Originally Published in Intellectual Property Magazine | July 8, 2015 | By Paul Mandell
A recent summit of chief IP officers identified key tasks facing counsel in the pharma and biotech industries, as host Paul Mandell reveals…
For chief IP officers and patent counsel in the pharmaceutical and biotechnology industries, today’s global marketplace is more demanding than ever. IP executives are charged with not only protecting both corporate success, but also the important innovations their companies are creating. While the stakes are always extremely high, the game keeps changing as regulations, risks and signals from the market continually evolve. According to Dorian Immler, chief patent counsel of Bayer IP, “This is a time of risk in IP, where the atmosphere is strange. People are more nervous about lack of predictability in decisions.”
How can IP leaders in the pharmaceutical and biotechnology industries best navigate this dynamic and complex global IP environment? At Consero’s recent 2015 IP Forum for Pharmaceuticals & Biotechnology in Switzerland, heads of IP management in the pharmaceutical and biotech industries addressed this question, identifying the most pertinent issues facing their industry and working through strategies to address them.
Set out below are three key areas identified by these executives for consideration, as well as some guidance that emerged from their discussions.
Chief IP officers must wear many hats, and a new one – expertise in antitrust issues – is becoming increasingly important. Chief IP officers have long benefitted from a background in subjects such as engineering and the sciences, as well as an understanding of relevant IP law. However, a newly critical area of knowledge for today’s chief IP officers is antitrust law. From enforcement actions to settlements, virtually every move a chief IP officer can make to protect the company’s interests seems to pose a risk of allegations of anti-competitive conduct. As a result, these executives must stay sufficiently informed of investigations by the Federal Trade Commission and other similar regulatory bodies, in addition to keeping a lookout for signals that these entities provide regarding the boundaries in which companies may lawfully operate.
Get ready to fight earlier
Enforcing IP rights has always been a challenge for chief IP officers. Yet companies are now facing IP battles earlier than ever before, posing greater risk to the launch and monetisation of new products. Historically, fighting over patents in the pharmaceuticals context took place primarily between originators and generics as patents were heading toward expiration, with generics eager to obtain market share and originators desperately trying to manage the impact of the patent cliff. Now, increasingly, patent battles are taking place on the way to the market.
Given the inevitability of patent litigation, and in order to be prepared to fight earlier, chief IP officers must ask themselves critical questions about the best ways to proceed, such as what best practices can be shared with the patent prosecution team to ensure the most defensible assets. Another key question that chief IP officers facing early IP battles must consider is that of when to settle. Indeed, even the process of settling is becoming more difficult, given increasing anti-competitive scrutiny.
Choose your enforcement venue wisely
Chief IP officers must be knowledgeable about the complex global enforcement environment. According to Jürg Simon, a Zürich-based partner at Lenz & Staehelin, “Today’s world still is peppered with remarkable differences between enforcement venues. It would be unwise, say negligent, not to take these into account when preparing and executing one’s enforcement strategy.”
In today’s international marketplace, the venue in which an enforcement action is filed bears more on the success or failure of that effort than ever before. Differences in geography dictate whether to bring a lawsuit, where to produce and where to enforce. For instance, arguments relying on public interest considerations that may help in some countries are generally unhelpful in Germany. In other countries such as Japan, a goal of settlement seems to have a higher likelihood of success. And in some locations, a positive decision may ultimately be useless, given the practical difficulties of enforcing the decision.
According to Bob Barker, principal patent counsel at Medtronic, “The examination of court infrastructure and available enforcement mechanisms is critical in considering where to bring an action.”
Barker further notes that, “Our strategy of where and when to bring a lawsuit is closely tied to our filing strategy; we typically bring lawsuits in major markets for our products and where we manufacture products.”
Whatever path chief IP officers choose, knowledge of the differences among forums is key. Enforcement actions are distracting and costly enough without pursuing them in a hopeless forum.
Navigating a path to success
In the pharmaceutical and biotech industries, IP is paramount. Today’s IP leaders in these arenas face numerous challenges in navigating an ever-changing global IP landscape. By being aware of antitrust risk, preparing to fight earlier, and choosing enforcement venues wisely, these executives will be better prepared to guide their companies on the path to success.
Paul Mandell is founder and CEO of Consero