25 Biotechnology Law Report 555Number 5 (October 2006)© Mary Ann Liebert, Inc.

Patents

555

Sanofi, Bristol-Myers Subject of DoJInvestigation

—Attempts to Block Generic Clopidogrel Are Scrutinized

WASHINGTON, D.C. 7/26/06—Sanofi-Aventisand Bristol-Myers Squibb have been notified by theU.S. Department of Justice that they are under crimi-nal investigation for their settlement of a patent dis-pute with Apotex over clopidogrel bisulfate (Plavix),a widely prescribed anticoagulant. The case had beenscheduled to go to trial in June. However, in March,Sanofi and Bristol-Myers agreed to pay Apotex an un-reported sum and to allow the generic manufacturer tobegin selling its own version almost a year before thepatent expired. That agreement was rejected by regu-lators.

Apotex has claimed for at least 4 years that thepatent is invalid and that it could introduce its prod-uct now, giving it entry to a $6 billion market. Thatcompany’s version of the drug has been approved bythe U.S. Food and Drug Administration, and Apotexbegan shipping it during the summer after regulatorsrejected the initial settlement agreement among thecompanies.

Bristol-Myers is obligated to give copies of anyagreements such as the one reached with Apotex forreview by the Federal Trade Commission and state at-torneys-general as the result of a suit settled in 2003over allegations that it was using its patents inappro-priately to block generic versions of the anticancerdrug paclitaxel (Taxol) and the anti-anxiety drug bus-pirone (Buspar).

If the Federal Trade Commission finds any evidenceof criminal activity in such agreements, it is obligatedto notify the DoJ.

The new investigation appears to have resulted froma secret deal arranged by Dr. Andrew G. Bodnar, anassistant to Bristol-Myers’s then chief executive, Pe-ter R. Dolan. According to a filing by Apotex attor-neys in U.S. District Court in Manhattan, Bristol-My-ers made the secret agreement to escape scrutiny bythe regulators reviewing the settlement. The agreementsupposedly contained two provisions deleted from thedocument submitted to regulators, one agreeing to giveApotex a 6-month head start before Bristol-Myers andSanofi introduced their own generic and the othergranting Apotex a $60 million fee.

Bristol-Myers and Sanofi told the Manhattan courtthat Bernard C. Sherman, Apotex’s CEO, had lied tothe U.S. government about the agreement to sabotageit. He denies doing so.

The trial of the patent suit is scheduled to begin inJanuary 2007 before U.S. District Judge Sidney H.Stein.

• • •

Two Groups Try for Revocation of HumanEmbryonic Stem Cell Patents

—Patents Said to Be Driving Research Overseas

WASHINGTON, D.C. 7/18/06—Two groups todayfiled requests for reexamination and revocation ofthree patents issued to the Wisconsin Alumni ResearchFoundation (WARF) covering human embryonic stemcells (the Thomson patents). The groups—The Foun-dation for Taxpayer and Consumer Rights (FTCR) andthe Public Patent Foundation (PUBPAT)—argue thatthe patents should never have been granted becausethey were obvious. Dr. Jeanne Loring, a stem cell re-searcher, filed a supporting declaration.

Another rationale for the challenge was given by of-ficers of the groups in comments to the press.

“It is absolutely absurd that one person or organi-zation could own the rights to life itself. But that isexactly what has happened because of these over-reaching patents,” according John Simpson, Stem CellProject Director for FTCR.

Dan Ravicher, Executive Director of PUBPAT, al-leged that “WARF has been allowed to profit at theexpense of public health while many American scien-tists have been barred from conducting life-savingmedical research.”

The filings have been posted at http://www.pubpat.org/warfstemcell.htm.

• • •

Neuralstem Patent Survives Third Challenge

—Human Cell Patent Had Been Target of Competitor

WASHINGTON, D.C. 7/19/06—For the third time,U.S. Patent No. 5,753,506, “Isolation, Propagation and

Directed Differentiation of Stem Cells from Embry-onic and Adult Central Nervous System of Mammals,”has survived a challenge, this one filed by StemCells,Inc. The U.S. Patent and Trademark Office issued acertificate of reexamination confirming the validity ofthe patent, which is held by Neuralstem, Inc., ofRockville, Md. The patent covers both the isolationprocess and composition of matter for human neuralstem cells.

Neuralstem is developing treatments for ischemicspastic paraplegia and spinal cord injuries.

• • •

A Round-Up of New Patents

—Drug Delivery, Peripheral Vascular Disease Products

On July 28, Generex Biotechnology Corporation(Toronto, Ont.) announced that it has been awarded anew United States patent and its first Japanese patentsexpanding coverage for its oral insulin spray, Oral-lyn™, which has been cleared for marketing inEcuador and is in clinical trials elsewhere in the world.

The U.S. patent, “Method for Administering Insulinto the Buccal Region,” contains claims relating to adelivery system for large molecules through the oraland nasal membranes. The Japanese patents, “AerosolFormulations for Buccal and Pulmonary Application”and “Pulmonary Drug Delivery,” contain similarclaims relating to delivery through the mouth as aero-sols for buccal or pulmonary absorption.

Another U.S. patent, “Methods of Administeringand Enhancing Absorption of Pharmaceutical Agents,”issued to Generex on August 16. Again, the technol-ogy is aimed at delivering drugs buccally by means ofstable mixed micellar solutions consisting of the drug,absorption enhancers, and other excipients. The goalis faster onset of action and greater bioavailability.

On August 21, Quigley Pharma (Doylestown,Penn.) announced receipt of its second U.S. patent, No.7,083,813 B2, entitled “Methods for the Treatment ofPeripheral Neural and Vascular Ailments.” The patentextends the company’s coverage for its leading drugcandidate, QR-333, which is in Phase II trials as a po-tential topical means of improving circulation in thefeet and hands and relieving the symptoms of diabeticperipheral neuropathy. The compound was designedto reduce oxidative stress in tissues.

• • •

Protiva Sues Inex

—Alleges Attempt to Capture Intellectual Property

VANCOUVER, B.C. 9/8/06—Protiva Biotherapeu-tics Inc., which is developing nucleic acid-based drugs,today filed suit against Inex Pharmaceuticals Corpo-ration in the Superior Court of the State of Californiaalleging that Inex had interfered with its business re-lationships in order to coerce it to surrender technol-ogy to Inex. The suit also charges that Index defamedProtiva’s top officers. Protiva is seeking general, spe-cific, and punitive damages.

On September 1, the company filed in the SupremeCourt of British Columbia to prevent assignment ofInex intellectual property to Tekmira PharmaceuticalsCorp. without Protiva’s consent. Protiva has scheduleda shareholder meeting at which it hopes to gain ap-proval to spin out its own assets to Tekmira.

Protiva’s proprietary stable nucleic-acid lipid parti-cle (SNALP) technology is an encapsulation and de-livery system for nucleic acids, such as short interfer-ing RNA (siRNA), aptamers, and plasmid DNA.

• • •

556 Biotechnology Law Report • Volume 25, Number 5