Our IP due diligence practice draws on our experience handling a wide range of patent and transactional matters for our clients, and we utilize that experience to the benefit of our clients.
Our work for clients includes:
- Performing due diligence evaluations of patent portfolios and related IP assets in the context of collaborations, licensing agreements, financings and mergers & acquisitions.
- Advising some of the largest pharma and medical device companies in the world on freedom-to-operate issues and strategic patent portfolio development for their commercial products, in the United States and Europe (and beyond).
- Handling due diligence for many transactions on both the investor and target sides, including pre-IPO investments by venture capital groups, pre-acquisition strategic investments by operating medical device companies and pharma-biotech collaborations.
Our diverse experience in patent and transactional matters uniquely positions us to assess strengths and weaknesses of target company IP positions, and translate those analyses into risk management strategies that benefit our clients' business interests. It also allows us to know which IP issues really matter in a deal, helping us focus client resources and energies.
Our patent attorneys also team with our FDA regulatory attorneys to advise on patent life cycle management, orange book listing and delisting matters, and issues relating to the follow-on biologics legislation.
We consider the full range of our IP clients’ needs and regularly provide opinions on matters, including:
- Analysis of patentability
- Freedom-to-operate studies, and non-infringement and validity opinions
- Pre-litigation assessments
- Orange book listing and delisting assessments
- Structuring business and tax aspects of transactions to maximize savings
Our attorneys are skilled at communicating complex ideas to judges, juries and government agencies. Our sophisticated team of patent attorneys works closely with our trial attorneys to develop litigation strategies by:
- Assessing infringement or noninfringement positions
- Assessing validity and enforceability positions
- Reviewing complex file histories and lab notebooks
- Assessing issues such as conception and inventorship
- Developing effective cross-border litigation strategy
When disputes arise, Ropes & Gray attorneys seek to resolve issues efficiently and economically. If litigation becomes necessary, we tap our experience in all aspects of interference practice and appeals, and work with our clients to devise the best overall litigation strategy. Our attorneys handle a variety of contested proceedings, including:
- Inter partes and ex parte re-examination proceedings
- Interference proceedings
- European oppositions, revocation proceedings and other strategies that consider cross-border, post-grant proceedings
- Advising companies regarding the new post-grant review mechanisms that have become, and will become, available as a result of the Leahy-Smith America Invents Act of 2011
Our approach focuses, at every turn, on coordinating strategies in the United States and Europe (and China, when relevant). Our portfolio development work and product clearance, FTO and counseling is all geared to help our clients maximize the value of their IP rights in the United States, Europe and China. We believe this approach is critical to the success of our clients as the IP market becomes increasingly global.
An important development is coming in 2015, with the unification of patent procurement and litigation in Europe under the unitary patent system. Anticipating that development, many of our IP attorneys have become dually qualified to practice before the USPTO and EPO and have several years of experience handling patent matters in both venues.Through that experience, our attorneys have developed a unique perspective on how the two major patent systems differ, and how to handle patent portfolio development and product clearance and FTO work in a way that accounts for those key differences. With regards to patent portfolio development, we have a state-of- the-art process for building international value into the patent portfolio from the outset, so a case is substantively and procedurally better prepared for both the United States and Europe from the initial drafting stages and beyond.
With more than 200 IP attorneys, 40 patent agents and technical advisors, and 34 paralegals, we assist our clients in strategically managing large, multinational patent portfolios. We have more than 150 advanced degrees, including 46 Ph.Ds. in science and engineering from top universities, including MIT, Harvard, Carnegie Mellon, Yale, the California Institute of Technology and the University of Tokyo.
Our experience in portfolio management includes:
- Handling a large, international patent portfolio for a midsized biotechnology company focusing on antibody therapeutics. The portfolio includes over 50 families of applications, including patents related to three products currently under development.
- Assisting a private, venture-backed biotechnology company in developing an international patent portfolio with broad claims to protein engineering technology. This portfolio was a key asset in the company's recent $400 million acquisition by a pharmaceutical company.
