Thursday, June 28, 2012


Agriculture stands on the verge of another technological transformation.  Just as genetically-modified crops and livestock have begun to achieve normality in the eyes of most, an even more radical approach to agriculture has arrived.  Synthetic biology combines de novo design of genes, cells, and organisms with an ethos of user, open, and collaborative innovation.  "Synagriculture" represents as large a departure from GM agriculture as GM agriculture did from traditional agriculture.  "Planted Obsolescence:  Synagriculture and the Law," newly published in the Idaho Law Review, explores the legal implications of synagriculture.  The article can be downloaded for free here.  Here is the abstract:
Supporters of GM agriculture have had a long row to hoe in achieving public acceptance for the safety of this important technology. Controversy has surrounded the foundational technology of recombinant DNA methods, the application of genetic engineering to crop plants and livestock, the safety of GM “Frankenfoods” as sources of human and animal nutrition, the potential environmental threats posed by the possible development of GM “superweeds,” and the corporate control over GM agriculture exercised by a relatively small number of agricultural companies armed with vast financial resources and powerful patent portfolios. Nevertheless, as exemplified by the United States and Canadian Supreme Court cases, Diamond v. Chakrabarty, J.E.M. v. Pioneer Hi-Bred, Monsanto Canada v. Schmeiser, and Monsanto v. Geertson, the law, and the society it reflects, have finally managed to accommodate the important technology of GM agriculture. However, a new paradigm in biological science — synthetic biology — has begun to remake the face of GM agriculture. Synthetic biology seeks to purge biology of some of its fundamental inefficiencies through the rigorous application of engineering principles. Rather than tinkering around the edges, biological engineering would remake living organisms from first principles, and employ standard parts to make qualitatively new biological devices and systems. Traditional arguments that GM crops and livestock are simply slightly-modified versions of their conventional counterparts may no longer be either appropriate or accurate in the face of synthetic biological approaches to engineering new plants. Moreover, both synthetic biology and do-it-yourself biology (“DIYbio”) seek to shift biological research and development out of traditional laboratories and the hands of credentialed biologists, and, instead, allow any interested and motivated user to become a research biologist, biotinkerer, or synthetic biological engineer. Home and community laboratories are already springing up at a rapid rate, and farm laboratories are sure to follow, as participation in this new, open, and democratized movement burgeons. In short, large numbers of individual and collaborating users, spread over many small and local laboratories, are beginning fundamentally to reengineer genes, cells, organisms, and systems composed of organisms or their substituent parts. The comfortable acceptance of GMOs at which society has only recently begun to arrive may soon be misplaced in the face of both fundamentally new scientific approaches and the democratization of innovation. The results for agriculture may be beneficial: enhanced rates of agricultural innovation through new biological approaches and wide participation. Moreover, synthetic biological agriculture (“synagriculture”) may prove to be as safe as GM agriculture or even conventional agriculture. However, assumptions about current GM crops and livestock may not easily apply to synthetic versions, nor may the current paradigm of GM regulation be possible when innovation becomes atomized among millions of farmers. Some of the “settled” legal issues surrounding GM crops and livestock may have to be revisited as new perceived or actual threats and benefits arise. One irony may be that the same patent system that has so often been criticized in the past for providing agricultural companies with too much control over farmers may soon represent one of the most effective methods for monitoring and regulating GM agricultural innovation. Although some farmer innovators may eschew patent coverage for their agricultural inventions, others may opt to seek patent protection for their innovative new synthetic crops and livestock. Because the USPTO will have to examine any new GM crop inventions prior to issuing letters patent, disclosures to the USPTO synthetic biological inventors who opt for patent protection may become a vital centralized locus for monitoring and regulating otherwise highly-decentralized synagricultural innovation. New methods of biological engineering and new models of user, collaborative, and open innovation are soon to affect the trajectory of GM agricultural innovation. Even if such changes turn out to be salutary, they will be changes nevertheless. To ensure that society receives the full benefits of open and democratized synthetic biological innovation in crops and livestock, it would be well and wise for the law to prepare itself to reexamine the brave new world of synagriculture with brand new eyes.
Henri Alain once wrote that "Life on a farm is a school of patience;  you can't hurry the crops or make an ox in two days."  Toutes les bonnes choses ont une fin.

Tuesday, August 02, 2011

Myriad Genes To Patent

The United States Supreme Court must be despairing of how many patent appeals are coming its way.  After all, patent law is few people's cup of tea.  As one old, though obscure, joke puts it:
Question:  What's the difference between a patent attorney and a tax attorney?
Answer:  Patent attorneys are like tax attorneys, but without the scintillating personalities!
Watch out, Supremes, because the Court of Appeals for the Federal Circuit may have just teed you up to grant yet another writ of certiorari in a patent case.

Like Prometheus v. Mayo, a dispute focused on the patentability of methods of medical diagnosis and treatment, Association for Molecular Patholody v. Myriad raises fundamental questions of patentable subject matter and the interpretation of 35 U.S.C. 101.  On July 29, 2011, the Court of Appeals for the Federal Circuit largely overturned a decision on summary judgment by Judge Sweet of the Southern District of New York that rendered unpatentable claims to isolated DNA molecules per se and methods of diagnosis relying on comparisons of mutated DNA molecules with corresponding patient DNA samples.

It would be natural for the Supreme Court to combine the appeals of Prometheus v. Mayo and Association for Molecular Pathology v. Myriad because they both probe similar and related issues of patentable subject matter.  Such a combined appeal would have the potential to settle fundamental issues of patent eligibility surrounding many biotechnology inventions for a generation.

The eyes of biologists, the biotechnology industry, and patient advocacy groups are now firmly fixed upon the Supremes.

More idealaw at LEXVIVO.

When Patents Attack

This American Life, a quirky and wonderful weekly radio program on National Public Radio, has featured stories on comedians, how to speak to kids, psychopaths, unconditional love, and mind games.  On July 22, 2011, TAL investigated a special breed of trolls:  patent trolls.  Here is how TAL describes the program:
Why would a company rent an office in a tiny town in East Texas, put a nameplate on the door, and leave it completely empty for a year? The answer involves a controversial billionaire physicist in Seattle, a 40 pound cookbook, and a war waging right now, all across the software and tech industries.  We take you inside this war, and tell the fascinating story of how an idea enshrined in the US constitution to promote progress and innovation, is now being used to do the opposite.
This patent who dunnit is fascinating and entertaining.  Moreover, it transforms a field of law often viewed - even by other, non-patent, attorneys - as dry, technical, and inaccessible, into something that, like Lord Byron, seems mad, bad, and dangerous to know.  Listen to the program here.

Hear it before you go infringing. You'll never go in the patent pool again!

More idealaw at LEXVIVO.

When Two Tribes Go To War

A war is raging in the United States between two great parties.  These two have radically different belief systems, seem unable to agree on fundamental issues, and are increasingly competing on every level for the support of the people.  Their hotly contested battlegrounds include budgets, culture, technology, foreign policy, and social policy.  Each party has a long and glorious tradition, and constantly yearns to wrest influence from the other.  One party currently controls the White House and leads the United States Supreme Court, while the other has a stranglehold over Silicon Valley.  Never the twain shall meet;  ever the twain shall battle for supremacy.

