Orange Book Blog

ACI "Pharma/Biotech Patent Boot Camp" Conference, San Francisco, Sept. 18-19

American Conference Institute will be holding its Pharma/Biotech Patent Boot Camp conference in San Francisco, September 18-19.

According to ACI, the conference "has been designed to give new patent attorneys and patent attorneys who are new to the life sciences industries--as well as business executives in pharma and biotech companies--a strong working knowledge of essential IP and regulatory competencies relative to life sciences patents."

The following talks sound particularly informative:

• Pre-Patent Considerations Relative to Product Development, Commercialization and Life Cycle Management
• Freedom to Operate: Analysis and Opinions for Pharma and Biotech Patents
• Finding Safe Harbors for Life Sciences IP: Assessing Protections and Identifying Infringing Activities Relative to Third-Party Patents
• The Nature of the Approval Process for Drugs and Biologics: What Every Life Sciences Patent Attorney Should Know
• Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress and More
• Patent and Non-Patent Exclusivity
• Bioequivalence and the "Same Active Ingredient" vis-a-vis Patentability
• Exploring Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration

The co-chairs of the conference are MaCharri R. Vorndran-Jones (patent counsel, Eli Lilly and Co.) and Thomas J. Kowalski (partner, Frommer Lawrence & Haug LLP).  Additional details and registration information are available at the conference website.

Orange Book Blog is a media partner of this conference.

USPTO To Present Webcast On New Claims and Continuation Rules Thursday, August 23, 1 p.m.

The USPTO contacted me yesterday and requested that I post the following announcement:

The U.S. Patent and Trademark Office (USPTO) will hold a special webinar on Thursday, August 23, 2007, at 1:00 p.m. (EST) on new claims and continuations rules that will allow the agency to continue to make the patent examination process more effective and efficient by encouraging applicants to use greater clarity and precision in describing the scope of their inventions.  The new rules will be published in the Federal Register available at www.uspto.gov after noon on August 21, and will be effective on November 1, 2007.

During this live, two-hour webcast, USPTO officials will explain the new rules and answer questions.  The presentation and audio for this event will be streamed over the Internet.  All participants need is a computer with an Internet connection, sound card, speakers and the ability to view Windows Media presentations.

To register for this free webcast, click on the following link:  https://uspto-ls.webex.com/uspto-ls/onstage/g.php?d=664144307&t=a

An advance copy of the presentation will be made available to registrants prior to the event.

If you would like to receive regular updates from USPTO on its eCommerce initiatives, please register by clicking on the following link:  http://uspto.websurveyor.net/mail/register.aspx

U.S. Patent Office Issues Initial Rejection of Pfizer's Reissue Patent Application on Lipitor

As The Wall Street Journal reported last week, the U.S. Patent and Trademark Office has issued an initial rejection of Pfizer's application for a reissue patent of U.S. Patent No. 5,273,995--one of two Pfizer patents covering Lipitor.

In a decision last August, the Court of Appeals for the Federal Circuit upheld one Pfizer patent on Lipitor (U.S. Patent No. 4,681,893) and invalidated another (the '995 patent).  Specifically, the court invalidated claim 6 of the '995 patent, covering the hemicalcium salt of atorvastatin acid (the active ingredient in Lipitor), because it failed to specify a further limitation to the claim from which it depended.  Pfizer sells about $12 billion worth of Lipitor annually.  The '995 patent (if valid) was set to expire more than a year later than the '893 patent will expire, so naturally Pfizer filed a reissue patent application to try to correct the '995 patent.

In a preliminary amendment filed as part of its reissue application in January, Pfizer amended claim 6 of the '995 patent to be an independent claim, and indicated that "this was one of the options . . . approved by the Federal Circuit in its decision."

Ranbaxy--the first ANDA filer for generic Lipitor and the defendant in the patent litigation decided by the Federal Circuit--filed a protest against Pfizer's reissue application in May.  Among Ranbaxy's arguments was that the defect in claim 6 is not correctable through a reissue patent.

The Patent Office mailed a first Office Action on Pfizer's reissue application last Thursday.  While the Patent Office stated that the defect in claim 6 is in fact correctable through a reissue application, the Office rejected all 14 claims of Pfizer's reissue application on grounds of anticipation, obviousness, or obviousness-type double patenting.  In particular, the Office rejected claim 6 for obviousness-type double patenting in view of U.S. Patent Nos. 6,605,729 and 5,969,156.

