Monday, 2 May 2016

Costs of New Pharmaceutical Development Approaching US $3 Billion

The Tufts Center for the Study of Drug Development (“Tufts Center”) has recently published a study estimating the cost of new pharmaceutical development approaching US $3 billion.  The Tufts Center at Tufts University "provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization."  The Tufts Center notes that:

The $2.558 billion figure per approved compound is based on estimated average out-of-pocket costs of $1.395 billion and time costs (expected returns that investors forego while a drug is in development) of $1.163 billion.
When post-approval R&D costs of $312 million are included, the full, product lifecycle cost per approved drug, on average, rises to $2.870 billion, according to Tufts CSDD. Post-approval studies, required by the U.S. Food and Drug Administration as a condition of approval, assess new indications, new formulations, and new dosage strengths and regimens, and monitor safety and long-term side effects in patients. All figures are expressed in 2013 dollars.
The Tufts CSDD estimate also accounts for expenses incurred for product development efforts that did not reach fruition, which Joseph A. DiMasi, director of economic analysis at Tufts CSDD and principal investigator for the study, said reflects the full cost of winning marketing approval for a new drug.
The press release concerning the study attributes the rising costs of drug development, in part, on the “higher failure rates for drugs tested in human subjects.” 
 
 

Thursday, 28 April 2016

AMD' s license deal in China: the start of something big?


The potential for a single technology license to change the fate of a public company is not a usual occurrence. For sure, there are companies,
such as Qualcomm, whose business model has a major licensing component. But what about companies whose main business has been selling products? A striking instance where a technology license could make all the difference took place late last week, when it was announced that Advanced Micro Devices (AMD), the perennial also-ran to Intel in the chip world, announced that it had entered into a transaction with Tianjin Haiguang Advanced Technology Investment Company.

As reported by the Wall Street Journal (WSJ), the companies will establish a new venture company (the WSJ article describes AMD's partner as “an investment consortium under the guidance and led by the Chinese Academy of Sciences”), whereby AMD will license its x86 chip technology to develop server systems intended to be sold only in China. AMD is expected to ultimately receive $293 million dollars in licensing fees plus a royalty payment for sales on chips that are developed by the venture. Thus far, the company has received $52 million dollars from this deal and recognized $7 million on its Q1 2016 income statement. Upon making the announcement, AMD’s shares rose a whopping 23% on after-hours trading on the Nasdaq Stock Market.

One way to appreciate the multi-faceted nature of this transaction is to consider it from several different perspectives.

1.AMD-- According to AMD Chief Executive Lisa Su, “Our new licensing agreement is a great example of leveraging our strong IP portfolio to accelerate the adoption of our technologies more broadly.” That said, one presumes that companies are always looking to better monetize their IP portfolio. Here, the deal allows AMD to try and gain some traction in the server chip area at the expense of Intel and also to gain access to the China market.

2. China— For every licensor, there also needs to be a licensee. The deal will potentially enable China to develop what the WSJ describes as “chips with home grown security circuitry to ease fears that foreign spies will penetrate computers in China”. Seen more generally, it is yet another step by China to try and lessen its dependency on non-Chinese technology.

3. Intel—The WSJ notes that Intel and AMD in 2009 entered into a cross-licensing agreement that is reported to provide that neither party may transfer rights to licensed technology to third parties. Intel has yet to respond on this point while AMD, for its part, has stated that because of the structure of the deal, the 2009 agreement is not being breached.

4. Chip manufacturers—Intel, IBM and Qualcomm have all reportedly entered into their own joint venture agreements in China in the area of chip manufacture and/or development.

5. United States government—US law has in place export control restrictions that limit the transfer of technology abroad if the transfer might affect national security. AMD has stated that the transfer contemplated under the agreement meets all US export rules and regulations.

Circling back to the beginning of this blogpost, the most immediate result will be the potential upside for AMD. Will it be the precursor to additional transactions for monetizing its IP or is the deal uniquely tied to the specifics of the Chinese market and national policies? Close attention should be paid to how this ultimately works out for the company.

