Patent Baristas

Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Eisai Inc. (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu) today announced that they received court decisions on ANDA-related summary judgement motions for Aciphex® (Active Ingredient Name: rabeprazole sodium, Product Name in Japan: Pariet®) on October 6, 2006 (U.S. Eastern time). Eisai won summary judgement for patent validity in its lawsuit against Teva and Dr. Reddy’s over generic Aciphex (rabeprazole). Eisai looks forward to the trial and will vigorously defend its Aciphex® patent in order to protect the company’s interests.

Aciphex is a proton-pump inhibitor indicated for the treatment of ulcers and had sales of $1.2 billion last year. Aciphex® has been shown to have a rapid onset of action and a reliable inhibitory effect on acid secretion related to duodenal ulcers and gastroesophageal reflux disease, which are confirmed in clinical studies. Aciphex® was launched in the U.S. in 1999 and is currently marketed worldwide. Aciphex® has a well-established safety profile. The most common side effect possibly related to Aciphex® is headache.

The opinion by Judge Gerard E. Lynch of the Southern District of New York granted Eisai’s summary judgement motion confirming the validity of the Aciphex® composition of matter patent in its ruling. The judgement states that Eisai’s U.S. Patent No. 5,045,552, would not have been obvious because there was no teaching, suggestion, or motivation to combine three prior art references. The Southern District Court reserved ruling on the enforceability arguments until after trial.

Motion for summary judgement is a request made by the defendant in a civil case. Asserts that the plaintiff has raised no genuine issue to be tried and asks the judge to rule in favor of the defense. Typically made before the trial. “Each element must be supported in the same way as any other matter on which the plaintiff bears the burden of proof” i.e., with the manner and degree of evidence required at the successive stages of the litigation.” Id. In order to defeat a summary judgement motion, the nonmoving party may not simply rely on his pleadings but must present some evidence on every material issue for which he will bear the burden of proof at trial. Celotex Corp. v. Catrett, 477 U.S. 317, 324 (1986).

Like any motion, a motion for summary judgement educates the opponent. Education is for the classroom, not in the courtroom. Unless the purpose is to inform the court of the law in advance of trial, motion practice is only successful if the defendant or the movant wins. This is true because filing motions informs the opponent about the intricacies, theories as well as the strategies behind the case. If the movant for motion for summary judgement loses the motion, the opponent enjoys the advantage of knowing what your defenses or theories are, and how you intend to implement them. But there is another reason: filing motions informs the court and opposing counsel of the strengths and weaknesses of the case.

If one is trying to settle the case, then bringing the motion may be justified. But if that’s not the case, then showing weaknesses may cause the litigation to drag on. It is often better to say nothing than to say something in an unconvincing fashion. Weaknesses are better left for the spontaneity of trial, as opposed to the deliberative process inherent in motion practice. An affirmative defense can achieve much more than a failed summary judgement motion or a motion to dismiss. The burden of proof in a summary judgement motion initially centers on the burden of production rather than the risk of non-persuasion. In other words, the thing which matters the most is… what facts you are required to muster to establish you are entitled to judgement as a matter of law.

What this means to the person seeking summary judgement is that, as the movant, he must anticipate what the other party’s proof will be. In move for summary judgement, one should show that the uncontradicted facts entitle you to judgement as a matter of law. On the other hand, one should presume that the opponent will attempt to create a disputed fact issue. Therefore, the movant need more than pleadings to win a summary judgement motion (i.e., requests to admit, depositions, affidavits). Once the party seeking summary judgement produces the evidence necessary to establish entitlement to judgement as a matter of law, the burden of production shifts to the party opposing the motion, who may not merely rely on the pleadings, but is required to come forth with some facts which create a material disputed issue of fact. At this point, with respect to summary judgement, it depends whether you are a plaintiff or defendant. If you are the former and opposing the motion, you must provide some factual basis that arguably contradicts the pleadings and affidavits of your opponent as well as shows the elements of your cause of action which would, if believed, entitle you to judgement as a matter of law. If you don’t produce such evidence, you are going to lose the motion.

Summary judgement can be an early demise for an unsuspecting litigant. Its primary function is to let a trial court fathom whether there is any question of material fact to be tried by the court or a jury and, if not, whether your client is entitled to judgement as a matter of law. At the same time, if utilized carelessly, this procedure can give an early view to an opponent’s case, theory(ies), and strategy. The utilization of, and responses to, motions for summary judgement should be undertaken with thoughtfulness, care and a command of the discovery rules that can make summary judgement a reality for your clients.

Today’s post comes from Gautam Bakshi and Ashu Gautm Bakshi, registered patent agents with the Government of India. Manager – IPR, Intas Biopharmaceuticals Ltd., Ahmedabad, Gujarat, India (Gautam.Bakshi – at – intasbiopharma.co.in).