Key Legal Outcomes in Hatch Waxman Litigation: 2023 Review

Patents are the lifeblood of innovation, granting inventors exclusive rights to their creations while encouraging progress across industries. One key aspect that often decides a patent's fate is proof of nonobviousness—showing that an invention goes beyond what a skilled person in the field might expect based on prior knowledge. Within this realm, "unexpected results" stand as a particularly compelling argument. They can tip the balance between a valid patent and an obvious invention.

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Unexpected Results in Hatch Waxman Litigation: A Review of Legal Decisions from 2023

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Ben Bourke

Transcript

Welcome to Womble Perspectives, where we explore a wide range of topics, from the latest legal updates to industry trends to the business of law. Our team of lawyers, professionals and occasional outside guests will take you through the most pressing issues facing businesses today and provide practical and actionable advice to help you navigate the ever changing legal landscape.

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Patents are the lifeblood of innovation, granting inventors exclusive rights to their creations while encouraging progress across industries. One key aspect that often decides a patent's fate is proof of nonobviousness—showing that an invention goes beyond what a skilled person in the field might expect based on prior knowledge. Within this realm, "unexpected results" stand as a particularly compelling argument. They can tip the balance between a valid patent and an obvious invention. 

This concept is especially crucial in the pharmaceutical industry, where incremental innovation could save lives. 

Under U.S. patent law, inventions must meet three key criteria to secure protection—novelty, usefulness, and nonobviousness. Nonobviousness assesses whether a person of ordinary skill in the field could have easily deduced the invention based on existing knowledge. To reinforce the nonobviousness of their patents, inventors often rely on "secondary indicia" such as unexpected results.

Unexpected results occur when an invention performs beyond reasonable expectations based on prior art. For pharmaceutical patents, this might include improved efficacy, reduced side effects, or unique mechanisms of action revealed during late-stage clinical trials. These results strengthen arguments that the invention isn’t simply a predictable step from prior art but represents a leap forward.

Courts evaluate unexpected results on a case-by-case basis, with factors such as expert testimony and the nature of evidence heavily influencing outcomes. While unexpected results can be persuasive, they aren't guaranteed to override other arguments for obviousness.

The past year brought notable legal decisions that illustrate the complexity of relying on unexpected results in patent disputes. Let's look at three key cases:

First up, UCB, Inc. v. Actavis Lab'ys UT, Inc.

This case involved a method for stabilizing rotiogine, a drug for Parkinson’s disease. UCB argued that their claimed weight range of excipients helped rotiogine resist crystallization during storage, an unexpected benefit. However, the Federal Circuit disagreed, finding that the results were merely a difference of degree, not of kind. They sided with Actavis, affirming the patent's obviousness. This ruling highlighted the challenge of proving unexpected results—specifically, the need to demonstrate that they represent a qualitative, rather than incremental, improvement.

Next, Taiho Pharm. Co. v. Eugia Pharma Specialities Ltd.

Taiho faced scrutiny over a method-of-treatment patent for digestive and breast cancers. They argued that twice-daily dosing resulted in improved anti-tumor activity, discovered during Phase I trials. However, the inventor failed to clearly demonstrate why the results were unexpected. The vague reasoning undermined Taiho's case, and the court invalidated the patent as obvious. This outcome underscores the importance of compelling, evidence-backed testimony when presenting unexpected results.

And last, Amgen Inc. v. Sandoz Inc. 

Amgen succeeded where others failed by presenting strong, scientifically grounded evidence. Their patent claimed a stereometrically pure version of apremilast, a psoriasis treatment. The unexpected result? A 20-fold increase in potency compared to the racemic mixture, far exceeding what a skilled person in the field would anticipate. The court found this reasoning credible and upheld the patent. This decision shows how detailed scientific explanations and clear nexus between the claim and the unexpected result can be pivotal.

The outcomes in the Taiho and Amgen cases highlight three key factors that courts consider when evaluating unexpected results. First, the type of patent plays a significant role. 

Composition patents, like Amgen's, tend to provide stronger grounds for claiming unexpected results compared to method-of-treatment patents, such as Taiho's. Second, the credibility of the inventor's testimony is critical. In Amgen's case, the inventor supported their claims with clear, scientifically valid reasoning, whereas Taiho relied on vague assertions. Lastly, the connection between the unexpected results and the patent claims is essential. Amgen's results were closely tied to its claims, making them more compelling, unlike the loosely associated arguments presented by Taiho.

These legal cases hold valuable insights for both patent applicants and litigants. First, they underline the importance of robust evidence and expert testimony in arguing unexpected results. A well-documented scientific foundation can make the difference between success and failure. Further, they highlight the evolving role of clinical trial data in pharmaceutical patents. Results from Phase III or IV trials, supported by clear, measurable benefits, could strengthen claims of unexpected results.

Looking ahead, "unexpected results" will likely remain a double-edged sword in patent law. They are fact-dependent and heavily influenced by nuanced details. However, with innovation continuing at breakneck speed in industries like pharmaceuticals, this doctrine will play an increasingly vital role in defining what truly counts as groundbreaking.

Thank you for listening to Womble Perspectives. If you want to learn more about the topics discussed in this episode, please visit The Show Notes, where you can find links to related resources mentioned today. The Show Notes also have more information about our attorneys who provided today's insights, including ways to reach out to them.

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