Welcome back to Legal Geek! This week, we review a Court of Appeals decision this week that clarified whether changes have occurred to the on-sale bar in patents after the America Invents Act of 2011, also known as the AIA.
https://archive.org/details/LegalGeekEp102
The AIA was the most recent major reform by Congress to U.S. patent laws, and it included some significant changes such as giving patent priority rights to the first inventor to file an application, instead of the first person who invented a given invention. The wording of what serves as prior art to a patent application was also updated.
That latter item is what was in controversy in the case decided this week. Two pharmaceutical companies were doing battle over four patents related to the anti-nausea drug Aloxi, but there had been a purchase agreement made between the patent owner and another party (privately) in early 2001, more than a year before filing these patent applications in 2003. There is a one year grace period for sales before patent applications, but that did not apply here in view of these facts.
The recently amended on-sale bar of the patent law states that an applicant is entitled to a patent unless the invention was in public use, on sale or otherwise available to the public before a patent is filed. The key difference from the old statute was the addition of the "otherwise available to the public" language.
The argument boils down to whether the added words "or otherwise available to the public" just applies to the words "on sale" or is another separate type of disclosure that triggers a bar date. Before the AIA, there were decades of court precedents that deemed even private sales to still qualify as bar date triggers that could block patents. In other words, it did not matter before the AIA whether sales were public or not.
The alleged infringer was arguing that this status quo of precedent should not change under the new AIA language, while the patent owner argued that only public sales that publicly disclose the details of an invention triggered a bar to patentability. The Federal Circuit disagreed with the patent owner, effectively confirming that the on-sale bar remains much the same as it was before the AIA.
This is a big result because an opposite conclusion would potentially gut the effectiveness of an on-sale bar, by allowing private sales and commercialization efforts more than a year before being forced to file a patent application. Indeed, the Patent Office itself had sided with the patent owner on this issue and that turned out to be wrong! In this case, all the patents were therefore deemed invalid and the generic drug can hit the marketplace unscathed by patent infringement.
The Bottom Line is, when Congress changes laws in even minor ways, there are always viable arguments regarding how far the changes go. This case settles a question that had been openly debated about the on-sale bar for the last 5 years, and it maintains the long standing limits on how far the U.S. patent grace period can be stretched by potential patent applicants. Furthermore, we can always count on big pharmaceutical companies to test the limits of patent law and help us clarify our laws.
----------------------------------
Thanks for reading. Please provide feedback and legal-themed questions as segment suggestions to me on Twitter @BuckeyeFitzy
No comments:
Post a Comment