Licensor Recovery of Attorneys’ Fees in Bankruptcy

November 18th, 2010, by Richard R. Bergovoy

Photo Courtesy tristam sparks under the cc 2.0 license

The only thing worse for a licensor than losing money when its licensee files for bankruptcy is paying attorneys’ fees on top of that to stop the bleeding.

Two of the most common bankruptcy proceedings that licensor creditors get involved in are: 1) hearings related to the licensee’s attempt to assume an executory license agreement; and 2) lawsuits against the licensor to recover so-called preferential transfer payments from the licensee.

But can a clever licensor recover attorneys’ fees incurred in post-petition bankruptcy proceedings, if it had the foresight to include a well-drafted attorneys’ fee provision in its boilerplate license agreement?

Since a 2007 Supreme Court decision, the answer has been “maybe,” which was a big improvement over the previous answer of “almost never.”

Until 2007, there were two hurdles against a licensor creditor recovering its attorneys’ fees in a bankruptcy proceeding. The first was that many courts invalidated attorneys’ fee provisions to the extent that they applied to bankruptcy proceedings, arguing that the Bankruptcy Code had a general policy to invalidate contractual clauses that were triggered by bankruptcy. The second was that some courts interpreted the Bankruptcy Code to prohibit recovery of attorneys’ fees by unsecured creditors under any circumstances.

In 2007, the US Supreme Court removed the first hurdle in Travelers Casualty & Surety Co. v. Pacific Gas & Electric Co., which held that the Bankruptcy Code did not contain a blanket prohibition on recovery of attorneys’ fees for bankruptcy related proceedings, as long as the attorneys’ fees provision is valid under state law.

But the Travelers case did not address the second hurdle, and there is currently a split among various courts whether unsecured creditors can recover attorneys’ fees even pursuant to a contractual provision valid under state law. So far, the Second Circuit, Ninth Circuit, and Sixth Circuit federal appeals courts have permitted such recovery, while the First Circuit and Eighth Circuit (in pre-Travelers opinions) have not.

Sigh, so confusing. What is a licensor to do? Well of course, put attorneys’ fee recovery language in your boilerplate license agreement. The worst that can happen is the court says no.

A starter attorneys’ fee provision might read as follows:

“If any legal action, arbitration, or other proceeding is brought under or in relation to this Agreement, including but not limited to any legal action, arbitration, or proceeding under the U.S. Bankruptcy Code, then in addition to any other relief to which the Licensor is entitled, if the Licensor is the successful or prevailing party, then the Licensor is also entitled to recover, and the Licensee shall pay, all: (a) reasonable attorneys’ fees of the Licensor; (b) court costs; and (c) expenses, even if not recoverable by law as court costs (including, without limitation, all fees, taxes, costs and expenses incident to arbitration, appellate, bankruptcy and post-judgment proceedings); incurred in that action, arbitration, or proceeding and all appellate proceedings. For purposes of this Section, the term ‘attorneys’ fees’ includes, without limitation, paralegal fees, investigative fees, expert witness fees, administrative costs, disbursements, and all other charges billed by the attorney to the Licensor.”

Adjust the above to be valid under the state law that governs the license agreement. Check whether that state law makes the provision reciprocal, by deeming that if an agreement grants one party the right to recover attorneys’ fees, then the other party is automatically entitled to recover its attorneys’ fees under like circumstances. Then cross your fingers.

Oh Man: Dora the Explorer Discovers She’s Been Swiped

November 2nd, 2010, by Richard R. Bergovoy

David vs. Goliath, Dora the Explorer vs. Swiper the Fox, Caitlin Sanchez vs. Nickelodeon.

Since our passion is the drafting and negotiation of intellectual property-related contracts, when 14-year-old Caitlin Sanchez, the voice of the popular Dora the Explorer cartoon character, filed a lawsuit against the Nickelodeon cable network claiming that Nickelodeon and its affiliates have duped her out of millions of dollars in royalties and residuals by pressuring her to sign a “bizarre, impenetrable, unconscionable contract,” it tweaked our curiosity.

But was it really a bad contract, or rather bad negotiation that resulted in Caitlin getting a lot less money than she and her family expected?

