Patent Prosecution and Counseling
Representative engagements include:
- patent counseling and prosecution involving a wide range of pharmaceuticals, including oligoribonucleotide-based therapeutics, various ophthalmic therapeutics and diagnostics, small molecule and enzyme-based therapeutics for restoring neurological function in patients with spinal cord injuries, multiple sclerosis and other neurological disorders, small molecule therapeutics for amyotrophic lateral sclerosis and other neurodegenerative diseases, small molecule oncology products, peptide-based therapeutics for the treatment of diabetes, peptide-based therapeutics for pregnancy and immune-related disorders, therapeutics for neonatal and pediatric patients; protein-based therapies, nucleotide technologies and a wide array of other therapies
- patent counseling and prosecution involving medical devices and technologies, including catheters, pacemakers and pacemaker leads, stents, external bone fixators, portable oxygen delivery devices, surgical device sterilization systems, robotics for surgical applications, laser systems for removal of tissue, MRI systems, bone cutting tools, hyperthermic perfusion devices, compression therapy products, spine products; CMF products; trauma products, diagnostic imaging technologies, inhalation devices, intraocular aqueous shunts, external blood flow boots, tracheostomy devices and a host of others
- counseling pharmaceutical companies on unique patent issues relating to drug development, including Orange Book listing, label claims, patent term restoration and extension, and subtle issues of written description, enablement, genus and species issues, and anticipation and obviousness in the “unpredictable arts,” negotiating and preparing technology-related agreements, including material transfer, pilot study, sponsored or collaborative research, option, license, supply or asset purchase agreements
- advising on the interplay of FDA and patent law on cosmetic, pharmaceutical, nutraceutical and medical device products
- managing diverse patent portfolios and invention disclosure programs to document and protect inventions through patent, trade secret and copyright laws
- conducting IP due diligence on specialty pharmaceutical and biotechnology companies on behalf of big pharma health care venture capital funds, venture capital firms and investment funds
- conducting internal IP due diligence reviews and audits on behalf of pharmaceutical, biopharmaceutical and medical device companies in preparation for partnering, financing and public offerings.
Representative engagements include:
- lead litigation counsel for a patentee in pharmaceutical patent litigations, responsible for coordinating responses to ANDA certification letters; drafting responsive pleadings and motions; conducting fact discovery in the United States, Europe, Asia and Australia; preparing expert reports; conducting Markman hearings and trials; and preparing appellate papers
- representation of an international pharmaceutical company in ANDA patent litigations over drug products.
- representation of a medical device company in patent litigations relating to dental implants
- represented Eli Lilly & Co. in a declaratory judgment matter relating to pharmaceutical patent formulation and method of use of fluoxetine (Prozac®) and successfully obtained favorable settlement
- represented an analytical instrument manufacturer in a patent infringement matter; resolved case prior to Markman hearing
- obtained a favorable jury verdict in a patent infringement matter on behalf of a medical device manufacturer enforcing its patents in a case involving surgical methods
- prevailed in an interference proceeding and obtained a precedential affirmance from the Federal Circuit for a biotechnology company’s patent
- successfully obtained a remand from the U.S. Court of Appeals for the Federal Circuit to the USPTO Board of Patent Appeals and Interferences for further proceedings to consider the separate patentability of protein and DNA
- represented Eli Lilly in pharmaceutical patent infringement action relating to a generic manufacturer’s filing of an ANDA to manufacture a generic version of a Lilly product
- successfully negotiated a license and settlement of a patent infringement case involving composition of cream for topical application of medication under terms favorable to our client during the initial pleading stage of the case
- secured a victory for Siemens Healthcare Diagnostics, Inc. when a federal court ruled that the Patent Trial and Appeal Board had erred in awarding a patent to Enzo Life Sciences, Inc., enabling Siemens to protect its own patent for HIV test technology
- participation in numerous U.S. patent reexamination proceedings and European patent oppositions on behalf of pharmaceutical and medical device clients
- obtained summary judgment of invalidity for a pharmaceutical company accused of patent infringement
- representing a research institution in international arbitration over ownership and licensing rights to patents involving semiconductor technology
- helped mediate a settlement and negotiated favorable license agreements to end three patent infringement cases in three countries, involving worldwide assertion of a pioneering patent in the field of biometric iris authentication; as a result of the settlement the client was able to successfully prevent and delay several would-be competitors from entering into this field
- obtaining early and favorable resolution to patent infringement matter on behalf of medical device manufacturer in case involving surgical method patents owned by a university
- representing respondent in Section 337 investigation before the ITC involving laser ablation technology; investigation terminated upon complainant’s withdrawal of claims.
Transactional Due Diligence and Licensing
Our lawyers regularly perform due diligence before an acquisition, merger or prior to an investment in which intellectual property may be assigned or licensed. Thorough due diligence can minimize our clients’ exposure to the many problems and pitfalls that can arise. We perform a structured, systematic research effort to accumulate the facts necessary to make an informed decision, thereby increasing the chances of the transaction’s success.
