08-28-02.pub

Circulating the latest Intellectual Property, FDA, legal and business news as it relates to the biotech, chemical, agricultural and pharmaceutical industries. ~~IMPAX Laboratories, Inc. (Hayward, CA) announced,
August 26, 2002, that the U.S. District Court for the North-
ern District of California has issued an order granting IM-
6,441,274 -- Cahoon, Rebecca E. et al.
PAX's Motion for Summary Judgment of Non-
Infringement regarding the Company's Abbreviated New
Assignee: E. I. du Pont de Nemours & Company Drug Applications for generic versions of Wellbutrin SR®
6,441,145 -- DiTullio, Paul et al.
and Zyban®. In this regard, GlaxoSmithKline markets
Transgenically produced Antithrombin III Wellbutrin SR® for the treatment of depression and Zyban®
for the cessation of smoking. For more information, contact
6,440,704 -- Ramakrishnan, Santha
Gene encoding 2,3-dihydroxybenzoic acid decarboxylase Assignee: University of Nebraska ~~Reuters reported. August 22, 2002, that former University
6,440,699 -- Tavtigian, Sean V. et al.
of California, Davis, scientist, Bin Han, was acquitted of
Prostate cancer susceptible CA7 CG04 gene theft, ending a case that originally charged the eye re-
Assignees: Myriad Genetics, Inc., The Hospital for Sick Children (Toronto) searcher with economic espionage. Han was accused of