To answer that question, we tracked down a copy of the agreement (“Agreement”) between Caitlin and Uptown Productions, Inc. (“Uptown”), the production company for the Dora program, and compared it to the allegations in the lawsuit complaint, filed by the law firm of Balestriere Fariello. (Agreement is here, complaint is here.)

And the comparison showed that the contract IS bad, but not confusingly bad, just transparently bad— extremely but obviously one-sided in Uptown’s favor. Despite that, Caitlin and her family signed the Agreement and several subsequent documents literally within minutes of receiving them, without negotiating or asking an attorney to assist them. That was akin to Dora the Explorer not chanting, “Swiper, no swiping!” when the larcenous fox was in plain sight.

In doing so, they made the same mistake that many artists, actors, musicians, designers, and other creative people make when they are approached by television, music, or theatrical producers—they silence their questions and sign, for fear of being ditched and missing their big break.

The framework for the Agreement between Uptown and Caitlin is that Uptown would pay for Caitlin’s exclusive services for seven episodes of the Fifth Cycle of the Dora series and would retain options for 10 episodes for each of the Sixth through Tenth Cycles of the show. Caitlin was to receive: a salary of $5,115 per episode (increasing 5% per cycle); plus residuals based on the number of re-broadcasts of the original episodes; plus merchandise license fees. She was also required to do a “reasonable” amount of promotional appearances and interviews.

(1) The complaint alleges: Nickelodeon “fail[ed] to fully compensate Caitlin for products she voiced, for which she is due a percentage of the products [sic].” Uptown has only paid Caitlin $9,636.39 in merchandising royalties to date, according to the complaint. Caitlin’s attorney claims that that is an absurdly low and definitely incorrect figure in light of the fact that Nickelodeon claims gross retail sales of $11 billion in Dora merchandise since 2002.

The contract states: Uptown “shall pay you 5% of 100% of the ‘net receipts’ actually received by [Uptown] from merchandising, should your name, voice or likeness be used alone in connection therewith, reducible to 2-1/2% of 100% if other artists are used…; ‘Net receipts’ shall mean the amount remaining after deduction of a distribution fee of 50% of the gross receipts actually received from agents and distributors; and all costs related to such merchandising use.”

Our take: Caitlin would get royalties based on only the subset of Dora merchandise that featured Caitlin’s voice or her actual (not Dora’s) image, and that the revenue stream on which the royalties would be calculated could be easily manipulated by Uptown’s “creative accounting.”


How do you say, “Swiper, no swiping!” in Swedish?

Read the rest of this entry »

Licensing and the Pharma Patent Cliff

October 22nd, 2010, by Richard R. Bergovoy


Photo courtesy Dennis Barnes Photography

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 2.0 Generic License.

Peering over the edge of a “patent cliff” that threatens to cut deeply into its profits, Big Pharma is considering modifying its current business model of in-house development of all-or-nothing blockbuster drugs towards a business model of in-licensing from biotech startups and university researchers.

The time and cost of developing new drugs from scratch is enormous– typically $2 billion per successful drug and 10 to 15 years from initial research to final regulatory approval.

But during the next five years, many top-selling blockbuster drugs will come off patent, and face severe price competition from generic versions, including: Pfizer’s Lipitor; Astra-Zeneca’s Seroquel; and Sanofi-Aventis’ and Bristol-Myers Squib’s Plavix. Between 2011 and 2014, four of Eli Lilly’s top five sellers will fall off the patent cliff: Zyprexa, Symbalta, Gemzar, and Evista. Estimates peg the total revenue loss to Big Pharma as high as $140 billion through 2016.

In response, analysts at Morgan Stanley are advocating a move away from the go-for-broke nature of the blockbuster business model, towards a Pharma 2.0 model of in-licensing from biotechs and academic researchers, who do all early-stage research and testing, and assume most of the risk. According to their analysis, the return on investment of in-licensed drugs is three times higher than drugs developed in-house.

And it appears that some of Big Pharma is listening. According to thepharmaletter.com, in 2009 the top 10 pharmaceutical companies entered into 12% more health-care focused licensing deals than the year before. Andrew Baum of Morgan Stanley estimates that large European pharmas will cut research spending by 40% in the next two years, and focus on licensing and acquisitions of promising drugs in development.

