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Jury Awards Elan $55M in Breast Cancer Drug Patent Suit, But Abraxis Bioscience Vows to Fight On

Elan Pharmaceutical International Ltd. v. Abraxis BioScience Inc.
06CV438, U.S. District Court, District of Delaware (Wilmington), 06/13/2008

Holding

A jury sitting in the Delaware district court found that Abraxis Bioscience’s drug Abraxane literally infringed Elan Pharmaceutical’s patent relating to metastatic breast cancer treatment, awarding the patentee damages in the amount of $55.23 million and fixing the applicable royalty rate used to calculate damages at 6 percent. The jury also ruled that this patent, as well as another related one, was valid and enforceable. The jury came out with the verdict after deliberating for about 12 hours at the end of an eight-day trial. Abraxis Pharmaceutical later issued a public statement, stating that it would pursue post-trial motions and appeal the adverse decision.

Detailed Summary

The patent at issue (‘363 patent) is entitled “Surface Modified Anticancer Particles.” Another one (‘025 patent) is entitled “reduction of Intravenously Administered nanoparticulate-Formulation-Induced Adverse Physiological Reactions”.

Plaintiff Elan Pharmaceutical International Limited, Ireland’s biggest drug maker, asserted in its complaint that defendant Abraxis Bioscience, Inc. “has been, and currently is, directly and/or indirectly infringing the ‘363 patent by making, using, selling, and/or offering for sale Abraxane, contributing to the use of Abraxane by others; and/or inducing others to use Abraxane.” Paragraph 13, Complaint.

Plaintiff also alleged that “defendant Abraxis has been, and currently is, directly and/or indirectly infringing the ‘025 patent by making, using, selling, and/or offering for sale Abraxane; contributing to the use of Abraxane by others; and/or inducing others to use Abraxane in a manner that infringes the ‘025 patent.” Paragraph 18, Complaint.

Plaintiff’s prayer for relief consisted of damages of up to three times, “in view of Abraxis’ willful infringement,” interest and cost of suit, “accounting of all gains, profits, and advantages derived by Abraxis’ infringement.” Elan likewise requested for the issuance of preliminary and permanent injunctions to restrain the acts of infringement. Page 5, Complaint.

On the other hand, defendant denied the charges of infringement, and argued in its Answer that both patents were “invalid and void for failure to comply with one or more of the provisions of Part II of Title 35 of the United States Code, including without limitation sections 102, 103, and/or 112.” Paragraph 12, Answer.

Abraxis likewise argued that “Elan is barred by the doctrine of prosecution history estoppel from contending that any claim of the ‘363 or ‘025 patents covers any product manufactured, used, sold, or offered for sale by Abraxis.” Page 6, Answer.

On the question whether Abraxis has proven by clear and convincing evidence that claims of the ‘363and the ‘025 patents are invalid for lack of enablement or for lack of adequate written description, the jury ruled in favor of Elan.

On the question whether the ‘363 and the ‘025 patents are unenforceable due to inequitable conduct, the jury likewise ruled in favor of plaintiff Elan.

In a public statement released on June 13, 2008, Abraxis declared: Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, today announced that it intends to appeal the jury ruling in the U.S. District Court for the District of Delaware that Abraxis has infringed upon a patent owned by Elan. In the suit, Elan claimed that Abraxis infringed upon two of Elan’s patents, 5,834,025 and 5,399,363, asserting ABRAXANE(R) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) uses technology protected by Elan-owned patents. Elan withdrew its claim that Abraxis infringed on its 025 patent. The jury ruled that Abraxis has infringed upon Elan’s 363 patent, which runs until 2011, and awarded Elan $55 million in damages for sales of Abraxane(R) to date. The company said it is disappointed by the jury ruling in this complex patent litigation and feels confident as it proceeds to appeal in this matter. Abraxis will pursue post-trial motions and appeal the judgment of the District Court.”

View a PDF of the verdict.

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Companies Mentioned

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The following companies are mentioned in Patent Law Updates:

Boston Scientific Corp.

Stryker Corp.

Howmedica Osteonics Corp.

Bridge Medical, Inc.

Smith & Nephew, Inc.

LG Electronics, Inc.

Quanta Computer, Inc.

Motorola, Inc.

Nokia, Inc.

Sanyo North America Corp.

Scimed Life Systems Inc.

Smithkline Beecham Corp. (d.b.a. GlaxoSmithKline, plc.)

United States Patent and Trademark Office

HT Window Fashion Corp.

Mylan Laboratories, Inc.

Mylan Pharmaceutical, Inc.

Ortho-McNeil Pharmaceutical, Inc.

Acumed, LLC

Samsung Electronics America, Inc.

Stryker Sales Corp.

Audiovox Communications Corp.

Stryker Orthopaedics

McKesson Information Solutions, Inc.

Eisai, Inc.

ExcelStor Technology, Ltd.

Sanofi-Aventis

Arrow International, Inc.

Zenith Electronics Corp.

Advanced Medical Optics, Inc.

ExcelStor Group Ltd.

Sanofi-Aventis Deutschland GmbH

Cohesive Technologies, Inc.

PDI Communications Systems, Inc.

VISX, Inc.

ExcelStor Great Wall Technology Ltd.

Arthrex, Inc.

Sanofi-Aventis U.S. LLC

Waters Corp.

Dominant Semiconductors Sdn. Bhd.

Federal Trade Commission

Shenzhen ExcelStor Technology Ltd.

Research Corp. Technologies Inc.

Polaris Industries, Inc.

OSRAM GmbH

Davison & Associates, Inc. d.b.a. Davison Design & Development, Inc.

Papst Licensing GMBH & Co. KG

Microsoft Corp.

VeriSign, Inc.

OSRAM Opto Semiconductors GmbH

Dr. Reddy's Laboratories, Inc.

Additional Resources

Patent Law

Patent Act (pdf, 1.4mb)

Patent Rules (pdf, 3.4mb)

Manual for Patent Examining Procedure (pdf, 56mb)

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