The following is excerpted from a July 22, 2008 IMPAX press release at Business Wire:

IMPAX Laboratories, Inc. today announced Boehringer Ingelheim Pharmaceuticals Inc. ("Boehringer") and Astellas Pharma Inc. ("Astellas") have filed suit for patent infringement in the United States District Court for the Northern District of California based on the Company's submission of Abbreviated New Drug Application ("ANDA") for tamsulosin hydrochloride capsules (0.4 mg), generic of Flomax®, to the Food and Drug Administration. In connection with this ANDA, IMPAX provided notice to Boehringer and Astellas that its submission includes a Paragraph IV certification stating the Company believes its product does not infringe any valid or enforceable claim of U.S. Patent No. 4,703,063.

Flomax® capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. According to Wolters Kluwer Health, U.S. sales of Flomax® capsules were approximately $1.5 billion in the 12 months ended May 2008.

See the full press release here.

A reader tipped me off to this interesting item by W. David Gardner in yesterday's (July 21, 2008) InformationWeek:

The mother of all wireless patent cases is scheduled to get under way Wednesday when Qualcomm (NSDQ: QCOM) and Nokia (NYSE: NOK) meet in Delaware Court of Chancery to decide on the amount of royalties Nokia should or should not pay to Qualcomm.
 
Interest in the case -- which could involve hundreds of millions of dollars, even billions -- is so intense that the case will be televised by Courtroom View Network via Webcast. Sources said the service will be available at a charge beginning at $400 and that financial institutions including hedge funds have been signing up for the service. The proceedings will be available online for 30 days for subscribers.

Qualcomm and Nokia have been battling for years over Qualcomm's patents, although Nokia notes that it has developed a patent portfolio of its own in recent years.

The case stems from a 1992 licensing agreement in which Nokia obtained certain rights to Qualcomm patents. Finland-based Nokia, which supplies 40% of the world's mobile phone handsets, is said to have paid $1 billion to Qualcomm and is seeking to cut payments going forward.

The Practising Law Institute is hosting a seminar with the above title in New York City and San Francisco (Live Webcast) on September 11, 2008 and October 15, 2008, respectively.

Pharmaceutical and biotech patent law is an important and rapidly changing practice area. Technological innovation, Federal Circuit appellate oversight, Congressional action and Supreme Court decisions have all driven significant changes in the law. Several different perspectives on many of the most pressing issues will be offered from experienced in-house and outside counsel, Federal District Court judges who have tried patent cases, and attorneys from the PTO's Office of the Solicitor.

What You Will Learn

• The patentability of active pharmaceutical ingredients and the impact of KSR v. Teleflex
• Issues relating to pharmaceutical and biotech transactions, including due diligence, practical considerations and patent misuse and antitrust considerations
• Patent issues impacting research tools used in drug discovery and development
• Testing the limits of patentable biotech and pharmaceutical subject matter
• How the PTO helps to shape the development of Federal Circuit and Supreme Court precedent
• Perspectives on trying pharmaceutical and biotech patent cases

More details and registration information are available here.

Co-Chairs

David K. Barr, Kaye Scholer LLP
Daniel L. Reisner, Kaye Scholer LLP

Speakers

Hon. William G. Bassler (Ret.), Senior District Judge, JAMS
Thomas Krause, Associate Solicitor, United States Patent and Trademark Office, Solicitor's Office
Hon. John C. Lifland (Ret.), District Judge, JAMS
Michael M. Shih, Director, Business Development, Eisai Inc.
Aaron Stiefel, Kaye Scholer LLP
Errol B. Taylor, Milbank, Tweed, Hadley & McCloy LLP
Jennifer A. Tegfeldt, Director, Business Initiatives and Strategy, Genzyme Corporation
Roy F. Waldron, Assistant General Counsel, Pfizer Inc.

Program Attorney

John M. Mola, Practising Law Institute

Eric Lane is the author of the Green Patent Blog ("covering intellectual property issues in clean technology") which launched in December 2007.  He is a patent attorney at Luce, Forward, Hamilton & Scripps in San Diego, where he is in the Intellectual Property and Climate Change & Clean Technologies practice groups.

The following is excerpted from his July 13, 2008 post titled, "A Lesson for Nilssen: Breaking the Rules Proves Costly for Prolific CFL Inventor:"

In a previous post I wrote about Ole K. Nilssen, who played fast and loose with the U.S. Patent & Trademark Office (PTO) disclosure rules while prosecuting and maintaining some of his 200+ patents directed to compact fluorescent lighting (CFL) technology.  Nilssen's shenanigans included incorrectly claiming the right to pay reduced fees reserved for small entities, submitting misleading affidavits, and failing to disclose to the PTO then-pending litigation with Motorola on related subject matter.

