Pharmaceutical / Biotechnology / Medical Devices Recent Matters

  • Representing Almac Diagnostics Limited as intellectual property counsel in connection with the worldwide patent protection of a range of genomic services, including gene expression, SNP, bioinformatics, and proprietary microarray technology for diagnostic use in colorectal cancer, breast cancer, ovarian cancer, prostate cancer and lung cancer.


  • Representing Nobel Prize winner Kary Mullis and his company Altermune, LLC as intellectual property counsel in connection with infectious disease diagnosis and therapeutic management; and also in connection with structuring strategic partnerships for research and commercial enhancement of proprietary technology.


  • Representing AC Immune SA, a Swiss-based product company focused on the area of CNS (conformational) diseases and cancer, as intellectual property counsel, including in connection with worldwide patent prosecution, due diligence for freedom to operate and also in connection with facilitating transactional and licensing partnerships. Assisted AC Immune with successful negotiation of license agreement with Genentech for further development and commercialization of Alzheimer’s therapeutic.


  • Representing AtheroGenics, Inc., a Georgia-based, publicly-owned pharmaceutical company focusing on treatments for cardiovascular and inflammatory diseases, in connection with worldwide patent protection on AGI-1067, a drug in Phase III clinical trials for the treatment of atherosclerosis, and AGI-1096, a drug in clinical trials for the treatment of solid organ transplant rejection. Also representing the company in general corporate and corporate finance matters, including a $60 million exchange offer of convertible note.


  • Representing CM Capital, an Australian life sciences investment firm, as intellectual property counsel in an intellectual property due diligence matter relating to a prospective investment.


  • Representing Conor MedSystems, Inc., a California-based medical device manufacturer, as general intellectual property counsel, including in connection with litigation in the High Court of Justice, Chancery Division, Patents Court of the United Kingdom before Justice Pumfrey and in the Federal Court of Australia, both against Angiotech Pharmaceuticals, Inc. and University of British Columbia to challenge the validity of the key patent licensed to Boston Scientific Corporation covering the TAXUS drug eluting coronary stent.


  • Representing Conor MedSystems, Inc., in litigation with Angiotech and Boston Scientific in connection with an assertion of patent infringement of Angiotech’s European patent with cross claims by Conor for invalidity and non-infringement at the District Court in The Hague, Netherlands.


  • Representing Conor MedSystems, Inc., in a patent infringement suit brought by Boston Scientific Corporation in the U.S. District Court of Delaware. Conor Medsystems’ drug eluting stent technology is in clinical trials in the U.S. and Europe for the treatment of restenosis that occurs in the coronary arteries following balloon angioplasty.


  • Representing Cortical Pty. Ltd., a company located in Melbourne, Australia, in patent matters. Cortical Pty. Ltd. is a drug discovery and development company focusing on small molecule solutions to therapeutic targets in inflammation.


  • Represented Cutanea Life Sciences, a developer of dermal filler and therapeutic products, in connection with various intellectual property due diligence, licensing and patent prosecution matters.


  • Representing CytImmune Sciences, Inc., a Rockville, MD-based biopharmaceutical company, as general intellectual property counsel, including in connection with worldwide patent prosecution and enforcement of proprietary pegylated colloidal gold tumor-targeting nanotechnology. Instrumental in addressing freedom to operate issues, and structuring partnering arrangements for human and veterinary use and commercial development in areas such as oncology. Provide assistance in the areas of FDA procedures and clinical trials.


  • Representing The Dow Chemical Company and Dow Global Technologies, Inc. in connection with its biotechnology program relating to the bacterial expression of commercial proteins, including drug products and organic chemical programs.


  • Representing Drug Royalty Corporation, now DRI Capital, in transactions totaling in value close to one billion dollars in royalty assets, involving conducting due diligence of the patents and license agreements that are the basis of royalty payments. Further representing DRI’s interests in negotiating the intellectual property issues relating to the royalty purchase agreements.


  • Representing an early-stage public biotech company in connection with a development, licensing and co-promotion agreement with an Israeli company for a new drug product.


  • Representing Emory University as intellectual property counsel in connection with the worldwide patent protection of FTC (Emtriva [emtricitabine]), a drug approved by the FDA in 2003 for the treatment of HIV. Emtriva is Emory University’s first commercial drug. In July 2005, Gilead Sciences and Royalty Pharma purchased the royalty interest owed to Emory for emtricitabine for a one-time cash payment of $525 million, considered to be the largest payout ever made to an American university.


  • Representing Emory University in connection with the patent portfolio on Reverset, a drug in Phase II clinical trials for the treatment of HIV, currently being developed by InCyte Corporation.


