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 2020  

  • Software as a Medical Device (SaMDs) has come to the attention of the US Food and Drug Administration (FDA) of late. In January 2020, the FDA uploaded a discussion paper for a new regulatory framework that would apply to the use of SaMDs that use AI and machine learning technology. Expect further debate on the topic and development of regulations that lawyers will be advising clients on. 

  • The Lower Drug Costs Now Act was passed following a House vote in December 2019. The stance of the Trump Administration, as detailed on the White House websitewas that the Act fitted with its desire to lower prescription prices but not with its vision of encouraging innovation in the medical sphere and creating new drugs. It was reported that no Democrats voted against the Act, while two Republicans voted for it. The next stop for the Act: the Senate, which will decide when it may become law. The website Vox reported that this is unlikely to occur in the near future. Drug pricing will remain a central issue in policy though. 

  • A recent report by Deloitte on the outlook for life sciences regulatory sphere identified many trends of note. Among them were increased transparency in the healthcare sector, which has seen the majority of states taking a role in the regulation of drug prescription pricing; the projected use of AI by life sciences manufacturers to assist their efforts with compliance programs; and the new risks involved in acquiring assets as life sciences companies look to branch out into areas such as cellular therapy. 

  • 2019 was a bumper year for life sciences M&A, with huge billions-busting deals hitting the headlines, including Bristol-Myers Squibb’s $74 billion tie-up with Celgene and AbbVie’s $63 billion move for Allergan. Sector-specialist website FiercePharma has a rundown of the top ten life sciences deals and also raises a trend to look out for: increasing interest from the Federal Trade Commission to investigate antitrust issues as deals get bigger and the market consolidates. Whether 2020 will see as much M&A activity in light of Covid-19 remains to be seen. 

  • 3D printing is being explored as a better way to manufacture cell and tissue products. Drugs and disease models can be tested on 3D-printed tissues instead of on animals or humans. 

  • The medicines industry will likely find ways to profit from the coronavirus pandemic, even with a vaccine months away from becoming suitable for the mass market. 

     

 

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

Life sciences goodwin