Our IP due diligence is more than creating a list of IP assets and confirming ownership. Our IP due diligence involves a thorough and substantive evaluation of the value of the IP assets by analyzing the ownership of the IP assets, assessing any potential limitations on the use of the IP assets, and evaluating the patentability of the IP. In addition, our attorneys conduct product candidate-specific analysis during IP due diligence to determine the potential for hurdles to commercialization of such a product candidate, determine its competitive landscape, and analyze the scope and breadth of its market exclusivity, including protection afforded by any applicable patents and applications and regulatory exclusivities. However, our due diligence does not often end here; indeed Pepper’s approach to IP due diligence also includes identifying and analyzing means to eliminate or mitigate the risks in order for our clients to fully realize or capture the value of the assets.
Pepper Hamilton’s approach to IP due diligence is comprehensive, yet pragmatic. We tailor the due diligence to the specific needs of the client, which are often principally driven by the type, size and subject matter of the transaction. We have the unique capability and capacity to tailor and focus the IP due diligence to meet both the needs of the life science client and the diligence itself, due to our breadth of experience and expertise across all areas of Pepper’s practice.
We are also able to draw upon Pepper’s full-service law firm capabilities to supplement our team of IP attorneys to perform additional analysis, when required by the particular diligence project.
Our comprehensive and sound approach to due diligence is a direct result of our IP attorneys’ strength and experience in areas such as intellectual property prosecution, litigation and strategic counseling, business counseling and transactional assistance, and technology transfer and licensing.
We represent universities and research institutions that develop and license technology to the pharmaceutical and medical device industries, including sponsored research agreements and licensing involving equity components. We also represent start-up companies who develop and commercialize pharmaceutical and device technologies. We frequently help such clients obtain debt or equity financing, including mezzanine and venture capital financing, and a registered offering of securities. We also represent venture capital funds that target technology-based companies and large corporations in their cooperative research and licensing transactions with start-up companies and research institutions, including government-funded laboratories and the National Institutes of Health.
Representative engagements include:
- represented Axovant Sciences, a subsidiary of Roivant Sciences, in an intellectual property due diligence analysis of the patent portfolio covering GlaxoSmithKline’s RVT-101, an Alzheimer’s drug that GSK had abandoned. Following the completion of that due diligence analysis, Axovant acquired GSK’s portfolio and, with RVT-101 as its core asset, Axovant set off the “biggest biotech IPO in history” (at that time), with Axovant valued at approximately $2.2 billion. Pepper continues to represent Axovant in intellectual property matters.
- represented Aduro Biotech in developing a biologic exclusivity strategy for a Listeria-based vaccine for cancer therapy (LADD) before Aduro had acquired the patent rights to the technology. To assist Aduro in developing this strategy, Pepper helped outline a commercial development strategy to complement the patent portfolio and focusing on the BPCI Act. The combination of Pepper’s legal and scientific acumen and Aduro's knowledge of commercial development prospects allowed Aduro to obtain the initial financing needed to develop its program and acquire the patent portfolio, which jumpstarted Aduro’s LADD program. Pepper has been with Aduro from idea to IPO, and has collaborated with other outside counsel to ensure a carefully crafted intellectual property and exclusivity strategy. Aduro raised $119 million in an IPO that valued the company at more than $2 billion to support the continued development of its cancer immunotherapies.
represented Recro Pharma, Inc. in all aspects of its acquisition of assets from Alkermes plc including worldwide rights to IV/IM meloxicam (long-acting COX-2 NSAID for moderate to severe acute pain). The transaction was transformative for Recro Pharma, as it brought together two complementary therapies for treating moderate to severe acute pain, IV meloxicam and Recro’s lead product Dex-IN, as well as a commercial manufacturing infrastructure. The Pepper team performed due diligence on several patent and trademark families, three paragraph IV litigations, and an interference, as well as advised on all acquisition documents regarding the asset purchase.
on behalf of a biopharmaceutical company in the molecular imaging field, navigated through the IP due diligence process that led to an acquisition of the company by a global pharmaceutical company worth up to $800 million
counseled a biotechnology company in a coordinated international licensing and development program, including (1) the licensing of patents and trade secrets from multiple U.S. and foreign patent holders, (2) the negotiation and documentation of research and development agreements with multiple U.S. and foreign research institutions and (3) the negotiation and documentation of debt and equity financing to fund the research and development program
represented a pharmaceutical company in negotiations with a publicly traded biotechnology company to acquire the rights to various potential cancer therapies; represented its parent company in negotiations to create a corporate partnering relationship to support the development of a promising cancer therapy and to distribute the resulting products to the world market
assisted the developer of a new drug delivery system in negotiating a license agreement with a major pharmaceutical company
counseled an international pharmaceutical company in its acquisition of and license to certain antibodies, intellectual property rights and other related assets
represented a privately held biotechnology company in the acquisition of a publicly traded biotechnology company
advised a U.S. subsidiary of a German pharmaceutical company in a series of acquisitions of products from other pharmaceutical companies.