Sunday, 24 April 2016

Can labor laws hollow-out software competencies: the case of Mercedes-Benz

The effect of legal provisions in enhancing or inhibiting innovation is often difficult to show. An interesting case where it may be able to
discern such a relationship was discussed in a piece that appeared recently on reuters.com. There, it was argued that German labor laws and rules may materially affect the economic viability of no less than the Mercedes-Benz car company (part of Daimler AG) to continue to maintain its software development capability in Germany, rather than outsourcing such software development activities abroad. That cars are increasingly aggregations of software to move people efficiently, safely and increasingly, enjoyably, is evident to all. As was noted in The Economist, citing Gabriel Seiberth of Accenture, in a piece last year--
“[a] high-end car, for instance, has the digital horsepower of 20 personal computers and generates 25 gigabytes of data per hour of driving ….”
These kind of data mean that software expertise is essential to the success of a Mercedes-Benz car, and that requires that the company engage leading software personnel to help keep its competitive advantage. The question is not whether the company will increase the number of software-related jobs, but how many of these software personnel will be German-based and, more broadly, whether the company can continue to foster such capabilities and know-how within Germany. The claim being made by the company is that local German labor laws are too restrictive in this regard. In particular, it is argued, in the name of the well-being of employees, German labor rules provide that a daily work shift cannot exceed 10 hours and there must be an 11-hour break before the employee’s next shift. Presumably, this requirement derived from a time when most of the skilled labor at the company was engaged in more of the heavy physical aspects of automobile production.

However, such labor rules, and the requirement that labor representatives must be informed about the extent of the company’s use of third-party contractors, make it “cumbersome” for the company to engage third-party software contractors. The claim by the company is that the processes that derive from this requirement “makes life too bureaucratic”. Not by accident, the company has approximately 3,500 R&D and IT staff located in Bangalore, India and another 200 or so in Silicon Valley. Indeed, Bangalore has become the company’s main digital engineering center, engaged in such activities as digital design and crash test simulation.

From the labor relations point of view, the tension rests between the interest in ensuring worker protection, on the one hand, and the need for more flexible work arrangements to meet the requirements of software R&D, on the other. Even taking into account the possibility that company management may be spinning the narrative to some extent to obtain worker concessions, the issue raised seems genuine. To what extent will continuing adherence to traditional models of industrial employment have a deleterious effect on the ability of a standard-bearer of German industry to maintain its competency in software and related 21st century innovation capabilities. Mercedes-Benz will find a way to obtain the necessary software skills; the question is to what extent this will take place within Germany.

The challenge so posed recalls the discussion in America in the wake of the decline of US manufacture. On the one hand, relying on China as the ultimate assembly factory certainly has resulted in less expensive products. On the other hand, some have claimed that this has led to a hollowing-out of the skills needed for the US to preserve a manufacturing presence, especially at the so-called high end. One wonders whether something like that might be over the horizon for companies such as Mercedes-Benz, where the declining presence of cutting-edge software within its German facilities might negatively affect the company’s design and manufacturing capabilities more generally. After all, software is not just another form of IP to be protected, but it is increasingly the foundation of the know-how that will, quite literally, “drive” the automobile industry.

Tuesday, 19 April 2016

Almost One Billion Dollar Verdict in U.S. Trade Secret Case

Wow!  That is quite a verdict.  A Wisconsin jury awarded $240 million in compensatory damages and $700 million in punitive damages for seven claims, including misappropriation of trade secrets and related claims.  That is a huge verdict.  The defendant is an Indian company, Tata Consultancies.  The Insurance Journal reports on the verdict, here.  Patently-O discusses the verdict, here.  Will a district in Wisconsin become the new Eastern District of Texas for trade secret claims post-Defend Trade Secrets Act?  For more information about the facts of the case, see here and here.

Tuesday, 12 April 2016

AIPLA 2016 U.S. Model Patent Jury Instructions Released

The American Intellectual Property Law Association (AIPLA) Patent Litigation Committee has released the AIPLA U.S. Model Patent Jury Instructions (Jury Instructions).  The Jury Instructions are up-to-date to December 2015 and are an impressive concise synthesis of patent law.  The introduction to the Jury Instructions states:

One of the fundamental goals of the Instructions is to provide a neutral set of jury instructions that would not be biased in favor of either the patent owner or the accused infringer. These Model Instructions are not intended to address every conceivable issue that might arise in patent litigation. Instead, Instructions are provided on those issues that typically arise in patent litigation and that have clear precedential support. It is incumbent upon the litigants to tailor these Instructions to the specific issues in their particular case and to simplify the tasks for the Court and the jury by not providing superfluous or confusing instructions. It is also intended that these Instructions will be used in conjunction with other instructions dealing with non-patent issues such as credibility, and that the trial court will further the jury’s understanding of these Instructions by relating the legal principles in the Instructions to the particular factual contentions of the parties.

The Jury Instructions also include helpful practice notes and substantial citation to relevant authority.  A sample practice note provides:


Practice Note: The concepts of direct infringement based on joint infringement and indirect infringement based on inducement to infringe (Instruction 3.10) are closely-related and may be confusing to the jury. Care should be taken to be clear regarding the Instructions on each issue and what findings the jury is being asked to make. Only if these theories of infringement are alleged and have been adequately supported by sufficient evidence should these Instructions be given. If both Instructions are being given, consideration should be given to instructing on joint infringement and inducement to infringe (Instruction 3.10) back-to-back and in a manner that readily allows the jury to appreciate the difference between the two theories, the evidence required to support each, and the specific findings they are being asked to make on each.

