IP Matters, Partnering & Commercialisation

Ensuring clear IP ownership and partnership parameters are vital to building value in the business and avoiding potential litigation in the future.

Our experienced team can work with you on innovation and know-how management, protection of research results, leading edge technologies, transfer of intellectual property, intellectual property due diligence, patent & trademark litigation, partner evaluation, joint ventures and co-operations, securing long-term interests, license and know-how transfer agreements, clinical trial agreements, manufacturing and commercial agreements.

Partnering, Licensing and Commercialisation
Excellent ideas in the life sciences sector are created by innovative minds in both academic and industrial environments all around the world. Identifying and evaluating opportunities for developing and marketing new products through strategic alliances or licensing is an integral part of the Life Sciences business. Our attorneys assist clients in all aspects relating to licensing including how to resolve intellectual property risks such as availability, exclusivity, enforceability and unwanted obligations. We advise across a full range of issues that affect the process of contract formation including due diligence, IP, tax and accounting matters. We act for a wide range of life sciences companies in the negotiation and settlement of patent and know-how licences, confidentiality, subcontracting, agency, joint venture and R&D agreements, as well as other types of commercial agreements.

Our services include:
 
Partner Evaluation. We assist in structuring an evaluation process, due diligence and drafting the appropriate legal documents to effectively protect your company’s interests from the very beginning of a potential corporate relationship.

Joint ventures and co-operations. Due to the particularities of the Swiss statutory law, joint venture arrangements and business co-operations need to be carefully considered and executed. VISCHER's experts understand that arrangements need to be tailor-made in order to protect your company's interest while avoiding legal pitfalls.
 
Securing Long-Term Interests. We support your company in establishing state-of-the-art contractual frameworks that reflect not only your company's temporary interests but also take account of long-term interests and unforeseen changes.
 
License and Know-How Transfer Agreements. We draft and negotiate licence and know-how transfer agreements. Our attorneys are familiar with the peculiarities of tech transfer units and research institutions (IP ownership and approvals).

Clinical Trial Agreements. We advise companies in compliance issues regarding clinical trials and other research projects involving humans and draft clinical trial agreements.

Manufacturing Agreements. We draft and negotiate manufacturing agreements, taking into account the special allocation of responsibilities and IP matters.

Commercial Agreements
We draft and negotiate a wide array of commercial agreements that are specific to the industry, taking into account the particularities of the life sciences sector as well as IP, tax and accounting issues. Examples include contract research, contract manufacturing, clinical trial, supply, logistics, or distribution agreements.

Selected recent transactions include:

• We advise AC Immune SA (NASDAQ: ACIU) in a license and collaboration agreement with Eli Lilly and Company (NYSE:LLY) as to Swiss law matters along Davis Polk & Wardwell LLP advising on US law matters. The collaboration aims to research and develop tau aggregation inhibitor small molecules for the potential treatment of Alzheimer’s disease (AD) and other neurodegenerative diseases. Under the terms of the agreement, AC Immune will receive an upfront payment of CHF 80 million as well as USD 50 million in exchange for a note, convertible to equity at a premium. AC Immune is also eligible to receive CHF 60 million in potential near-term development milestones, as well as other potential development, regulatory and commercial milestones up to approximately CHF1.7 billion, and tiered royalty payments in the low double digits.
• We advise Oculis SA, a clinical-stage biopharmaceutical company developing next-generation topical ophthalmic treatments in Lausanne, in the license agreement for a novel topical anti-TNF alpha antibody from Novartis.
• We advised Polyphor in the collaboration and CHF 6.8 million investment by Novo REPAIR Impact Fund relating to the OMPTA program. The novel Polyphor OMPTA antibiotics target the highest priority Gram-negative ESKAPE pathogens, (Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter spp) which are the leading cause of severe and often deadly infections throughout the world, such as bloodstream infections and pneumonia.
• We advised Polyphor AG in its exclusive global license agreement with Santhera Pharmaceuticals to further develop and commercialize the inhaled neutrophil elastase inhibitor, POL6014, in Cystic Fibrosis (CF) and other neutrophilic lung diseases. Under the terms of the agreement, Polyphor will receive an upfront payment of CHF 6.5 million paid in the form of Santhera shares and could receive up to an additional CHF 121 million in potential development, regulatory and sales milestones for the initial indication, as well as tiered double-digit royalties on sales. Santhera will have the exclusive worldwide rights to develop and commercialize POL6014, and assume full responsibility for its development within agreed timelines.
• We advised VAXIMM AG, which entered into development and commercialization collaboration agreement with and received an equity investment by China Medical System Holdings Limited (CMS) (HKSE:0867). VAXIMM is a privately held biotech company that is developing oral T-cell immunotherapies for patients suffering from cancer. CMS is a well-established, innovation-driven specialty pharma with a focus on sales and marketing in China.
• We advised ABBA Therapeutics AG, a Swiss biotechnology company developing innovative immuno-oncology therapies under its licence from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND). Under the licence, ABBA Therapeutics AG will be able to use the OmniRat, OmniMouse and OmniFlic platforms to generate fully human mono- and bispecific antibodies. 
• We advised AC Immune SA in a worldwide exclusive license agreement and research collaboration with Janssen Pharmaceuticals (Johnson & Johnson (NYSE: JNJ)) to develop and commercialise therapeutic anti-Tau vaccines for the treatment of Alzheimer's disease and potentially other tauopathies, including the lead therapeutic vaccine for an upfront payment and milestone payments potentially totalling up to USD 509 million. 
• Following the acquisition of GlycoVaxyn by GSK, GSK commissioned the management team to create a new company, LimmaTech Biologics AG, in Schlieren near Zurich, which acquired GlycoVaxyn's operational research business. LimmaTech Biologics is not a GSK owned company. GSK and LimmaTech Biologics have signed a research agreement with a minimum term of five years to allow LimmaTech Biologics to develop novel bioconjugate antigen-based vaccines exclusively for GSK. VISCHER assisted LimmaTech Biologics starting at foundation and then in the collaboration agreement with GSK. 
• VISCHER assists CRISPR Therapeutics in all Swiss law matters regarding a joint venture to discover, develop and commercialize new breakthrough therapeutics to cure blood disorders, blindness and congenital heart disease. Bayer will provide a minimum of USD 300 million in R&D investments to the JV over the next five years. In addition, Bayer will acquire a minority stake in CRISPR Therapeutics for USD 35 million in cash. 
• We advised CRISPR Therapeutics in all Swiss law matters of the strategic research collaboration concluded with Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) focused on the use of CRISPR's gene editing technology, known as CRISPR-Cas9, to discover and develop potential new treatments aimed at the underlying genetic causes of human disease, to be used in the field of cystic fibrosis and sickle cell disease. As part of the collaboration, Vertex made an up-front commitment of USD 105 million to CRISPR, including USD 75 million in cash and a USD 30 million equity investment in addition to downstream profit sharing and royalty payments. 
• We represented a pharmaceutical company in the field of various therapeutical applications for steroids, to implement a worldwide licensing and IP strategy (deal volume over CHF 300 million). 
• We represent a number of venture financed Swiss start-up companies including AC Immune, GlycoVaxyn, Pantec Biosolutions and Nouscom in their numerous collaborations with industry (in particular licensing, clinical trials and manufacturing) and academia. 
• We advised a listed Swiss company in its clinical trial agreements ranging from early phase I to phase III trials. 
• We have been advising a biopharmaceutical company in its clinical trial agreements for several drug candidates including securing support from listed pharma companies, CROs, central labs, and external scientific advisors. 
• We advised a major international pharma company in setting up its phase III clinical trial for a vaccine candidate with Swiss investigators. 
• We advised an international CRO in establishing co-marketing agreements with major pharmaceutical companies. 
• We advised a specialist cell media manufacturer in drafting and negotiating a distribution agreement for research reagents. 
• We advised a specialty pharmaceutical company in modifying and terminating supply and distribution agreements following dissatisfying results of clinical studies. 
• We advised a US life sciences technology company in setting up its product distribution and services agreements for Europe. 