The proceedings over Pfizer's reissue patent application are far from over.  Pfizer will certainly file a response to last week's Office Action, after which the Patent Office might issue a final Office Action.  If Pfizer is unsatisfied at that point, it might request continued examination or file an appeal to the Patent Office Board of Appeals.  If rebuffed there, Pfizer could appeal to the Federal Circuit.  Given how much money is at stake, Pfizer is likely to pursue all its options before giving up on the reissue application.

RELATED READING:

• Bloomberg News
• CNNMoney.com
• India Business Standard
• Pharmalot
• Reuters
• Earlier OBB posts on Lipitor litigation: 29 Jan 07; 23 Oct 06; 31 Aug 06

Informa Life Sciences "European Pharmaceutical Law Forum" Conference, Washington D.C., October 23-25

Informa Life Sciences will be presenting a unique conference entitled "European Pharmaceutical Law Forum" in Washington, D.C., October 23-25.  The conference will provide an invaluable introduction to the laws and regulations governing the pharmaceutical, biotech and generics industries in Europe.

At this premier global event you will be brought up-to-date with the key European cases shaping international pharmaceutical law and hear the latest regulatory and legal developments governing drug development, registration and commercialization in Europe.  Leading European lawyers, in-house counsel and representatives of the European Commission and the Federal Trade Commission will present crucial information to help optimize your international legal strategy.

Informa Life Sciences is offering Orange Book Blog readers a $200 discount on registration (use promotional code CQ50270E).  For additional details or to register, please visit the conference website.

Orange Book Blog is a media partner of this conference.

ACI "FDA Boot Camp" Conference, Chicago, Sept. 25-26

American Conference Institute's popular "FDA Boot Camp" returns to the University of Chicago's Gleacher Center in downtown Chicago on September 25-26.  ACI expects a sell-out of this conference and recommends early registration.

The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies.  It features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.

Presentations on the agenda include:

• The Basics: Understanding and Working with the FDA--Jurisdiction, Functions, Organization, and Operations
• The Nature of the Approval Process
• Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More (I'll be on this panel, speaking about Hatch-Waxman)
• Drugs and Biologics: Labeling
• Non-patent Exclusivity
• Bioequivalence: What Patent Lawyers Need to Know
• Follow-on Biologics
• Medical Devices: Classification and the Essentials of the Device Premarket Review Process

The co-chairs of the conference are Coleen Klasmeier of Sidley Austin LLP and Erika Lietzan of Covington & Burling LLP.  Additional details and registration information are available at the ACI FDA Boot Camp web site.

Orange Book Blog is a media partner of this conference.

American Conference Institute's popular "FDA Boot Camp" returns to the University of Chicago's Gleacher Center in downtown Chicago on September 25-26.  ACI expects a sell-out of this conference and recommends early registration.

The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies.  It features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.

Presentations on the agenda include:

• The Basics: Understanding and Working with the FDA--Jurisdiction, Functions, Organization, and Operations
• The Nature of the Approval Process
• Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More (I'll be on this panel, speaking about Hatch-Waxman)
• Drugs and Biologics: Labeling
• Non-patent Exclusivity
• Bioequivalence: What Patent Lawyers Need to Know
• Follow-on Biologics
• Medical Devices: Classification and the Essentials of the Device Premarket Review Process

The co-chairs of the conference are Coleen Klasmeier of Sidley Austin LLP and Erika Lietzan of Covington & Burling LLP.  Additional details and registration information are available at the ACI FDA Boot Camp web site.

Orange Book Blog is a media partner of this conference.

Pharma News Briefs

• The Wall St. Journal Health Blog had an interesting post Thursday on how Genzyme's struggle to produce enough Myozyme heightens worries about generic biotech drugs.
• The New York Times published an interesting article Wednesday on the recent "tidal wave" and the coming "golden era" of generic drugs.
• Novartis lost its challenge to India's drug patent law on Monday (see New York Times; Business Week; WSJ Health Blog).  PhRMA reacted in this press release.
• The Spicy IP blog has been providing a thoughtful, in-depth perspective on the Novartis India case.
• FDA Law Blog reported Monday that the House passed an FDA appropriations bill with a provision allowing for reimportation of prescription drugs.
• MarketWatch.com had this interesting article Monday on recent growth in pharmaceutical R&D in China and India.

