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Life Sciences and Medical Devices

Overview

The Life Sciences Group at Nutter has a long track record working with clients in the life sciences sector throughout the product lifecycle to achieve their legal and business objectives. We understand how critical it is to know a client’s business and the unique pressures driving it, whether it's research and development costs, complex intellectual property and licensing matters, clinical trial programs, the web of government regulation, the risk of off-label marketing, or the opportunity to acquire, merge or form a joint venture. By applying our wealth of expertise and depth and breadth of knowledge, we help transform the client’s ideas and goals into viable strategies and products.

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Our Services
With an understanding of science and technology and a business savvy approach, our interdisciplinary team provides biotech, pharma and medical device clients with a comprehensive service solution – from intellectual property and transactional advice to government enforcement, products liability and regulatory matters. This includes:

  • Capital raising and corporate finance
  • IP strategy, prosecution and litigation
  • Strategic collaborations and licensing
  • Product liability
  • Mergers and acquisitions, joint ventures and strategic alliances
  • Regulatory compliance
  • Government investigations and defense 
  • Advice on product distribution issues
  • Trade secret and non-competition litigation

Our Clients
Nutter represents an international roster of innovative clients involved in a range of sophisticated technologies who include:

  • U.S. and multinational medical device, biotech and pharmaceutical companies 
  • Renowned medical institutions and research universities 
  • Major hospitals and other health care providers
  • Payors, benefits managers and plans 
  • Emerging growth companies 
  • Venture capital firms, private equity and entrepreneurs

Our clients choose us for our legal credentials but what they value most is Nutter’s passionate commitment to client service and to enhancing the business of each client. With in-depth legal and scientific credentials, our attorneys take responsibility for knowing the client’s needs and objectives, and for partnering to achieve successful outcomes and competitive advantage. Clients work with a cross-functional Nutter team with expertise tailored to their particular requirements, who call on our knowledge of the industry, the players and the law to get things done.

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Representative Matters

Representative Matters

  • Ekso Bionics Holdings, Inc.

    Strategic acquisition of gravity balancing arm technologies of Equipois, LLC.

  • Ekso Bionics Holdings, Inc.

    $15 million public offering of common stock and related listing on the Nasdaq Capital Market

  • Clintara

    Sale to strategic acquirer, Bracket Global, LLC

  • Admune Therapeutics LLC

    Sale to Novartis Institutes for BioMedical Research

  • Obtained Summary Judgment of Invalidity for Life Science Company Accused of Patent Infringement

    Our client, a life sciences company, was accused by a competitor of patent infringement relating to an insertion method for a medical device. After briefing and a hearing, the Court disposed of the case on summary judgment, finding the patent-in-suit obvious as a matter of law.

  • Represented large pharmaceutical company in a federal investigation involving allegations of off-label promotion

    Counsel for one of world's largest healthcare companies in six-year investigation into alleged off-label use of one of its leading products.

  • Representation of a manufacturer of prosthetic knee, hip and spinal implants in cases around the country

    Ongoing representation of a manufacturer of prosthetic knee, hip and spinal implants in lawsuits around the country including so-called “mass tort” multi-district litigation (MDL) proceedings and other coordinated national litigation.

  • Representation of major corporations in cases involving diverse pharmaceutical and medical device products

    Ongoing representation of major corporations in cases involving diverse pharmaceutical and medical device products such as contact lenses, contraceptive patches, pediatric painkillers, quinolone antibiotics, and migraine medication in lawsuits in Massachusetts and New Hampshire.  

  • Strategic Counseling for Successful Exit

    Developed strategic patent portfolio for early stage emerging medical device company focused on minimally invasive wound closure. Defended company in due diligence evaluation by prospective investors. Asserted patents against large medical device company, resulting in successful exit for investors through sale of company assets to the competitor.

  • Represented a manufacturer of prosthetic spine implants in multi-district product liability litigation involving over 250 plaintiffs

    Represented medical device manufacturer in a multi-district product liability litigation involving over 250 plaintiffs. Managed team of associates in the review and production of over four million pages of documents contained in an Electronic Reading Room.

  • Representation of a manufacturer of prosthetic hip implants in multi-district product liability litigation

    Member of the science team responsible for expert witness preparation.

  • Patent Prosecution and Portfolio Development (medical)

    Provided strategic advice on the development and management of robust patent portfolios to help medical device companies present a significant entry barrier to competitors. These companies include DePuy Spine, Ethicon Endo-Surgery, and DePuy Mitek, all Johnson & Johnson companies.

  • Market Clearance

    Analyzed claims of third party patents, and provided strategic counseling and advice to major medical device companies in connection with planned commercial launches. Products include a broad range of surgical devices in various fields, including bariatrics, spinal surgery, soft tissue fixation, neurosurgery, nutritional products, contact lenses, and pharmaceuticals.

  • Won jury verdict in major business torts case

    After a client’s competitor acquired a client’s exclusive supplier and threatened to terminate the client’s supply of a key component, we sued the competitor and supplier. In a month long trial, we obtained a jury verdict holding the competitor and a supplier liable for breach of contract, tortious interference, and misappropriation of trade secrets, ultimately leading to a favorable judgment for declaratory and injunctive relief, double damages, and a multi-million dollar legal fee award under Massachusetts’ unfair trade practices statute.

