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Pharma Law and Business – A Monthly Roundup December 2012

Litigation always factors into the pharmaceutical world, but the US Supreme Court commanded a special place in recent days. The high court figured in no fewer than four contentious issues that, not surprisingly, play a vital role in how drug makers can and will operate. Let’s start with a case that is not yet before the court, but many predict will be headed there thanks to one of its earlier rulings. Earlier this month, a three-judge panel of the US Court of Appeals for the Second Circuit overturned the conviction of a former sales representative, who argued that prosecuting him for remarks made about off-label use violated his free speech rights.

USPTO: One of the Best Places to Work

Earlier today the United States Patent and Trademark Office received special recognition as one of the best places to work in the United States federal government. The Best Places to Work in the Federal Government® rankings draw on responses from nearly 700,000 civil servants to produce a detailed view of employee satisfaction and commitment across 362 federal agencies and subcomponents. With a score of 80.3, the USPTO ranked #5 out of 290 in the agency subcomponent category.

A Night at the Smithsonian, Patent Style

This year the IPO recognized Alex Kipman of Microsoft, the inventor of Kinect, as the 39th Inventor of the Year. Kipman was introduced and presented the award by David Kappos, the outgoing Director of the United States Patent and Trademark Office. The fact that Kappos was the presenter allowed the IPO to sneak in a moment of appreciation for all that Kappos has done for the patent and innovation communities. For his efforts, and to say thank you, those in attendance gave Director Kappos a standing ovation.

Europe Achieves Historic Agreement on Unitary Patent

The European patent with unitary effect (unitary patent) in the 25 participating states is based on two regulations, one creating the instrument, and one on the applicable language regime for the new patent. The EPO has been entrusted by 25 EU member states to deliver and administer unitary patents. The third element of the package is the creation of a unified patent litigation system set up under an international convention establishing the Unified Patent Court (UPC), a specialised court with a first and an appeal instance with exclusive jurisdiction concerning infringement and validity questions related to unitary patents. The positive vote in the Parliament became possible after the EU member states endorsed the regulations in their Competitiveness Council meeting on Monday. The unitary patent now has to be formally adopted by the EU Council and the European Parliament, which is expected soon.

Authors Challenged by Shifting Industry Business Models

The new reality is that content creators are getting squeezed all around. Increasingly many want things to be free and don’t care whether they copy a public domain work or whether it is something that is copyrighted. They don’t see it as wrong, but this makes it difficult to make a living for content creators. Truthfully, for some content creators it is darn near impossible. Yet everywhere you turn content creators are getting the short end of the stick. If it isn’t blatant and wanton copyright infringement online (which I have to deal with all the time), it is authors getting pennies on the dollar for eBooks or musicians who worked with Pandora to help the company get off the ground taken to Congress so the U.S. government can step in and take from creators for the benefit of the company they helped create. Even the name of the bill supported by Pandora — the Internet Radio Fairness Act — is insulting and misleading.

Defensive Patent Pools: There are Surprisingly Few Options

Unlike NPEs, defensive patent pools entities do not (at least initially) seek to generate revenues. Rather, they charge admission fees into the pool to fund IP acquisitions and the administrative costs to operate the pool. In sum, defensive patent pool aggregation is analogous to an insurance policy. But, where classic insurance lowers a company’s costs when accidents happen, patent pools are designed to reduce the likelihood of accidents (i.e., being sued for patent infringement) from happening at all.

University Tech Licensing Has Substantial Impact on Economy

In the case of product sales, 58 institutions (31 percent of the 186 respondents) reported that 2,821 of their licenses paid $662 million in running royalties based on $37 billion in product sales, implying an average royalty rate of 1.8 percent. In the case of startups, 66 institutions (35 percent of the 186 respondents) reported employment of 24,653 by 1,731 operational startups, an average of 14 employees per startup. Assuming all 3,927 startups still operational averaged 14 employees, total employment would have been 55,929.

Supreme Court Agrees To Tackle Drug Patent Settlements

In the past several years, the Second, Eleventh, and Federal Circuits have upheld these settlements (known as “reverse payment” agreements since the money flows from the patentee to the alleged infringer rather than the other way around). These courts have focused on the benefits of settling cases and the presumption of patent validity, and they have explained that payments fall within the “scope of the patent.” In contrast, the Third Circuit recently applied more aggressive scrutiny, rejecting the scope test and finding that payments for delay were “prima facie evidence of an unreasonable restraint of trade.”

