and environmental factors. (Id.) At a minimum, Dr. Stella’s testimony

undermines Dr. Mitra’s testimony and Defendants’ ability to meet its burden of demonstrating a

motivation to combine. 

Third, Plaintiffs have presented evidence that ACULAR®, the commercial embodiment of the

patented invention, supports a finding of non-obviousness. Particularly, in its first year in the market,

ACULAR®’s net sales exceeded $18 million, and have steadily increased since that time. (R.T.

1541:13-1555:14; 1558:23-1562:18; Trial Exs. 090, 091.) Moreover, ACULAR®’s sales have exceeded

other competitor drugs, including Voltaren Ophthalmic®, which like ACULAR® is an ophthalmic

NSAID, but does not contain ketorolac tromethamine or Octoxynol 40. (Trial Exs. 091, 092, 095, 096;

R.T. 1561:20-1562:18, 1577:8-14.) Thus, this evidence also ways in favor of a finding that ACULAR®

satisfied an unmet need in the market. 

Additionally, Plaintiffs have put forth persuasive evidence that the patented inventions produced

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For the Northern District of California

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unexpected results, even when viewed in light of the criticisms of the first patent examiner and the

prosecution history. As Plaintiffs highlight, data in the prosecution history shows that Octoxynol 40

outperformed both Polysorbate 80 and Myrj 52. (R.T. 695:1-701:14; Trial Exs. 204, 205.) 

Taken together, the foregoing evidence creates a strong likelihood that Plaintiffs will succeed

in defending against Defendants’ obviousness challenge to the ‘493 patent. Thus, this factor weighs in

Plaintiffs’ favor. 

B. Threat of Irreparable Harm

Next, the Court must assess whether Plaintiffs will suffer severe and irreparable harm absent

injunctive relief. Plaintiffs have previously submitted compelling evidence that: (1) the release of a

generic equivalent to Plaintiffs’ product would be devastating to Allergan’s commercial goodwill and

competitive position in the ophthalmic anti-inflammatory market; (2) the damage to Allergan’s goodwill

and pricing structure could not be repaired if Defendants’ product was pulled off the market following

final judgment for Plaintiffs in this matter; and (3) Allergan’s goodwill would be further harmed by its

causing a recall of a generic product a short time after its general release. See Doc. #431, Decl. of Julian

Gongolli at ¶ ¶ 3-4. Further, this harm is not remediable by monetary damages and Plaintiffs have no

other adequate remedy at law. 

C. Balance of Plaintiffs’ Harm and the Harm Caused by Granting the Injunction

The balance of hardships tips in Plaintiffs’ favor because, should Plaintiffs prevail in upholding

the validity of their patent, denying injunctive relief at this stage will subject Plaintiffs to the irreparable

harm detailed above, whereas Defendants will remain in the same position. 

D. Public Interest 

Finally, the public interest strongly favors enforcement and protection of patent rights.

Defendants’ temporary loss of market share pending the Court’s ruling on the issue of obviousness, is

insufficient to overcome Plaintiffs’ right to enforce their patent until and unless it is invalidated. See

Pfizer, Inc. v. Teva Pharms. USA, Inc., 429 F.3d 1364, 1382 (Fed. Cir. 2005). 

III. Conclusion

Based on the foregoing analysis, the Court finds that Plaintiffs have make the requisite showing

entitling them to temporary injunctive relief. The Court therefore GRANTS Plaintiffs’ Ex Parte Motion

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For the Northern District of California

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The Court anticipates that it will issue its ruling by the expiration of this TRO. 

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for Temporary Restraining Order as follows: 

Defendants Apotex, Inc. Apotex Corp., and Nova Pharma, along with the representatives,

officers, agents, servants, employees, and attorneys, and any persons acting in concert or participation

with them, are restrained and enjoined, pending this Court’s decision as to whether a preliminary

injunction should issue and concurrent resolution of Defendants’ obviousness challenge to the ‘493

patent,1 from commercially manufacturing, using, offering to sell, or selling within the United States or

importing into the United States any drug product the approval for which is sought through Abbreviated

New Drug Application 76-109. 

In light of the short time the temporary injunctive relief will be in place and based on the parties’

previous calculations of the amount of damages that would be directly attributable to the injunction, the

Court finds that a $500,000 bond is appropriate. Accordingly, the Court orders Plaintiffs to post a

$500,000 bond with the Clerk of the Court during the pendency of the TRO.

IT IS SO ORDERED.

Dated: 5/18/2006 MARTIN J. JENKINS

UNITED STATES DISTRICT JUDGE

Case 3:01-cv-02214-MJJ Document 491 Filed 05/18/06 Page 5 of 5