Democrats and Republicans?  No, far more important:  Harvard and Stanford.

Technology provides a vivid illustration of this clash of titans.  Over the past two decades, Harvard has seen its once seemingly-unassailable champion - Microsoft - challenged, and toppled, by Stanford's relentless battler - Google.  However, Stanford is now threatened anew by a Cantabridgian contestant - Facebook - whose spectacular rise may end Google's hegemony.  Where Google accommodated itself (for a time, at least) to the requirements of the Chinese government, brash Facebook has helped sweep aside dictatorial regimes in Tunisia and Egypt, with the mere flick of its newsfeed.  Perhaps more importantly, Facebook now commands more attention (in traffic and stickiness) than Google.

The battle is far from over.  Not only is Stanford's current champion fighting back with new initiatives, such as Google+ - a social media service aimed at the heart of Facebook, and currently exploding in popularity -  it continues to attract, educate, and graduate new generations of entrepreneurial talent unmatched anywhere in the world.  Unmatched anywhere, that is, except at Harvard.

When the two great tribes go to war, far more is at stake than scoring a point.

More idealaw at LEXVIVO.

Wednesday, July 06, 2011

Prometheus Rebound To The Supreme Court

On its second opportunity, the United States Supreme Court has granted a writ of certiorari to hear an appeal of Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Mayo Clinic Rochester ("Prometheus v. Mayo"), a decision by the Court of Appeals for the Federal Circuit ("Federal Circuit") that ratified - for the second time - the patentability of methods to determine optimal drug dosage levels in therapeutic treatments.  This bodes ill for the patentability of inventions involving methods of medical diagnosis and therapy.
As discussed previously on LEXVIVO, on December 17, 2010, Prometheus, Inc., a San Diego-based biotechnology company, prevailed in appealing a district court's grant of summary judgment that had found claims in Prometheus' exclusively licensed patents (U.S. Pat. Nos. 6,355,623 and 6,680,302) invalid as drawn to non-statutory subject matter under 35 U.S.C. §101.  In Prometheus v. Mayo, a unanimous panel of the Federal Circuit "again [held] that Prometheus' method claims recite patentable subject matter under §101."  The court's previous finding that Prometheus' claims constituted statutory subject matter was successfully appealed by defendants-appellees Mayo Collaborative Services and Mayo Clinic Rochester (hereafter, "Mayo") to the Supreme Court, which vacated and remanded the Federal Circuit's decision on April 29, 2010, "for further consideration in light of Bilski v. Kappos," a business method patent case the Supreme Court had decided the day before.  It would appear that the Supreme Court has now called two strikes on the Federal Circuit on this issue.

The claims at issue cover methods for determining the optimal dosage of thiopurine drugs, such as 6-mercaptopurine and azathiopurine, used to treat inflammatory bowel diseases that include Crohn's disease and ulcerative colitis.  For example, claim 1 of the '623 patent involves (1) administering a drug capable of producing 6-thioguanine inside a patient suffering from a gastrointestinal disorder, (2) determining the concentration of 6-thioguanine in the patient's blood, and (3) indicating the need to increase or decrease the drug's dosage depending on whether the drug's blood concentration is outside of the therapeutically desired range of 230-400 pmol per 80,000,000 red blood cells.

Now, the Supreme Court will have an opportunity to clarify the patentability of inventions directed to methods of diagnosing medical conditions, as well as those that combine such diagnostic methods with methods of treatment.  Any optimism the biotechnology industry might have derived from the Federal Circuit's December 17, 2010, decision in Prometheus v. Mayo may now be tempered by the specter of the Supreme Court adopting the argument that Justice Stephen Breyer (joined by now-retired Justices John Paul Stephens and David Souter) made in his vigorous dissent to the dismissal of the writ of certiorari of a kindred case, Laboratory Corporation v. Metabolite Laboratories, Inc..  In his dissent, Breyer described the medical diagnostic method contested in that case as follows:

At most, respondents have simply described the natural
law at issue in the abstract patent language of a "process." But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.
A similar conclusion in Prometheus v. Mayo by a majority of the Supreme Court could redraw the boundaries of patentable biological subject matter in United States patent law.

See more idealaw at LEXVIVO.

Sunday, May 01, 2011

Osama Bin Laden - Pioneer Of Bioterrorism

It appears that Osama bin Laden was killed on May 1, 2011.  Among his nefarious "accomplishments", bin Laden was the first internationally prominent proponent of bioterrorism. Worries about the deliberate misuse of biological agents have prompted the United States Federal government to set up new anti-bioterrorism facilities, such as the Center for Excellence for Emerging and Zoonotic Animal Disease, to be located in Kansas.  Despite the demise of bin Laden, the threat of bioterrorism is likely to remain firmly fixed both in the public consciousness and in the wishlists of terrorists.

More idealaw at LEXVIVO.

Wednesday, April 27, 2011

On Fast Track, Patent Office Run Over By Budget Deal

As LEXVIVO previously reported, the United States Patent and Trademark Office ("USPTO") entered 2011 by proposing several significant reforms designed to improve the efficiency and quality of the patent application process.  Included in these proposed changes were a new fast-track patent pathway and new satellite Patent Offices.  The Federal budget compromise recently agreed between Congress and President Obama, the Full-Year Continuing Appropriations Act, 2011 (Pub. Law 112-10), brings this brief patent office perestroika to a halt.  Here is an email USPTO Director David Kappos sent to his employees last week:
As you may know, the FY 2011 budget was signed by the president on April 15, 2011 and contains the USPTO’s appropriation through the end of this fiscal year, September 30, 2011. With the enactment of the Full-Year Continuing Appropriations Act, 2011 (Pub. Law 112-10), USPTO spending authority for FY 2011 has been limited to $2.09 billion. In view of the funding cuts reflected in the final budget and affecting the U.S. government as a whole, we will be unable to expend the additional $85-100 million in fees that we will be collecting during this fiscal year—funds that we had anticipated being able to use to fund operations this year.
In short, the Continuing Appropriations Act for FY 2011 does not allow us to maintain spending at the levels planned for this year. Further, I am mindful of the fact that we may very well be operating at the FY 2011 level for the foreseeable future. As a result, we have had to make some difficult decisions in order to ensure the responsible stewardship of the agency. It is against that backdrop that I must reluctantly announce, effective immediately, that:
• All overtime is suspended until further notice;
• Hiring—both for new positions and for backfills—is frozen for the rest of the year unless an exemption is given by the Office of the Under Secretary;

• Funding for employee training will be limited to mandatory training for the remainder of the year;
• Funding for contracting of Patent Cooperation Treaty (PCT) search is significantly reduced;
• The opening of the planned Nationwide Workforce satellite office in Detroit and any consideration of other satellite locations are postponed until further notice;

• Only limited funding will be available for mission-critical IT capital investments;