But for other pharmaceutical companies, the “Not Invented Here” syndrome still rules the day. Eli Lilly, which faces probably the most severe patent cliff among the major pharmas (above), has announced that it will meet the challenge mainly through cost cuts, job cuts, and modifications of existing product lines, rather than major new licensing or acquisition initiatives. It argues that slashing in-house research and development to boost return on investment is a short-term fix that would undermine Lilly’s long-term mission.

As we have argued in other contexts, while licensing may not always be appropriate as a complete replacement for in-house research and development, it is almost always appropriate as a complementary business model. When you are looking over the side of a cliff, Not Invented Here goeth before the fall.

Witches, and Bozos, and IP, Oh My

October 13th, 2010, by Richard R. Bergovoy

Trick or Tea!

Is she a witch?

And was her father a Bozo?

In observance of the upcoming Halloween and Election Day holidays, and in the spirit of fun, we take a look at the intellectual property issues raised by the candidacy of Christine O’Donnell, the Republican and Tea Party candidate for U.S. Senate from Delaware.

Almost as soon as Ms. O’Donnell upset the party favored candidate in the Republican primary on September 14, video surfaced of her on the “Politically Incorrect” television show confessing that as a young woman, she had “dabbled into witchcraft,” and had had a date on a satanic altar. Her confession made her the punch line of a thousand late night one-liners– and the subject of her very own witch action figure. Internet toy seller herobuilders.com has capitalized on the publicity by offering a 12 inch Christine O’Donnell witch action figure for $39.95, featuring a smiling likeness of Ms. O’Donnell dressed in sorceress basic black flowing cape and pointy hat (sorry, no broomstick).

Can they do that?

Rights of publicity laws in many states prohibit commercial usage of the name, image, signature, or other indicia of the identity of a person without her consent. However, rights of publicity can be superseded by the First Amendment rights of the speaker, for example if the identity is used in news reporting, political commentary, parody, or (at least in California) if significant original transformative content has been added.

At first glance, the O’Donnell action figure seems to qualify under the commentary and parody exceptions.

But even when it is a much closer call — for example, an action figure that is an outright copy of a political figure solely in order to free-ride on his/her popularity — politicians usually decide it is bad publicity to sue. Herobuilders.com also sells action figures and bobbleheads of President Obama, Sarah Palin, Nancy Pelosi, Dick Cheney, and others. A notable exception to the “no sue” rule was California Governor Arnold Schwarzenegger, who sued an online seller of Schwarzenegger bobblehead dolls in 2004, but later agreed to a settlement in which the company could sell the dolls after a few modifications, such as removing the Governator’s toy assault weapon.

IP issues seem to run in Ms. O’Donnell’s family. According to this hilarious clip from MSNBC’s “Countdown,” Ms. O’Donnell’s father was the “fill-in Bozo the Clown” for a Philadelphia television station. He could not be the “official” Bozo because he did not attend the official Bozo training school in Texas.

Indeed, “Bozo” is a registered trademark of Larry Harmon Pictures Corporation (“LHPC”) for “Entertainment Services In The Nature Of A Children’s Television Program; Entertainment Services In The Nature Of Live Performances By A Clown Character.” So as licensor of this trademark, LHPC had a duty to maintain Bozo quality standards, for example by requiring CBE (Continuing Bozo Education) of all those licensees who represented themselves as Bozos to the public. Licensing without such quality controls would have been a naked license– in effect, a naked Bozo license. And that is a thought even more scary than a witch in the Senate.

Licenses 2, Sales 0 in Eminem and Autodesk 9th Circuit Rulings

September 22nd, 2010, by Richard R. Bergovoy

The growing popularity of licensing as a strategic business and legal tool is likely to grow even greater as a result of a pair of cases decided one week apart in the federal Ninth Circuit Court of Appeals that broadened the scope of and increased the powers of licenses.