The Jury Instructions also include pre-AIA as well as post-AIA law.  The Jury Instructions are 75 pages long and a substantial contribution to patent law practice.  Kudos to Jennifer Librach Nall and Ajeet Pai, Co-Chairs, Model Patent Jury Instructions Subcommittee, Patent Litigation Committee, and all involved.  

Georgetown Conference: Taxation of Intellectual Property in the Global Economy

On Friday, March 11, Georgetown University sponsored a conference titled, “Taxation of Intellectual Property in the Global Economy.”  A description of the conference states:

The United States now lags behind its global competitors in tax incentives for research and development. In recent years, at least fourteen developed economies have adopted patent or innovation boxes, which provide a special low tax rate on business income that is derived from innovative activities. This development has sparked debate in the United States, and several recent U.S. tax reform proposals include a patent or innovation box. A discussion draft for a U.S. innovation box was released last year by Rep. Charles Boustany (R-LA) and Rep. Richard Neal (D-MA).

This conference brought together experts from a variety of backgrounds to share their perspectives on these important emerging issues in tax policy.

The panels included: “Taxation of Intellectual Property in the United States and Abroad”; “Effects of Taxation on Economic Activity: A Review of the Literature”; “New Evidence on the Impact of Patent Boxes”; and “Should the United States Implement a Patent Box.”  The following presentations are available: Paul W. Oosterhuis, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, presentation Basic U.S. Multinational Tax Planning Strategies for Intellectual Property;  Lilian V. Faulhaber’s, Associate Professor of Law, Georgetown Law, presentation Taxation of Intellectual Property in the United States and Abroad; Sebastien Bradley’s, Assistant Professor of Economics, Drexel University, LeBow College of Business, presentation Effects of IP Taxation on Economic Activity: A Review of the Literature;and Eric Ohrn’s, Assistant Professor, Grinnell College, presentation International Royalty Flows and Research and Development Responses to IP Box Regimes.  The other panelists and moderators included: Alan J. Auerbach, Robert D. Burch Professor of Economics and Law & Director, Burch Center for Tax Policy and Public Finance, University of California, Berkeley; Mihir A. Desai (Moderator) Mizuho Financial Group Professor of Finance, Harvard Business School; James R. Hines, Jr. (Moderator) L. Hart Wright Collegiate Professor of Law & Co-Director of the Law and Economics Program, University of Michigan; Rosanne Altshuler (Commentator) Professor of Economics & Chair, Department of Economics, Rutgers University; Jason Furman, Chairman, Council of Economic Advisers; Michael J. Graetz (Moderator), Columbia Alumni Professor of Tax Law, Columbia Law School; Martin A. Sullivan, Chief Economist, Tax Analysts; and Itai Grinberg, Associate Professor of Law, Georgetown Law.

The Webcast of the conference (over three hours) is available here.  

Tuesday, 5 April 2016

Just Who is a Patent Troll? Ask VirnetX.

This blog recently reported on an East Texas jury awarding VirnetX over $600 million against Apple.  In a recent interesting article in Corporate Counsel by the Chairman and CEO of VirnetX Kendall Larsen titled, “Are We Patent Trolls? Ask Jason Bourne,” Mr. Larsen complains about the popular press labeling his company a “troll,” and explains why his company is not a “troll.”  First, Mr. Larsen defines a troll as having the following characteristics: “Their patents cover no real invention, no true breakthrough in science or technology[;] They are led by lawyers, not scientists, engineers or technology business executives[;] They neither develop, make nor sell any real products or licensable technology[; and] They assert weak patents — and usually seek nuisance settlements.”  First, Mr. Larsen explains how the venture capital arm of the Central Intelligence Agency paid a contractor to solve a problem covered by the invention—code named “Net Eraser,” came a simplified zero-click way to enable secure encrypted communications.”  Second, Mr. Larsen explains that his company is not led by lawyers, but scientists, engineers and technology business executives.  Third, Mr. Larsen explains how the “Gabriel Collaboration Suite, a set of integrated applications that enable secure messaging, secure voice and video calling, secure mail and secure encrypted file sharing with any other device,” is used in Google’s Play Store, Apple Apps Store and in Apple’s iMessage.  Notably, he states that, “Current licensees include Microsoft, Aastra, Mitel, NEC, Siemens and Avaya.”  Finally, he notes that his patents have been held valid four times by courts. 

Do you agree with Mr. Larsen’s definition of a troll?  On the IPKat blog, I recently asked whether myth and metaphor are the primary drivers of innovation in intellectual property law.  Co-blogger Neil Wilkof subsequently asked the question of what happened to patent trolls.  Are the trolls still around?  Or, have they been relabeled away?  Does the popular media just need to stop using the term?  What do you think?