• The Track One expedited patent examination program, scheduled to go into effect on May 4, 2011, is postponed until further notice.
In addition, all business units will be required to reduce all other non-compensation-related expenses, including travel, conferences and contracts.
Trademark activities are unaffected and will maintain normal operations.
I want each of you to know that we have not come by these decisions easily. I recognize that these measures will place additional burdens on your offices, your staff, and your ability to carry out the agency’s mission. However, I believe that they are absolutely necessary to ensuring that the agency can continue to operate through the remainder of this fiscal year and into FY 2012.
I thank you for continuing cooperation and patience, and I appreciate your dedication and service during this challenging time.
David Kappos
Under Secretary of Commerce for Intellectual Property and Director of the USPTO
Ironically, the USPTO does not contribute materially to the Federal deficit.  Instead, it is financially self-supporting, covering its operations through the collection of fees from patent and trademark applicants.  However, Congress has traditionally appropriated these fees for other governmental purposes, leaving the USPTO continually short of money to pay for improvements, such as skilled new patent examiners to help alleviate the huge backlog of patent applications.  In an age of austerity, the USPTO might be celebrated as a governmental exemplar of financial self-sufficiency.  Instead, it continues to act as a piggy bank continually filled by inventors, only to be raided by Congress.  It is difficult to see how this strategy benefits technological innovation.

More idealaw at LEXVIVO.

Friday, April 22, 2011

Opening The Closed While Closing The Open

The Public Patent Foundation describes its mission as "Representing the Public's Interests in the Patent System."  As its website explains,
Undeserved Patents and Unsound Patent Policy Harm the Public
... by making things more expensive, if not impossible to afford;
... by preventing scientists from advancing technology;
... by unfairly prejudicing small businesses; and
... by restraining civil liberties and individual freedoms.
PUBPAT Represents the Public's Interests Against Undeserved Patents and Unsound Patent Policy
Patent Attorney David Garrod, who has served as Senior Litigation Counsel for the Public Patent Foundation, assisted the Public Patent Foundation in its campaign against false patent marking, and authored several free claim construction dictionaries.  Meanwhile, his company, Bedrock Computer Technologies, LLC, asserted its own patent (United States Patent No. 5,893,120, entitled  "Methods and Apparatus for Information Storage and Retrieval Using a Hashing Technique with External Chaining and On-The-Fly Removal of Expired Data") against software giants such as Google, Amazon, and PayPal.  On April 21, 2011, Bedrock won a $5 million jury award against Google, whose use of open source Linux software code allegedly infringed claims of the '120 patent.

The result is a fascinating and apparently quixotic juxtaposition of opening the closed while simultaneously closing the open, and is as clear as mud.

More idealaw at LEXVIVO.

Thursday, April 07, 2011

The Patent Conference

Early in A Connecticut Yankee In King Arthur's Court, the titular Yankee, Hank Morgan, upon becoming King Arthur's "perpectual minister and executive", explains the importance he places on patents:
the very first official thing I did, in my administration—and it was on the very first day of it, too—was to start a patent office; for I knew that a country without a patent office and good patent laws was just a crab, and couldn't travel any way but sideways or backways.
Although this sentiment appears in a work of humor, many earnestly share Morgan's views on the importance of patents.  The recent explosion of patent scholarship reflects the growing perception that patents and patent systems are crucial instruments of public policy - instruments capable of generating benefits and costs for society.  Now, the increasingly important field of patent research has its own annual home:  The Patent Conference.

On April 8, 2011, the inaugural Patent Conference will be held at the University of Kansas School of Law.  The Patent Conference will be an annual event featuring the bleeding edge of patent scholarship.  This year, The Patent Conference schedule features research on patent infringement, patent damages, patent courts, empirical patent analysis, patent litigation, interdisciplinary patent studies, and Asian patent law.  Here is a press release from the inaugural host institution, the University of Kansas School of Law, describing the event:

Conference to bring world’s top patent scholars to School of Law

LAWRENCE — A critical mass of the world’s foremost patent scholars will present their latest research at the inaugural Patent Conference at the University of Kansas School of Law. 
The Patent Conference, or PatCon, will run from 8 a.m. to 6 p.m. Friday, April 8, in the Stinson Morrison Hecker Lecture Hall, 104 Green Hall. The event is free and open to the public.
The conference is a cooperative effort between the KU School of Law, the Chicago-Kent College of Law, the University of San Diego School of Law and Boston College Law School to hold an annual conference at which patent scholars in law, economics, management science and other disciplines can share their research. After this year’s inaugural conference, future gatherings will rotate among the four schools, returning to KU in 2015. 
“The scholarly study of patents has exploded in importance over the last decade,” said Andrew Torrance, a KU associate professor of law and an internationally known scholar in patent law, intellectual property law, food and drug law, and biodiversity law. “It has undergone a rapid transformation from a small niche field within intellectual property, largely overshadowed by copyright and trademark law, to an academic discipline that now attracts the enthusiastic attention of schools of law, business, public policy, engineering and medicine, as well as departments of economics, history, science and technology studies — and even science and mathematics.
“Clearly, the time has arrived for the field to have a permanent academic home, which is why we decided to found The Patent Conference.”
Torrance cofounded the conference with his colleagues David Schwartz, Chicago-Kent College of Law; Ted Sichelman, University of San Diego School of Law; and David Olson, Boston College Law School.
Nearly 40 patent scholars will make presentations in a series of panel discussions. Broad themes will include patent infringement, patent damages, patent courts, empirical patent analysis, patent litigation, interdisciplinary patent studies and Asian patent law. A complete schedule is available on the law school website.
“We are delighted that the response to the inaugural Patent Conference has been so positive,” Torrance said. “With almost 40 confirmed speakers from dozens of institutions in attendance, many of the finest patent scholars in the world will be presenting their work right here at KU School of Law. In a world that depends on technological innovation more than ever before, the cofounders and I hope this event will help spur the field of patent research to even greater success.”
The Patent Conference is sponsored by Shook, Hardy & Bacon LLP and the KU School of Law.
Patent law has attracted considerable controversy of late.  Patents are capable of inspiring both passionate support from those who believe they are necessary to spur technological innovation, on the one hand, and grave concern from those who oppose the monopoly rights to exclude others they confer upon their owners and favor more open models of innovation, on the other.  The importance of these and other issues has led to the founding of The Patent Conference, which will provide an annual venue for the free exchange of ideas and research about patents.

More idealaw at LEXVIVO.

Tuesday, March 22, 2011

Judge Opts Out Of Google Books Opt Out

In a sharp rebuke to the Google Books Project, an ambitious effort by Google Inc. to digitize all books and make them searchable on the web, Judge Denny Chin today (March 22, 2011) rejected the latest agreed settlement to a class action lawsuit between defendant, Google, and plaintiffs, The Authors Guild (attempting to represent the "Author Sub-Class") and the Association of American Publishers (attempting to represent the "Publisher Sub-Class").  The case, The Authors Guild et al. v. Google Inc, was filed in the United States District Court for the Southern District of New York, a court often chosen to decide high profile litigation, and has been presided over by Judge Chin, a Second Circuit Court of Appeals judge who is sitting in the lower court by designation.