The first Ninth Circuit decision, F.B.T. Productions vs. Aftermath Records, involved a dispute between rap artist Eminem and his record label Aftermath about whether Aftermath’s provision of Eminem’s songs to iTunes was a “sale” or “license” for purposes of a contract drafted in the pre-digital age. The difference was significant, because the agreement provided that the label would pay Eminem royalties of between 12% and 20% of the adjusted retail price of all “full price records sold in the United States… through normal retail channels,” but would pay 50% of its net receipts “[o]n Masters licensed by us… to others for the manufacture and sale of records or for any other uses.” The agreement was signed in 1998, before iTunes was established, and did not further define either “sale” or “license.”

The record label argued among other things that the custom in the recording industry was that the “masters licensed” provision applied only to “compilation records and incorporation into movies, TV shows, and commercials,” and furthermore, that the iTunes download was functionally no different than a purchase of a vinyl record or CD at a record store.

The court rejected that argument, and held that under copyright law, a license is, “an authorization by the copyright owner to enable another party to engage in behavior that would otherwise be the exclusive right of the copyright owner, but without transferring title in those rights.” Because the record label retained ownership of the copyrights for the Eminem songs as well as title to the digital music files that it made available to iTunes in exchange for periodic payments based on the volume of downloads, the transaction was a license, and the higher 50% royalty rate applied.

One week later, in the case of Vernor vs. Autodesk, Inc., the court ruled that most written license agreements will preserve the licensor’s right to prohibit resales not only under the license agreement, but also under the Copyright Act. There the issue was whether Timothy Vernor could sell on eBay outdated copies of Autodesk’s AutoCAD software for a few hundred dollars that normally sell for several thousand dollars per copy when new.

Copyright law confers several exclusive rights on copyright owners, including the exclusive right to reproduce their works and to distribute their works by sale or rental. An important exception to this exclusive right is the so-called “first sale doctrine” codified at Section 109 of the Copyright Act, which says that the, “owner of a particular copy or phonorecord… is entitled without the authority of the copyright owner, to sell or otherwise dispose of the possession of that copy or phonorecord.” So for example if a publisher sells a book to a bookstore, the bookstore is free to resell it to anyone, and the purchaser is in turn free to sell the same book to anyone on eBay.

Vernor had purchased the AutoCAD software from an architectural firm that had licensed it from Autodesk. The AutoCAD license agreement contained standard provisions prohibiting transfer to or use by any party other than the original licensee, however, it did not require the licensee to return old installation disks. Vernor argued that under prior case law in the Ninth Circuit, since the license did not require the architectural firm to return its copies of the install discs, the firm was an “owner of a particular copy,” which kicked in the first sale doctrine which exempted the firm and any of its purchasers from a copyright infringement claim arising out of resale of the discs. Although the architectural firm had violated its license agreement by reselling the discs, Vernor argued that he had not, because he had neither installed the software nor agreed to any online license agreement before the eBay sales.

After an extensive review of prior case law the appeals court disagreed with Vernor, and held that a software user is a licensee rather than an “owner of a copy” where the copyright owner: 1) specifies that the user is granted a license; 2) significantly restricts the user’s ability to transfer software; and 3) imposes notable use restrictions. Like most well-drafted software license agreements, the Autodesk agreement passed with flying colors, despite the absence of a requirement to return old install discs. Thus, because the architectural firm was a licensee, not an “owner,” then the first sale doctrine did not apply, and Vernor had infringed Autodesk’s exclusive distribution rights in violation of copyright law.

Takeaway: the Eminem case is not expected to have much of a practical impact on the recording industry, because since the time of that agreement, almost all record label agreements deem that provision of songs to iTunes will be treated as a “sale” at a 12% to 25% royalty rate. But when the nature of a copyright transaction is unclear, the Ninth Circuit will presume it is a license rather than a sale where the copyright owner retains control of the copyright, retains title to the media on which the content is delivered (CD, mp3 file, etc.), and receives periodic payments after the original transaction. Vernor says that when a standard license agreement is in place during the original transaction, the copyright owner can use both the license agreement and copyright law to prohibit later resale or disposition of the content. This will encourage copyright owners to cast transactions as licenses rather than sales, and with the proliferation of digital content that can be made easily subject to clickwrap license agreements even after the original point of sale, they will likely succeed in their efforts. So the purchaser of a hard copy of The Girl With the Dragon Tattoo will be able to resell it, because she (and the bookstore before her) took title to the media (book) on which the content was delivered. But she might not be able to resell her e-book version, if she purchases it subject to a standard license agreement at the time of download. One practical effect is that copyright owners will now be able to easily assert that resale of software, digital games, and many other kinds of digital content is a copyright infringement. Please note that these rulings only apply in the Ninth Circuit (California, Oregon, Washington, Nevada, Arizona, Idaho, Montana, Alaska, Hawaii, and Guam), and that other circuits may not follow them.