AMP v. Myriad: SCOTUS Must Remember What Case Is Not About*

As Myriad has correctly pointed out in its brief in opposition to the grant of certiorari, the question posed by the ACLU/PubPat (“Are Human Genes Patentable”) is absolutely the wrong one to answer: “The first question presented [by the ACLU/PubPat] bears no relation to the uncontroverted facts of this case.” (Myriad’s brief in opposition has also pointed out at least 4 other significant factual and legal “misstatements” made in the petition for certiorari by ACLU/PubPat.) As much as the ACLU/PubPat (and others) want to make the Myriad case into about “Who Owns You,” what Myriad has claimed does nothing of the sort. In fact, a “yes” answer to the question posed by the ACLU/PubPat does not automatically lead to Myriad’s claimed “isolated” DNA sequences being patent-ineligible. Those claimed “isolated” DNA sequences are not “genes” by any standard molecular biology definition of what that term actually means. Instead, and as accurately characterized by Judge Lourie, these claimed “isolated” DNA sequences are “novel biological molecules.”

Troll Turning Point? Federal Circuit Breathes Life into Rule 11

This is very good news for defendants and for the patent system. If Rule 11 is actually enforced against those who sue without a reasonable basis the bad actors will be wiped out. It will also work to identify those who are REALLY the patent trolls compared with those who are patent owner who simply seek redress for rights that are being trampled. As long as the bad actors operate the patent system will remain in jeopardy because the popular press and critics of the patent system unjustifiably paint all non-practicing entities with the same brush. Meaningful and appropriate use of Rule 11 will deal with the bad actors, while distinguishing from those non-practicing entities that have reasonable grievances that deserve consideration rather that ridicule.

Croc Counterfeiters in China get Jail Time

Crocs, Inc. (NASDAQ: CROX) announced earlier today that Chinese courts have sentenced 18 individuals to a total of more than 46 years in prison for producing and selling counterfeit Crocs goods. Seventeen individuals were convicted of counterfeiting, and two of the 17 also were convicted of offering bribes. Another individual also was convicted on bribery charges in connection with production of counterfeit Crocs™ shoes. In addition to prison sentences, the above men together face fines totaling RMB 2,832,500 (approximately $450,896).

IPO to Award National Inventor of the Year to Kinect Inventor

On Monday, December 10, 2012, Intellectual Property Owners Education Foundation will honor 39th Annual National Inventor of the Year Alex Kipman, 2012 Distinguished IP Professional Judge James Holderman, and the six winners of the Second Annual IP Video Contest, in a ceremony at the Smithsonian American Art Museum and National Portrait Gallery.

Apple vs Samsung: The Smartphone Patent War Continues

Why is this fight so important? It could be a crucial decision for both companies, with the winner gaining leverage in the fast-paced and ever-growing billion dollar market. Each side wants to protect their stake, since they risk losing their high position on the mobile leaderboard as so many companies before them have done. Prime examples of companies that were once at the top of the game but are nowhere to be seen are BlackBerry and Nokia. Both of these were once the biggest names in mobile phones and handheld devices, but lost their edge once new technology started coming out.

Patent Law Changes – Claims Unnecessary to Obtain a Filing Date

On Wednesday, December 5, 2012, the House of Representatives passed two bills that are now await President Obama’s signature. The bill — S. 3486— implements both the Patent Law Treaty (PLT) and the Hague Agreement Concerning the International Registration of Industrial Designs. The U.S. Senate previously passed the same bill in the same form on September 22, 2012. Thus, the remaking of U.S. patent law and patent practice continues, and we will see more rulemaking coming from the United States Patent and Trademark Office.

Forfeiting the Future Over Irrational Fear of Software Patents

If you haven’t noticed America doesn’t make anything any more, at least nothing that is tangible. Everything we buy is made in China, or Mexico or Viet Nam or somewhere else. The U.S. economy is based on intellectual property and the foundational intellectual property we have for the 21st century innovation based economy is software. We know from history that where patent rights are strongest is where companies locate, innovate and grow. Where patent rights are weakest there is no foreign direct investment, companies do not go there and economies suffer. Once upon a time the UK dominated in biotechnology, but now the U.S. is dominant thanks to a strong and liberal patent system. If we curtail software patents we will be forfeiting not a single industry, but an enormous software industry AND any number of other industries and sub-industries in various other technology fields that rely upon the development of software. Think bio-informatics, for example.