LSIPR 50 2018: The promise of IP

Although she has focused exclusively on patent litigation for the past ten years, Manisha Desai stays in touch with patent procurement through remaining active in various IP policy matters, as LSIPR reports.

“The best parts of the job are also some of the greatest challenges,” Desai explains. “I love working with our affiliates and local counsel, especially in the emerging markets, as I can learn so much from them about local laws and procedures,” she adds, saying that she has managed patent litigation in Latin America, Russia, the Middle East, and South Asia, as well as across the US.

However, in emerging markets, expectations have to be managed when engaging in litigation in a country with a less-developed IP system.

It’s a balancing act. “It’s important to me that our affiliates know we care about how an outcome affects them, but we also have a responsibility to help them understand how our decisions in their country can impact our patent portfolio more broadly,” she says.

Complementing her work is her scientific background: Desai has a PhD in pharmacology and spent a decade conducting neuroscientific research before pursuing a law degree.

“Working on IP policy has been a great way for me to stay engaged in the research,” she explains. With her scientific understanding, Desai is well placed to liaise with policymakers on agreements which may affect the way research is conducted and protected.

Desai is never too far away from the research at Lilly. “Our patent attorneys get involved very early during the basic research process and stay involved through launch of a product,” she says. As with any biopharmaceutical company, developing a new product can be a lengthy project, spanning ten to 15 years.

“Discovering and developing medicines is a risky endeavour, but we should all be hoping for its success, as we need new medicines to combat existing and evolving diseases,” she adds.

A global backlash

Desai is particularly interested in the impact of the TRIPS Agreement in her native country, India.

“When I started in the patent division, there was a lot of hope and expectation about the certainty that the TRIPS Agreement would bring,” she explains. TRIPS promised that IP rights could be secured in countries that had not previously allowed pharmaceuticals to be patented.

Desai was not surprised that there was resistance to the implementation of TRIPS-compliant laws in countries such as India. “Their domestic generic industry thrived in the absence of pharmaceutical patents,” she explains, but what has surprised her is the global backlash against IP, particularly in the area of patents.

“The backlash against IP is surprising because TRIPS member countries need time to give the implementation of IP laws a chance to succeed,” Desai says.

She adds that the backlash is evident via efforts to make patents harder to obtain, harder to enforce, and harder to maintain, but the promise of agreements such as TRIPS “can be achieved only if member countries respect and abide by their agreed obligations”.

“A combination of factors contribute to the negative perception of IP,” she explains. In the context of life sciences, where a particular patent could be vital in protecting a new medicine, patents are viewed as the reason for a lack of access to medicines.

Despite this, Desai retains her faith in multilateralism and believes in the power of promoting “the promise of IP as an important tool to encourage innovation”.

She says TRIPS has created baseline standards for protecting all forms of IP and “all stand to benefit if the brightest, most talented people—in every country—are motivated to develop innovations with the knowledge that their efforts will be recognised and rewarded”.

Adverse impacts

As well as remaining up to date on relevant policies and agreements, Desai has kept a close eye on decisions which could adversely impact the status of patent eligibility and protection.

Speaking at the AIPPI World Congress in 2016 she described the US Supreme Court decision in AMP v Myriad Genetics, which assessed the patentability of gene-based sequencing, as “troubling”. The court held that isolating genes found in nature is not inventive and therefore cannot be patented.

She explains: “I expressed concern about the lack of understanding of the technology and the way questions of patent matter eligibility were being decided by courts more generally.

“With due respect to the important role of our courts, I was concerned that patent cases were being decided on the threshold issue of patent eligibility (section 101 in US patent law), rather than the more fact-intensive issues of novelty, inventive step, enablement, and written description.”

As the lower courts remain bound by the decision in this case—as well as others such as Bilski, Alice, and Mayo—questions of patent eligibility cannot change unless the Supreme Court elects to revisit the issue, or section 101 faces legislative reform.

“Without such an intervention, those engaged in biopharmaceutical R&D will continue to face uncertainty with regard to the ability to protect certain innovations, such as diagnostics and methods of treatment,” according to Desai.

She feels that there is “an increasing lack of clarity on the scope of protection afforded to biopharmaceutical innovations”. The restrictive approach to patent eligibility and the overly-expansive treatment of patent claims, such as when patenting antibodies, only add to the uncertainty.

“The anti-IP stance taken by some governments and non-governmental organisations in their efforts to address concerns over access to medicines is also likely to spread well beyond the access-to-medicines debate,” Desai says.

The ambiguity surrounding the scope of protection afforded to innovation is, arguably, felt most acutely by those in the life sciences, but Desai believes that, in the long term, “negative consequences on R&D may well extend far beyond the sector”.

Questions around access, innovation, and pricing stray well beyond circumstances which affect just the pharmaceutical industries. Other innovative industries, such as renewable energy and green technologies, are impacted by the broad use of compulsory licences, for example.

In addition to her contributions in the legal and policy sphere, Desai has made appearances to represent her industry at the Convention on Biological Diversity and the World Intellectual Property Organization.

For Desai, sharing her knowledge and experience to ensure best practice across an industry facing uncertainty and anti-IP sentiment is key to promoting the promise of IP.