Which Is Better for My Startup, C Corporation or LLC?

September 13th, 2010, by Richard R. Bergovoy

Photo Courtesy NASA’s Marshall Space Flight Center

Startup clients frequently ask– which is the better business entity, a C corporation or a limited liability company (LLC)?

Before answering that question, let’s quickly review the basic differences between C corporations and LLCs. (For more detailed treatment, see here.)

In a corporation, control is held by the shareholders, but they frequently delegate most major decisions to the board of directors and day-to-day control to the officers. The corporate entity shields shareholders from the corporation’s liability and income. But if the corporation’s income is distributed to the shareholders, for example as dividends, the income is effectively taxed twice, once at the corporate level, once at the shareholder level. The corporate entity is especially advantageous for allowing changes in ownership– in the absence of special provisions such as shareholder agreements, existing shareholders can buy and sell stock without restriction to new shareholders.

Pros

  • More “professional” image
  • More attractive to venture capital funding and more flexible for granting options and other incentive compensation
  • Easier to take public

Cons

  • More formalities such as required shareholder and directors meetings, capital maintenance, etc.
  • Income to shareholders is taxed twice

The LLC is a relatively recent creation, within the last 25 years in most states. It is based on the partnership model, where partners share all control, income, and liability personally. Like partners, LLC “members” share control and income, but like corporate shareholders, members are shielded from liability for the acts of the LLC. LLC income is taxed only once, but all profits (and losses as well) are attributed to the members, even if the LLC retains it and does not distribute it to the members, as frequently occurs in the startup stage. (Note that an LLC can make an election with the IRS to be taxed like a corporation, while a corporation can make an election with the IRS to be taxed like a partnership, as a so-called S corporation.) However, as with a partnership, an LLC does not easily release old members or admit new members– the default rule is that normally at least a majority of existing members must approve any change in membership.

Pros

  • Inexpensive and easy to set up and maintain
  • Income to members only taxed once (but all of it is taxed, even if not distributed)

Cons

  • More difficult for old members to leave, and new members to join (may be a pro for some startups)
  • Disfavored by venture capitalists and incentive recipients
  • Must be converted to a C corporation to take public

Bottom Line: if VC funding and/or publicly listed stock is part of your business plan, then a C corporation is your best startup entity. In almost all other cases, an LLC is cheaper, easier, and lower maintenance, but be sure to address your exit strategy, both for individual members and the company as a whole, in your LLC documents at the startup stage. To help you make the correct choice, please consult a knowledgeable business attorney and/or accountant.

Trademark Licensees Catch a Tax Break

September 2nd, 2010, by Richard R. Bergovoy

The federal Second Circuit Court of Appeals has ruled that trademark licensees can in certain circumstances immediately deduct royalty payments as current expenses, rather than capitalizing and deducting them over time.

Overruling both the IRS and the United States Tax Court, the Second Circuit ruled in Robinson Knife Manufacturing Company, Inc. vs. IRS that where the royalty payments: 1) are calculated as a percentage of sales revenue from inventory, and 2) are incurred only upon the sale of that inventory, such payments are immediately deductible.

Robinson Knife designs, manufactures, and markets kitchen tools such as spoons, soup ladles, spatulas, and cooking thermometers, and sells them to retail customers such as Wal-Mart and Target. Sometimes it sells the products under the store brand. In this case, Robinson Knife sold the goods under the Pyrex and Oneida trademarks, which it licensed from Corning and Oneida respectively. Both license agreements required payment of royalties as a percentage of sales revenue only on sale to the retailers, with no royalty advance payments or minimum guaranteed royalties.

