Archive for January 2010

President Obama Bets Big on Solar Energy

3 comments

From a technical/efficiency standpoint, it’s hard to imagine solar energy not becoming a significant contributor to our national grid.  Unlike conventional energy sources, photovoltaic cells contain no moving parts, produce minimal waste heat, and have no thermodynamic losses from fluids.  Of course, they emit no pollution and, operate safely and silently.

Unlike other energy sources, solar cells can be fully integrated into individual buildings throughout urban areas, minimizing transmission losses.  As their energy densities rise and production costs fall, solar cells are positioned to become attractive environmental and economic alternatives to traditional sources of domestic power.

Obama announced a three-part funding increase for clean energy at the annual meeting of the National Academy of Sciences in April, 2009:

  • The creation of a new research agency (ARPA-E), modeled on the defense-minded DARPA, to research alternative energy sources with a proposed $400 million budget.
  • Designating 46 universities and research agencies as ‘Energy Research Frontier Centers,’ and providing them with $777 million in research grants.
  • Creating a link (RE-ENERGYSE) between the Department of Energy and the National Science foundation to promote energy careers among students.

In addition to environmental and efficiency benefits, Obama is using green energy as a much-needed injection of skilled positions to help ease strains on domestic employment.

Last May saw over $467 million of federal funding devoted to renewable energy from the American Reinvestment and Recovery Act.  The Department of Energy has earmarked $117.6 million dollars of this funding to the research and implementation of new solar technologies.  The bulk of this ($51.5 million) will be devoted to photovoltaic technology research.

Written by

January 25th, 2010 at 11:49 am

Posted in Legal/Tech News,Technology

Tagged with

Supreme Court Temporarily Stays YouTube Streaming of Proposition 8 Case

2 comments

In May 2008, the California Supreme Court held that the Equal Protection Clause of the California Constitution required same-sex marriages be recognized. However, the voters passed Proposition 8 just a few months later, redefining marriage as only between a man and woman. Last May, after a second round in the state courts, the California Supreme Court upheld the state constitutionality of Proposition 8. The court’s ruling eliminated the right of same-sex couples to marry, but the court rejected the nullification of the marriages of couples that had already received marriage licenses.

Today marked the next phase of the battle, a challenge to Proposition 8 under the United States Constitution. The plaintiffs are attempting to show that the sponsors of Proposition 8 unconstitutionally proposed the amendment with discriminatory intent.  The plaintiffs hope to make such a showing by placing the sponsors on the witness stand.

Last Wednesday, Chief U.S. District Judge Vaughn Walker in San Francisco ordered a delayed YouTube stream of the trial. However, the Supreme Court has issued a stay for the YouTube streaming (streaming to other rooms within the courthouse will continue).  According to the stay, it will expire on Wednesday at 4PM unless extended. The stay contained no reasoning as to why it was ordered, however, one would think that the court worried about witness harassment. Justice Breyer, while pleased at the limited duration of the stay, dissented by cursorily arguing that delayed video streaming would not cause irreparable harm.

Written by

January 13th, 2010 at 12:13 pm

Posted in Cases,Technology

Heading toward a pathway for biosimilars

leave a comment

On December 24, 2009, the Senate passed a landmark health care reform bill. Included within the Patient Protection and Affordable Care Act is the Biologics Price Competition and Innovation Act, which contains provisions for the regulation of cheaper versions of biologic drugs. While an abbreviated pathway already exists for generic chemical drugs to gain FDA approval, similar regulations are not in place to bring less expensive versions of biologic pharmaceuticals, known as biosimilars, to the market. However, differences in the structure and function of biologic as compared to chemical drugs preclude the simple extension of current legislative provisions for generics to also apply to biosimilars.

Chemical drugs are the traditional small-molecule pharmaceuticals, often compounded into tablets and capsules, that the public is most familiar with. Biologic drugs are relatively new, having only entered the market in the 1980s, and have revolutionized treatment for many serious diseases, including cancer and HIV. The two drug types follow separate pathways towards FDA approval. The approval of new chemical drugs is regulated under the Federal Food, Drug and Cosmetic Act (FDCA), while biologics fall under the Public Health Services Act (PHSA). Biologics are a fast-growing area of drug research, with over 250 biologic drugs already approved by the FDA, and hundreds currently in development.

Traditional pharmaceuticals are created from combining chemicals and reagents in inert reaction vessels, whereas biologics are made from proteins produced within living cells, plants, and animals. An important difference between chemical drugs and biologics is that biologics have the ability to elicit an immune response. Chemical drugs are not recognized as foreign by the body’s immune system, but biologics can stimulate the production of antibodies. An immune response can cause an allergic reaction and more seriously, deplete naturally occurring proteins in the body, causing serious and sometimes fatal conditions. For some patients, biologic drugs have provided therapeutic relief beyond what chemical drugs are able to achieve, but at a steep price. Biologics are on average over twenty times more expensive than chemical drugs per day and can cost up to hundreds of thousands of dollars per year for a patient. The cost can be attributed in part to the higher expenses associated with research and development. Raw materials for biologics cost 20-100 times more than for chemical drugs, and manufacturing facilities take years to establish and hundreds of millions of dollars for building and maintenance. The high price for biologics also results from a lack of competitor products on the market, which has contributed to the growing push for less expensive versions of branded biologic drugs.