  • Representing Emory University in connection with the patent portfolio licensed to NeurOp, Inc., an early stage company developing pH sensitive NMDA receptor antagonists to treat stroke, Alzheimer’s disease and neuropathic pain.


  • Representing Emory University in connection with a patent portfolio licensed to Metastatix, Inc., a venture capital-backed company developing novel antagonists to multiple chemokine receptors, including the CXCR4 receptor, for treatment of diseases including cancer, HIV and inflammatory disorders.


  • Representing EntreMed, Inc., a clinical-stage pharmaceutical company, as general intellectual property counsel, in connection with worldwide patent prosecution and enforcement of new generation multi-mechanism drugs for the treatment of cancer and inflammatory diseases. Comprehensive range of intellectual property support including strategic advice for developing a balanced portfolio of clinical product candidates and promising preclinical compounds for at least two product candidates (Panzem® (2-methoxyestradiol or 2ME2) NCD and MKC-1) in multiple Phase II oncology studies, a Phase I oncology product candidate (ENMD-1198), plus late-stage preclinical programs for an Aurora/angiogenesis inhibitor (ENMD-2076) for the treatment of cancer, and Panzem for the treatment of rheumatoid arthritis. Additional support in the areas of freedom to operate, partnership development (in and out licensing), FDA compliance, clinical trials and financial structuring.


  • Representing Friedman, Billings, Ramsey & Co., Inc. as financial advisor in connection with an equity offering for an early-stage pharmaceutical company.


  • Representing FOB Synthesis, Inc., a hybrid chemical company and provider of custom organic synthesis to the pharmaceutical and industrial chemistry industries, in patent prosecution and general corporate matters, including a potential joint venture for the commercialization of a product.


  • Representing Gilead Sciences, Inc. in connection with patent prosecution in the area of antiviral therapy, and in particular, patents covering FTC, the active component in Emtriva, and one of the two active components in Truvada.


  • Representing GlaxoSmithKline in a patent infringement action relating to nasal dilator products.


  • Represented Grace Laboratories, LLC, a developer of diagnostics for brain related seizures and epilepsy, in a variety of corporate and intellectual property matters.


  • Representing Hoffmann-La Roche Inc. and Roche Laboratories Inc. in state and federal court actions challenging the use of average wholesale prices for prescription drugs as a basis for governmental and private healthcare reimbursement.


  • Representing Lantibio, Inc., an emerging company focusing on the treatment of dry eye disease, cystic fibrosis and other diseases, as intellectual property counsel.


  • Represented LaserGen, Inc., a developer of next-generation DNA sequencing technology, in intellectual property and general corporate matters.


  • Representing a large generic drug manufacturing company in connection with an internal reorganization of its sales function.


  • Representing a major branded pharmaceutical company in interference proceedings against a competitor involving patented drug formulations and delivery devices.


  • Conducted a Hatch-Waxman pre-litigation evaluation of the patent portfolio of a major branded pharmaceutical company covering compounds and combination products, formulations and associated delivery devices.


  • Representing Merck in connection with the sale of a manufacturing facility.


  • Representing Mount Cook Pharmaceuticals, Inc., a Princeton, NJ-based emerging company focused on the clinical development of new drugs to treat urological disorders and other select indications, as general patent counsel.


  • Representing New Ice Ltd., a Colorado-based company focusing on the development and manufacture of biodegradable and biocompostable containers, in connection with patent portfolio development.


  • Represented Nitrox LLC, a biomedical company developing nitrogen-based pharmaceutical products, in connection with various financing matters.


  • Representing Noven Pharmaceuticals, Inc., a world leader in transdermal drug delivery located in Miami, Florida, in connection with certain patent matters and due diligence relating to transdermal systems.


  • Represented Oncose, Inc., a developer of in-vitro cancer diagnostic tests for early cancer detection, in general corporate and licensing matters.


  • Representing OxyPlus, Inc. a privately held, international biopharmaceutical company, as general intellectual property counsel, including in connection with proprietary products that regulate the binding affinity between oxygen and hemoglobin specifically in the area of oncology, including hepatocellular carcinoma and pancreatic cancer, as well as to congestive heart failure and diabetic retinopathy. Provide assistance in the areas of FDA procedures and clinical trials.


  • Represented Paramount BioCapital, a biotech venture capital investment firm in connection with various intellectual property due diligence, licensing and patent prosecution matters.


  • Represented ProEthic Pharmaceuticals in connection with $13 million debt financing provided by Merrill Lynch Capital with proceeds being used to advance phase III clinical development of ProEthic’s migraine treatment.


  • Represented Prolong Pharmaceuticals, a developer of novel peglyated protein compounds and related pegylation processes, in intellectual property and contracting matters, including patent prosecution and licensing.


