In Brief: A Digest of Life Sciences Projects

Client Success

Assisted with the global commercialization of a patent portfolio for a German innovator company in the technology industry, including resolving potential infringements with new licenses.
Negotiated licenses for pharmaceutical companies for both brand and generics in matters involving abbreviated new drug applications (ANDA) under the Hatch-Waxman Act.
Negotiated numerous pharmaceutical licenses and settlements, including the negotiation of supply arrangements for authorized generics and agreements for early market entry in matters involving abbreviated new drug applications (ANDA) under the Hatch-Waxman Act.
Conducted due diligence and provided counseling regarding business strategies to a pharmaceutical manufacturer regarding the acquisition of patent portfolios covering various types of pharmaceuticals.
Negotiated a license and supply agreement for human embryonic stem cells for a manufacturer of high-purity human cells for therapeutic development and clinical application.
Assisted a client with administering a semiconductor technology licensing program for a Fortune 100 company.
Negotiated licenses to use trademarks in marketing materials along with the novel compound license.
Negotiated licenses for trade secrets of a dietary supplement company to a larger supplement company, including subsequent intellectual property improvements and new inventions.
Served as outside licensing counsel to a large university for all of its drug biologic and related research. As such, negotiated numerous successful licenses with provisions sensitive to the type of technology being licensed as well as the market value of the technology.
Negotiation of FDA compliance protocols and procedures for stem-cell-related development and storage, including Freedom-to-Operate (FTO) opinions and Infringement/Non-Infringement Opinions concerning stem cell products and protocols.
Conducted due diligence and provided counseling on business strategies to a pharmaceutical manufacturer regarding the acquisition of pharmaceutical patent portfolios.
Negotiated a license and supply agreement for human embryonic stem cells for a manufacturer of high-purity human cells for therapeutic development and clinical application.
Represented an international healthcare equipment company in a patent infringement case in the U.S. District Court for the Central District of Colorado, in related proceedings before the International Trade Commission and in review proceedings before the USPTO regarding a patent directed to HDL cholesterol tests and associated strips.
Advised a manufacture of imaging systems in a patent infringement suit in the U.S. District Court for New Jersey on patents directed to panoramic dental X-ray technology. Negotiated world-wide resolution of dispute, including infringement claims filed in Germany and South Korea.
Represented large medical device manufacturer in a patent infringement suit involving endovascular stent technology and obtained favorable settlement just prior to trial.
Represented generic pharmaceutical manufacturer in Hatch-Waxman patent litigation in a first-to-file (FTF) opportunity relating to a methylphenidate transdermal patch. Obtained partial summary judgment rulings of noninfringement and invalidity due to inadequate written description.
Represented large medical device manufacturer in response to a motion for preliminary injunction, where the client was alleged to have infringed patents relating to esophageal ligators. After a truncated discovery period and a four-day preliminary injunction hearing, the adverse party’s motion was denied.
Advised and conducted intellectual due diligence for a pharmaceutical company regarding potential investments and asset purchases.
Prepared and filed three re-examination petitions on behalf of IntroMedic, one re-examination petition involving ongoing participation by the client and the Husch Blackwell team, and two ex parte re-examination petitions. First office actions issued by the USPTO in all three re-examination proceedings canceled a majority of the claims associated with these patents.
Successfully challenged four patents claiming a composition and method of using a synthetic active folic acid metabolite.
Defended an API supplier to a generic pharmaceutical company and forced the brand drug company to withdraw all patent infringement claims against our client, resulting in a final termination of the ITC investigation. Later, challenged the validity of four of those same patents in review proceedings The USPTO held all of the challenged claims were invalid or canceled.
Obtained FDA 510(k) clearance for nonvascular interventional stenting products for Merit Medical Systems Inc.
Implemented strategy with FDA that resulted in the lifting of a warning letter, allowing a leading medical technology manufacturer to go to market.
Represented numerous startups in successfully navigating legal issues through various funding and growth stages across a number of technology industries, including medical devices, medical records, software and business services.
Represented Anchen Pharmaceuticals in a patent infringement case alleging its generic version of Biovail’s Wellbutrin XL infringed several patents. The court granted Anchen’s motion for summary judgment, finding that Anchen’s product did not infringe any Biovail patent. Biovail also made two attempts to seek an injunction against the FDA to prevent approval of Anchen’s ANDA product, both of which were denied.