IRS rules under Section 263A of the Internal Revenue Code require the capitalization of, “all direct costs and certain indirect costs properly allocable to property produced,” and include, “licensing and franchise costs” as examples of indirect costs, “that must be capitalized to the extent they are properly allocable to property produced.” Examples of indirect costs not allocable to property produced include, “marketing, selling, advertising, and distribution costs.”

Robinson Knife argued that because the famous trademarks were intended to boost sales of their products, the royalties were in the nature of advertising expenses and thus currently deductible. It was overruled by both the IRS and the Tax Court, which ruled that the royalty expenses must be capitalized under complex inventory accounting rules and deducted over time.

But the Second Circuit ultimately agreed with Robinson Knife, on the grounds that the obligation to pay royalties was not incurred unless and until a sale was made, thus royalties were not incurred by reason of production activities, and did not directly benefit such activities.

This is an important victory for licensees, but its scope is unclear. It remains to be seen whether: 1) the IRS follows this ruling outside of the Second Circuit (New York, Connecticut, and Vermont); and 2) it applies as well to royalties paid on copyright, patent, and other intellectual property licenses. Logically it should, because the ruling was based on the timing of the royalty payments, not on the nature of the intellectual property.

Takeaway: trademark licensees based in New York, Connecticut, or Vermont that pay royalties as a percentage of sales revenue of goods only upon sale of those goods can immediately deduct the royalties as current expenses. It remains to be seen whether the IRS allows analogous treatment for licensees based in other states, as well as licensees of patents, copyrights, and other intellectual property.

5 Minute FAQ: License Agreements vs. SaaS Agreements

August 26th, 2010, by Richard R. Bergovoy


Photo Courtesy NASA

Q: Computing used to be based on the model of the end user running another party’s software on its local computer through a client-server or fat client architecture. Now the business model is moving increasingly towards cloud computing and software as a service. If the end-user no longer has someone else’s software on his computer, does that mean the license agreements are no longer necessary?

First, let’s start off with some definitions. Cloud computing means computing where data is input and stored on a remote third party’s computer, on the Internet or “cloud.” Think Facebook. Software as a service or “SaaS” is a subset of cloud computing where not just data is stored, but also processed via a specific application in the cloud, which is often being used concurrently by many other users. Think Salesforce.com and Google Apps. The end user of SaaS pays a fee over the time of usage, using a subscription or utility model, in contrast to local software where the cost is usually paid all upfront. Also, since the SaaS user does not possess SaaS intellectual property, but accesses it remotely through a Web browser, it pays for access to, rather than use of, the IP.

Q: Well, that was my question. If there is no license of third-party IP, then is a license agreement even necessary?

I was not ignoring your question. You are correct– although there is technically no license involved in an SaaS business model, a user agreement most definitely is necessary, call it what you will. At the end of the day, the difference between an SaaS agreement and a typical end user software license agreement is more a matter of degree than kind. The meta-theme of a software end user license agreement is, “We allow you to use our intellectual property as long as ____ .” The meta-theme of an SaaS agreement is, “We allow you to access our service as long as ____ .” Despite the difference business models, large chunks of both kinds of agreements are interchangeable, because the software licensor and the SaaS service offeror are addressing many of the same business risks. Also, note that some SaaS offerings require installation of software on the local client in combination with access through a web browser, in which case the agreement would be a hybrid even closer to a traditional software end user license agreement.

Q: In what ways is an SaaS agreement different from an EULA?

Obviously, the SaaS agreement would not contain license grant language, except if it were a hybrid, as noted above. Also, an SaaS agreement needs to address business risks that are specific to a cloud environment, such as:

  • Performance and uptime guarantees and/or SLA’s
  • Data privacy and security
  • Data backups and disaster contingency
  • Data portability, especially in case of nonrenewal of the SaaS agreement
  • Term, termination, and renewal provisions, given the periodic nature of the SaaS subscription model

Besides the license grant provision, a typical SaaS agreement also often omits common EULA provisions relating to maintenance, support, and updates, because it is usually done behind the scenes by the service offeror, on a multi-user basis.

