As Benjamin Franklin wrote in 1789, “Our new Constitution is now established, and has an appearance that promises permanency; but in this world nothing can be said to be certain, except death and taxes.” It’s Tax Day and all the little people have to pay their taxes by today to the Internal Revenue Service. Well, at least April 17 is Tax Freedom Day! Just think, you only had to work 107 days to pay your share of taxes to the government.

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The Baristas, of course, are sunning themselves and sipping Long Island Iced Tea in the beautiful Cayman Islands. (There are no taxes in the Cayman Islands – government revenue comes from indirect taxes such as customs duties, stamp duty and annual fees levied on corporations.)

As we’re enjoying the proceeds of all the money we make off our Patent Baristas blog – which have been deposited in an Offshore Holding Company – we thought this would be a good time to ponder a few items about taxes.

The first U.S. income tax was in 1862 when the federal government was raising money for the Civil War. The first permanent U.S. income tax didn’t come along until the 16th Amendment in 1913. The deadline for paying taxes, though, wasn’t on April 15 until 1955 when it was moved later in the year to give the Tax Man more time to hang on to your money.

It’s funny to imagine that a system designed so that only the wealthy paid taxes currently puts middle-class taxpayers in the rich category. Now, the alternative minimum tax, originally designed to catch just 155 super-wealthy Americans who paid no taxes at all, will hit nearly 3 million taxpayers, up from fewer than 200,000 in 1990. Unless something is done, some 20 percent of taxpayers will be caught in the AMT net next year, up from 4 percent currently.

“Worried about an IRS audit? Avoid what’s called a red flag. That’s something the IRS always looks for. For example, say you have some money left in your bank account after paying taxes. That’s a red flag.” — Jay Leno

But the Baristas are not the only ones who can benefit from traveling to the Caribbean. Intellectual property is often the principal source of value and revenue for pharmaceutical and biotechnology companies. To lessen the tax burden, companies should consider whether to place their intellectual property rights in a holding company outside the United States.

Typically, this is a subsidiary intellectual property holding company in a tax-free foreign jurisdiction. The offshore holding company then grants a license to the parent company or other third parties in exchange for royalty payments. The goal, of course, is to minimize the parent company’s tax burden and limit taxation on revenue. Not only should the royalties generated by this offshore subsidiary be tax-free, but also generally the profits made abroad aren’t taxable in the United States until they’ve been repatriated.

Sound good? Consider these tidbits:

1. You need to establish the holding company early in the development of your intellectual property — before the IP has significant value (presumably prior to commercialization). You will be taxed on the transfer of the IP offshore, so you’ll want to soften the bite. Consider seeking the advice of a valuation expert to help substantiate the IP’s value.

2. Once IP rights are transferred, you usually pay royalties to the holding company in exchange for use of the IP. When you deduct these royalties from your company’s taxable income, the royalty rates become subject to scrutiny by U.S. taxing authorities. To lessen such scrutiny, establish a royalty rate as if it were between third parties in an arm’s-length transaction. Due to the complexities of setting royalty rates for IP — especially noncommercialized IP — seek advice from an independent expert.

3. Depending on which foreign jurisdiction you choose, your subsidiary may be required to withhold a percentage of the royalty payments for tax purposes. This is why you want to choose a tax-haven country with a favorable U.S. tax treaty — or no treaty at all. Jurisdictions with no U.S. tax treaties and no corporate tax infrastructure may appear the best choice, but in this post-Enron* business climate, U.S. tax authorities have heightened inspection of offshore holding companies.

Note: In the past few years, the Caymans have adopted information-sharing with the U.S. government, which makes it a bit tougher to launch that offshore corporation.

Warning: Do not make this kind of move without seeking adequate legal and tax advice for your jurisdiction in order to pass scrutiny from the IRS.

Enjoy the weekend. You deserve it!

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*Enron had about 800 Offshore Companies set up in the Cayman Islands for tax purposes. This was not the reason, by the way, that Enron had problems, in fact, it saved them millions of dollars in taxes. It was reported that Enron has not paid Federal income taxes for five years (since 1997) due to the tax credits, etc.

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Its so nice to see Kos and Barr deciding to kiss and make-up and come to an agreement over the generic versions of Niaspan and Advicor. I am not taking sides in this dispute. Rather, I feel that this settlement agreement is in the best interest of the patients that need these drugs, and that should be the bottom line here, with issues of patent validity and infringement aside. So, regardless of how these two companies were brought to the negotiating table to come up with this three-part agreement, it would appear to be an equitable solution without court intervention and both parties should be applauded for their efforts at constructing this settlement agreement.

The Settlement and License Agreement permits Barr Laboratories to launch generic versions of Niaspan and Advicor, as well as future dosage formulations, strengths or modified versions of the Products, under terms of an exclusive license commencing on September 20, 2013, approximately four years earlier than the last-to-expire Kos patent. In other words, what this settlement agreement provides for is the certainty of generic entry by Barr four years before the Kos patents expire, or potentially earlier in certain circumstances.

Upon launch, Barr would pay Kos a royalty equal to a portion of profits generated from the sales of generic versions of the Products. As part of the settlement, Barr admits that Kos’ patents are valid and enforceable and that Barr infringes the Kos patents.
(more…)

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The premier issue of Blawg Review was hosted Monday, April 11th, at Evan Schaeffer’s Notes from the (Legal) Underground with 31 noteworthy posts from this past week in the blawgosphere. Presented as “a group of law bloggers who are committed to making the best of the blawgosphere more easily accessible and enjoyable to read,” Blawg Review is a site for the review of law blogs and postings.

