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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.

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 that includes:

  • 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, that calls on our knowledge of the industry, the players, and the law to get things done.

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Representative Matters

Representative Matters

  • Boston Biomedical Associates, LLC

    Nutter represented Boston Biomedical Associates, LLC, a full service medical device, biotech, and pharmaceutical clinical research organization (CRO), in its acquisition by Factory CRO USA Group, LLC, a global leader of specialization in medical device trials.

  • Clintara

    Nutter advised Clintara in its sale to strategic acquirer Bracket Global, LLC.

  • Admune Therapeutics LLC

    Nutter advised Admune Therapeutics LLC in its sale to Novartis Institutes for BioMedical Research.

  • Obtained summary judgment of invalidity for a life sciences 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 hemodialysis catheter. 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

    Nutter served as counsel for one of the world's largest health care companies in a 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

    Nutter provides 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

    Nutter represents 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

    Nutter developed a strategic patent portfolio for an early-stage, emerging medical device company focused on minimally invasive wound closure. We defended the company in a due diligence evaluation by prospective investors and asserted patents against a large medical device company, resulting in a successful exit for investors through the sale of company assets to the competitor.

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

    Nutter managed a 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

    Nutter was a member of the science team responsible for expert witness preparation.

  • Patent prosecution and portfolio development (medical)

    Nutter 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

    Nutter analyzed the claims of third party patents, and provided strategic counseling and advice to major medical device companies in connection with planned commercial launches. The products included 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 a 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 multimillion dollar legal fee award under Massachusetts’s unfair trade practices statute.

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

    Nutter conducted an internal investigation for the audit committee of a 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

    Nutter's representation included securities, financing, and intellectual property 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 startup company on business structure, early-stage planning, and venture financing and provide ongoing representation for this company, which operates specialized testing labs

    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. The company has grown over 40% per year over the last five years.

  • 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

    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

    Following FDA notification and the development of a product recall plan, the entire deal had to be 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

    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

    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

    Nutter 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. We successfully avoided any material liability claims while adhering to budget constraints.

  • Represent a company in multi-district product liability litigation

    Nutter represented a medical device company in a multi-district product liability litigation involving a recalled device. Nutter was a member of the team responsible for analysis of the science, retention of expert witnesses, analysis of company documents, and development of narrative themes for company witnesses.

  • Medical device manufacturer

    Nutter represented a 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

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

  • IP due diligence

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

  • Senior executive of a major pharmaceutical company

    We represented a senior executive 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 it 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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