- For more than a decade, working with a publicly traded biotechnology company (later acquired by a larger company) to develop and implement a strategy for building a large, worldwide patent portfolio covering the company's core technology platform for producing antibody therapeutics, the antibodies themselves (a number of which are in clinical trials) and improvements to, and uses of, the antibodies for therapy.
- For more than 25 years, acting for one of the largest and oldest biopharmaceutical companies, assisting the company's scientists and business managers in developing an IP strategy, and obtaining patents protecting the company's products, including three that each have worldwide sales of over $1 billion.
- Acting for the biotech division of a large orthopedic company for more than 15 years, including assisting the company in patenting the results of its research in the area of bone growth – patents that now protect the company's first biotech product.
- For more than 15 years, acting for a major rational drug design company, having designed, drafted, prosecuted and defended its patent portfolio. Several of these small molecule patents are directed to aspects of the company's commercial products and late-stage clinical candidates.
- Managing a patent portfolio relating to the use of xenotypic antibodies for the treatment of cancer for a biotechnology company, actively pursing patent protection on the core technology and five different antibody products currently under development. The portfolio consists of approximately 20 separate patent families in the United States and more than 100 international patent applications.
- Assuming the prosecution of a university-owned patent portfolio mired in fruitless prosecution. We identified the commercially relevant aspects of the patent filings and obtained issued patents with valuable claims. The portfolio was sublicensed to a major pharmaceutical company for substantial monetary value.
Third-Party Analyses and Opinions of Counsel
Our experience in patentability, freedom-to-operate, invalidity and noninfringement analyses includes:
- Conducting due diligence for a pharmaceutical company on patents held by a European target company and in structuring a Supply and Manufacturing Agreement based on the IP evaluation. The patent portfolio covered a new formulation of an existing drug, and the project involved conducting an extensive freedom-to-operate analysis that included a family of third-party patents asserted against the target company in various European jurisdictions. We also advised the client on potential litigation risks in the United States.
- For the venture capital wing of a major pharmaceutical company, performing a patentability and freedom to operate assessment of an investment target with five products in the pipeline. We identified critical but correctable errors in the patent portfolio, and the client made an investment of under $10 million. Less than one year later, the investment target received over $90 million for the rights to license one of the five products in Japan.
- Advising a client, in the context of a partnering negotiation, regarding the proper inventorship of a key patent application. The disclosed inventions were made in a collaboration with a third party that performed high throughput screening to identify candidate therapeutics. Our analysis demonstrated that our client's employee was the sole inventor and provided clear title to our client, thus facilitating the transaction.
- Conducting a thorough freedom to operate assessment in connection with final FDA approval and expected rollout of a new therapeutic antibody for a publicly traded biotech company. We evaluated third-party patents and assisted the client in restructuring its set of licenses to minimize royalty payments.
- Auditing a pharmaceutical company’s patent portfolios covering a therapeutic product in clinical trials. The company was preparing for product launch and asked us to analyze its portfolio from the perspective of an ANDA filer to discover and address any issues that could render the portfolio vulnerable to attack.
- Representing the biologics arm of a large medical device company in the assessment and possible acquisition of a privately held German company. The patents and patent applications were directed to biologics that were useful in an implantable medical device. We conducted a patentability analysis to evaluate the strength and likely enforceability of the issued patents. We also conducted a complex freedom to operate analysis to identify potential barriers that might impede the ultimate development of products based on this interdisciplinary technology.
- Conducting an extensive freedom-to-operate analysis for a large chemical company wishing to enter the biotechnology sector through the use of platform research tools in the area of food safety. Our analysis included clearance of the integrated system: the instrumentation, the reagents, and various testing and detection methods. Our analysis enabled the client to design around potentially blocking patents.
- Conducting extensive analyses of the patent landscape related to commercializing recombinant and humanized antibody products. In particular, we have advised clients on patents of broad applicability in the antibody field, such as those issued to Genentech, PDL Biopharma and the Medical Research Council.