| Client Successes |
Harvard University and Massachusetts Institute of Technology
Our lawyers have been retained by Harvard University and Massachusetts Institute of Technology in several projects, and have obtained worldwide patent protection for numerous pioneering inventions in organic chemistry and chemical engineering. For example, we have obtained for the institutions domestic and foreign patents protecting asymmetric transition-metal-catalyzed reductions; asymmetric transition-metal-catalyzed cycloadditions; and transition-metal-catalyzed carbon-heteroatom and carbon-carbon bond-forming reactions.
|
Protecting a Leading Pharmaceutical Company
Our lawyers assembled and directed a team of professionals to respond to a legislative initiative in Massachusetts that would have imposed tighter controls on an internationally marketed prescription drug. On behalf of our client, a leading international pharmaceutical company, we brought together a public relations team, with statehouse lobbying support, to combat the action. By preparing the regulatory filings and developing the overall case strategy, our team was able to implement a plan that resulted in no change to the drug's classification.
|
Defending Companies against Federal Healthcare Fraud Allegations
Our client, an international pharmaceutical company, was a subject of several complex federal healthcare fraud investigations concerning various practices allegedly implicating the federal health care anti-kickback statute. We investigated the facts surrounding the government's allegations, interviewed witnesses and analyzed the voluminous documents obtained by the government, and were able to demonstrate to the government that our client did not violate the anti-kickback statute in any of the investigations. Ultimately, our client was not charged criminally or civilly or otherwise penalized.
|
Driving Biopharma Forward
Our lawyers identified, on the eve of FDA approval of one of our client's biopharmaceuticals, a prior public use that would cause a court to invalidate the otherwise blocking patent claims. This enabled our client to negotiate a license under the patent on commercially reasonable terms.
|
Due Diligence Across the World
We were retained by one of the world's largest pharmaceutical companies to join a team of in-house management-level scientific and business decision-makers on an IP due-diligence trip to eastern Europe. The team vetted the potential licensor's patent and trade-secret portfolios, and also considered potential associated regulatory and logistical issues.
|
Protecting Individuals from Allegations of Federal Healthcare Fraud
Our client, a senior executive at a large international pharmaceutical company, was a subject of a complex, wide-ranging criminal and civil healthcare fraud investigation. During the nearly three-year investigation, the government explored various theories of culpability including use of an unauthorized medical device, violations of the anti-kickback statute and off-label promotion. We were able to demonstrate legal and factual inaccuracies and weaknesses in the legal basis for the government's evolving theories. Ultimately, our client was not charged criminally or civilly or otherwise penalized.
|
Helping a Canadian Proteomics and Drug Discovery Company
Our lawyers helped a Canadian proteomics and drug discovery company in the establishment of its first proteomics research facility in the United States, a facility closely tied to a prominent U.S. academic research institution. This new facility enables the company to further develop and market its proteomics methodologies both in the United States and internationally.
|
Biomedical Advanced Research and Development Authority (BARDA)
In a move that created enormous opportunities for early-stage life sciences companies, last year the U.S. Congress revitalized the federal government’s program supporting the development of medical countermeasures critical to protecting the nation against bioterrorism and pandemic threats. The resulting legislation created an agency within the Department of Health and Human Services (HHS), the Biomedical Advanced Research and Development Authority (BARDA). BARDA will inject more than $1 billion into research, development, and procurement of vaccines, antivirals and diagnostics. BARDA enhances coordination between government and emerging companies through support of advanced research and development, the vital phase that occurs in between basic research and commercialization. On behalf of the venture capital firm, Kleiner Perkins Caulfield & Byers, Foley Hoag worked with the HHS, Congressional members, and staff to craft legislation strengthening the nation’s response to pandemic outbreaks and bioterrorism. The key financing aspect of the legislation provides much-needed funding to allow early stage companies to traverse the “valley of death” before product commercialization. The legislation authorizes the Secretary of HHS to expedite contracts and grants, and the Director of BARDA to identify areas of unmet need, spurring further innovation and investment. BARDA institutionalizes the important partnership between the federal government and the life sciences industry, critical to safety, innovation and economic vitality.
