Patent Term Restoration – Denied!

Published on by Erika LietzanLeave a comment

In 1984, Congress amended the Patent Act to permit a patent extension for certain types of inventions — many (but not all) of those subject to premarket testing and federal government approval requirements.  Some people call this patent term extension; others call it patent term restoration.  Between enactment of the statute in September 1984 and the end of March 2017, the Patent and Trademark Office received 1113 applications for patent term extensions in connection with new drugs and biological products.  But by April 1, 2018, it had granted only 664 extensions.  Why do companies not get patent term extension?  Usually because this wasn’t FDA’s first approval of the active ingredient. 

More after the jump.

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SSRN Reading List; Genetically Modified Food and the Public’s Voice

Published on by Erika LietzanLeave a comment

Anyone who teaches Food Law & Policy knows that “genetically modified food” will get all the students participating and bring out some passion in the classroom.  As the National Academies of Sciences pointed out in their 2016 report, Genetically Engineered Crops (see pages 48-51), public opinions are very strong and range from intense opposition (on the view that genetically modified food is “extremely risky”) to strong support (“overwhelmingly beneficial”) even though, as NAS pointed out, most Americans nevertheless do not know much about genetic engineering as it relates to agriculture.  Continue reading “SSRN Reading List; Genetically Modified Food and the Public’s Voice” →

SSRN Reading List — Is “Milk” Worth Fighting For?

Published on by Erika LietzanLeave a comment

In late August, two professors — from George Washington University Law School and Lund University (in Sweden) — uploaded a fascinating article proposing that plant milk companies stop fighting for the right to call their products “milk” and instead embrace the disruptive term “mylk” in order to disassociate their products from oppression and exploitation linked to dairy milk.  It’s a very interesting read, and it turns out to be very timely . . . because one month after they posted their article, FDA issued a notice asking for comments on the naming of these products . . . .  after a summer in which the media and social media decried imminent “censorship” of names for plant-based foods.  I lay this out — and discuss the article — after the break.

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SSRN Reading List — Food Law and Policy Articles

Published on by Erika LietzanLeave a comment

Cannabis in my brownies and crickets in my soup today.  All good, as far as I am concerned, but the food law and policy issues are fun to chew on.  Monday I will post about two more recent food law and policy articles, one relating to genetically modified food (really pertaining to agency use/misuse of guidance documents) and the other a fascinating read on gender and race aspects of the debate over plant “milk.”  For the weekend, though, cannabis and crickets.

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The Puzzling Uncertainty about Umbrella Exclusivity

Published on by Erika LietzanLeave a comment

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

Published on by Erika Lietzan2 Comments

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

Published on by Erika LietzanLeave a comment

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

Published on by Erika LietzanLeave a comment

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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Whither FDA’s drug approval paradigm? — A Debate from Recent FDA Law SSRN Postings

Published on by Erika LietzanLeave a comment

A series of thoughtful articles in the spring tackled some basic questions about the drug development and approval paradigm.  I’ll be reviewing other SSRN postings in later posts, but the articles described below work well together — presenting fundamental questions about how drugs should be studied (when and by whom), how the resulting information is processed, and what information (how much and what type) should be required before drugs are permitted on the market.  And they tee up what might be a spirited debate about what, exactly, a “public health” approach to new drug approval might mean.

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Opening Up the OTC Market

Published on by Patti ZettlerLeave a comment

Cross-posted on Stanford’s Law and the Biosciences Blog

Yesterday, FDA announced a new draft guidance “Innovative Approaches for Nonprescription Drug Products” intended to expand the range of drugs available over-the-counter (OTC). Specifically, the agency’s proposal indicates a willingness to make available OTC drugs for certain historically prescription-only therapeutic categories—such as overdose reversal drugs, like naloxone, or cholesterol-lowering drugs. As I told a journalist yesterday, overall I see this as a positive step—and one that is consistent with long-standing interest in making more drugs available without a visit to a physician, including interest at the state and local level.

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