Life sciences – the basics

In a nutshell

Life sciences (1)Life sciences is an umbrella term that denotes all of the medical and scientific products and services that fall under the following areas: biotechnology, pharmaceuticals, medical devices, dietary supplements, foods, cosmetics and environmental agents.

For lawyers, the practice area is particularly diverse as it encompasses several areas of traditional practice including regulatory, criminal investigation, enforcement, compliance, competition, intellectual property and many more. Clients range from governments to major global pharmaceutical manufacturers to start-up companies that are inventing new medical drugs.

All of this variety is broken down into three core areas for lawyers: regulatory, intellectual property and corporate. Regulatory work encompasses the likes of market authorization of products, government affairs, competition matters and compliance work. Life on the intellectual property side is focused on protecting clients' patents, while corporate lawyers assist companies with both their everyday and transformative matters, from basic employment needs and governance issues to business-altering M&A deals.

 

What life science lawyers do

Regulatory

  • Assist clients with getting their products to market in various jurisdictions.
  • Liaise with the government when there are objections to clinical trials.
  • Help companies to improve their manufacturing techniques.
  • Advise clients on how to distribute their products in line with healthcare laws.

IP

  • Represent clients during patent infringement proceedings.

Corporate

  • Advise on complex contractual relationships like collaborations and alliances.
  • Facilitate commercial transactions involving a life sciences element.
  • Assist with M&A and venture capital work containing a life sciences element.
  • Take the role of lead negotiator in business transactions.

 

Realities of the Job

  • Working hours vary across the three core areas. Regulatory work offers the most flexibility, while the hours experienced by patent trial lawyers – especially as a case heats up – can be intense. Corporate hours, as you might expect, are dictated by the peaks and troughs of the deal cycle, so periods of late nights are followed by lulls of more standard hours. 
  • “It is important to be a specialist but also to learn about other fields and how they impact on each other, e.g. how the area of product liability might influence regulatory advice,” says Scott Bass of Sidley Austin. “One of the main challenges is keeping up with fast-changing developments and staying informed.”
  • This fast pace is at the same time one of the most exciting elements of the practice, Bass feels: “The sector is constantly changing, so there's the opportunity to break new ground often. You get to help industry but also assist governments and consumers in a lot of what you do.”
  • Latham & Watkins' Judith Hasko agrees: “I think you have got to have a comfort level with an ever-changing legal and regulatory environment, and you have to be interested and comfortable with change. It is an exciting industry, but people who do well like change."
  • “You also have to be commercially sophisticated and have an interest in the commercial drivers as to why a company wants to do something,” Hasko continues. “In my experience you need to work well with your client. They have critical information you need. You need the full input of your client and its your job to do that. It is also challenging to tailor advice so that it makes sense to them. You just need to fully understand their goals. What is also tricky is the ability to keep a lot of different elements in your head about the law and the client's business at the same time when you are negotiating."
  • “There is a lot of opportunity in life sciences as the legal frameworks and government's policies are constantly changing," Hasko explains. "This creates opportunities for lawyers. It is very exciting and rewarding to help to move products forward that will help people. It's not a practice for everyone as it can be very technical, but for those who have a connection with the industry I would say go for it.”
  • On the corporate side, Covington & Burling's John Hurvitz tells us: “You have an opportunity to be involved in all phases of the deal cycle from structuring to negotiating to implementation. Also, there is a lot of deal activity in the industry so you have an opportunity to work with clients over many years and multiple transactions. These deep and longstanding relationships are very rewarding, both professionally and personally.”
  • Hurvitz adds: "A scientific background is useful but not necessary. It is more important to have an interest in the underlying science and technology, as there is ample opportunity to learn about the latest innovations and breakthroughs. The practice is multidisciplinary so to be successful you need to be comfortable working across a range of legal disciplines, such a IP, competition, corporate, and also to have a business mindset. The business issues and legal issues are inextricably intertwined in this practice."
  • Life sciences collaborations are, Hurvitz tells us, “very complex. In addition to working across legal disciplines, there are often multiple facets of the deal that have to be managed in parallel. It is like four or five dimensional chess at times. People who are smart, curious, have good memories and attention to detail will do well. You also need to be comfortable in making judgment calls. There are often so many business and legal issues at play in any given deal, that the clients typically look to the lawyers to offer practical guidance."
  • When it comes to regulatory work, “the most challenging thing we face in our practice is the challenge faced by industry as a whole: it is an extremely difficult and long process from invention to product,” says Daniel Becker of Fenwick & West. “In a 25-year career only two or three inventions that I've worked on have become a marketed pharmaceutical product. We don't get instant or even near-term gratification.” However, “every time I come to work it's nice knowing that the work I am doing makes a difference. Very few products I work on make it to market, but when they do and you see the positive benefits it is so thrilling.”