While acknowledging the great benefits of a "universal digital library," Judge Chin noted that the settlement, in its current 166-page form,
would give Google a significant advantage over competitors, rewarding it for engaging in wholesale copying of copyrighted works without permission, while releasing claims well beyond those presented in the case.
Judge Chin deemed the notice given to members of the class to be adequate.  However, he described the quality of class representation as "troubling."  He doubted that the opt-out mechanism contemplated by the settlement should override the exclusive rights granted copyright owners under Copyright Act provisions 17 U.S.C. 106(1) and 17 U.S.C. 201(e).  Also noting possible antitrust, privacy, and international law concerns raised by the settlement, Judge Chin strongly suggested that Congress, not court, would be the best venue for deciding issues of copyright policy as important as those raised by the Google Books Project.  After evaluating a variety of arguments favoring and disfavoring the settlement, he concluded that it "is not fair, adequate, and reasonable."

Notwithstanding the rejection of this particular settlement, Judge Chin did hint at one feature a defensible settlement might have.  Perhaps the most controversial feature of the settlement was the obligation of copyright owners to opt out of the Google Books Project.  Borrowing from the amicus curiae brief filed by the United States, Judge Chin suggested that "many of the concerns...would be ameliorated if the [settlement] were an "opt-in" settlement."  So, with that guidance, the parties will likely reopen settlement negotiations.

That seer of intellectual property, Marilyn Manson, once observed that "No person can own the copyright to what God means."  Although not aspiring to heights quite as lofty as these, Google, like Icarus, may still have flown too close to the sun with its latest copyright settlement.  Discovering what can constitute a legally durable settlement will remain a challenge, given the great uncertainty and flux in copyright law.  This may be especially true if Mark Twain's observation of a century ago remains true today:  "Only one thing is impossible for God:  To find any sense in any copyright law on the planet."

More idealaw at LEXVIVO.

Friday, March 11, 2011

Après Loi Le Déluge

Preparing for rare natural disasters, such as the massive earthquake and tsunami that hit Japan on March 11, 2011, is vitally important, if human tragedies are to be minimized.  The invention of technologies useful in disasters, such as earthquake-resilient buildings, pharmaceutical drugs to treat outbreaks of disease, and even logistical methods, may be spurred by policy tools as diverse as patents, innovation prizes, and protection for open, user, and collaborative innovation.  Thus far, patents have received the most attention.  Here is the abstract an article entitled Patents to the Rescue - Disasters and Patent Law:
The patent system can play a vital role in preparing for, mitigating, reacting to, and preventing disasters. In the far term, it ensures that society continually improves its technological capacity to deal with disasters. In the near term, the patent system includes a diversity of legal options for ensuring access to patented inventions needed in disasters. Foreseeable and surprise disasters require different legal approaches to ensure timely access to patented inventions while ensuring that society is able to continue enhancing both its general and specific technological capacities. Accomplishing optimal results requires careful balancing of far term and near term interests, respect for both international and United States patent law, a clear understanding of the interrelation of different aspects of patent law, insight into the incentives that drive technological innovation, and appreciation of the disparate challenges posed by different kinds of disasters. When employed wisely, the patent system can offer society powerful assistance to prevent, prepare for, and mitigate disasters.
The entire article is available here for free download.  Once the immediate crisis passes, in Japan and its Pacific neighbors, policy makers should reevaluate how best to promote technological innovations useful in preventing and responding to natural disasters.  The more natural disaster-related innovation can be encouraged, the more likely it is that the next natural disaster will take fewer lives than the disaster that preceded it.

More idealaw at LEXVIVO.

Saturday, February 05, 2011

Eight-Track Tape, Meet Three-Track Patent

A lot can happen in five years.  One could write a great novel - or two.  One could run around the world.  One could complete an MD degree, and begin saving lives.  One could get pregnant, have a baby, watch that baby learn to crawl, walk, talk, and read, and begin kindergarten.  Or, one could apply for, and receive a final determination about, a patent.  Enter the new "Three-Track" patent system being proposed by the United States Patent and Trademark Office ("USPTO").

Gary Locke, U.S. Secretary of Commerce, has described the Three-Track system as a strategy for shifting the speed of patent prosecution for higher quality patents from lentissimo to allegro:
“The Patent and Trademark Office plays a key role in promoting innovation and entrepreneurship,” Locke said. “This new system will bring the most valuable patents, as determined by inventors, to market faster and will help shrink the backlog by catering to the business needs of America’s innovators.”
The USPTO placed a notice of its prioritized "Track I" proposal in the Federal Register on February 4, 2011, describing this new fast track to patenting as follows:

Under Track I prioritized examination, an application would be accorded special status and placed on the examiner’s special docket throughout its entire course of prosecution before the examiner until a final disposition is reached in the application. The aggregate goal for handling applications under Track I prioritized examination would be to provide a final disposition within twelve months of prioritized status being granted.
The main elements of Track I would be (1) a very expensive examination fee of $4,800 (that is, almost five times more expensive than the filing, search, and examination fees currently paid by large entities (companies with more 500 employees), and almost ten times what small entities (with 500 or fewer employees) currently pay), (2) strict limits of 4 independent claims and 30 dependent claims per application, and (3) mandatory filing of patent applications using the USPTO's electronic filing system ("EFS-Web").

Track III would allow patent applicants request that docketing of an application be delayed, allowing the application to hibernate from prosecution for up to 30 months (corresponding to the Patent Cooperation Treaty ("PCT") deadline for taking a patent application national).  Unless a patent applicant specifically affirmatively opted for Track I or Track III, that applicant would be placed by default on Track II, the current patent prosecution pathway.

The USPTO has proposed that the Track I pathway would be limited to 10,000 patent applications during its first year, and the USPTO would hire "additional examiners above the number of planned that the non-prioritized applications would not be delayed due to resources being diverted to process the prioritized applications."  This may be somewhat optimistic given the U.S. Congress' penchant for diverting fees collected by the USPTO to other governmental purposes, and 10,000 expedited patent applications, yielding almost $50,000,000 in the first year of the program alone, would present an extremely tempting target in this dawning age of federal austerity.

Monday, January 31, 2011

USDA Decides GM-Alfalfa Is No Little Rascal

Alfalfa (Medicago sativa) is one of the most important crop plants in the world. Its uses range from cattle forage to human food. Worldwide, it is cultivated more than any other legume crop. Monsanto Corporation developed a patented genetically modified ("GM") variety of alfalfa - Roundup Ready Alfalfa - that is resistant to glyphosate (N-(phosphonomethyl) glycine), a powerful herbicide used to eliminate weeds from agricultural fields.