In the 1980s, public concern grew over the rising cost of pharmaceuticals. In response, the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act (HWA), created two abbreviated pathways for the approval of generic pharmaceuticals. The HWA explicitly amended the FDCA only and not the PHSA, leaving no clear route for the approval of generic biologic products. The HWA has been successful in encouraging the entry of generics to the market and reducing drug prices. The Generic Pharmaceutical Association (GPhA) reports that generics comprise 69% of the total prescriptions dispensed in the US, but only 16% of dollars spent. However, even if similar provisions for biosimilars are created, they are not expected to yield the same cost savings as generic chemical drugs.

Differences between chemical and biologic drugs affect the ability of generic manufacturers to create similar products that can be sold more cheaply. For chemical drugs, innovator and generic companies can use different processes to synthesize identical molecules. For biologics, innovators maintain that “the product is the process” and since generic firms do not have access to proprietary information regarding manufacturing, they cannot produce an identical product. Adding to the difficulty in creating generic versions of biologic products is that biologic drugs are typically 100-1000 times larger than chemical drugs and unlike chemical drugs, the structure of biologic drugs cannot be fully characterized with current technology. Under the HWA, generic firms do not need to provide their own clinical data, which can result in significant cost savings that can then be passed on to consumers, but given the potential for biologic drugs to produce immune responses, biosimilars may need additional clinical testing to ensure safety. According to GPhA, generic versions of chemical drugs cost 30-80% less than brand-names, but the group predicts savings for biosimilars will be 10-25%. The Congressional Budget Office estimated that during the first year of competition, the discount on biosimilars would be 20-25% and increase to 40% by the fourth year.

The first bill for biosimilars was introduced in Congress in 2006. Since then, multiple bills have been introduced in both the House and Senate. Other nations, including the European Union and Canada, have already implemented regulation of biosimilars. The recently passed Senate bill allows for the approval of biosimilars that show no clinically meaningful differences in safety and efficacy from the innovator product, which must be established using analytical testing, animal data, and clinical trials. A biosimilar may be declared interchangeable with the innovator after it has been shown that the biosimilar drug produces the same clinical effects and there are no adverse effects from switching the products. Similar to the HWA, the Senate bill provides an accelerated route for litigation between innovator and generic firms to expedite the identification of patents that are potentially infringed. While the HWA provides 5 years of market exclusivity to innovator products, the Senate bill grants 12 years of market exclusivity to innovator biologic drugs. The Senate bill must be merged with the House bill passed in November to create a final health reform bill, but the key provisions for biosimilars are similar under both bills, so it appears that the US may soon have a pathway in place for the approval of cheaper biologic drugs.

Written by

January 9th, 2010 at 12:37 pm

Texas DA uses Twitter to scrooge with people arrested for a DWI

one comment

PC World wrote a story that people arrested for DWI during holidays in Montgomery County, Texas will have their names put up on Twitter by the local district attorney.  So far Brett Ligon’s tweets haven’t included any names although there sure is a lot of information about DWI activity in his county.

Although it’s apparently not an uncommon practice for newspapers to put up this kind of information, Twitter obviously distributes this information far further than any local papers.  A Google search of a persons name will reveal tweets although it’s not clear how recent the post would have to be.  It’s also not clear that names would be removed if people were exonerated.  The prosecutor’s office has said they will only post arrests that are “strong enough to prosecute.”  Despite the fact that conviction rates for DWIs are quite high, charged and convicted are still not the same thing.

One place where this information could be quite harmful is if someone were to look for a job.  A DWI arrest could be enough to keep somebody from being hired irregardless if the charge was dropped, the person was exonerated or if the record was sealed or purged.

Written by

January 9th, 2010 at 12:37 pm

Posted in Commentary

CPSIA – Building a Castle to Protect from the Rain

one comment

It’s been seventeen years since I tore the wrapping paper off my G.I. Joe Battle Wagon.  I believe I ended its electronic-missile-firing life a few months later with a poorly thought out tour through the bathtub.  But nearly a score later, it’s not so certain that the Battle Wagon would have had a life to begin with, at least without a lot of testing and retroactive product liability in the form of the Consumer Product Safety Improvement Act.

This is the first Christmas since the testing requirement of the Consumer Product Safety Improvement Act was made effective for toys (the lead ceiling currently has a one year stay).  The bill sailed in the wake of the lead paint scare for toys made in China and nearly passed unanimously (lone wolf – Ron Paul) in the House.  The Act covers all children’s products, or any product intended primarily for children under 12.  This would include hard-to-access microchips in toys and other items not readily removable. 