|
Strategic Advice on Landmark Legislation
On behalf of a national life science trade association and leading biodefense companies, our Government Strategies lawyers provided substantive counsel and strategic advice to leading Members of Congress and the Administration in the enactment of landmark legislation promoting advanced research and development against bioterrorist attack and pandemic infectious diseases.
|
Bringing Law and Science Together
On behalf of a leading biotechnology company, our Government Strategies lawyers assembled a persuasive legal and scientific case that secured a critical federal policy decision affecting the coding and payment of important therapies for Medicare beneficiaries.
|
Cellulosic Biomass Conversion
Our lawyers provided general business advice and assistance with venture capital financing and technology licensing for a new corporation developing and commercializing technology for converting cellulosic biomass and other biomass wastes into ethanol.
|
Successful DRG Reclassification
Our lawyers provided counsel to a leading biotechnology company and cancer center in obtaining a DRG reclassification for hospital inpatient reimbursement for therapy for renal cell carcinoma and melanoma.
|
Reimbursement Strategies in the Fight Against Cancer
We represented a leading biotechnology company in increasing hospital outpatient reimbursement for supportive anti-cancer therapy.
|
Guiding Clients through CMS
Our lawyers advised a coalition of leading academic medical centers and medical device manufacturers in the development of one of the first data registries under CMS’s Coverage with Evidence Development policy. We also represented a leading cancer center in obtaining a DRG reclassification for hospital inpatient reimbursement for an anti-cancer therapy for renal cell carcinoma and melanoma.
|
Engaging FDA and Congress
On behalf of a national coalition of innovative medical technology companies, our lawyers engaged FDA and Congress regarding the appropriate regulation of break through genetic and molecular diagnostic tests. We also devised a strategy to persuade an FDA review division to accept a medical technology company’s proposed development plan, after the company had reached an impasse with the review division over its data requirements.
|
Leading the Way for Innovative Treatments
Our lawyers advised an innovative early-stage company on obtaining a $102 million contract with the U.S. Department of Health and Human Services to develop an influenza neuraminidase inhibitor for the treatment of pandemic influenza.
|
Abiomed, Inc.
Our lawyers serve a general counsel for the developer/manufacturer of the world’s first fully implantable replacement human heart, providing all aspects of corporate services including stock offerings, Exchange Act disclosures and filings, employment matters, and acquisition of technology.
|
C.R. Bard, Inc.
We have represented C.R. Bard, a leading biotechnology and health-care company, in various joint ventures, acquisitions, and dispositions since 1982, including agreements providing for the development, regulatory approval, manufacturing and licensing of numerous medical devices; the purchase from St. Jude Medical, Inc. of its Cardiac Assist Division; an agreement providing for the donation (for subsequent development and commercialization) to a major Boston area teaching hospital of all rights related to an atrial septal defect occluder; and agreements providing for the licensing and sale of its cardiopulmonary and cardiac assist divisions and all related products, together with a secondment agreement providing for the use by one of the buyers of the seller’s employees and facilities to produce certain products until such time as the buyer could develop its own manufacturing facilities.
|
HyperBranch Medical Technology, Inc.
For our client HyperBranch Medical Technology, Inc., a leader in the field of polymeric medical sealants, we assisted with the intellectual property portfolio strategy in connection with obtaining CE Mark designation for the company’s OcuSeal product. OcuSeal is a liquid ocular bandage used to stabilize ocular wounds following surgical or non-surgical trauma. CE Marking denotes that a product complies with all requirements of European health, safety, and environmental product legislation, and is an important step in bringing products to market overseas. HyperBranch began its research in 2004 with the objective to develop strong enough polymer sealants to ultimately replace sutures that would be easy to use, and would not interfere with natural healing. The Durham, North Carolina medical device company has also, been developing advanced surgical sealants for dura (brain), pleural (lung) and hernia mesh fixation. These products are all at various stages of clinical and pre-clinical development. Read more about HyperBranch Medical Technology here.
