Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Secularism, Sharia, and the Turkish Financial Markets

The financial markets in Turkey provide a laboratory to help resolve these competing views. Islamic law or Sharia contains a number of proscriptions that directly affect financial practices. The payment and receipt of interest is prohibited; so are most kinds of commercial insurance. These interpretations provided the impetus in the Islamic world for the creation of a class of banks that sought to offer Sharia compliant services. The first Islamic Banks in Turkey began operations in the 1980s. Their entry was initially tepid, in no small part because of secularist principles. Islamic financial institutions could not overtly advertise their religious orientation. The country had no “Islamic” banks, only finance houses. They were not Sharia compliant but “interest-free.” Moreover, the government left them in an uncertain regulatory status and subjected them to restrictions on growth. In this environment, the Islamic banks remained a peripheral part of the financial system. With the election of the AKP in 2002, however, the environment for Islamic banks in Turkey changed. Limitations on branch networks and capital raising were lifted. The government removed restrictions on the issuance of Sharia compliant bonds. Officials from the Islamic banks were appointed to the highest levels of government. This Article does several things. First, it examines principles of Islam that affect banking practices, with a particular emphasis on deposit insurance and credit cards. Second, the Article discusses the emergence of secularism in Turkey and the introduction of Islamic banks into the Turkish financial markets. The Article then examine their evolution, with particular emphasis on the changes implemented by the AKP. Finally, the Article examines the impact of these reforms, and what that impact says about Islamic influence in Turkey.

Comment Letter: The NYSE and the End of the Structural Separation between Regulatory and Commercial Interests of the Exchange

The NYSE transformed into a for profit entity in 2006. As part of the approval process, the NYSE agreed to structurally separate the regulatory function from the business function. In doing so, the NYSE created NYSE Regulation, a non-profit with an independent board, to handle most regulatory matters. During the comment period, a spirited debate arose over the ability of a for profit company to carry out a regulatory mission. Some suggested that the regulatory function was incompatible with a "for profit" motive and that NYSE Regulation should be spun off. Others accepted the proposed structure but called for additional changes designed to reduce the possible influence of the public holding company over the regulatory function. In the end, the SEC approved the structure but with a number of prophylactic safeguards including the requirement that NYSE Regulation have a board consisting of all independent directors (save the CEO) and that directors from the for profit holding company could not make up a majority of the board. More recently, however, the NYSE has proposed to end the structural separation of the two functions and instead put in place a functional separation. The proposal would result in the termination of the delegation agreement between the Exchange and NYSE Regulation and the creation of both a Regulatory Oversight Committee of the Board of Directors of the Exchange and the creation of a Chief Regulatory Officer. This letter examines the history of the separation of the two functions and critiques the NYSE's proposal.

The assignment of credit through bills of exchange and transmission documents in Andalusi Law

The exchange traffic was a practice that suited the modus vivendi of caravanners and traders in the Islamic world. The inclusion of the Iberian.Peninsula into the most important commercial routes of Muslims – such as the silk route through the North Africa – provides a very solid reason to deepen in the study of the sources that have been preserved about the role that certain credit instruments, which represented an alternative to the coin, might have played in trade centres.

Open-access operating algorithms for commercial videokeratographer and improvement of corneal sampling

We present an algorithm to process images of reflected Placido rings captured by a commercial videokeratoscope. Raw data are obtained with no Cartesian-to-polar-coordinate conversion, thus avoiding interpolation and associated numerical artifacts. The method provides a characteristic equation for the device and is able to process around 6 times more corneal data than the commercial software. Our proposal allows complete control over the whole process from the capture of corneal images until the computation of curvature radii.

Syria and the red lines of international law. CEPS Commentary, 4 September 2013

As the US and its allies France and Turkey dither over whether or not to punish Assad for having used sarin gas to kill his own people, the crucial question is: What response might the outside world legally take without the authority of the UN Security Council, which remains blocked by two veto-wielding members, Russia and China? Sadly, international law provides no clear-cut answers to this dilemma. To respond to what US Secretary of State John Kerry has rightly called a “moral obscenity”, this commentary explores ways in which formal interpretations of international law might give way to a more pragmatic approach to punish the Assad regime for its use of chemical weapons.