Negotiated FDA compliance protocols and procedures for stem-cell-related development and storage, including freedom-to-operate opinions and infringement/noninfringement opinions on stem cell products and protocols.
Obtained FDA 510(k) clearance for adult stem cell therapeutic methods, stem cell products and processes for producing stem cell products.
Achieved favorable results in arguing an oral and written appeal before the Patent Trial and Appeal Board (PTAB) regarding an anti-cancer pharmaceutical agent.
Advised numerous pharmaceutical clients on the development and implementation of FDA-mandated Single Shared Risk Evaluation and Mitigation Strategies (REMS) programs.
Served as counsel for numerous healthcare systems, ambulatory surgery centers (ASCs), large physician groups and individual physicians on a wide variety of physician contracting matters including PSA’s, MSA’s, employment agreements, medical director agreements, contract pharmacy services, clinic-use, equipment and space leases, collaborative practice agreements and other types of contracts.
Assisted durable medical equipment (DME) facilities, ambulatory surgery centers, laboratories, independent diagnostic and testing facilities (IDTFs) and hospitals on both their state and Medicare licensing and certification matters.
Assisted a renal dialysis provider with federal and state licensure requirements related to providing dialysis services in post-acute care settings.
Support a variety of national and state associations to advocate favorable legislative and regulatory positions for clients and their provider industries.
Negotiated and developed numerous ambulatory surgery centers throughout the country including a chain of hospital/physician ASCs and other ancillary provider facilities.
Represented a healthcare products company in a $100 million expansion of its facilities. Facilitated obtaining personal and real property tax and sales tax exemptions for the expansion. Worked with the local economic council on the tax increment financing and corresponding $88 million bond closing.
Provide outside counsel for numerous ancillary healthcare providers, independent diagnostic and testing facilities, rehabilitation providers, compound pharmacies and laboratories both anatomical and clinical.
Counseled service providers on numerous regulatory issues, patient care and other federal and state laws and regulations, and provided guidance from a variety of government provider manuals as well as requirements of third party payors and Medicare Administrative Contractors (MACs).
Obtained patents for new therapeutics and therapeutic methods.
Successfully challenged four patents claiming a composition and method of using a synthetic active folic acid metabolite.
Prepared and filed three re-examination petitions on behalf of IntroMedic, one inter partes re-examination petition involving ongoing participation by the client and the Husch Blackwell team, and two ex parte re-examination petitions. These petitions were aimed at invalidating claims associated with three U.S. patents. The team has been successful in getting all three patent re-examination petitions granted and first office actions issued by the U.S. Patent and Trademark Office in all three re-examination proceedings have canceled a majority of the claims associated with these patents.
Developed and implemented the quality management system for Mobilizer, which designs, manufactures and distributes ambulation products.
Obtained Food and Drug Administration (FDA) 510(k) clearance for certain nonvascular interventional stenting products in the portfolio of the Endotek Division of Merit Medical Systems Inc.
Implemented strategy with FDA that resulted in the lifting of a warning letter, allowing a leading medical-technology manufacturer to get new products to market.
Defended an API supplier to a generic pharmaceutical company and forced the brand drug company to withdraw all patent infringement claims against our client resulting in a final termination of the ITC investigation. Merck CIE, et al. v. Gnosis S.p.A., et al. (ITC) and (E.D.Tex.) The patents generally claimed a method of using a synthetically produced active metabolite of folic acid to treat folate deficiency and other conditions associated therewith. Later, we challenged the validity of four of those same patents in inter partes review proceedings before the Patent Trial and Appeal Board. In its final written decisions, the Patent Office agreed with our client and held that all 58 out of the 58 challenged claims were invalid or cancelled.
Represent high-technology and life science companies in intellectual property matters, including licensing agreements and infringement actions.
Represented an I 500 plant biotechnology company in a declaratory judgment action involving patents covering transgenic seed technology where, following a three-week trial, the jury returned a verdict in favor of client and the district court judge entered a finding of inequitable conduct and awarded attorneys’ fees and costs.
Advise generic drug makers on patent invalidity and noninfringement to facilitate generic market entry.