|
Driving State-of-the-Art Research Facilities
We represent Boston University and Boston Medical Center in connection with the development of the National Emerging Infectious Diseases Laboratories, to be located in a new building on the Medical Center campus. The NEIDL will perform advanced research to identify vaccines and cures for infectious diseases. We provided advice concerning the National Environmental Policy Act and the Massachusetts Environmental Policy Act, as well as other matters.
|
Successful High-stakes Patent Defense
Our lawyers were victorious as counsel to Johns Hopkins University, Baxter Healthcare Corporation, and Becton Dickinson and Company in a closely watched biotechnology patent litigation against CellPro, Inc., enabling our clients to successfully enforce monoclonal antibody and stem cell technology patents
|
Major Legislative Milestones
Our lawyers worked on key pieces of health legislation while working as congressional staff members. These include the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), the 1997 Food and Drug Administration reform law, the Orphan Drug Act, and the Health Insurance Portability and Accountability Act of 1996, and the Public, Health, Security and Bioterrorism Preparedness and Response Act. We have also worked on legislation involving specific changes to Medicare and Medicaid law. Today, our lawyers represent several leading pharmaceutical and biotechnology companies and industry trade associations in their implementation of and ongoing preparedness for these laws.
|
Ryan White CARE Act
Our lawyers advocated on behalf of a national civil rights organization to assure the timely reauthorization of the Ryan White CARE Act, the largest publicly funded program dedicated to providing people with HIV/AIDS in the United States with a wide range of community-based health and support services.
|
Driving Scientific Innovation through Sponsored-research Agreements
Our lawyers have prepared numerous sponsored-research agreements between biotechnology and other companies, universities and not-for-profit institutions. In these arrangements, we work with our clients and the licensing university to arrange for a suitable disposition of the ownership of new inventions and commercialization rights. In addition, our lawyers have negotiated several such agreements with foreign universities and research institutions.
|
Advising a Leading Proteomics and Drug Discovery Company
We represented a proteomics and drug discovery company in connection with a research, development and commercialization collaboration with a company possessing human antibody technology, including the development and commercialization of human antibodies directed against more than 100 different protein targets. Our service to this client has included devising a number of business and legal mechanisms for prioritizing the different protein targets, maintaining commercialization rights in certain fields, and protecting against claims of intellectual property infringement.
|
Protecting a Global Genetics Testing Company
Our lawyers served as counsel for a genetics testing company in connection with domestic and international licensing of patented technologies to detect human susceptibility to genetically influenced disease. Our work with this client included advising on the revamping of its U.S. marketing and supply relationships, as well as the termination of a previous European distribution contract and the preparation of a broader license agreement with a potential new European partner. Our lawyers also worked actively with the client to develop a licensing strategy that takes into account its business goals and intellectual property position.
|
QLT
We represented QLT in complex patent and trade secret litigation arising out of a collaboration among QLT, Massachusetts Eye and Ear Infirmary, and Massachusetts General Hospital that led to the development of photodynamic therapeutic treatment for age-related macular degeneration. We obtained a district court order correcting inventorship to add QLT’s scientist to the patent, leading to a stipulated dismissal.
|
Smith & Nephew, Inc.
On behalf of our client, Smith & Nephew, Inc., we secured a reversal by the Sixth Circuit of a district court opinion granting an insurer summary judgment. The Court of Appeals held that the insurer had a duty to defend our client, the policyholder, under the “personal injury” provisions of a general liability policy for an underlying action alleging the policyholder’s participation in a conspiracy to defame a self-styled “whistle-blower.”
|
Helping to Bring Technology and Sciences Together
Our lawyers represent a software company specializing in data visualization and query tools for use in applications ranging from drug discovery to biotechnology, including agreements covering domestic and international software distribution and bundling, enterprise licenses, shareware licenses, joint marketing and partnering.
|