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.”
- “A key issue at the moment is how governments will regulate emerging technology such as diagnostics, wearables, and home testing kits,” Sidley Austin's Scott Bass explains. “There is also an issue when it comes to the regulation of breakthrough drugs like biologics and genetically based drugs.”
- While the full effect of the Trump administration remains unclear, our interviewees made some predictions. Scott Bass takes a glass half-full approach: “The prevailing view is that it will provide more incentives for companies to explore new areas with less government regulation.”
- In contrast, Fenwick & West's Daniel Becker adopts a somewhat bleaker view: “It's going to be a disaster. There will be many fewer individuals who have medical insurance; there will be an uninformed and unnuanced assault on drug pricing; and there will also be a chill on bringing in talent from other countries, as collaboration will become more difficult.”
- Latham & Watkins' Judith Hasko raises another Trump-related issue: "What Trump is going to do is really unclear. He has made comments recently that he would impose some types of limits on drug prices or reimbursement for drugs, which would have a ripple effect across the industry. There are also some concerns that conservative government leaders may implement policies that could hinder certain types of scientific research.”
- On a positive note, the 21st Century Cures Act was enacted in 2016. $6.3 billion has been set aside for funding medical research, including former vice president Joe Biden's 'Cancer Moonshot' program. The law could speed up the approval process for prescriptions and medical devices, increasing activity in the sector.
- According to a report by Deloitte, global prescription drug sales are forecast to grow at an impressive rate of 6.5% over the next five years. Worldwide sales are expected to be $1.06 trillion in 2022. Worldwide pharmaceutical and biotech research and development is forecast to grow at 2.4% per year up to 2022 - slightly lower than the 2.5% annual growth between 2008 and 2016. Total R&D spend is expected to reach $181 billion in 2022, compared to $156.7 billion in 2016.
- The global personalized medicine market is forecast to reach $2.4 trillion in 2022 at an annual rate of 11.8%, more than double the projected 5.2% annual growth for the overall health care sector.
- Recent large-scale and innovative life science deals included Gilead Sciences acquiring Kite Pharma for $11.1 billion, Johnson & Johnson acquiring Swiss biotech firm Actelion for $30 billion and Thermo Fisher Scientific acquiring Patheon for $7.2 billion.
- 2017 was a breakthrough year in scientific achievements with drug approvals hitting a 21-year high. This will likely make it easier for drug manufacturers to eventually get their product to market.
- 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.