Practice Areas & Industries: Duane Morris LLP

 




Life Sciences and Biotechnology Return to Practice Areas & Industries

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Practice/Industry Group Overview

Duane Morris attorneys understand the issues that innovators in the life sciences industry face from every angle: from the science and technology, to the business realities, to potential legal challenges. We know because we have been there. Many of our life science attorneys have been in-house counsel at life sciences companies and/or have worked as scientists in research laboratories. Our lawyers have decades of experience guiding life sciences clients from startups to publicly traded companies, as well as academic and research institutions, working in a broad range of technologies, including pharmaceuticals, biotechnology, medical devices and diagnostics at all stages of the product life cycle, from discovery through clinical development and commercialization.

The Duane Morris Life Sciences practice group and its individual attorneys have received numerous accolades, including being named one of the top global legal advisors for biotechnology and pharmaceutical licensing transactions, being recognized as one of the most prominent Intellectual Property practices in the United States and winning statewide and international client service awards.

Corporate Startups and Financing Transactions

Attorneys in Duane Morris' Life Sciences practice group have been involved in the initial formation of some of the most successful companies in the life sciences industry and have assisted dozens of companies raise an aggregate of over $500 million in private transactions, including from angel investors, venture capital funds, corporate venture arms, and public offerings. Duane Morris welcomes representation of early-stage companies and frequently partners with them by extending substantial fee-deferral arrangements to foster innovation and support promising entrepreneurs. Duane Morris also works tirelessly to introduce our early-stage clients and entrepreneurs to prospective investors and strategic partners through our vast network of connections and a variety of programs and events.

Representative Matters

  • Represented Agile Therapeutics, Inc., a pharmaceutical company specializing in women's healthcare products, in its $45 million Series B preferred stock financing co-led by Investor Growth Capital and Care Capital, with strong participation from ProQuest Investments.
     
  • Represented Celator Pharmaceuticals, Inc., a pharmaceutical company specializing in cancer drugs, in a $32.5 million private placement led by Valence Life Sciences.
     
  • Advised Biofutures International plc (now called Graphene NanoChem plc), an AIM listed company, on its £32.5 million sale of shares. The underwriter was Panmure Gordon.

Collaborations and Licensing

Our Life Sciences practice group has extensive experience in representing life science companies and academic institutions with critical partnering, licensing, joint venture and other collaboration transactions. For example, Duane Morris has been recognized as one of the top legal advisors worldwide in biotechnology and pharmaceutical licensing deals.

Representative Matters

  • Represented Gliknik Inc., in its exclusive worldwide license agreement with Pfizer Inc. for Gliknik's recombitant stradomer™ GL-2045, a drug candidate designed to replace and improve on pooled human intravenous immunoglobulin (IVIG). Gliknik received an upfront payment of $25 million and is eligible to receive additional milestone payments and royalties.
     
  • Represented Inovio Pharmaceuticals, Inc. in its $422.5 million collaboration agreement with Roche to research, develop and commercialize Inovio's highly-optimized, multi-antigen DNA immunotherapies targeting prostate cancer (INO-5150) and hepatitis B (INO-1800) as well as use of Iniovio's CELLECTRA® electroporation technology for delivery of the vaccines.
     
  • Represented Intelligent Medical Devices, Inc. (IMDx) in connection with its agreement with Abbott Laboratories for the design, development and manufacture by IMDx of molecular diagnostic tests to be distributed by Abbott worldwide.

Mergers and Acquisitions

Duane Morris has represented life sciences industry companies in mergers and acquisitions and related aspects of M&A in matters valued at upwards of $1.5 billion. Corporate attorneys throughout Duane Morris are experienced in developing and implementing creative strategies to help maximize value and position emerging and mid-market life sciences companies as advantageously as possible to meet their immediate needs and long-term business goals.

Representative Matters

  • Represented biopharmaceutical company Ception Therapeutics, Inc. in its acquisition by Cephalon, Inc. for $250 million and up to $500 million in milestone payments.
     
  • Represented Quest Diagnostics in the sale to Royalty Pharma of royalty rights from commercialization of the drug candidate Ibrutinib for $485 million.
     
  • Represented Orthovita, Inc. in its agreement to be acquired by Stryker Corp. for $316 million.