The Baristas have been tied up (Karlyn’s move and all) and didn’t manage a submission in this inaugural edition but we plan to be a regular contributors to this tremendous effort. The Blawg Review will be hosted by the Baristas on August 15th so be sure to check back.

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Barr Pharmaceuticals Inc. announced that it dropped its lawsuit against the Food and Drug Administration (FDA) over exclusive marketing rights to a generic version of the Allegra allergy drug made by France’s Sanofi-Aventis.

In February, Barr sued the FDA to challenge its decision to make the company share a 6-month exclusive selling period. The company said it is now dismissing the suit because the FDA has said it can obtain sole exclusivity by slightly modifying its application for the drug.

Barr’s version of the 12-hour Allegra-D tablet has tentative FDA approval, meaning the company cannot sell the drug until its patent protection expires. Sanofi-Aventis’ first patent related to the drug expires in 2012. Barr’s stock was up on the news.

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TheDeal.com has a nice article outlining the issues that can arise in a large pharma mega-merger such as between French pharmaceuticals company Aventis SA takeover by Gallic rival Sanofi-Synthélabo SA, in a €53.3 billion ($69.1 billion) after Paris intervened to fend off a Swiss attempt. The results are still mixed.

Sanofi-Aventis SA, the world’s No. 3 drug company, faces patent challenges to its three biggest-selling drugs — blood thinners Plavix and Lovenox and allergy drug Allegra and the patent on a fourth blockbuster drug, Ambien, used in the treatment of insomnia, expires in 2006.

If Sanofi-Aventis loses the court cases, generic drugmakers will certainly take a substantial portion of the $5.3 billion in sales revenue the three products earned last year.

A preliminary hearing on Plavix is slated for May 13. The challenges to the patent’s on Lovenox and Allegra could be heard in September. The outcome will certainly be looked at carefully by large pharmas and generics with equal interest.

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The U.S. Federal Circuit voted en banc to vacate a holding from a panel opinion with regard to the issue of experimental use, and the panel (J. Rader) has issued a new decision regarding a previous holding that the paroxetine hydrochloride anhydrate product produced by Apotex Corp. infringes Smithkline’s U.S. Patent No. 4,721,723 covering crystalline paroxetine hydrochloride hemihydrate, a form of Paxil that has some water molecules.

There is an exhaustive review and postings of the various opinions and brief’s at Dennis Crouch’s Patently Obvious blog here and here.

This case has quite a bit of history and in 2003, Seventh Circuit Judge Posner dismissed a patent infringement case involving paroxetine on the ground that the patent was not infringed. In 2004, a panel of the Federal Circuit affirmed the judgment, on the alternate ground that the patent was invalid due to public use of the invention more than a year before the patent was applied for because Smithkline conducted clinical trials more than one year prior to filing of the patent application. However, Smithkline argued that the clinical trials were an experimental use but the panel ruled that the use was not experimental. The Federal Circuit reversed the claim construction of the district court and held that claim 1 covers any amount of crystalline paroxetine hydrochloride hemihydrate without further limitation. Based on the factual findings of the district court, the Federal Circuit affirmed the district court’s finding that Apotex’s PHC anhydrate product will infringe claim 1 under that broad construction. Notwithstanding that conclusion, the Federal Circuit held, based on the undisputed facts, that SmithKline’s clinical trials constituted a public use under § 102(b) rendering claim 1 invalid. Apotex was thus not liable for infringing claim 1 of the ’723 patent.

In its new decision, the CAFC majority simply avoided the issue of experimental public use by finding alternative grounds to invalidate the patent, holding that the asserted claims “invalid for inherent anticipation by the ’196 patent under § 102(a).” This was originally rejected because Apotex “did not prove by clear and convincing evidence that it was impossible to make pure PHC anhydrate in the United States before the critical date.” The appellate panel found that Judge Posner erred by requiring Apotex to meet this standard of proof.

Now, the Federal Circuit en banc issued an order that granted the parties’ petition for rehearing en banc “for the limited purpose of vacating the panel’s original opinion addressing the issue of experimental use” and “remanded to the panel for further proceedings,” without analysis. Additionally, the panel issued a new opinion, “pursuant to an order issued by this court en banc,” deleting its earlier public use/experimental use holding and replacing it with a new holding that the patent was invalid for a completely different reason.

There’s a good discussion of the issues on Howard Bashman’s blog, How Appealing.

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I realize there are about 9 million blogs out there so new sites do not generate the excitement they once did. And while I can only monitor a handful, I keep finding news blogs that are quite worthwhile. In case you didn’t see these, I wanted to mention a couple of new ones noted by Steve Nipper.

The first is billed as “the final resting place for all of our thoughts, comments, insight, podcasts, whitepapers, action figure order forms, etc.” to come out of the ABA Techshow meeting: the rethink(ip) blog.

This is another effort (evolution, really) by Douglas Sorroco, Stephen Nipper, and Matthew Buchanan to go with their pocasting site RETHINK(IP) ALOUD (in MP3 format). These guys are like the Army. They do more before 9 a.m. than most people do all day.

Also of note, the folks at TechnoLawyer.com have officially launched the TechnoLawyer Blog, a legal technology resource that will supplement the TechnoLawyer website. It is cited as “an amalgam of pithy commentary, industry news, and other helpful information compiled by Neil Squillante and Sara Skiff.”

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