Hatch-Waxman Tracker Update

New cases added:

• Aggrenox: Boehringer Ingelheim v. Barr Labs
• Benicar HCT: Daiichi Sankyo v. Mylan Labs
• Keppra: UCB v. Cobalt Pharms.
• Temodar: Cancer Res. Tech. and Schering v. Barr Labs
• Xopenex: Sepracor v. Barr Labs

Pending cases updated:

• Clarinex: Sepracor v. Glenmark Pharms.
• Effexor XR: Wyeth v. Mylan
• Eloxatin: Sanofi-Aventis v. Abraxis; S-A v. Actavis; S-A v. Ebewe Pharma (NJ); S-A v. Ebewe Pharma (SC); S-A v. Mayne Pharma; S-A v. Par Pharma.; S-A v. Pharmachemie; S-A v. Sun (NJ); S-A v. Sun (MI); Mayne Pharma v. S-A
• Floxin Otic: Daiichi Sankyo v. Apotex
• Lotrel: Novartis v. Dr. Reddy's
• Prilosec OTC: AstraZeneca v. Dr. Reddy's
• Rilutek: Impax v. Aventis
• Toprol-XL: In re Metoprolol Succinate Patent Litigation
• Ultracet: Ortho-McNeil v. Apotex; Ortho-McNeil v. Par Pharma.
• Valtrex: GlaxoSmithKline v. Ranbaxy

Cases removed

• Zithromax: Pfizer v. Sandoz (settled)

As always, thanks to everyone who provided information for this update!

Pharma News Briefs

• FDA Law Blog had a post Thursday about "The Dog Ate My Homework Act," which would give a reprieve to companies that miss the deadline for filing a patent term extension request.
• Pharmalot had this post Wednesday, reporting that Congress has delayed the FDA bill until September.
• Patently-O reported Wednesday on the Federal Circuit's decision on Washington, D.C.'s drug price law.  PhRMA made a press release on the decision.  The Washington Post published this article on the case.
• Tuesday, Wyeth announced a deal with Teva and Sun concerning generic Protonix.  Today, Teva announced that FDA approved its ANDA for Protonix.
• Investor's Business Daily had an interesting article last week, "RNAi Stirs Excitement in Big Pharma."
• The Patent Prospector had a neat post last week, "Dealing with KSR."

Federal Circuit Affirms Denial of Somerset Pharma's Interim Patent Term Extension on Depression Patch

Somerset Pharmaceuticals v. Dudas, No. 2007-1447 (Fed. Cir. 2007)

The Federal Circuit decided an unusual case yesterday respecting Somerset Pharmaceuticals' application for an interim patent term extension for U.S. Reissue Patent No. RE 34,579.  The '579 patent covers a method of treating depression using Emsam, a transdermal patch that includes selegiline as the active ingredient.

35 USC 156(e)(1) provides for a patent term extension to compensate for delays in FDA regulatory review of a new drug application.  35 USC 156(e)(2) provides for an interim patent term extension if the patent "would expire before a certificate of extension is issued or denied under paragraph (1)."

Somerset's '579 patent is set to expire on August 18, 2007.  In April 2006, Somerset filed a request for patent term extension under Section 156(e)(1) on the '579 patent.  In February of this year, the Patent and Trademark Office had still not ruled on Somerset's request, and therefore Somerset filed a request for an interim patent term extension under Section 156(e)(2).

Shortly thereafter, Somerset filed suit against Mr. Dudas, the director of the PTO, seeking to compel the PTO to rule on its request for an interim patent term extension.  Somerset also filed a motion for preliminary injunction at the same time.  The district court denied Somerset's motion in June, and Somerset promptly appealed to the Federal Circuit.  Meanwhile, on July 12, the PTO denied both Somerset's application for a patent term extension under Section 156(e)(1) and its application an interim extension under Section 156(e)(2).

In yesterday's decision, the Federal Circuit dismissed as moot Somerset's request to compel the PTO to act on its request for an interim patent term extension.  Moreover, the Federal Circuit affirmed the district court's denial of Somerset's motion for a preliminary injunction to compel the PTO to grant Somerset's request for an interim patent term extension, finding that because the PTO denied Somerset's application for a patent term extension under Section 156(e)(1), the PTO has no statutory authority to issue an interim extension.

The Federal Circuit stated expressly that yesterday's opinion does not address any claim that Somerset may have on the underlying merits of the PTO's July 12, 2007 denial of its request for a patent term extension under Section 156(e)(1).  Presumably, Somerset is appealing that decision separately.