Patent Prosecution and Maintenance and IP Due Diligence

The Intellectual Property practice at Duane Morris is recognized as one of the most prominent IP practices in the United States by national publications such as U.S. News & World Report, Intellectual Property Today and IP Law360. Duane Morris' IP attorneys provide counsel on the most effective methods of establishing and developing IP holdings. Our attorneys understand that a thorough and accurate IP asset due diligence review is essential to help companies protect their IP rights and realize the most value from their assets. Duane Morris' due diligence can help reduce risk and identify opportunities for our life sciences clients.

Representative Matters

  • Advised Quest Diagnostics on patent, licensing and IP litigation due diligence issues in connection with Quest's acquisition of Athena Diagnostics from Thermo Fisher Scientific for $740 million.
     
  • Advised Quest Diagnostics on IP litigation due diligence issues in connection with Quest's definitive merger agreement with Celera Corporation.
     
  • Prosecuted U.S. Patent No. 8,523,870, pertaining to an adjustable femoral resection guide, on behalf of Wright Medical Technology, Inc.

Regulatory and Compliance

We regularly represent our clients' interests before government agencies such as FDA, DEA, CMS and the FTC. Depending on where a client stands in its lifecycle, we counsel on regulatory strategies, assist with clinical study issues and advise on marketing submissions issues. For firms with marketed products, we help ensure compliance with the myriad of regulatory requirements impacting operations and marketing, including review of marketing materials (real and virtual) and responding to agency enforcement actions ranging from Warning Letters to criminal prosecutions. For all clients, we also engage in training and procedures development to enhance regulatory compliance and reduce the potential for adverse agency actions.

Representative Matters

  • Developed an FDA regulatory and quality strategy for a CLIA-accredited Diagnostic Laboratory producing an innovative web-based software system that calculates appropriate dosage for a narrow-therapeutic range cardiovascular drug used for life sustaining indications.
     
  • Represented a healthcare technology company in providing FDA, privacy and security compliance support for a mobile health application targeted at cardiac conditions.
     
  • Detailed review and analysis of impact of FDA’s then new T.E.A. (Time and Extent Application) regulations for OTC drugs.

Litigation

Life sciences clients draw on Duane Morris' trial teams to defend them against patent infringement and products liability claims. Our lawyers provide clients with counsel experienced in patent infringement, products liability and toxic tort law, including the use of class actions in mass tort litigation, and problems arising from the acquisition of another company.

Representative Matters

  • Aspex Eyewear Inc. v. Zenni Optical, LLC, Case No. 2012-1318 (Fed. Cir. 2013): Obtained a decision in the Federal Circuit on behalf of Zenni Optical, LLC, affirming a trial court decision barring patent infringement claims on grounds of collateral estoppel in litigation related to magnetically attached auxiliary frames for prescription eyeglasses.
     
  • AngleFix v. Wright Medical (W.D. Tenn. 2013): Represented Wright Medical in patent litigation concerning orthopedic surgery.
     
  • Obtained a $65 million plus settlement on behalf of Tekmira Pharmaceuticals Corp. from Alnylam Pharmaceuticals Inc. and AlCana Technologies, Inc. in connection with alleged misappropriation of Tekmira's trade secrets related to gene-silencing therapeutics.

Clinical Trials, Manufacturing, Distribution and Other Life Sciences Agreements

Duane Morris' Life Sciences practice group has significant experience in drafting, negotiating and advising clients in connection with a variety of agreements and other documentation relating to U.S. and pre-clinical and sponsored research, global clinical trials, manufacturing activities, distribution arrangements and various other matters unique to the life sciences industry.

Trademarks, Copyrights, Trade Secrets and Unfair Competition

Duane Morris has been repeatedly ranked among the top trademark filing law firms by Intellectual Property Today and Managing IP. Our IP lawyers work with life sciences clients, filing and maintaining applications to register trademarks, current trademark registrations and copyrights each year in the U.S. and throughout the world. We also handle an array of disputes related to trademarks, copyrights, trade secrets and unfair competition claims.

International Trade, Customs and Taxation

Life sciences companies engaged in the import or export of goods face numerous regulatory issues and Duane Morris routinely assist clients regarding presentations to U.S. Customs relating to royalty and license agreements and dutiable value of goods; transfer pricing; tariff classification of products; country of origin issues; and interdiction of unauthorized shipments of products produced in non-FDA-certified foreign facilities.


 

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FDA Releases Draft Guidance on Bioequivalence Requirements for ANDA Applicants
, December 11, 2013
On December 4, 2013, the U.S. Food and Drug Administration (FDA) issued a draft guidance on demonstrating bioequivalence for drugs submitted under an Abbreviated New Drug Application (ANDA). Entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, the new...