Innovation and Know-How Management
The proper protection of inventions and innovative concepts generated by companies in the life sciences sector is of utmost importance for their sustained success. Our specialized lawyers keep a close eye on the legislation and case law regarding life sciences-related intellectual property, including the ongoing amendment concerning biotech inventions in the Swiss patent act.

Protection of Research Results. Our attorneys understand that patents are an important business tool and form part of an overall business strategy. We work with patent lawyers specialised in various technical areas to ensure optimum patent coverage and defence that are tailored to the specific needs of our clients. We develop international protection strategies for patents, trademarks and domain names.

Leading Edge Technologies. We are familiar with transactions involving checkpoint inhibitors, vaccines, gene editing, small molecules, diagnostics, antibodies, genomics, proteomics, RNAi, drug delivery technologies, immunohematology, and other platform technologies.

Transfer of Intellectual Property. We structure, negotiate and draft transfer and development agreements for Life Sciences companies.

Intellectual Property Due Diligence. VISCHER's experts conduct due diligence reviews of intellectual property rights typically in the framework of mergers or acquisitions. We analyse the legal status of these rights and identify the legal issues which your company will presumably wish to deal with when determining the conditions of the envisaged transaction.

Patent & Trademark Litigation. Working with patent attorneys locally and overseas, we represent clients in patent litigation. We prosecute and defend patent infringement actions and related claims for revocation in the Swiss courts and in multi-national patent disputes. We also assist in mediation proceedings. We further advise clients on trademark matters and have considerable experience advising clients on filings and related opposition and revocation actions. We evaluate and help resolve technology ownership disputes.

Recent cases include:

• We advised a Swiss biopharmaceutical company in establishing a collaboration with a German university regarding the development and pre-clinical evaluation of human therapeutic antibodies. 
• We advised a Swiss biopharmaceutical company in acquiring and sublicensing rights to proprietary mouse models for development of therapeutics for central nervous systems diseases. 
• We advised a Swiss company in establishing and implementing a worldwide strategy for the distribution and marketing of its innovative blood sugar meter. 
• We represent a number of firms as legal counsel or act as arbitrator in various disputes concerning the licensing and co-development of pharmaceuticals. 
• We advised a manufacturer of a proprietary cell culture growth medium in negotiating a supply agreement with a global specialty pharmaceutical company. 
• We advised an international medical device company in negotiating a supply agreement for infusion sets. 
• We advised a medical device company in entering into a supply agreement regarding neuroprosthetic modules. 
• We advised a Swiss biopharmaceutical company in establishing contractual relationships with CMOs for the development and manufacture of several drug candidates in the field of central nervous systems diseases. 
• We advised a company developing orphan drugs in setting up a development and manufacturing agreement with an international CMO specializing in biopharmaceuticals. 
• We advised a major Medtech company on the termination of its manufacturing agreement with a Polish manufacturer and in negotiating a new manufacturing agreement with a manufacturer in Central Europe.