 

Current issues

June 2024

  • The Covid-19 pandemic had a profound impact on every industry, with the major pharmaceutical giants like Pfizer, Johnson and Johnson, Moderna and AstraZeneca becoming household names. The growing visibility of life sciences culminated in an investment high in 2021. In 2022, this did subdue, but the sector remains strong despite the troubling economic climate.

  • PwC indicates that M&A activity will rise over the next year, partly thanks to big pharma acquiring smaller start-ups with attractive scientific advancements. For example, last year, Pfizer acquired Seagen in a deal worth $43 billion, and GSK has acquired Bellus Health for $2 billion.

  • A recent move by Bristol Myers Squibb has seen the acquisition of Mirati Therapeutics for $5.8 billion, adding to its extensive oncology portfolio.

  • Healthcare will continue to become increasingly digitized. Referring to the pandemic, “The acceleration of telehealth and virtual visits has been huge,” says Ira Coleman, managing partner of McDermott, Will & Emery. “Nobody expected this kind of development and adoption for at least another 10 years, but the crisis has pulled the future forward by five years at least - maybe more. We have seen providers go from two telehealth appointments a day, to 5,000 a week.”  Alongside the obvious benefits to telehealth (it’s time-saving and cost-effective), we’re likely to see significant legal challenges around data privacy, indemnity, and professional insurance.

  • More broadly, the industry has faced growing developments in technology with AI and machine learning in robotics, wearables, and smart devices. This is creating exciting business opportunities for developers such as AstraZeneca, who recently extended its partnership with BenevolentAI for another three years. However, it means stricter regulatory control is likely on the horizon.

  • Back in October 2023, the White House released an executive order around the use of AI and the safety around it. A report by Sheppard Mullins highlighted that this would affect the regulations around Food and Drug Administration to ensure privacy and safeguarding is met.

  • Drug pricing is a central issue in healthcare policy for the Biden administration, with its aim to lower prescription drug prices by enabling Medicare to conduct negotiations for certain expensive medicines and making it a requirement for drug manufacturers to pay rebates if prices overtake inflation. New regulation proposed in May 2023 by the US Department of Health and Human Service and the Centers for Medicare & Medicaid Services aims to drive down the price of prescription drugs under Medicaid by allowing states to make the costs of expensive drugs transparent.

  • The industry also continues to focus on their environmental and sustainability efforts. A JLL study found that 72% of companies in this space are aiming to make a positive impact on the environment, including paying for high quality facilities that can hit sustainability goals.
  • Deloitte previously predicted that D&I will be a major focus for the sector. However, this is more than just a labor and employment issue. The report noted that there are significant “racial health disparities,” highlighting a potential growth area as companies look go to “promote inclusion and equity in healthcare and promote research equity in the medtech industry.” In recent years, FemTech has been a huge phenomenon and has started to bridge the gap between men's and women's experiences in healthcare. Apps such as ‘Flo’ can now provide valuable insight into a huge array of women's healthcare issues relating to the menstrual cycle.

  • The life sciences market is feeling the implications of market forces diminishing growth capital. With the introduction of the Inflation Reduction Act and the Federal Trade Commission's crack down on drug pricing tactics, biotech and pharma companies are having to compete for funding and IPOs. As a result, companies feeling the pinch are turning to restructurings which bring about a number of legal considerations, including employment law, privacy restrictions, contract agreements, and real estate matters.

  • The Supreme Court is set to hear two cases that challenge the Chevron doctrine. Discarding or modifying the doctrine will have large implications on the healthcare and life sciences industries.

  • A previously dormant rule around health information has resurfaced this past year. The Health Breach Notification Rule has been revived, and the FTC has proposed modernizing its approach to defining and protecting health data. Legal experts will likely be called upon to ensure compliance across the healthcare and life sciences industries.

 

Learn about the current issues from the lawyers facing them...