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Michael A. Carrier is a Professor of Law at Rutgers University School of Law, Camden. He has published and spoken widely on the antitrust and intellectual property laws, and is one of the leading authorities in the country on the intersection of these laws. His new book, Innovation for the 21st Century: Harnessing the Power of Intellectual Property and Antitrust Law, looks at how innovation has been threatened by the United States legal system and seeks to reverse the trend, offering ten revolutionary proposals, from pharmaceuticals to peer-to-peer software, to help foster innovation. In the post below Carrier reports on today’s decision in the Cipro case.  Read Carrier’s previous post here.

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits: agreements by which brand-name drug manufacturers pay generic firms to stay off the market. This issue has been raging in the halls of Congress, the courts, and the government agencies.

And now, perhaps, the first full appellate court. This morning, a panel of three Second Circuit judges upheld a settlement involving the antibiotic ciprofloxacin hydrochloride (Cipro), the blockbuster drug used to treat bacterial illnesses. In a nutshell, Bayer paid firms interested in making generic versions of Cipro $398 million in return for the generics agreeing not to enter the market during the term of Bayer’s patent.

This type of settlement, which is becoming more common by the day, includes a “reverse payment.” Such a payment differs from typical licensing payments that flow from challengers to patentees by preventing competition and by paying the generic more than it could have earned by entering the market. This is possible because, by delaying generic entry, the brand firm dramatically increases its monopoly profits and uses a portion of these profits to lavish windfalls on generics.

Agreements like these have been blessed by most courts in recent years. Courts have explained that the agreements reduce costs and increase innovation. They have referred to settlements as “natural by-products” of the Hatch-Waxman Act (the 1984 law designed to foster generic competition and drug innovation). And they have pointed to patents’ presumption of validity in demonstrating the agreements’ reasonableness. In fact, the Second Circuit had previously made these very arguments in upholding an agreement involving the breast-cancer drug Tamoxifen.

The court today relied on the Tamoxifen case in upholding the Cipro settlement. But the most interesting aspect of the decision was the panel’s recommendation that “because of the ‘exceptional importance’ of the antitrust implications of reverse exclusionary payment settlements of patent infringement suits, we invite plaintiffs-appellants to petition for rehearing in banc.” The panel could not overturn its earlier decision absent an intervening decision by the U.S. Supreme Court or an in banc proceeding involving the entire Second Circuit. But it offered four reasons for rehearing:
(1) “The United States has itself urged us to repudiate Tamoxifen” (in a brief filed by the DOJ by invitation last summer);
(2) “There is evidence that the practice of entering into reverse exclusionary payment settlements has increased since we decided Tamoxifen”;
(3) The principal drafters of the Hatch-Waxman Act have criticized settlements after Tamoxifen was decided; and
(4) “Tamoxifen relied on an unambiguous mischaracterization of the Hat

Hi Holly, thanks for stopping by. Before I pick your brain about marketing, tell us a little about yourself.

Sure, Shelli. Thanks for having me. I started out in publishing in my hometown of Nashville, TN. I worked for a Christian publisher in the children's division before moving to NY and hopping the fence to the world of agenting. My first job in New York was as an agent trainee at the William Morris Agency, and then I moved to Trident Media Group. I came to Waxman Agency in the spring of 2007 where I am currently representing authors of both fiction (young adult/middle grade, commercial women's fiction, romance and mystery) and nonfiction (self-help/relationships, lifestyle, soft business, and narrative).

At Waxman, we have both an agency site and an agency blog. I do a lot of the blog management--but if you have a question for any of Team Waxman to tackle, please do pass it on! I also twitter and really enjoy connecting with authors there (I don't auto-follow back but I do check out my @repliers. And if none of that made a lick of sense to you, I promise Twitter does get easier!).


I think I'm following you in every sphere possible :) In your opinion , what are the top 3 things every author should and must do to promote their book?

In general, I think you have to be human and remember others are too. 2. Work your connections. 3. Have an author web site that is clean, professional, and updated regularly.

1. Social networking and the internet have opened up a huge opportunity for authors to spread the word about their work. But they've also introduced new and exciting ways to shoot yourself in the foot. Approach all interactions with thoughtful humility and remember that the people on the other end are not just book-buying-bots. Making a real connection on a human level will make your friends or followers or readers that much more excited to see your book soar. Don't we all love it when nice guys finish first?

