The Life Sciences Practice has long been involved in the process of protecting
and commercializing agriculture biotechnologies, including hybrid and transgenic
plants and animals, pesticides and antiparasitic compounds and formulations,
and algal production of food, biofuels and medicinal products. We assist
our clients with regulatory issues in the field including representation
before the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture
(USDA), and the U.S. Environmental Protection Agency (EPA). Our attorneys
and scientists are also active in legislative and litigation issues involving
state and federal support of agricultural biotechnologies. We have assisted
agriculture biotechnology companies obtain investment funding as well as
promoted federal and state funding for stacked-trait technologies. Our attorneys
have experience with litigating issues relating to gene flow and other legal
issues related to genetically modified organisms.
The Life Sciences Practice works with such diverse alternative energy technologies
as mechanical and electrical 'green' energy devices, and energy production
using living organisms. We have experience protecting and commercializing
a wide variety of alternative energy solutions, including energy produced
from algae and hybrid or genetically modified plants having enhanced metabolism
of biofuels.
The Life Sciences team focuses on protecting and commercializing vaccines,
monoclonal antibodies, blood factors, cytokines, and cell-based medical
therapies. Our team has over a decade of experience assisting clients with
protecting and commercializing these technologies on both a domestic and
international level. In addition, we assist clients with legislative issues
involving the implementation of policies that support biologics technology
development, as well as state and federal funding of cell-based medicines.
The Life Sciences Practice assists clients with developing, protecting,
and commercializing such technologies as antiviral polyamides, RNA interference
(RNAi), RNA activation (RNAa), antisense DNA, and other polynucleotide-
and polypeptide-based technologies. We prepare and prosecute patent applications
internationally in this area, provide guidance on complex licensing transactions,
and draft freedom to operate and validity opinions in the field. In addition,
we have experience with Hatch-Waxman regulatory issues to assist us in developing
both branded and generics strategies for our clients.
The Life Sciences Practice assists clients with chemical technologies including
medicinal chemistry, fuel compositions and additives, polymers and biopolymers,
catalysts, dyes, and synthetic processes. We prepare and prosecute patent
applications throughout the world in these technical areas, and also provide
guidance to our clients with respect to licensing and investment transactions.
Our experience in the field of chemistry also includes technologies relating
to novel batteries and electrochemical devices.
Our Life Sciences team has broad experience with medical devices and related
technologies directed to the medical profession. We have a wide range of
experience with surgical devices, including those related to orthopaedics,
spinal, bone, and joint surgery. Our attorneys are accustomed to dealing
with surgical imaging and registration systems, and computer-implemented
methods for establishing a sterile surgical field and keeping track of instruments
within the field. The Life Sciences Practice also has a depth of knowledge
in novel computer methods for diagnostics, providing treatment regimens,
supplying information to physicians, tracking medications, tracking interactions
between medications, tracking patient response to medications, and a wide
variety of other computer-implemented methods, particularly in relation
to psychiatry and psychiatric compounds. This includes protection of novel
peer-to-peer diagnosis, treatment, and education methods for physicians.
We also have experience protecting implant devices and processes relating
to metal doping techniques.
The Life Sciences Practice has over a decade of experience preparing and
prosecuting patents relating to small molecules that target a number of
diseases. We are involved at every stage of opinion drafting, including
freedom to operate, validity, Hatch-Waxman and infringement opinions. We
assist clients with drafting and negotiating license agreements related
to small molecules, as well as conducting patentability searches and competitive
intelligence searches. Our team has conducted due diligence for Fortune
500® companies and entrepreneurs on multiple transactions including
mergers, acquisitions, collaborations, joint-venture, and initial public
offerings (IPO), among others. In addition, we work with Contract Research
Organizations (CROs) and Contract Manufacturing Organizations (CMOs) that
assist our clients in commercializing their pharmaceutical technologies.
Our attorneys and consultants advise both branded and generics companies
in the regulatory process, assisting with responses to FDA compliance letters,
litigating patent infringement and product liability matters, reviewing
standard operating procedures and quality assurance procedures, analyzing
certified good manufacturing practices (cGMP), and assisting with labeling
issues for products that have reached the market. We also assist clients
with reimbursement issues and Medicare and Medicaid guideline compliance.
The Life Sciences Practice is broadly experienced in both companion animal
and livestock veterinary technologies, including small molecule drugs and
biologics (including vaccines, adjuvants and batch processing), nutritional
supplements and feed, delivery systems such as implantable devices, and
sustained-release formulations. We prepare and prosecute patents in these
and other animal health fields. In addition, we prepare freedom to operate
and other intellectual property opinions, provide patentability and competitive
intelligence information, assist with preparing and negotiating licenses,
conduct due diligence in commercial transactions, and work with regulatory
agencies including representation before the U.S. Food and Drug Administration
(FDA), U.S. Department of Agriculture (USDA), and the U.S. Environmental
Protection Agency (EPA) in order to guide our clients through the commercialization
process.