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Following all of the latest IP developments in life sciences.

 

Federal Circuit Affirms As Obvious Suite of Patents Directed to Methods Of Treating Opioid Overdose

(Co-authored by Alexandra Kim)

Introduction

In February of 2022, the Federal Circuit affirmed a New Jersey District Court’s determination that four patents claiming methods of treating opioid overdose by intranasal administration of a naloxone formulation, as well as devices for intranasal administration, were invalid as obvious over two, three-reference, sets of prior art. A panel majority found that all of the individual components of the claimed methods were taught in the prior art and that a person of ordinary skill in the art (POSA) would have been motivated to combine such teachings because there was a strong desire in the prior art to improve upon existing but deficient methods for treating overdose.

In a 15-page dissent, Judge Newman criticized the majority’s logic, asserting that there was no evidence of “teaching or suggestion in the prior art” to make the claimed combination of ingredients for use in the claimed method so as to achieve the described beneficial results. She faulted the majority for relying on “the need for a better product” to provide motivation since “the artisan’s knowledge that the available products are deficient does not render the remedy obvious when it is eventually discovered.”

While the challenger here prevailed, this opinion—both the majority and the dissent—provides valuable guidance (and caution) for assembling multi-reference obviousness challenges.

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Your IPR Petition Was Denied at Institution – What Next? The Federal Circuit Provides Insights on Petitioners’ Options

Mylan v. Janssen considers a topic IPR petitioners may be concerned about when institution of their petition is denied by the PTAB – is there any way to appeal the decision? The Federal Circuit held that while there is an avenue for relief, it is reserved for “extraordinary circumstances.”

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Lessons on Inherency Challenges After Hospira v. Fresenius Kabi USA

The Federal Circuit’s recent decision in Hospira v. Fresenius Kabi USA is the latest to show how the court handles allegations of inherency in life sciences patent litigation. Jonathan Roses dissects the case, addresses whether the court created a new burden-shifting framework for such challenges and summarizes lessons that parties on both sides on an inherency argument can take away from the decision. To read the full article, which was published in Westlaw Journal, click here.

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Genentech, Inc. v. Hospira, Inc. – Overlapping Temperature Ranges Can Leave a Patentee Out in the Cold

When can a prior art reference that discloses a protein purification step at room temperature render invalid a patent claim with a temperature range from about 10°C to about 18°C? Answer: When that prior art reference defines room temperature to include 18°C (which is about 64.4°F). The Federal Circuit reiterated, in Genentech, Inc. v. Hospira, Inc., that even a small overlap at the extremes of a range can invalidate claims that incorporate that range, absent a showing that the particular range is critical or that the parameter is not a result-effective variable.

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