At Gilbert’s LLP, we pride ourselves on our ability to think outside the box and offer creative solutions to complex legal problems. One of the most significant examples of this approach took place when Tim Gilbert, our founding partner, played a pivotal role in changing U.S. law—despite being a Canadian lawyer. This case study offers a glimpse into Tim’s efforts to solve a complex patent law issue, culminating in a visit to the White House Rose Garden.
The Problem: A Patent Litigation Quagmire
Tim’s journey began when he was approached at a conference by an attorney in the U.S. with whom he had crossed paths. The problem they presented to him was both complicated and frustrating: brand pharmaceutical companies in the U.S. were using a loophole in the law to obtain successive stays against generic ANDA approvals, almost indefinitely.
Under the Hatch-Waxman regime as it then-read, each time a new patent was issued on a product, companies could file for 30-month injunctions, preventing competitors from bringing cheaper, generic versions to market. Brand pharmaceutical companies often took advantage of this by having staggered patent issue dates. The result? A “daisy chain” of legal battles that could stretch on for years, blocking market access and driving up costs for consumers.
Billions of dollars were at stake, and while both Congress and the FDA were aware of the problem, no one had yet found a solution. Complex proposals were circulating in Washington, backed by powerful industry lobbyists, but no real progress had been made. As Tim recalls, the situation had become an intractable problem.
The Solution: Simplifying the Path Forward
Drawing inspiration from Sun Tzu’s The Art of War, Tim knew that complexity was the enemy of success. What was needed was not more litigation, but a direct fix. He proposed a straightforward solution: limit pharmaceutical companies to a single injunction, a one-time opportunity to enjoin competitors. After that, they could still sue, but without the ability to continually delay market entry with new injunctions.
This approach would eliminate the endless cycle of litigation, while still allowing companies to protect their patents. It was a solution that cut through the legal thicket and would bring much-needed relief to generic drug manufacturers and, by extension, consumers.
But coming up with the solution was only half the battle. Tim now had to figure out how to turn his idea into law.
The Washington Strategy: Building Consensus
Tim became the unlikely emissary for the Canadian pharmaceutical company Apotex, which had been unsuccessful in their attempts to launch a product in the U.S. To his surprise, gaining access to Congress was much easier than expected. Senators like Charles Schumer and John McCain were already engaged in discussions about potential solutions, and they welcomed Tim’s input.
What followed was a crash course in Washington politics. Tim worked closely with policymakers and congressional aides, educating them about the issue and advocating for his proposed solution. He describes this process as grassroots lobbying, often meeting in cafeterias and working side-by-side with young congressional staffers who were eager to learn.
The next phase of Tim’s strategy involved enlisting public support. He went on a speaking tour around the U.S. to garner support for the legislation. Major media outlets began to take notice of the issue, with publications like The New York Times, The Wall Street Journal, and The Washington Post running editorials in favor of patent reform. Public interest groups like the American Association of Retired Persons (AARP) also rallied behind the cause, adding pressure on Congress to act.
With bipartisan momentum building, the stage was set for the next big step in the campaign.
The White House Call: A Visit to the Rose Garden
After years of effort, Tim’s work culminated in a call from the White House. The Bush administration had taken notice of the rising support for patent reform, and eventually made executive decisions and passed the key measures that were sought. Tim was invited to the White House Rose Garden to witness the president speak about the issue.
While Tim never met the President in person, the event was a momentous occasion. The president endorsed the solution, marking a major victory for Tim, our client, and all those fighting to bring affordable drugs to market. What started as a small conference conversation had turned into a legislative change with far-reaching implications.
The Outcome: Changing U.S. Patent Law
The solution Tim helped craft ultimately became part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the first major reform to U.S. drug approval law since 1984. It curtailed the ability of pharmaceutical companies to indefinitely delay market access for generics, saving consumers billions in drug costs.
The impact of this change went beyond just the pharmaceutical industry. It demonstrated the power of creative problem-solving and the importance of building broad coalitions to support meaningful legal reform. Tim’s experience in Washington remains a powerful example of how Gilbert’s LLP approaches legal challenges—with innovation, persistence, and a dedication to achieving results for our clients.
Lessons Learned: The Power of Neutrality and Creativity
Looking back, Tim sees his role as an “honest broker” as one of the key factors that helped him navigate the often polarized world of U.S. politics. Being a Canadian and, thus, politically neutral in Washington, allowed him to bridge divides and gain the trust of both sides of the aisle. As Tim often says, “There’s always a solution—it just takes the willingness to find common ground.”
At Gilbert’s LLP, this philosophy continues to guide our work. Whether we’re advocating for clients in regulatory matters, intellectual property disputes, or complex litigation, we believe that creativity and collaboration are the keys to success. The story of our journey to Washington is a testament to the power of these values.