  • Representing Q Care International, LLC, a novel medical device manufacturer, as general intellectual property counsel, including in connection with worldwide patent prosecution of unique hand-held devices that provide an effective and affordable solution for rendering a used hypodermic syringe harmless to health care professionals and patients, thereby significantly reducing the accidental transfer of contagious viruses. Provide assistance in the areas of FDA compliance and acquiring public funding through governmental support.


  • Representing Regado Biosciences, Inc., a North Carolina-based company, as general intellectual property counsel and in connection with its patent portfolio covering REG1, an antidote controlled anti-thrombotic in Phase I clinical trials which represents a new class of random nucleic acid sequences, which modulate blood coagulation during coronary artery bypass graft (CABG) surgery.


  • Represented Regado Biosciences, Inc., as intellectual property counsel in connection with a $20 million series B financing co-led by Domain Associates and Quaker BioVentures, and the negotiation of strategic license agreements.


  • Representing Revivicor, Inc., a company focusing on regenerative medicine, in connection with its patent portfolio directed to genetically engineered, cloned animals for therapeutic purposes, including xenotransplantation and stem cell technologies. Provided strategic advice on collaborative agreements, including in connection with its license of nuclear transfer technology from Geron Corporation and its acquisition of assets from XTL therapeutics, Inc. covering technologies licensed from Austin Research Institute in Australia.


  • Representing the Roskamp Institute, a private research institute located in Sarasota, Florida, in connection with intellectual property in the area of novel treatments for neurodegenerative diseases such as Alzheimer’s disease.


  • Successfully defended and settled a patent infringement suit for sanofi-aventis relating to biodegradable polymer drug delivery technology.


  • Representing Sequella, Inc., a Rockville, MD-based clinical stage biopharmaceutical company, as general intellectual property counsel, including in connection with patent prosecution of a wide international patent portfolio ranging from novel small molecule therapeutics for infectious disease to innovative diagnostic and compliance solutions for disease and disorders with epidemic potential. Provide comprehensive legal support in areas of business alliances (out and in licensing), strategic partnership with global organization, as well as in areas of FDA compliance and clinical trials.


  • Representing Signal Coordinating Therapy, Inc., as intellectual property counsel including in connection with patent prosecution of its international patent portfolio with regard to therapeutics for treatment of disorders involving immunological dysfunction, for treatment of demyelinating diseases such as multiple sclerosis, as well as treatment for herpes related disorders, Parkinson’s disease and cancer. Provide comprehensive legal support for the reorganization of the company, FDA regulatory advice, and licensing.


  • Represented a Special Committee of the Board of Directors of SpineMedica Corporation, a development stage company focused on medical device technologies for application in the spine, in connection with the sale of the company.


  • Representing Stanford University in connection with patent protection on inventions of Professor Paul Wender, an internationally renowned organic chemist, in the area of new drugs based on natural products for the treatment of cancer.


  • Representing The Regents of the University of California in connection with patent matters relating to combinatorial synthesis technology licensed to and co-owned by Symyx Technologies, Inc.


  • Representing Tikvah Therapeutics, Inc., an emerging company developing therapeutics for CNS disorders, neurology and psychiatry, in intellectual property matters including patent prosecution.


  • Representing Tillotson Healthcare Corporation in one of the largest patent infringement actions ever brought before the U.S. International Trade Commission (ITC) in order to prevent the importation of patented medical gloves.


  • Representing UCB Pharma (UCB) in connection with the sale of proprietary drug products to strategic and private equity buyers, as well as development, licensing and commercialization agreements for early-stage products. Negotiating co-promotion agreements with Cobalt Pharmaceuticals (Moexipril), Schwarz Pharma (Keppra and Neupro), Salix Pharmaceuticals (Trilyte), Teva Specialty Pharmaceuticals (ProAir), and a commercialization agreement with sanofi-aventis (Xyzal). Further representing the company with respect to the prospective sale of product manufacturing plants.


  • Representing The University of Georgia Research Foundation, Cornell University and Georgetown University in connection with one of the first patent filings to address a method to treat hepatitis delta (HDV), as well as other filings in the antiviral area.


  • Helped secure a preliminary injunction against the U.S. government’s implementation of new Patent Office Rules by filing an amicus curiae brief on behalf of several early-stage biotech clients.
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Contacts  

Andrew T Bayman (Andy)
Partner
Atlanta
Phone: (404) 572-3583
Fax: (404) 572-5100
abayman@kslaw.com

Richard C Pettus (Rich)
Partner
New York
Phone: (212) 556-2130
Fax: (212) 556-2222
rpettus@kslaw.com

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