As discussed earlier at LEXVIVO, Roundup Ready Alfalfa has inspired considerable legal controversy - controversy that has already reached the U.S. Supreme Court. On January 27, 2011, the United States Department of Agriculture ("USDA"), after completing an Environmental Impact Statement, announced in a press release that it has opted for full deregulation of Roundup Ready Alfalfa.  This decision will place no more restrictions on Monsanto's GM-alfalfa than on non-GM varieties.  As the USDA's press release relates,
"After conducting a thorough and transparent examination of alfalfa through a multi-alternative environmental impact statement (EIS) and several public comment opportunities, APHIS has determined that Roundup Ready alfalfa is as safe as traditionally bred alfalfa," Agriculture Secretary Tom Vilsack said.
This decision comes on the heels of a January 19, 2011, letter that U.S. Representative Frank Lucas (R-Okla.) and U.S. Senators Saxby Chambliss (R-Ga.) and Pat Roberts (R-Kansas) sent to USDA Secretary Tom Vilsack, warning that taking into account non-scientific factors in the regulation of GM-alfalfa would exceed the statutory authority granted to his agency by the Plant Protection Act:
It is unfortunate that those critical of the technology have decided to litigate and as you rightly point out that courts may unwisely interfere in normal commerce. However, the alternative you propose and include in the EIS is equally disturbing since it politicizes the regulatory process and goes beyond your statutory authority and indeed Congress’ intent in the Plant Protection Act (PPA). The PPA requires the Secretary to make a scientific determination if the product under review is a plant pest (7 U.S.C. 7711(c)(3)). If the final decision is that the product is not a plant pest, nor would the movement of the product in question impose the risk of dissemination of a plant pest, then USDA has no authority to impose further restrictions (7 U.S.C. 7712(a)).
Further legal challenges of GM-alfalfa are certain, especially from organic farmers who worry that GM-pollen will infect the their non-GM crops.  As a signal that it takes the growing war between advocates of agricultural biotechnology and organic farming seriously, USDA has decided to resurrect its Advisory Committee on Biotechnology and 21st Century Agriculture and the National Genetic Resources Advisory Committee to
tackle a broad range of issues, from ensuring the availability of high quality seed, to helping ensure that growers have access to the best tools available to support their production choices, to whether risk management and indemnification options can play a role.
Victory in this battle goes to agricultural biotechnology, but the wider war will assuredly continue.  In the meantime, the Food and Agriculture Organization of the United Nations ("FAO") has reported that food prices reached near-record heights in 2010.

More idealaw at LEXVIVO.

Thursday, January 27, 2011

Innovation As An Innovation

On January 25, 2011, U.S. President Barack Obama delivered a State of the Union Address packed with references to innovation.  In fact, he mentioned "innovation" no fewer than nine times during his speech.  In each of his 2010 and 2009 Addresses, President Obama mentioned innovation only twice.  During his entire eight years as U.S. President, George W. Bush mentioned innovation quite sparingly in State of the Union Addresses:  twice each in 2006 and 2003.  Even technophile President William J. Clinton employed the word only four times in his two terms in office.  So, why is innovation suddenly so popular with President Obama?

There are a number of possible explanations for why innovation has caught the presidential, and national, Zeitgeist.  One reason is that technological innovation is closely associated with economic growth.  From Robert Solow's neoclassical growth model, which estimated that about four fifths of productivity gains stem from new technology, to Paul Romer's suggestion that investments in research and development may be particularly effective means of encouraging technological improvements, much modern economic thought recommends the promotion of innovation as an especially wise policy goal.

Another motivation is the fashionable fear that the United States is at risk from being overtaken by China, whose students (along with students from South Korea, Finland, Canada, and quite a few other countries) recently outperformed their American colleagues in science, mathematics, and other subjects in the Organisation for Economic Cooperation and Development's Programme for International Student Assessment ("PISA").  The sensation caused several weeks ago by Amy Chua's publication of Battle Hymn of the Tiger Mother, in which she critiques the results of what she pejoratively terms "Western" parenting, tapped this Angst and found a gusher.

A third explanation may arise from a dawning realization that classical models of innovation may not be succeeding as well as they once did.  Witness the National Institutes of Health's new National Center for Advancing Translational Sciences ("NCATS"), whose euphemistic goal, "to leverage science to bring new ideas and materials to the attention of industry by demonstrating their value," is a reaction to the worrying relative decline in the rate of discovery, development, and market-availability of new pharmaceutical drugs, coupled with a looming "patent cliff" off which many existing medicines are beginning to tumble.

Finally, the fruits of innovation, such as the iPad, the Nissan Leaf, and Roundup Ready alfalfa, are usually viewed as cool, compelling, and a welcome distraction from the distressing realities of slow economic growth and high unemployment.  Where the Romans had panem et circenses, one can now enjoy the latest update of Angry Birds.

More idealaw at LEXVIVO.

Wednesday, January 12, 2011

An Apple Patent A Day Keeps Competitors At Bay

The big news about Apple Inc. is not their new agreement to sell iPhones that work on Verizon Wireless' 3G network.  Much more significant is newly released evidence that Apple aspires to become a patent superpower.  On January 12, 2010, patent information company IFI CLAIMS Patent Services published a new league table ranking the assignees of the most U.S. patents granted in 2010.  For the first time, Apple, at 46th, made it into the top 50, and was the assignee of 563 newly granted patents.  Although it leads the top 50 in growth rate, with a 94% increase in assigned patents since 2009, Apple still has a long climb to match the top patent assignee, International Business Machines Corporation, which received an astonishing 5,896 patents in 2010.  Nevertheless, Apple has already begun to flex its patent-strengthened muscles, particularly in the increasingly important market for smartphones.  Apple appears to be investing in an expansive patent estate to protect its prodigious profits, perhaps signaling its transition from iPhone to iSue.

Sunday, January 02, 2011

Patently Innovative China

China long ago became a manufacturing superpower.  However, its earlier-industrialized competitors have consoled themselves that China is merely a copycat of others' innovation.  The government of China is not content with such a role.  Even though the evidence that patents best spur innovation is far from conclusive, the Sunday New York Times today (January 2, 2011) reports that patents are a central pillar in the official Chinese strategy to foster a culture of home-grown invention.

The article, "When Innovation, Too, Is Made in China," references a document entitled "National Patent Development Strategy (2011-2020)," recently published by the State Intellectual Property Office of China ("SIPO"), and suggests that China plans to double its complement of patent examiners and to increase its utility patent filings to an impressive 1,000,000 by 2015.  By contrast, the United States Patent and Trademark Office ("USPTO") employed 6,413 utility, plant, and reissue patent examiners in the fourth quarter of 2009, and, during the whole of 2009, received 456,106 utility patent applications, of which 49.3% had a U.S. resident as first-listed inventor.  As the article also notes, to increase patent filings by its own residents, "China has introduced an array of incentives [including] cash bonuses, better housing for individual filers and tax breaks for companies that are prolific patent producers."

China may find, as other countries have before, that the connections between patents and innovation remain less than fully elucidated.  As Eric von Hippel has persuasively demonstrated, much innovation is either open (that is, non-proprietary), generated by users rather than producers, or both.  James Besson and Michael Meurer have shown that the relative costs and benefits of patents differ between fields, and the costs may sometimes outweigh the benefits.  And, the results of experiments (for example, see the article "Patents and the Regress of Useful Arts," published in the Columbia Science and Technology Law Review (2009)) by Profs. Bill Tomlinson and Andrew W. Torrance (author of LEXVIVO) using a variety of simplified computer-based simulations of patent systems have found relatively greater rates of innovation in systems lacking patent protection (for more, see the August 16, 2010, Google Tech Talk "The Patent Game:  Experiments in the Cathedral of Law").

