Month: December 2018

On December 4, 2018, the Supreme Court heard argument in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. This case arose out of a dispute over the validity of a patent covering a product used to reduce the likelihood of chemotherapy-induced nausea and vomiting. At issue in this case is whether agreements entered into by Helsinn more than one year prior to filing for patent protection put the invention “on sale” and thus would invalidate the patent. Although the meaning of “on sale” in the Patent Act was long believed to be settled, the 2011 America Invents Act (AIA) made changes to the statutory provisions that include the “on sale” bar. The question for the Supreme Court is whether these changes to the statute change the previous understanding of the term “on sale.”
In April 2001, Helsinn entered into two agreements with MGI Pharma. Although these agreements were announced in a press release, specific information about the products, like dosing formulations, were omitted. In 2003, Helsinn filed a provisional patent application covering the product. Three patents arose from this provisional patent application prior to the enactment of the AIA; however, one patent was subject to the new provisions of the AIA.
In 2011, Teva sought FDA approval to make a generic version of the patented product. Helsinn sued Teva for patent infringement based on this ANDA filing. Teva argued that the patent was invalid because Helsinn’s agreements with MGI put the product “on sale” before the relevant date. The district court rejected Teva’s argument, concluding that the AIA had changed the meaning of “on sale” to require the invention be made public by the sale. Because the dosing information was not provided in the press release regarding the agreements, the district court concluded the agreements did not make the invention public and there was no “on sale” bar.
The Federal Circuit reversed, holding that inventions are made available to the public whenever there is a commercial offer for sale and that the sale is public even when the details of the invention are not disclosed to the public by the sale. Thus, the “on sale” bar applied to Helsinn’s patent.
The U.S. Supreme Court then granted certiorari to address whether under the AIA, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.
To the discuss the case, we have Kristen Osenga, Professor of Law at University of Richmond School of Law.

Today's Rapid Response episode takes a look at three breaking stories related to the White House:  (1) the recent ruling requiring Stormy Daniels to pay Trump's attorneys' fees; (2) the sentencing of Trump's former lawyer, Michael Cohen; and (3) most importantly, the plea deal signed by American Media, Inc. -- parent company to the National Enquirer -- to cooperate with the Special Counsel's Office.

We begin by revisiting the question of whether, in fact, Stormy Daniels is still a legal genius.  (Hint:  she is.)  But what does it mean that a court just ordered her to pay Trump nearly $300,000 -- and why could it have been much, much worse?  Listen and find out.

After that, we check out Trump's ex-"fixer" and the former Taxi King of New York, Michael Cohen, who was just sentenced to three years in prison.

Then it's time for a fascinating look into a non-prosecution agreement reached between the Special Counsel's Office and American Media, Inc. that tell us an awful lot about where Yodel Mountain is headed.

Finally, we end with an all new Thomas Takes The Bar Exam #105 on modifications to a contract.  As always, if you'd like to play along with us, just retweet our episode on Twitter or share it on Facebook along with your guess and the #TTTBE hashtag.  We'll release the answer on next Tuesday's episode along with our favorite entry!

Appearances

None!  If you'd like to have either of us as a guest on your show, drop us an email at openarguments@gmail.com.

Show Notes & Links

1. Here's the merits ruling defamation we referenced during the show; you can also check out Trump's motion for attorneys' fees, Avenatti's (rather weak) opposition brief, and the court's ruling directing Stormy to pay almost $300,000.
2. And because it never ends, check out the mediation questionnaire filled out by Avenatti for their appeal to the 9th Circuit.
3. You know you want to read the press release regarding Michael Cohen's sentence; after that, you can check out the sentencing memoranda filed by the SCO's office ("good cop") as well as the brief filed by the SDNY ("bad cop").
4. Finally, this is the AMI agreeement as well as the DOJ guidelines on prosecuting corporations.
5. Oh, and just for fun, here's Jose Canseco's audition to be Trump's Chief of Staff.  #YesWeCanseco

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