Has Pay for Delay Seen Its Day?

August 12th, 2010, by Richard R. Bergovoy


Photo by Sage Ross, CC by-sa

What do you call it when a patent holder pays royalties to a possible infringer, and not the other way around?

In the pharmaceutical industry, it is called “reverse payment” or “pay for delay,” a practice in which the inventor of a patented drug pays the developer of a generic substitute not to produce until the patent is nearly expired.

The practice has withstood multiple court challenges, but is coming under increasing fire from the executive and legislative branches of the federal government as anti-competitive.

And a three judge panel of the influential federal Second Circuit Court of Appeals, which recently upheld a reverse payment arrangement, has even taken the unusual step of inviting the challengers to appeal their loss to the entire 10 judge circuit court panel.

The origins of pay for delay are in the Drug Price Competition and Patent Term Restoration Act of 1984, popularly known as the Hatch-Waxman Act. Hatch-Waxman provides that when a developer of a patented drug applies to the Food and Drug Administration for permission to market it, the maker of a generic version of the drug may file a certification that the generic does not infringe the new drug’s patents, or that the new drug’s patents are invalid. The certification itself is deemed an infringement of the new drug’s patents, and sets the stage for the new drug’s inventor to sue the makers of the generic version for patent infringement.

The original logic of Hatch-Waxman was to encourage development of generics without undue cost to patented drugs by resolving infringement issues at an early stage, before either party had invested huge amounts of money in production and marketing. But it did not work out that way. Many innovators chose instead to pay the generics a “reverse payment” not to produce, usually until shortly before the new drug’s patents expire. Often payment to the generic is in the form of a percentage of sales on the patented drug, in effect, a “reverse royalty.”

Reverse payments have been widely criticized as an unreasonable restraint of trade in violation of Section 1 of the Sherman Antitrust Act.

The Federal Trade Commission estimates that pay for delay settlements cost consumers $3.5 billion per year because of the unavailability of cheaper generic drugs.

But pharmaceutical manufacturers reply that the agreements are reasonable commercial agreements to avoid the expense and uncertainty of litigation, especially where the prospective generic manufacturer has not risked significant market entry expenses or infringement damages, and has little to lose in filing a challenge.

And courts for the most part have agreed. The Eleventh Circuit and the Federal Circuit have upheld the practice, while the Sixth Circuit has held it unlawful.

Two of the biggest class-action antitrust challenges to pay for delay were lengthy class action lawsuits decided by the Second Circuit Court of Appeals.

In 2005, the Second Circuit upheld the practice in In Re Tamoxifen Citrate Antitrust Litigation, in which it ruled that reverse payment agreements do not violate antitrust laws, “[u]nless and until the patent is shown to have been procured by fraud, or a suit for its enforcement is shown to be objectively baseless,” or the settlement agreement extends the patent beyond its original scope.

In Re Ciprofloxacin Hydrochloride Antitrust Litigation challenged a settlement of a 1991 patent infringement lawsuit in which Bayer Corporation paid Barr Laboratories reverse payment royalties estimated at nearly $400 million not to manufacture a generic version of Bayer’s patented drug Cipro. A three-judge panel of the court ruled in April that in light of the circuit’s earlier ruling in the Tamoxifen case, it was compelled to dismiss the plaintiffs’ case, because they had not properly alleged that Bayer’s patent was procured by fraud, nor that the underlying patent lawsuit was objectively baseless.

But the appellate panel had significant reservations about the practice of reverse payments as a whole, and invited the plaintiffs to challenge the decision before an en banc hearing of the circuit’s 10 active judges. The plaintiffs accepted the panel’s invitation, and filed a petition for an en banc hearing, which was joined by briefs submitted by the Federal Trade Commission and the Department of Justice criticizing reverse payment settlements. A ruling on the petition is expected shortly.

Sentiment is also mounting against pay for delay in the legislative branch. Senator Orrin Hatch, who lent his name to the Hatch-Waxman Act, has criticized the practice as increasingly anti-competitive. A bill pending in the Senate would greatly curtail pay for delay by presuming that such agreements are anti-competitive, while permitting the parties to rebut that presumption in court. The bill is similar to a measure that has already passed the House of Representatives.

