White & Case
With dual practices in Boston and London, how do you manage cross-border workloads to such a high standard?
As a life sciences practitioner, I routinely develop world-wide patent strategies for clinical candidates and the United States and Europe are the two jurisdictions capturing the largest market share in this space. While working across borders presents unique challenges, understanding the ins and outs of these markets is critical to my job and consistently keeps it interesting. We work on cutting-edge matters and recently I was asked to develop a strategy for filings directed to covid-19 therapeutics. The large volume of data being generated by some of the best minds across the globe in an attempt to combat the virus makes me hopeful. Ongoing efforts such as this inspire me to go above and beyond to provide robust patent protection for my clients.
What are some of the main differences between patent prosecution before the USPTO and the EPO that rights holders need to be aware of?
Following the implementation of the America Invents Act in 2011, many differences between the two jurisdictions have been reconciled; however, some key variations remain. There are fundamental differences in how the two offices approach patent-eligible subject matter such as claims directed to diagnostic methods and computer-implemented inventions. Other key differences include inventorship assessments, the ability to rely on post-filing data, the impact of prosecution history estoppel and the duty of candour. There are also some nuanced differences in approaches to novelty, non-obviousness and sufficiency, in addition to procedural differences between the respective offices.
Once granted, the approach to post-grant proceedings between the two jurisdictions is also very different. One example of this is the patent owner’s ability to provide multiple auxiliary requests in opposition proceedings at the EPO, which is in contrast to the higher thresholds for successfully filing motions to amend at the PTAB.
What emerging trends or technologies are having the biggest influence on patent activity in the life sciences sector?
The use of AI and Big Data analytics are transforming the way that we think about traditional patent strategies. With inventions such as apps that manage diabetes, digital multi-sensor contact lenses that read the glucose levels of tears and digital birth control, there is a greater need for multidisciplinary patent teams to implement a robust patent strategy. The adoption of AI and Big Data technology in the medical sector is calling into question our fundamental understanding of issues such as inventorship, ownership, how to define a person of ordinary skill in the art and what constitutes prior art.
Additionally, we have seen an immense increase in filings related to covid-19 therapeutics over the past few months.
How do you measure the success of a patent portfolio development strategy?
A successful patent strategy is one that is tailored to protect a company’s business needs. One size does not fit all. Early-stage companies need protection that will be attractive to investors, whereas larger companies need enforceable patents that cover their clinical candidates in all relevant jurisdictions. A good strategy for clinical candidates includes obtaining patents that track marketing authorisations and can obtain patent-term extensions where available. It should consider available regulatory authorisations and help to maximise available exclusivities. Ultimately, a key indicator of a robust patent portfolio is whether it accomplishes the company’s underlying business goals: either attracting licensing/investment dollars or withstanding third-party challenges.
How fair is it to say that the United States has become less patent friendly over the years and what could be done to change this opinion?
There has been a lot of ambiguity around patent-subject matter eligibility in the United States over recent years, which has largely been driven by numerous Supreme Court decisions. In 2019 the USPTO released the Revised Patent Subject Matter Eligibility Guidance, which has helped to reduce the number of patent applications being rejected on eligibility grounds. The guidance has also helped to streamline the process for patent examiners, which has helped to make the US market somewhat more attractive for patent owners than it was 18 months ago.
Similarly, PTAB statistics show that post-grant proceedings have not been patent-owner friendly historically. However, with the recent pilot programmes regarding motions to amend, this could also change and this reputation could hopefully be reversed.
Anita Varma is dually qualified to practise before the USPTO and the EPO. Ms Varma provides strategic patent counselling to life sciences companies, guiding them through every stage of a product’s lifecycle. She works with clients to obtain enforceable claims, leads them through post-grant challenges and guides them in financing transactions. Ms Varma helps clients to develop and execute both offensive and defensive patent strategies.
Click here to see her IAM Patent 1000 2020 profile.