In a nutshell
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
- 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.
- Represent clients during patent infringement proceedings.
- 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.”
- The pandemic has 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 means that there has been a lot of investor interest in the sector in 2021, with PwC reporting that the volume of M&A deals was up 25% in the second half of the year compared to the first half. The Asia-Pacific region accounted for much of that.
- Although the rollout of the vaccine has indeed bolstered the healthcare and life sciences industry, the idea of a compulsory vaccine has come under questioning. There’s been concerns raised surrounding ethical practice and autonomy or lack thereof. In September 2021, it was proposed that all US corporations with over 100 employees must impose full vaccinations on all members of staff; if they do not, they must then take lateral flow tests on a weekly basis. In February 2022, Austria became the first EU democracy to contemplate legislating a compulsory vaccination for everyone, though it has since dropped the mandate.
- According to a report by PwC, deals in the pharmaceutical sector totaled $269.4 billion in 2021, a 46% increase on the previous year. Similarly, the total volume of deals was up 52%. The report anticipates that M&A investments in the sector could reach up to $400 billion in 2022.
- To minimize contact, healthcare has become and will continue to become increasingly digitized. “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.
- In March 2022, the Food and Drug Administration released new guidance on healthcare products, such as medical devices and pharmaceutical drugs. The rules touch on guidance that were proposed in April 2019; advising companies on how to prepare when administrating a voluntary recall. The main premise of the guidance is to help medical companies recognize and eliminate potentially dangerous products and thus keep consumers safe.
- 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. In February 2022, Biden urged US Congress to approve his Build Back Better legislation to make prescription drugs provided through the company Medicare more cost-effective. The new legislation will help American citizens afford prescription medication, particularly seniors and people with disabilities.
- Deloitte predicts that D&I will be a major focus for the sector, both internally and externally. However, this is more than just a labor and employment issue. The report notes 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.
- 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.