A key provision of the bill is its requirement that all children’s products be tested by third-parties.   It isn’t enough for the materials to be of reputable quality; samples of every component must be tested.  Writing in Forbes, Walter Olson catches the first wave of unintended consequences.  “[N]ew kids’ goods will all have to be subjected to more stringent ‘third-party’ testing, and it will be unlawful to give away untested inventory even for free.” While retailers aren’t required to test themselves, they will be subject to liability if the products don’t conform to the regulatory standards. 

The Act contains specific limits for lead content.  In addition to reiterating a ban on lead paint, the Act limits lead in other components to less than 300 ppm.  In the Wall Street Journal, Richard Posner likened the Act to “killing a gnat with a bazooka”.  “Instead of targeting the known sources of lead contamination, this ill-conceived statute extended coverage to the max…”  said Posner.  These lead limits apply retroactively as well.   But there are (very unlikely) exceptions: no testing if you can show “on the basis of the best-available, objective, peer-reviewed, scientific evidence” that a lead product won’t lead to harm.  I wouldn’t hold my breath. 

This Act can affect technology for toys in a number of ways.  The most obvious is higher costs in getting to market.  Testing is expensive, and testing the numerous components and combinations of components could be prohibitively so.  With electronics, chips are often manufactured by third parties and integrated into toys separately.  This could lead to a lot of companies doing the same testing for the same chips once integrated, even with a proven track record. 

Additionally, soldering is used in nearly all electronics, and most commercial solder contains some amount of lead.  In 2003 the EU passed the lead-limiting Restriction of Hazardous Substances Directive (RoHS), prompting many manufacturers to begin removing lead from all products, and some electronics companies such as Intel have been using lead-free materials for a few years now.  However, most commercial solders still contain lead, and lead-free alternatives by manufacturers such as Kester cost up to five times as much as their lead-based counterparts. 

A related effect is increased liability, which can both increase costs and deface a company’s public image.  Since the 1970’s lead poisoning has cast a dark shadow on paint products, of which toys are the most recent example.  Lead poisoning and its effects are real threats, and the absent sensibilities of children pose a unique risk.  To avoid potential liability and looking the part of villain, manufacturers will probably pay the “for-the-kids” premium expected by the public, even though the risk of consumption of lead in electronic goods is low compared to the potentially high testing costs.  As noted on Popehat.com, no child was injured in the lead paint scare of 2007. 

It’s hard to say what effect the Act has had on companies this past toy season.  Due to changes in the economy, sales figures probably won’t tell an accurate story as to testing costs, and initial dissidents to the legislation have tended to be on the small side.  But the potential for high costs of testing and the even higher liability for violation could limit a lot of technological toys making their way into the market.

Written by

January 9th, 2010 at 12:36 pm

Butt of a Joke? The North Face v. The South Butt: Accounting for Viral Media When Suing the “Little Guy”

one comment

Owners of famous trademarks are often faced with making the difficult decision that arises when their mark becomes the subject of a parody.  Spend a lot of money in court with the goal of obtaining an injunction to stop the potentially infringing use, or do nothing and hope that the parodist goes out of business.  Both choices can carry significant negative repercussions.  However, the negative side-effects can be significantly magnified in the age of web 2.0’s user created content and the unlimited potential of viral marketing.

A recent example is the suit filed on December 10 by the popular clothing company, The North Face (TNF).  See the complaint here. TNF became the subject of a parody created by a Missouri college student who began marketing and selling clothes under the name The South Butt.  The South Butt (TSB) argues that they are poking fun at those who will never set foot on a mountain, but every morning don $600 worth of outdoor gear on their way to class.

Along with the similar name, what has TNF crying infringement and dilution is that TSB sells a jacket that looks very similar to TNF’s “iconic” Denali jacket and adorns it with an upside down version of TNF’s famous “Half Dome” trademark.  (See an example of TSB’s jacket here).  Based on this activity TNF has sued to enjoin the TSB’s use of its name, symbol and the overall appearance of the jacket.  But in the wake of this suit internet media has made thousands aware of upstart TSB.  A recent check of The South Butt’s Facebook page shows that there are now more than 7,000 fans of the company.   A Google search yields almost 300 news articles related to TSB, and a YouTube advertisement for TSB has over 14,000 views.  TSB has also reported massive increases in sales and hits to its website.  The founder and owner of TSB, Jimmy Winkelmann, has even been dubbed “Little Jimmy” by those who have embraced his role as David, in a David versus Goliath showdown against the multi-billion dollar TNF.

Although it is unlikely that all the negative attention directed at TNF and the exposure TSB has gained will cause TNF to have second thoughts about suing Little Jimmy, it exemplifies the ability of the internet to significantly change the game for companies like TSB. In the age of viral media and social networking, plaintiffs must take into account the ability of “the little guy” to use a lawsuit to gather significant support.  This free exposure can generate revenue to fund the defense and create ill will towards the plaintiff.

With a legitimate parody defense to TNF’s claims and more money in the bank from increased sales caused by TNF’s suit, the battle between TNF and TSB could prove to be much more expensive and challenging than TNF initially anticipated.

Written by

January 9th, 2010 at 12:36 pm

Posted in Commentary