Patent law, patent economics, and the innovation process are all exceedingly complicated.  Even an otherwise fascinating New York Times article stumbles on specifics, stating that, unlike China, "[i]n the American system, there are no utility patents," despite the fact the United States patent system does, indeed, offer utility patents;  where China does differ is in offering petty patents ("utility model" protection) for minor incremental innovations.  Better public understanding of the specifics of patent systems would help improve policy debates about innovation.  More fundamentally, much additional research will be required to determine the conditions under which patent systems best spur innovation.  By setting an aggressive set of patenting goals, China is clearly signaling its intentions to become a patent superpower.  However, achieving the status of innovation superpower may require more than patents alone.

More idealaw at LEXVIVO.

Thursday, December 30, 2010

The Evolution And Development Of Biolaw

For those interested in a fuller description of the origins, progress, and ambit of "biolaw," below is one recent view, entitled "The Evolution and Development of Biolaw":

Biolaw has come of age as an academic discipline. This rapidly growing legal discipline possesses a Janus nature that encompasses both the law of biology and the biology of law. Advances in the biological sciences, such as genetics, biochemistry, cell biology, synthetic biology, biological engineering, reproductive biology, embryology, developmental biology, systems biology, evolutionary biology, ecology, behavioral ecology, ethology, and neurobiology continually challenge both society and the laws that attempt to order, regulate, and protect it. Biolaw combines the use of biological science to describe, analyze, and improve the law with legal analysis of biological science, its institutions, and its societal implications. It integrates insights from such biologically-informed research areas as law and genetics, law and neuroscience, reproductive law, behavioral economics, cognitive psychology, law and biotechnology, biotechnology patent law, neuroethics, and biodiversity law. Building on early advocacy of the field by academics such as Hank Greely and June Carbone, the field is currently experiencing a renaissance in interest both inside and outside the academy. Indicia of its new prominence include a large and growing constituency among legal academics, academic conferences (i.e., Law and the Life Sciences, held in 2007 at the University of Louisville School of Law; Biolaw: Law at the Frontiers of Biology, held annually at the University of Kansas School of Law in 2007, 2008, 2009, and 2010), weblogs (e.g., Biolaw: Law and the Life Sciences, LEXVIVO), a scholarly listserv (i.e., the Biolaw Listserv), and high attendance at Biolaw “open programs” at the 2008, 2009, and 2010 American Association of Law School ("AALS") annual meetings. A watershed moment for the field of biolaw arrived in the summer of 2010, when the AALS officially recognized the "Section on Biolaw," which holds its inaugural meeting at the 2011 AALS annual meeting in San Francisco.  As advances in the biological sciences increasingly challenge the vocabulary, legal regulation, and understandings of the role of biology in society, and the law increasingly attends to the regulation of these challenges, biolaw is likely to emulate the growth of cyberlaw as an important and prominent scholarly discipline within the legal academy.
This description will require frequent updating as biolaw continues to change and grow.

More idealaw at LEXVIVO.

Tuesday, December 28, 2010

Genetically Modified Food For Legal Thought

he United States Department of Agriculture ("USDA") justifies the Plant Protection Act ("PPA")(7 U.S.C. §7701 et seq.) as "necessary because of the major impact plant pests currently have and could have on the agriculture, environment, economy, and commerce of the United States."  The PPA empowers the Animal and Plant Health Inspection Service ("APHIS") "to prohibit or restrict the importation, exportation, and the interstate movement of plants, plant products, certain biological control organisms, noxious weeds and plant pests."  Under subsections of 7 CFR §440, APHIS presumes certain genetically modified ("GM") crops to constitute plant pests.  However, the owner of a GM crop may petition APHIS to have that GM crop deregulated upon a showing that it poses no plant pest risk.

In 2004, Monsanto petitioned APHIS to have two types its GM Roundup Ready Alfalfa ("RRA") granted nonregulated status.  After drafting an environmental assessment of the environmental impact of granting this petition, and soliciting public comments on the issue, APHIS granted Monsanto a "Finding of No Significant Impact," and the RRAs were deregulated.  Several seed farms and environmental groups filed suit in the federal district court for the Northern District of California, winning a preliminary (and, later, a permanent) injunction largely banning any planting of the RRAs until APHIS complied with NEPA (the "National Environmental Policy Act", 42 U.S.C. §4321 et seq.) by preparing an environmental impact statement ("EIS") on RRA deregulation.  On appeal, the Ninth Circuit Court of Appeals affirmed, after finding that the district court below had not abused its discretion.  In Monsanto v. Geertson Seed Farms (decided on June 21, 2010), an almost unanimous U.S. Supreme Court reversed the judgment of the Ninth Circuit, finding that "the District Court had abused its discretion in enjoining APHIS from effecting a partial deregulation and in prohibiting the possibility of planting [RRAs] in accordance with the terms of such a deregulation," and remanded the case.

On December, 2010, APHIS released its final EIS, which found the RRAs substantially equivalent to non-GM alfalfas.  Normally, such a finding of substantial equivalence would warrant deregulation.  However, the USDA expressed its preference that deregulation of the RRAs be accompanied by safeguards to prevent genes from GM alfalfa from contaminating neighboring organic crops.  The issue of colliding GM and non-GM crops has already reached the courts on several occasions, most notably in In re Starlink Corn Products Liability Litigation (N.D. Illinois 2002) and Monsanto v. Schmeiser (Supreme Court of Canada 2004).  Like the English Railway Fires Acts, which were intended to provide modest compensation to owners (often farmers) whose lands were damaged by sparks from steam engines, while simultaneously preventing tort liability from discouraging the perceived economic progress offered by railways, the PPA deregulation pathway could become a method of encouraging the expansion of GM crops.  The decision by APHIS to deregulate, but only with potentially onerous conditions, has even raised the ire of, among others, the Wall Street Journal, which led its December 27, 2010, editorial page with an indictment of USDA's decision to rely on non-scientific factors alongside scientific ones.  The editorial warns that "[i]f nonscience criteria are introduced as considerations for allowing the sale of biotech crops, the effect would be disastrous for the USDA's regulatory reputation."

If GM crops continue to be rapidly adopted around the world, legal issues involving colliding crops are sure to become more common.  Managing the legal consequences of such collisions awaits solutions.

More idealaw at LEXVIVO.

Sunday, December 26, 2010

FDA Slams Brakes On Avastin's Accelerated Approval

Sunday New York Times editorials are often the venue for weighty issues of broad interest, such as war, peace, growth, recession, and politics.  Seldom do they tackle the technical considerations of the drug approval process administered by the U.S. Food and Drug Administration ("FDA").  However, on December 26, 2010, a full third of the Times' influential editorial space was devoted to the paper's views on a drug used to treat metastatic breast cancers.

Bevacizumab is a recombinant humanized mouse monoclonal antibody that binds to vascular endothelial growth factor ("VEGF"), a protein that promotes angiogenesis, the growth of new blood vessels.  By binding to VEGF, bevacizumab blocks binding at the VEGF receptor.  Under some circumstances and for some specific cancers, AvastinÒ (the brand name under which Genentech - recently aquired by Roche - markets bevacizumab) has been observed to inhibit angiogenesis in cancerous tumors, thereby slowing tumor growth.

