Patent Docs

USPTO News: Patent Office Proposes Adjustments to Patent Fees

    By Donald Zuhn --

The U.S. Patent and Trademark Office published a notice in the Federal Register today proposing adjustments to certain patent fees for fiscal year 2009.  The adjustments are intended to reflect fluctuations in the Consumer Price Index (CPI).

Written comments regarding the proposed adjustments can be submitted at the Federal eRulemaking Portal, or by e-mail ([email protected]), fax (571-273–6299), or regular mail (Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450, Attn: Walter Schlueter), and must be received on or before July 3, 2008.  Those submitting comments should consult today's notice for additional instructions.

A listing of current fee amounts can be obtained here.

USPTO to Reexamine ExonHit Therapeutics Patent

    By Donald Zuhn --

Last month, Larkspur, California-based biotech Jivan Biologics, Inc. announced that the U.S. Patent and Trademark Office had granted its request for an ex parte reexamination of U.S. Patent No. 6,881,571, which is owned by ExonHit Therapeutics S.A.  The '571 patent is directed to devices for identifying differentially spliced gene products.  ExonHit, which is based in Paris, France, had originally asserted the '571 patent against Jivan in an infringement suit filed in the U.S. District Court for the Northern District of California on March 12, 2007 (see complaint here).

In its Order granting the reexamination, the Patent Office stated that Jivan, in a request filed in mid-March, had identified nine references each of which raised a substantial new question of patentability.  Independent claims 1 and 12 of the '571 patent recite:

1.  A device for identifying at least one differentially spliced gene product, wherein said device comprises a solid support material and single-stranded oligonucleotides of between 5 and 100 nucleotides in length attached to said support material, wherein said oligonucleotides comprise at least a first and a second oligonucleotide molecule arranged serially on the support material, wherein said first oligonucleotide molecule comprises a first sequence that is complementary to and specific for an exon or an intron of a first gene, and wherein said first sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing, and wherein said second oligonucleotide molecule comprises a second sequence that is complementary to and specific for an exon-exon or exon-intron junction region of said first gene, and wherein said second sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing, said device allowing, when contacted with a sample containing at least one nucleic acid molecule under conditions allowing hybridisation to occur, the determination of the presence or absence of said differentially spliced gene product.

12.  A method of producing a device comprising a support material and single-stranded oligonucleotide of between 5 and 100 nucleotides in length attached to said solid support material, wherein said method comprises: (a) providing said oligonucleotides, wherein said oligonucleotides comprise at least a first and a second oligonucleotide molecule, wherein said first oligonucleotide molecule comprises a first sequence that is complementary to and specific for an exon or an intron of a first gene, and wherein said first sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing, and wherein said second oligonucleotide molecule comprises a second sequence that is complementary to and specific for an exon-exon or exon-intron junction region of said first gene, and wherein said second sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing; and (b) arranging and immobilizing said oligonucleotides serially on said support material, said device allowing, when contacted with a sample containing at least one nucleic acid molecule under conditions allowing hybridisation to occur, the determination of the presence or absence of at least one differentially spliced gene product.

In its press release, Jivan CEO Dr. Subha Srinivasan stated that the company was "pleased to hear that the USPTO has decided to reexamine the validity of this patent," and expected that the Office would either require ExonHit to amend the claims or invalidate the claims in their entirety.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Wyeth v. Sandoz Inc.
1:08-cv-00317; filed May 28, 2008 in the District Court of Delaware

Infringement of U.S. Patent No. 6,500,814 ("Hormonal Contraceptive," issued December 31, 2002) following a paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Wyeth's Lybrel® (levonorgestrel/ethinyl estradiol, used as oral contraception).  View the complaint here.

Oxford Gene Technology IP Ltd. v. BioArray Solutions Ltd.
1:08-cv-00320; filed May 28, 2008 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,307,039 ("Method for Analyzing a Polynucleotide Containing a Variable Sequence and a Set or Array of Oligonucleotides Therefor," issued October 23, 2001), 6,770,751 (same title, issued August 3, 2004), and 7,192,707 ("Method for Analyzing Polynucleotide Targets Using Tethered Oligonucleotide Probes," issued March 20, 2007) based on BioArray's manufacture, use, and sale of its BeadChip products.  View the compliant here.

Sepracor Inc. et al. v. Sun Pharmaceutical Industries, Ltd.
5:08-cv-00247; filed May 28, 2008 in the Eastern District of North Carolina

Infringement of U.S. Patent No. 5,698,558 ("Methods for Treating Allergic Disorders Using Optically Pure (-)Cetirizine," issued December 16, 1997), licensed to UCB, following a paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of UCB's XYZAL® (levocetirizine dihydrochloride, used to treat seasonal and perennial allergic rhinitis).  View the complaint here.

Novartis Corp. et al. v. Dr. Reddy's Laboratories, Inc. et al.
2:08-cv-02566; filed May 23, 2008 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,162,802 ("Synergistic Combination Therapy Using Benazepril and Amlodipine for the Treatment of Cardiovascular Disorders and Compositions Therefor," issued December 19, 2000) following a paragraph IV certification as part of Dr. Reddys' filing of an ANDA to manufacture a generic version of Novartis' Lotrel® (amlodipine besylate/benazepril hydrochloride, used to treat hypertension).  View the complaint here.  As reported here, plaintiffs have previously asserted this patent against Dr. Reddy's; the present complaint includes an additional generic Lotrel® dosage form.

AstraZeneca LP et al. v. Barr Laboratories Inc. et al.
1:08-cv-00305; filed May 22, 2008 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,423,340 ("Method for the Treatment of Inflammatory Bowel Diseases," issued July 23, 2002) and 5,643,602 ("Oral Composition for the Treatment of Inflammatory Bowel Diseases," issued July 1, 1997) following a paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of AstraZeneca's Entocort® EC (budesonide, used to treat mild to moderate Crohn's disease).  View the complaint here.

Conference & CLE Calendar

June 4, 2008 - Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting (U.S. Patent and Trademark Office)

June 11, 2008 - Advanced Patent Licensing 2008: What You Need to Know Before Licensing Your Patent (Practising Law Institute) - San Francisco, CA

June 16, 2008 - Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA

June 17-20, 2008 - BIO International Convention (Biotechnology Industry Organization) - San Diego, CA

June 18-20, 2008 - Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

June 23, 2008 - Multilateral Patents (Law Seminars International) - San Francisco, CA

July 1, 2008 - Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY

July 9-11, 2008 - Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

July 16, 2008 - Patent Claim Construction Workshop (Law Seminars International) - Seattle, WA

July 24-25, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

August 11-12, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

August 10-15, 2008 - Advanced Courses (Patent Resources Group) - Washington, DC

September 11, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY

September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA

September 15-16, 2008 - Biotech Patents*** (American Conference Institute)

September 22-23, 2008 - USPTO Boot Camp: Patent Edition*** (American Conference Institute) - Alexandria, VA

September 22-23, 2008 - FDA Boot Camp*** (American Conference Institute)

October 15, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA

***Patent Docs is a media sponsor of this conference or CLE