Month: September 2018

The Puzzling Uncertainty about Umbrella Exclusivity

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In the middle of July, FDA announced a public hearing on facilitating competition and innovation in the biologics marketplace.  Following the hearing, September 4, comments were accepted in the docket (FDA-2018-N-2689) until last Friday, September 21.

The agency’s Federal Register notice listed a series of questions, but one of them struck me — at the time — as surprising.  FDA asked for comment on the “potential application” of “umbrella exclusivity” for biologics.  Why surprising?  Because I would not have thought it controversial.  More than five dozen comments have been filed, though, and at least one company (Mylan) has argued that the statute doesn’t permit the umbrella.

So it seems like it might be timely to back up and explain this.

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Cannabis and the Often Overlooked Drug Exclusion Rule

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Earlier this week, several major news outlets (CNN, Fox Business, and Bloomberg) reported that Coca-Cola is considering making a move into “cannabis drinks” — as evidenced by supposed talks with Aurora Cannabis, Inc., a Canadian owned and operated company that sells a variety of cannabis products including several strains of dried cannabis as well as several oils.  The company finally issued a statement, in response to many media inquiries:  “We have no interest in marijuana or cannabis. Along with many others in the beverage industry, we are closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world.  The space is evolving quickly. No decisions have been made at this time.”

Caution might well be warranted with respect to products for sale in the United States, because of the often-overlooked drug exclusion rule at FDA.  Coca-Cola has sophisticated FDA counsel, and I am sure they are on top of this issue.  But others watching legal and real-world developments relating to sale of cannabis may not be aware of the rule, which presents a significant legal impediment to the sale of CBD in any form other than approved new drugs (even if no medical claims are made).

Many people don’t know about the drug exclusion rule . . .

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The Patent Dance: A Reasonable Response to the Specter of Reasonable Royalties

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Based on the dispute between Celltrion and Genentech over Celltrion’s biosimilar version of Rituxan (rituximab), it should be clear that interpretive disputes relating to the patent dance in the 2010 biosimilar law are far from over.  The patent dance is indeed the gift that keeps on giving.  And some of the interpretive conundrums lead to ridiculous results, at least, if you’re at all interested in saving litigants money.  Look at what Genentech recently found itself doing.

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Biosimilar Patent Litigation: the “Finish What You Started” Rule

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As earlier posts on this blog have noted (here and here), the Supreme Court’s 2017 ruling in Sandoz v. Amgen effectively put an end to arguments that biosimilar applicants can be forced to participate in the “patent dance” with biologics innovators.  Even still, there are lots of interesting issues relating to the patent litigation provisions of the 2010 biosimilars law.  Here’s one percolating in the courts right now:  can a biosimilar company start to dance and then change its mind?  Or does it have to finish what it started?

This arises in a dispute between Genentech and Celltrion over a biosimilar copy of Rituxan (rituximab).  There’s a second issue in this dispute, which I will describe in another blog post.  First some background, and then I’ll unpack the litigation.

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