Pay for delay may have seen its day.

Update, 9/17/10: But maybe just not yet. The Second Circuit declined by 9-1 to rehear the Cipro case en banc, which means that pay for delay has withstood yet another legal challenge.

IP & Licensing Trends in Japan

August 9th, 2010, by Richard R. Bergovoy

“It is often said that Japan wins at technology, but loses at business,” said Kimikazu Noumi, chairman of the Innovation Network Corp. of Japan (“INCJ”) at a recent press conference announcing INCJ’s initiative to monetize Japanese intellectual property assets in the life sciences.

This is a welcome reversal of a trend that we have previously noted, in which Japan has not effectively monetized its abundant intellectual property assets, through licensing and similar means.

INCJ is collecting billions of yen from Japanese public and private investors to launch the “Rising Sun Fund” to purchase dormant life sciences patents from universities and public research institutions, package them, and license them to domestic and foreign companies so they can develop new medicines and treatments without fear of infringement lawsuits. The initial areas of concentration will be embryonic stem cells; cancer; Alzheimer’s disease; and biomarkers.

According to the Japanese newspaper Asahi Shimbun, a main purchase target of the fund will be universities, because they use only an estimated 20% of their patents.

A Japanese version of the story from the same newspaper notes that the impetus for the fund was the 2007 arrival in Japan of the American bioventure fund, Intellectual Ventures, and its subsequent purchase of Japanese university research patents for relatively low license fees. The fund founders feared that the technologies would be developed overseas, and that Japan would not share in the fruits of medical innovations developed from patents developed at its own taxpayer-supported universities.

INCJ is expected to invest up to 1 billion yen (approximately $11.7 million), and several private companies, such as pharmaceutical heavyweight Takeda Pharmaceutical, are expected to invest millions of yen more.

On the other side of the coin, Japanese book publishers failure to license e-books has created a phenomenon known in Japan as 自炊 (jisui), or “cooking for oneself,” in which readers purchase hardcopy versions of books, slice out the pages with razor knives, and scan them into PDF form to read on their iPads. Japanese are avid book readers and big fans of compact technology, yet publishers have made only about 50,000 book titles available in e-book form, with few current best-sellers, compared to about 630,000 English language titles available for the Amazon Kindle.


How to Cook Your Own E-Books, Japanese Style

In fact, consumer demand is so great that new businesses have arisen to fill it– companies that will save readers the hassle of slicing and scanning by performing the service for about 200 yen per volume (approximately $2.38). The reader mails in the hard copy, the company e-mails back the digitized book. Between the service fee and the postage, the reader is probably paying a $4 or $5 premium (or 15 to 20 minutes of his time), over the hard copy price, to have his e-book.

It appears that the delay in making more e-book titles available through official channels is due to publishers’ fears that e-books will be sold at discounted prices relative to paper versions (as in the United States), thereby shrinking profits. But it appears that at least some Japanese readers want e-books so badly, they are willing to pay a premium over the hard copy price. It is a shame that publishers have not adapted their business model, and are leaving money on the table.

Update, 8/24/10: for a good survey of the jisui trend, see this article in the Mainichi Daily News (includes link to original Japanese article). It appears that competition in the jisui service bureau industry has pushed the price down to near 100 yen per volume.

Speaking of the iPad, the Washington Post recently ran an interesting article on how the iPad has become a hit with Japanese senior citizens who were not previously computer adept, because of its sleek design and intuitive, user friendly interface. The iPhone is also a smash hit in Japan– when I was in Osaka in late June, there were literally lines around the block of people waiting to purchase the iPhone 4. Many thought that Japanese would never become enthusiastic about a non-Japanese made electronic device, much less a smartphone, a product for which Japan has long had its own specialized, highly competitive market.

Why has Apple succeeded where so many others have failed? As noted in the link above, Japanese smartphones tend to be feature-centric, but somewhat clunky to navigate, while the Apple devices have been designed from the ground up to provide an elegant, seamless user interface among hardware, software, and abundant content. The usually compact size and sleek design of Apple devices also appeal to Japanese tastes.