LSIPR 50 2018: Personalised medicine: the way forward

Being part of a team that “discovers, develops, and delivers” transformational medicine is one of the reasons that Paul Golian’s job at Bristol-Myers Squibb (BMS) is so rewarding. Another is meeting patients that have benefited from the drugs he has worked on, something that makes him particularly proud.

As vice president and assistant counsel of IP at BMS, New-York based Golian plays a pivotal role in protecting the company’s new therapies.

“My team and I are laser-focused on protecting BMS’s innovations,” he tells LSIPR. This encompasses patent procurement, freedom to operate counselling, negotiating and managing IP provisions in agreements, and patent enforcement.

To achieve this, BMS has a team of patent attorneys and other professionals who work closely to secure and enforce the company’s IP rights around the world.

Evolution

Golian identifies two significant changes during his time at BMS that have provided him with development and leadership opportunities.The first was BMS’s evolution of the pipeline from small molecule assets (such as pills or tablets), to include many biologic assets that are grown in living cells and administered intravenously.

“With this evolution, my role changed to focus on more complex biology inventions,” he explains. “The patentability and freedom to operate considerations for biologics are very different from those of small molecule assets, and I have been fortunate to participate in growing and leading a group that focuses on these new biologics programmes.”

The second development happened in 2007 when BMS chose to transform from a traditional, diversified pharmaceutical company—focusing on many therapeutic areas as well as non-pharma businesses in areas of medical imaging, nutritionals, and medical devices—to a smaller but “highly focused” biopharma company.

“During this significant transformation, I focused much of my work on acquiring new assets (via in-licensing) and companies,” says Golian. “This largely consisted of IP due diligence and transactional matters, which was a significant shift from my previous responsibilities of patent procurement and IP counselling.”

Golian says that deepening his expertise in diligence and transactional matters has provided him with the platform to make him a more well-rounded biopharma attorney with the capability of working across a range of practice areas and geographies. It’s also allowed him to have greater exposure to top executives across BMS, enhancing his leadership skills.

BMS, Golian explains, is an innovator company that focuses on transformational medicines which address diseases with high unmet medical needs. The company doesn’t manufacture generics or biosimilars.

“Given the significant costs and time to successfully take a drug from bench to bedside, patent protection is absolutely necessary to ensure our products of today can fund our research of tomorrow,” he notes.

Without adequate exclusivity, the business would not be sustainable, he adds.

A big part of the BMS strategy is its investment in personalised medicines. According to the vice president, BMS seeks to understand the biology of a disease, which gives the company an understanding into why and how its medicines work.

“Focusing on cancer, BMS’s interdisciplinary teams are working together to answer key questions and more intimately understand the interplay between the immune system and cancer,” he says.

“Through our research into the tumour microenvironment, we are learning more about how a patient’s dynamic tumour biology can be used as a guide for treatment decisions throughout his or her cancer journey.”

BMS’s teams are also continuing to evaluate less invasive diagnostic tools to help identify biomarkers in patients, such as liquid biopsy.

In the past, BMS has focused on ways to treat cancer, using different strategies depending on where the cancer is in the body. Now, BMS is generating data and conducting research that will provide it with insights into the genetic biomarkers in tumours.

“We are making important new discoveries across all our therapeutic areas in our quest for more personalised medicine.”

Brand protection

Given the complexity of the pharmaceutical industry, coupled with the need to help doctors and patients with treatment decisions, Golian believes that it is important that products (and often clinical study programmes) are protected by trademarks.

He says: “We have a robust brand protection programme—a targeted strategy that monitors the internet for unauthorised uses of key BMS brands and works to remove infringement in complement with existing BMS product quality efforts.”

Golian’s commitment to BMS and the life sciences field has secured him a place on the LSIPR 50 list, but he does admit that there are “significant” challenges coming from “many interested parties”.

“Put simply, there is a push by payors to reduce healthcare spend,” he says, explaining that the cost of pharmaceutical products can be reduced if they lose their exclusivity. As a result, Golian says, there are many parties that argue for the diminishment of patent rights as a vehicle to reduce healthcare spend.

“Moreover, there are industries where IP protection is viewed as unnecessary and a significant cost of business, so it is in their interest to seek to weaken the patent system. Taken together, the last few years have resulted in legal and business uncertainty in many aspects of
IP rights.”

Golian is also having to address a lack of IP harmonisation globally. The courts and governments often cause further complexity, he adds. For example, in the US, the Supreme Court has upended subject matter eligibility with decisions such as Alice v CLS Bank in 2014.

Meanwhile, in Europe, BMS has other obstacles to overcome, such as evaluating what impact the UK’s departure from the EU will have on IP rights.

“We are in a new era of medicine where breakthrough science is transforming care with innovative treatments,” he says.

“It is important to understand the value of prescription medicines in improving patient outcomes, and that prescription medicine cost is a small percentage of total healthcare spend around the world.”

With a career spent committed to developing life-changing medicines, it’s little wonder that Golian finds pride in his work.