What prompted the Times' editorial was a recent decision by the FDA to reverse its previous accelerated approval for the use of AvastinÒ to treat metastatic breast cancers.  In 1992, the FDA introduced "accelerated approval" as a means to speed up the regulatory approval of some drugs and biologics.  As provided for in 21 CFR 314.510, accelerated approval is a pathway through which a drug applicant carrying out clinical trials can temporarily substitute a "surrogate endpoint" - a marker indicating a clinically meaningful outcome - for an actual "clinical benefit" to gain preliminary approval.  A similar pathway for the accelerated approval of biologics is set out in 21 CFR 601.41.  This approval pathway is especially valuable in the case of drugs whose clinical benefits may not fully manifest themselves for years.  Upon accelerated approval, the drug may be marketed with a label listing the specific disease indication evidenced by the surrogate endpoint.  However, the applicant must then conduct post-marketing (or "phase 4") confirmatory clinical trials.  If these phase 4 clinical trials support an actual clinical benefit, then the FDA grants the drug regular, full, approval.  In the case of AvastinÒ, the FDA judged phase 4 trials non-confirmatory, and has announced its intention to withdraw its preliminary approval in the case of metastatic breast cancers.

Without FDA approval, by law Genentech will have to remove the metastatic breast cancers indication from the drug's label.  Unless the FDA is forced to reverses its decision as a result of the scheduled hearing, or after Genentech's further legal appeals in federal court, insurance companies will soon drop their coverage for AvastinÒ treatment, which can cost more than $100,000 per patient per year, and has generated blockbuster earnings for Genentech.  The FDA has suffered much passionate criticism of this decision, including from patient advocates and Roche.  Nevertheless, the Times supports the FDA's reversal, and believes the agency "has shown courage in following the scientific evidence on this highly emotional issue."

In recent years, the FDA has been criticized - even demonized - for limiting access to experiment drugs, even to those for whom such drugs might be their only hope of survival.  An especially contentious, and tragic, example of this ongoing controversy culminated in  the Abigail Alliance v. Eschenbach (D.C. Circuit 2007;  en banc) decision, in which the court held that there was "no fundamental right...of access to experimental drugs for the terminally ill."  Though the facts surrounding the preliminary approval differ markedly, the current regulatory dispute over AvastinÒ may generate similar emotional echoes.

More idealaw at LEXVIVO.

Wednesday, December 22, 2010

Lex Libris

A number of exceptional books relating to genes, demes, or memes have been published in 2010.  Here is the LEXVIVO list of the top three:

Genes.  The $1,000 Genome:  The Revolution in DNA Sequencing and the New Era of Personalized Medicine.  In this tour de force tour of genomics, Dr. Kevin Davies, Ph.D. (University of London) molecular geneticist and Editor-in-Chief of Bio-IT World (a LEXVIVO must-read), masterfully charts the recent, explosive, and fascinating rise of rapid DNA sequencing technology, explains the wealth of genomic information it enables, interviews the entire cast of characters driving progress in the field, and then frames this powerful technology and its myriad implications for individuals and society in scientific, cultural, ethical, and legal context.

Demes.  Greening through IT:  Informational Technology for Environmental Sustainability.  In this wonderful book, Professor Bill Tomlinson (Informatics Department, Bren School of Information and Computer Sciences, University of California Irvine), a Ph.D. graduate of the MIT Media Lab, brilliantly shows how code, both alone and in conjunction with law, can promote environmental sustainability.

Memes.  The Rational Optimist:  How Prosperity Evolves.  Dr. Matt Ridley (Ph.D. Oxford University), who has written widely and boldly on human evolution (e.g., The Red Queen:  Sex and the Evolution of Human Nature), genetics (e.g., The Agile Gene:  How Nature Turns on Nurture), and the genome (e.g., Genome:  The Autobiography of a Species in 23 Chapters), here posits an elegant, eloquent, and challengingly controversial evolutionary explanation for economic growth via relentless innovation.  If one prefers moving pictures to thousands of words, here is Ridley's cheekily named TED talk, "When Ideas Have Sex."

Enjoy these wonderful books.

More idealaw at LEXVIVO.

Saturday, December 18, 2010

Prometheus Patents Unbound

The Titan Prometheus suffered from a chronic liver condition.  The diagnosis was fairly straightforward:  every day, a great eagle would devour his liver, which then regenerated, affording the eagle its next meal.  Preventive medicine to avoid this condition might have involved Prometheus not stealing fire from the gods, and then giving it to humanity, since these actions caused Zeus to impose his brutal aquiline punishment.

On December 17, 2010, a more modern Prometheus, Inc. - a San Diego-based biotechnology company - received news that its torment in the Federal court system might ease.  In Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Mayo Clinic Rochester (hereafter, "Prometheus v. Mayo"), the Court of Appeals for the Federal Circuit ("Federal Circuit") reversed a district court's grant of summary judgment that claims in Prometheus' exclusively licensed patents (U.S. Pat. Nos. 6,355,623 and 6,680,302) were invalid because they were drawn to non-statutory subject matter under 35 U.S.C. §101.  In an eagerly anticipated decision, a unanimous Federal Circuit panel, made up of Chief Judge Rader and Circuit Judges Lourie and Bryson, "again [held] that Prometheus' method claims recite patentable subject matter under §101."  The court's previous finding that Prometheus' claims constituted statutory subject matter was successfully appealed by defendants-appellees Mayo Collaborative Services and Mayo Clinic Rochester (hereafter, "Mayo") to the Supreme Court, which vacated and remanded the Federal Circuit's decision on April 29, 2010, "for further consideration in light of Bilski v. Kappos," a business method patent case the Supreme Court had decided the day before.

The claims at issue cover methods for determining the optimal dosage of thiopurine drugs, such as 6-mercaptopurine and azathiopurine, used to treat inflammatory bowel diseases that include Crohn's disease and ulcerative colitis.  For example, claim 1 of the '623 patent involves (1) administering a drug capable of producing 6-thioguanine inside a patient suffering from a gastrointestinal disorder, (2) determining the concentration of 6-thioguanine in the patient's blood, and (3) indicating the need to increase or decrease the drug's dosage depending on whether the drug's blood concentration is outside of the therapeutically desired range of 230-400 pmol per 80,000,000 red blood cells.

The Federal Circuit's decision in Prometheus v. Mayo supports the potential patentability of inventions that claim "therapeutic methods that determine the optimal dosage level of a course of treatment," (Opinion, page 24) including the inventions claimed in Prometheus' patents, that is, "a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs (Opinion, page 25).  More broadly, this decision may raise optimism within the biotechnology and pharmaceutical industries that methods of personalized medicine, including individually tailoring therapies based on specific genomic information, may be patentable, and, thus, worth investment in research and development.

More idealaw at LEXVIVO.   