6,440,691 -- Garger, Jr., Steven et al.
stealing 20 vials of a protein gel researchers were using in
Melanins with improved ability to inhibit HIV replication an attempt to grow replacement corneas for the blind. Upon
Assignee: Large Scale Biology Corporation searching Han’s home, police found vials of the gel in his freezer and a plane ticket to his native China. He was origi- ~~Reuters reported, August 22, 2002, that Los Angeles Dis-
nally charged with three felonies, including the theft of trade trict Court Judge Edward Kakita has upheld a $500 million
jury verdict against Genentech, Inc. denying the firm's con-
tention that the $300 million award to City of Hope National
~~The law firm of O'Melveny & Myers LLP announced, Au-
Medical Center was "grossly excessive." In this regard, the
gust 26, 2002, that five patent attorneys, all whom specialize court not only denied Genentech’s motion for a new trial, but in the life sciences, biotechnology and medical device in-
also denied its motion to reduce an additional $200 million in
dustries, will join the firm effective September 1. In this re-
gard, David Murphy, Dr. John Kappos, Michael Davidson,
Paul Veravanich and Dr. Diane Wong will be leaving the
~~Lexicon Genetics, Inc. (The Woodlands, TX) announced,
firm of Lyon and Lyon to join O'Melveny & Myers.
August 21, 2002, that it has received U.S. Patent No.
6,436,707 covering Lexicon's OmniBank® library, which
~~Elan Corporation, plc (Dublin, Ireland) announced, Au-
includes more than 200,000 gene knockout embryonic stem
gust 23, 2002, that it has entered into a licensing agreement (ES) cell clones. In this regard, Lexicon estimates that Om-
with Watson Pharmaceuticals, Inc. for the exclusive market-
niBank® contains gene knockout clones for more than half
ing rights to Nifedipine ER, the generic version of Bayer
of all mammalian genes. For more information, visit lexicon AG's Adalat CC hypertension product, in the United States.
For more information, contact Jack Howarth at 212-407-5740.
~~Ribapharm, Inc. (Costa Mesa, CA) announced that it has
~~Geron Corporation (Menlo Park, CA) announced, August
filed suit in U.S. District Court in Los Angeles, California,
27, 2002, that it has received U.S. Patent No. 6,440,735 cov-
against Hoffmann-La Roche, Inc. for alleged infringement of
ering telomerase-based cancer immunotherapy. For more
Company patents covering Ribavirin. Earlier this month, the
information, contact David Greenwood at 650-473-7700. company initiated patent infringement actions against Roche
in the Netherlands and Germany, and will be filing a
counter-action suit for patent infringement against Roche in
BioChem-AgPharma News is published by HARBOR CONSULTING, IP
Switzerland, where Roche is seeking a declaratory judg-
Services, Inc., 1500A Lafayette Rd., #262, Portsmouth, N.H. 03801 USA.
ment that their marketing of Ribavirin does not infringe Ri-
James A. Coburn, Editor. Annual subscription: $445 domestic / $545 bapharm's patents. For more information, visit Ribapharm at foreign (U.S. currency). Subscription inquires: Mail, fax 877-775-7756 or e-mail general@seqidno.com. Editorial inquiries: fax 877-775-7756 or e- mail jcoburn@seqidno.com. 1996-2002 HARBOR CONSULTING and
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~~Demegen, Inc. (Pittsburgh, PA) announced, August 27,
. Note: The publisher will not be liable for
misinformation, typographical errors, etc. For information concerning 2002, that it has received European Patent No. 0 832 120
other services provided by HARBOR CONSULTING, including
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BioChem-AgPharma News™ August 28, 2002 - Page 2 ~~The Federal Circuit decided Bayer AG v. Carlsbad Tech-
~~Dow Jones Newswires reported, August 22, 2002, that nology on August 14, 2002, affirming the district court’s ex-
GlaxoSmithKline has filed suit against Swiss drug giant No-
tension of the patent term of Bayer’s patent from October 1, vartis, its Geneva Pharmaceuticals unit and Germany's
2002 to December 9, 2003. Bayer’s patent in suit claimed the Biochemie GmbH in Broomfield District Court in Colo-
antibiotic ciprofloxacin (CIPRO®), and it disclaimed its pat-
rado alleging the use of a stolen strain of bacteria to make
ent term that extended beyond the term of a previous Bayer generic versions of GlaxoSmithKline’s antibiotic Augmentin.
patent, which initially expired on October 1, 2002. After pas- The Company, which also filed similar suits against Indian sage of the Uruguay Round Agreements Act (URAA), the
company Ranbaxy Laboratories Ltd and Israel-based
previous Bayer patent term was automatically extended from Teva Pharmaceutical Industries Ltd., recently carried out
October 1, 2002 to December 9, 2003, which automatically scientific testing on generic versions of Augmentin, with re- extended the term of the Bayer patent in suit. sults suggesting that the key ingredient was made using a strain of bacteria developed at GlaxoSmithKline. ~~On August 15, 2002, the Federal Circuit decided Bionx
Implants v. Linvatec Corporation, vacating and remanding
the district court’s summary judgment ruling of no infringe-
ment. Bionx’s patent recited a “rigid” surgical fastener that
was adapted to repair tears in the meniscus of the knee, and
Bionx alleged Linvatec’s BioStinger suture infringed its pat- Ambion, Inc. announced that it has been awarded a $1.6 million ent’s claims. The Federal Circuit agreed with the district Phase II Small Business Innovation Research (SBIR) grant from court’s interpretation of the term “rigid,” but disagreed with the NIH National Institute General Medical Sciences to develop certain RNA amplification technologies. their dismissal of videotaped evidence submitted by Bionx to show insertion of the BioStinger. (“We vacate the summary Praecis Pharmaceuticals, Inc. announced that it would pay Am- judgment because the ground on which the district court did gen, Inc. $13 million in final settlement of all amounts payable rely. . . did not render the test invalid on the ground that it con- under their collaboration agreement, which was terminated by Amgen, effective December 17, 2001. stituted an alteration of the BioStinger or the context in which the rigidity of the patented device was to be judged.”) Sequenom announced that it plans to acquire privately held Axiom Biotechnologies to help Sequenom’s nascent pharma ~~The Federal Circuit decided In re Cruciferous Sprout
division build its internal biology, assay, and drug-discovery Plat-forms. Litigation on August 21, 2002, affirming the district court’s
finding that the patents in suit were invalid as anticipated. The Johns Hopkins University and Correlogic Systems, Inc. jointly patents in suit claimed methods of preparing food products announced that they have entered into a collaborative research rich in glucosinolates by using certain sprouts, which were
agreement to develop computational diagnostic models of in- described as being capable of reducing the level of carcino- flammatory vascular diseases in an attempt to identify patients with specific inflammatory diseases by analyzing patterns of gens in animals due to the presence of Phase 2 enzyme-
inducing agents. The Federal Circuit found the claims inher-
ently anticipated by prior art disclosing preparing food prod- Cepheid announced that it has been awarded a $376,00, one ucts using sprouts, even though the prior art did not recognize year grant from the National Institutes of Health to develop rapid diagnostic tests for Mycobacteria tuberculosis. the cancer-reducing properties of the sprouts. (“In summary, the prior art inherently contains the claim limitations that Bras- The first state court to decide an OxyContin®-based lawsuit on sica relies upon to distinguish its claims from the prior art.”) its merits has dismissed the claims of a West Virginia plaintiff against Purdue Pharma L.P., the Stamford Connecticut-based distributor of OxyContin®. ~~On August 23, 2002, the Federal Circuit decided Monsanto
Co. v. McFarling, affirming the district court’s grant of a pre-
Researchers at Cyternex and the University of Arizona jointly liminary injunction enjoining McFarling, a Mississippi farmer, announced research results identifying the specific DNA knot from using plant genes and seeds from soybean crops
structure that inhibits the expression of c-myc, an oncogene grown using Monsanto’s soybean seed. Monsanto owns a number of patents that claim glyphosate-tolerant plants,
Novartis Oncology announced that Gleevec (imatinib mesylate) including soybeans, and offers Roundup Ready® seed for
has been granted priority review by the U.S. Food and Drug sale to farmers upon signing a “Technology Agreement.” The Administration for the treatment of Philadelphia-chromosome Technology Agreement restricts the farmer’s use of the seed positive (Ph+) chronic myeloid leukemia in the chronic phase, the earliest stage of the disease. for planting only in a single season, and contains on the back of the signature page a forum selection clause stating that all Maxygen, Inc. announced that it has received a $2.4 million, disputes are to be brought in the state of Missouri. The district three-year grant from the U.S. Army Medical Research and Ma- court of Missouri found that it had personal jurisdiction over teriel Command to develop cross protective vaccines against three types of encephalitis virus. McFarling and the Federal Circuit agreed. (“McFarling’s argu- ment that his voluntary failure to read the forum selection Johnson & Johnson reported that the U.S. Government is main- clause entitles him to exemption from its effect is unsupported taining its original decision not to intervene in a lawsuit filed by any law. Due process as to these issues is satisfied when against the Company by a former employee at its Ortho Biolog-ics plant in Manati, Puerto Rico, alleging improper record- a party consents by contract to personal jurisdiction in a se- keeping at the plant, which produces bulk erythropoietin used in lected forum.”). Judge Clevenger dissented. the formulation of EPREX (epoetin alfa). These Fed. Cir. cases were summarized by Patrick A. Doody, a partner at
the firm of Hunton & Williams in Washington, D.C., who may be reached
at 703-714-7645 or pdoody@hunton.com.

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