2. Along those lines your connections are your base. If you're asking people to go out on a limb with you (whether it's an event, a promotion, or just plonking down cash for your book), they're much more likely to do that if they already feel some sort of vaguely positive emotion toward you. I'd rather you focus on relationship-building with your local booksellers or doing a self-funded friends & family "tour" than spend your time composing a package to send to Oprah. An extreme example, but in many cases those "big" efforts result in authors trying to do things a publisher is better set up to do, or that aren't useful expenditures of time. Think about the markets of people you know would love your book (hopefully because you yourself are part of that group), but that are perhaps too niche for a publisher to focus on. You can reach those people. All the social networking sites are tools you can use to get to your people. And people want to be part of your success--if you give back and remember connections aren't just one-way.

3. No dancing kitten .gifs would be my preference, much though I love kittens. Err on the side of simple and readable when in doubt. Have some humanizing details (it's all about connection) and make sure it's easy to click-to-buy your book! I don't think this site has to be up before your book sells to a publisher, either, though it's fine if it is.


Oh good, I don't have any dancing kittens! How important is technology to an author’s marketing plan?

It's fabulous if you have a tech aspect to your platform. But if it's not proven, it just won't be very persuasive to a publisher, and if you present it like it's impressive and it isn't, then you risk looking small-time. If you tout your blog with its audience of 150 readers...those numbers won't be compelling to a publisher--they're more of a nice start. Saying "I will get 1500 Twitter followers" is nice but how do we know that 1) you can do it and 2) it sells books? I'd focus more on conveying that you are part of a community that will support a work like yours, whether it's YA authors who have offered to let you do a blog tour (a promo idea I love) or the Jane Austen websociety you co-chair with its 30,000 subscribers. Also focus on existing things, rather than hypotheticals: ie, you write for the Huffington Post and they'll link your books next to your columns, rather than you will start a blog and get lots of hits somehow.

Most of all you want to demonstrate that you are reasonably tech-savvy and willing to work on it. I'd rather you show me that (say, by joining in the conversation on Twitter or by having a blog, even if it's basic and not yet about your published-ness) than tell it to me. I definitely swing by to see what people's online presence is like; it's often a good cue as to whether we're likely to be a fit. I know editors who do the same.


Do you feel it is beneficial for authors to team up and promote books as a group? Why?

I am a big fan of this, although you do have to choose the team wisely. The best case scenario is, you've got a group of authors who are enough alike that readers of one would probably like the others, but different enough that you get a range of points of view. It shares the time commitment of promotional work and I think, with multiple voices in the conversation, it's less likely to turn into a me-fest. Two of my clients blog together with four other debut authors at The Novel Girls and I love their Topics of the Week, and the different takes each one has on the subject at hand.

I think you can also do things in a group setting that are less about promotion, per se--for instance, Living Your Five is run by four YA authors, but it's about something so much bigger than "buy our books"--they're out to make a difference, and bringing together their readers & fans to do so. The power of the group at its best!


What things do Publishers expect in terms of Marketing? What does the average author receive or is it different, depending on the book?

Publicists are the busiest people in the business, and the least appreciated to boot. So having an author who's out there spreading the word, especially an author who expresses gratitude for the efforts of the house, is a recipe for happy publisher. (I would advise against any dispatches that start "You aren't doing jack for my book so I'm doing it myself." Strongly advise against.)

I don't think publishers "expect" anything from authors, per se. But they also know that an author who is smart about promotion and publicity can make a big difference between a book that does just OK and a book that quietly outperforms expectations. Publishers necessarily have to focus on the wide angle, whether that's just flat-out getting the book in stores, or securing co-op, or a special push for libraries. A savvy author can go for the close-up, the local and affinity based efforts, and I find houses generally very supportive of those sorts of efforts.

But when you're preparing for your own plans and figuring out what you need from your house, be thoughtful about how much work that "tiny favor" or six you're asking for creates on the other end of things for your editor or publicist. Your agent should be able to give you a sense of whether what you've got in mind is something the house might want to share in, or best handled on your own.


Finally, as an agent, what (if any) things do you expect an author to do in terms of marketing?

I want my authors to be out there connecting with readers and potential readers, whether via blog or twitter or even in real life, or best yet, all three. Different approaches are right for different kinds of personalities and books. I expect authors to ask questions if they're unsure of what to do next, and to conduct themselves professionally even when frustrated. Beyond that, I want authors to play to their strengths, because you can always tell when someone has a blog only because someone told them that to move copies you have to have a blog (exchange "blog" for whatever other promo tool suits). No two authors' promotional efforts will look exactly the same, and that's a good thing.


Thanks Holly for the great advice!

Thanks Shelli!

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