Thursday, December 16, 2010

PCSBI Report: Synbio Much Ado About Not Much Yet

In its first report, released today, the Obama administration's Presidential Commission for the Study Bioethical Issues ("PCSBI") largely ratifies the current legal environment in which synthetic biology operates, while also urging close monitoring and future study of this rapidly evolving field.  The PCSBI's mission is "to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner."  On May 6, 2010, the J. Craig Venter Institute ("JCVI") quietly deposited the full genome sequence of "Synthetic Mycoplasma mycoides JCVI-syn1.0 clone sMmYCp235-1" into GenBank.  Then, on May 20, 2010, the JCVI surprised the world by announcing, and publishing in Science, its successful "Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome."  The White House responded immediately by requesting that the PCSBI study relevant ethical issues raised by this biological breakthrough, and complete its study by November 20, 2010.  On December 16, 2010, the PCSBI released the results of its first mandate from President Obama.  Prepared with the assistance of two consultants, Alison Davis (Ph.D. in Cell Biology from Johns Hopkins School of Medicine) and Kathi E. Hanna (Ph.D. in Business and Public Management from George Washington University), and a public relations firm, Burness Communications, the report is entitled "New Directions - The Ethics of Synthetic Biology and Emerging Technologies."

More idealaw at LEXVIVO.

Wednesday, July 23, 2008

Affymetrix' Wings Get SNPed

Sometimes a single nucleotide variant among the thousands that make up a typical gene can indicate significant abnormality in a patient. These needles in genomic haystacks, called "Single Nucleotide Polymorphisms", or "SNPs", can be not only medically useful, but also quite lucrative to medical diagnostic companies as well.

In 1999, Biologists John Landers, Barbara Jordan, David E. Housman, and Alain Charest filed a patent application claiming "method[s] of genotyping...based on the use of single nucleotide polymorphisms (SNPs) to perform high throughput genome scans." These methods claimed by Lander et al. allow high-throughput screening of patients' genomes for SNPs relevant to diseases. Lander et al. assigned to the Massachusetts Institute of Technology ("MIT") their patent, United Patent Number 6,703,228 (the "'228 patent"), claiming, for example:

Claim 1. A method for detecting the presence or absence of a single nucteotide polymorphism (SNP) allele in a genomic DNA sample, the method comprising:

preparing a reduced complexity genome (RCG) from the genomic DNA sample, wherein the RCG is a randomly primed PCR-derived RCG, and
analyzing the RCG for the presence or absence of a SNP allele.

Affymetrix is a California company that sells microarrays - devices capable of rapidly testing large numbers of genes for the presence of particularly indicative SNPs. On July 1, 2008, MIT and E8 Pharmaceuticals sued Affymetrix for infringing the '228 patent, and engaged the services of Wiley Rein, a D.C. law firm that won a patent infringement settlement of more than half a billion dollars from BlackBerry-maker, Research In Motion. Affymetrix had previously lost an interference proceeding in the United States Patent & Trademark Office ("USPTO") that contested Lander et al.'s claim to have been the first inventors of these methods, and now stands to suffer huge damages should it be found to infringe the '228 patent.

Affymetrix has long been a vocal opponent of the validity of many so called "gene" patents, a position that dovetails nicely with the company's strong desire not to be forced to license the many existing SNP patents one by one. Now, the company is being sued not on specific SNP patents, but on a patent that claims methods of detecting those SNPs. Affymetrix has alleged that claims of the '228 patent are invalid. Where Affymetrix previously argued that it was the rightful owner of '228 patent-like claims, now the company considers such claims - owned by another - to be invalid. The result may exert considerable influence over the future of personal medicine.

Monday, July 07, 2008

Lowering the costs of switching between Windows and Mac

For years I've resisted switching from the world of Microsoft-powered computers to that of Apple, the Mac, and Leopard OS. Not out of any belief in Microsoft's technological superiority, mind you — I am firmly convinced of Microsoft's inferiority — but rather out of fear that the switching costs would be prohibitive. And being locked into a PC-based machine at work would compound the misery, so I thought, because my fingers would never manage to master two different sets of routines.

I took the plunge anyway — thank you, Nancy Rapoport, for giving me the courage to do this — and have discovered, mirabile dictu, that it is actually quite easy to manage both worlds. Surely it advances IdeaLaw principles to enable consumers to choose between operating systems on the basis of technological superiority rather than lock-in effects.

With those considerations in mind, I beamed with joy when I discovered this list of tips for those who, like me, have switched to Mac from Windows (all text quoted from Walt Mossberg's column, unless otherwise bracketed):
  • In general: While the Windows and Mac user interfaces are broadly similar, they do have subtle variations in day-to-day use that require some re-education for switchers. And because there are so many fewer Mac users than Windows users, help from friends and co-workers can be harder to obtain than it is for people switching the other way, to Windows from Mac. . . .

  • iMac
  • Menu bars: In Windows, each program typically has its own menu bar. On the Mac, there’s a single menu bar at the top of the screen that changes, depending on which program you are actively using.

  • Task bar: The equivalent of the Windows XP Task Bar on the Mac is the Dock. Unlike the Task Bar, which primarily holds icons representing open windows, the Mac Dock primarily holds icons of programs you use most often. To place a program onto the Dock, you just drag its icon there. To remove it, you just drag its icon off the Dock and it disappears in a puff of animated smoke.

  • Start menu: There is no Start Menu on a Mac. Its functions are divided between the Dock and the Apple menu at the upper left of the Mac screen.

  • Control panel: The Mac equivalent of the Windows Control Panel is called System Preferences, and it can be launched from either the Dock or the Apple menu.

  • Keyboard shortcuts: Common Windows keyboard commands, such as Ctrl-S for Save, Ctrl-P for Print, and many others, are also available on the Mac. However, instead of using the Control key, they use the Mac’s Command key, which bears either a cloverlike symbol or an Apple logo. So, on the Mac, for instance, Command-S is for Save.

  • Quitting programs: In Windows, you can quit a program by clicking on the red “X” in a square at the upper right corner of the window you’re using. But on the Mac, if you click on the equivalent button — a red “X” in a circle in the upper left corner — you are merely closing the window, not quitting the program. To quit the program, you must either select Quit from the leftmost menu or press the Command and “Q” keys together.

  • Maximizing windows: When you click on the blue maximize button in Windows XP, the window you are viewing occupies the whole screen. In Leopard, the equivalent button — a green circle at the upper left — increases a small window’s size to a footprint deemed optimal for its contents, which isn’t always the whole screen.

  • Switching programs: One common way to switch among running programs in Windows XP is to press Alt and Tab together. This displays icons of each running program and allows you to switch among them. On a Mac, the same trick can be performed by pressing the Command and Tab keys together. The Mac also has a terrific feature called Expose, which shows every open window at once, in miniature form, so you can navigate among them. [On my iMac, I trigger Expose either by mashing the F3 key or by pressing the side buttons on my mouse.]

  • Right-clicking: Contrary to common belief, the Mac has a right-click menu function, just like Windows. Most desktop Macs now come with a mouse that allows right-clicking, and you can use almost any two-button USB mouse with any modern Mac. [You do need to readjust mouse settings in System Preferences.] If you are using a Mac laptop, which has only one button under the track pad, you can simulate a right-click by either holding down the Control key when you click, or by placing two fingers on the track pad while clicking. . . .
Failing all else, refugees from Planet Microsoft can seek succor from Apple directly, either at Mac 101 or at Switch 101.