The inventor's conduct before the PTO was later deemed inequitable conduct by the district court and the Federal Circuit Court of Appeals (Federal Circuit) (Patent rule 1.56 imposes a duty of candor on the applicant, and patent case law deems such deception and incomplete disclosure of material information during the patent application process "inequitable conduct" that renders any resulting patents unenforceable).

It turns out that Nilssen's sloppiness before the PTO spilled over to the courtroom and has cost him about $6 million.  Last month the Federal Circuit affirmed a district court decision that Nilssen should pay Osram Sylvania, Inc.'s (Sylvania) attorney fees to cover the cost of the patent infringement suit Nilssen brought against Sylvania.

See the full post here.

I was recently contacted by reader and author, Colleen V. Chien, Assistant Professor, Santa Clara University School of Law.  She has written a paper on the International Trade Commission titled, "Patently Protectionist? An Empirical Analysis of Patent Cases at the ITC."

Based on an analysis of all cases filed at the ITC between 1995-mid 2007, it makes the case for rethinking the interface between the ITC and district courts. 65% of the time cases are being filed in both venues, yet their outcomes and remedies can be different with a lack of res judicata of ITC decisions and different standards for granting injunctions. It reports statistics on and explores how the venue is being used, in general and compared to the district court, and argues for improved coordination between the two venues.

Some have charged "that the ITC is protectionist, is unfair to defendants, and fosters inconsistency in US patent law."  The author's empirical analysis "fails to find support for the first two contentions. ITC cases involve domestic defendants as often as they do foreigners, and often in combination. Thus, plaintiffs are using the ITC to prosecute not only foreign companies, but US companies as well. When cases were adjudicated, plaintiffs were more likely to win in the ITC than in district court. However, when cases filed in both venues were compared, the difference disappeared, cutting against claims of an anti-defendant bias. The data provide some support for the third contention, however."

The paper is available for download here. The final version will be published in the William and Mary Law Review in October.

Chief Judge James F. Holderman of the United States District Court, Northern District of Illinois and Halley Guren, Senior Law Clerk to Chief Judge Holderman make four proposals (PTO post-grant review; the Federal Circuit's changing the standard of review and providing more guidance; district judges' increased use of special masters; and H.R. 34's pilot patent program of designated district judges) in their work in progress titled, "The Patent Litigation Predicament in the United States."  They believe these proposals taken in conjunction will "provide the most comprehensive approach to correcting the intertwined problems of high costs, inaccuracy, and unpredictability that plague our current patent system."  Below, I provide their remarks related specifically to the increased use of special masters.

To benefit fully from the better guidance the Federal Circuit will be providing us as to the patent law and procedure, we district judges should increase our use of specialized advisors, such as special masters, to assist us in better understanding the technology involved in the specific patent cases before us.  A special master is generally a court-appointed attorney or professor authorized under our Federal Rule of Civil Procedure 53 to assist judges in various pretrial proceedings, such as discovery, settlement, recommendations for findings of law and fact, the formulation of remedies, or the calculation of damages. 

Because we generalist district judges in the United States are expected to decide claim term meanings from the viewpoint a person of ordinary skill in the field of invention and to determine how such a person would understand the claim at the time of invention, we typically could use some assistance in understanding the technology that is relevant to the patent in the suit.  The premise behind a district judge's designation of a special master to assist the judge with claim construction or other tasks in patent litigation is to delegate to an individual with a better technical background an otherwise judicial task and obtain a recommendation from that person that can be evaluated by the parties and the judge before the judge decides to accept or reject the special master's recommendation.  The special masters selected for such tasks would have technical expertise that would assist us district judges, who typically do not have the extensive background that is necessary to address a particular patent.  Employing the expertise of special masters more than we district judges do at the present time would help us to be better informed when making our claim language determinations and, hopefully, to lower the reversal rate.  For example, Judge John T. Ward in the United States District Court of the Eastern District of Texas, who has helped to make the Eastern District of Texas one of the busiest federal districts for patent litigation filings, in part due to the enactment of the Eastern District of Texas's local patent rules, appoints technical advisors to provide recommendations as to claim construction.  More of us should follow Judge Wards's lead and appoint special masters or technical advisors.

There are drawbacks, however, to the patent litigation system that must be considered regarding the appointment of special masters.  Our system of justice places a high value on the concept of generalist judges addressing a wide range of issues, under a theory that the decisions of many generalists judges synthesize to give rise to a better system of law.  By using a special master, whose expertise is patent or technical issues, the parties may lose some of the benefits provided by having a generalist judge experienced in all procedural aspects of litigation.  A special master typically will not have that expertise.  Generalist judges also protect against what has been referred to as the "capture" of a specialized judge, or here, a special master, who deals only with one area of law, to a particular specialized view of a special interest group.  I note that the "capture" concept is often raised by commentators as a concern associated with specialized courts and judges as well.  However, I certainly believe that we district judges can keep an open mind and decide each case on its individualized merits.  That is what our oath of office demands, and I believe we have and will continue to uniformly perform our judicial duties in that manner.

Read the full article here.