Millennium Pharmaceuticals v. Sandoz?When Inherency Does Not Mean Obvious

• Author: Jennifer T. Nguyen - Preston K. Ratliff II
• Position: Jennifer T. Nguyen is an associate at Paul Hastings, LLP in New York, New York. She is a member of the intellectual property practice and focuses her practice on complex patent litigation. She can be reached at jennifernguyen@paulhastings.com. Preston K. Ratliff II is a partner and chair of the litigation practice at Paul Hastings LLP in New ...
• Pages: 14-16

Published in Landslide® magazine, Volume 10, Number 3 , a publication of the ABA Section of Intellectual Property Law (ABA-IPL), ©2018 by the American Bar Association. Reproduced with permission. All rights reserved.

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Is the natural result of a known process considered inherently obvious? Patent practitio-

ners might quickly jump to the conclusion that any natural result of an arguably known

and/or obvious process is itself inherently obvious and unpatentable. The Federal Cir-

cuit’s ruling in Millennium Pharmaceuticals, Inc. v. Sandoz this past summer, however,

demonstrates this is not always the case.1

Indeed, the Federal Circuit in Millennium sent an important message that the existence

of inherent disclosures may not necessarily be enough to render a patent claim obvious.

The claimed invention in Millennium concerned a chemical compound known as bortezo-

mib. Bortezomib is used in the treatment of patients with multiple myeloma and mantle cell

lymphoma who have received at least one prior therapy, and Millennium Pharmaceuticals

markets it under the brand name Velcade.2 Although bortezomib was known and described in

a prior art patent, it had not achieved FDA approval by the time the patent-in-suit was applied

for.3 It was previously known that bortezomib suffered from instability, rapid degradation in

liquid formulations, and insolubility. After many failed attempts to develop a viable liquid for-

mulation that resolved the issues in bortezomib, the patent applicants developed a promising

formulation. This formulation was prepared by lyophilization (freeze-drying) using a known

bulking agent, mannitol.4 The formulation was the subject of U.S. Patent No. 6,713,446 (’446

patent) and ultimately became the formulation for Velcade.

Three generic drug manufacturers led abbreviated new drug applications seeking approval

for a generic version of Velcade. In response, Millennium led suit in the District of Delaware. At

trial, the closest and sole prior art was found to be an earlier patent led by Millennium’s predeces-

sor claiming the bortezomib compound, and both parties agreed that bortezomib was the proper

lead compound for the obviousness analysis.5 Both parties also agreed that the Velcade compound

provided unexpected properties that solved the problems of bortezomib.6 The generic defendants

argued that lyophilization would have been an obvious process to stabilize bortezomib. Speci-

cally, the generic defendants argued it was a “standard” formulation method that a formulator

would have considered.7 They further argued that there were “only ‘half a dozen or so’ ... ‘phar-

maceutically acceptable bulking agents’” with the “most prominent” being mannitol, and thus

it would have been obvious to lyophilize bortezomib with mannitol.8 According to the generic

defendants, if the court nds freeze-drying with mannitol to be obvious, then the patent is nec-

essarily invalid because the claimed formulation “is the inherent result of that combination.”9 To

further support their position, the generic defendants argued that Millennium had also admitted to

Millennium

Pharmaceuticals

v. Sandoz

When Inherency Does Not Mean Obvious

By Jennifer T. Nguyen and PrestonK. Ratliff II

Jennifer T. Nguyen is an associate at Paul Hastings, LLP in New York, New York. She is a member

of the intellectual property practice and focuses her practice on complex patent litigation. She can

be reached at jennifernguyen@paulhastings.com. Preston K. Ratliff II is a partner and chair of the

litigation practice at Paul Hastings LLP in New York, New York. He focuses his practice on complex,

high-stakes patent litigation with an emphasis on the biotechnology, pharmaceutical, chemical,

agricultural, and renewable fuel sectors. He can be reached at prestonratliff@paulhastings.com.

Image: iStockPhoto