  • Conducted an internal investigation for audit committee of public biotechnology company

    Conducting an internal investigation for audit committee of public biotechnology company concerning securities law compliance.

  • Served as corporate counsel to a global biopharmaceutical company and have represented the company in mergers, product acquisitions and two public offerings in excess of $340 million

    Served as corporate counsel to a global biopharmaceutical company and have represented the company in mergers, product acquisitions and two public offerings in excess of $340 million. Representation includes securities, financing and IP issues, as well as highly specialized counsel in the development of clinical trials programs and commercialization of products in the EU.

  • Advised a health care start-up company on business structure, early-stage planning, venture financing and provide ongoing representation for this company, which operates specialized testing labs

    Advised a health care start-up company on business structure, early-stage planning, venture financing and provide ongoing representation for this company, which operates specialized testing labs. The company has grown over 40% per year over the last 5 years. Nutter helped the company in securing two rounds of VC financing, navigating reimbursement procedures from insurance carriers, complying with complex health care regulations, drafting detailed licensing and research agreements, and preparing strategic collaboration agreements with doctors, hospitals and medical groups.

  • Represented defendants in government enforcement actions and secured acquittal of major pharmaceutical company’s manager after a three-month federal trial on conspiracy and health care fraud charges

    Represented defendants in government enforcement actions. Nutter secured acquittal of major pharmaceutical company’s manager after a three-month federal trial, which received national attention, on conspiracy and health care fraud charges. In another instance the firm defended an officer of a major health care company against a target letter from the government. Nutter convinced the government not to bring criminal charges, while other officers of the company who received target letters were criminally charged.

  • Represented a medical device manufacturer that became aware of adverse medical incidents (failures of a small number of their products during usage) shortly before closing a deal to divest this product line

    Represented a medical device manufacturer that became aware of adverse medical incidents (failures of a small number of their products during usage) shortly before closing a deal to divest this product line. Following FDA notification and the development of a product recall plan, the entire deal had to restructured to provide for a partial closing and a supply and distribution agreement, under which the client would complete the product recall and supply the buyer with products in the interim. The sale was successfully completed. Throughout this process, Nutter attorneys also advised the client, a publicly traded company, on its obligations under the Securities Exchange Act to report this transaction as it developed to the regulators and the investment community.

  • Served as trial counsel for a medical device company that was sued for patent infringement by two separate competitors

    Served as trial counsel for a medical device company that was sued for patent infringement by two separate competitors. In one case, Nutter attorneys worked with the company’s engineers to develop product modifications that were clearly outside the scope of the patent-in-suit and then negotiated a settlement on favorable terms that allowed the client to sell off existing inventory at a modest royalty rate. In the other suit, we successfully terminated the litigation by winning a summary judgment of patent invalidity in court.

  • Advised several Fortune 500 companies on patent and trademark prosecution, counseling, opinion work, and patent litigation on portfolio of pharmaceutical, medical and biotechnology products

    Advised several Fortune 500 companies on patent and trademark prosecution, counseling, opinion work, and patent litigation on portfolio of pharmaceutical, medical and biotechnology products. Nutter has been identified as a “go-to firm” in intellectual property in national trade press. We also handle patent prosecution for many of Boston’s renowned teaching hospitals and elite research universities for their biotechnology, pharmaceutical, and medical innovations.

  • Represented national corporations devoted to pharmaceutical, surgical and health care services in litigation of discrimination and wrongful termination claims

    Represented a family of national corporations devoted to pharmaceutical, surgical and health care services, handling litigation of discrimination and wrongful termination claims, litigation of non-competition agreements, non-solicitation agreements and trade secrets, and preventive training on disability law, internal corporate investigations, layoffs and reductions in force. Successfully avoided any material liability claims while adhering to budget constraints.

  • Represent company in multi-district product liability litigation

    Represent medical device company in a multi-district product liability litigation involving recalled device. Member of team responsible for analysis of the science, retention of expert witnesses, analysis of company documents and developing narrative themes for company witnesses.

  • National representation of corporate tenant on all facets of real estate acquisition, sale, leasing, financing, permitting, environmental, brokerage, construction contract and architect

    Representation of medical device manufacturer on a national basis on real estate leasing, acquisition, disposition, financing, permitting, environmental and other land use related activities, including negotiation of letters of intent, purchase and sale agreements, leases, lease amendments, architects and construction contracts, brokerage agreements and other consulting arrangements.

  • IP Due Diligence

    Provided IP due diligence counseling for lead investor syndicate of institutional investors for $20+ million series B investment in a clinical diagnostic company.

  • IP Due Diligence

    Provided IP due diligence counseling for lead investor syndicate of investors for > $25+ million series C investment in a neuro stimulation company.

  • Recently Convinced Justice Department Not to Charge Senior Executive of Major Pharmaceutical Company

    We represented a senior executives of one of the world's largest pharmaceutical companies, in an investigation based on alleged adulteration of several products at a large manufacturing plant. After the company paid over $500 million to settle the matter, the Justice Department informed the company that was considering "responsible corporate officer" charges against two executives who had oversight of the factory, including our client. After more than a year of intensive efforts on our part, the government decided to close its investigation.

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