EU-Turkey Relations: Turning vicious circles into virtuous ones. CEPS Policy Brief No. 317, 26 March 2014

The coming weeks and months will be decisive for the general tenor of politics in Turkey. The country faces local elections this March, presidential elections in August and general elections next June, while top-level political scandals compound the deterioration in the state of democracy and rule of law. At the same time, stagnation in Turkey’s accession process continues to sour relations with the EU. In this new Policy Brief, Steven Blockmans puts forward a number of recommendations to help drive the EU accession process forward, namely the early opening of negotiation chapters 23 (judiciary and fundamental rights) and 24 (justice, freedom and security), in line with the EU’s so-called New Approach. In that way reform could not just be assured on paper, but a track record in implementation could be established throughout the process. To achieve this, member states, and Cyprus in particular, need to be persuaded to end their opposition to formulating benchmarks for the opening of accession negotiating chapters 23 and 24.

Turkey votes: Part II - Erdoğan reloaded. EPC Commentary, 3 April 2014

On 30 March, Turkey’s ruling Justice and Development Party (AKP) scooped a significant victory in local elections, taking almost 44 percent of the vote despite accusations of corruption, undermining the rule of law, fundamental rights and freedoms. While there have been claims of election fraud and the main opposition party, the Republican People’s Party (CHP), has demanded recounts in several cities including Istanbul and Ankara, it is clear that even allowing for some level of fraud the win was substantial and more than most people expected. Prime Minister Recep Tayyip Erdoğan has reached a juncture. He has two choices: return to the path of democracy after a period of democratic back-sliding which included passing several controversial reforms such as a new internet law which led to the recent banning of Twitter and Youtube; or alternatively he can forge ahead with his much talked of revenge campaign against those he has accused of creating a “parallel state” and conspiring to remove him from power. Given that Erdoğan viewed this election as a referendum on his popularity and leadership there is a serious risk that he will do the latter; using the significant mandate given to him to do whatever he wants, including further cracking down on democracy.

Why the EU must reengage with Turkey. EPC Commentary, 29 September 2014

Democratic values and basic rights in Turkey are hanging by a thread. Over the past eighteen months the rule of law, civil liberties and freedoms have been eroded which has left many Turks anxious over the direction in which their country is heading. With Turkey’s accession negotiations de facto frozen, the EU finds itself with little leverage over Ankara. Calls of concern have fallen on deaf ears as Turkey’s leadership has become increasingly belligerent, with its EU related narrative overflowing with resentment. Because Turkey’s accession negotiations are irreversibly intertwined with Turkey-EU cooperation in other areas, this has had a negative impact on the broader relationship between both sides. Recent examples include the issue of foreign fighters traveling from Europe to Syria via Turkey. Each side has accused the other of not doing enough to stem the flow. Likewise, following the decision of Russian President, Vladimir Putin, to ban the import of agricultural goods from countries that have placed sanctions on Moscow, the EU asked Turkey to demonstrate solidarity, as a “candidate country”, and not to increase exports of agricultural products to Russia. Turkey rejected this request and is reportedly working on strengthening trade ties with Moscow. Turkey remains an important partner in a number of key areas including trade, energy, foreign and security policy and migration. At a time when the EU faces crises in both its Eastern and Southern neighbourhoods, a reliable and predictable Turkey, with which it can cooperate in the Black Sea and Middle East neighbourhoods is crucial. Hence the vision and plans of the EU’s new leadership, in particular new Foreign Policy Chief, Federica Mogherini, and Commissioner for European Neighbourhood Policy and Enlargement Negotiations, Johannes Hahn, how to shape relations with Ankara is particularly significant. The Union’s current policy is counterproductive and is further eroding trust and cooperation rather than enhancing it. It needs to be turned around.

International trade mark law and practice,

The laws of all countries have been analyzed and arranged under a series of headings; full texts of the various international conventions on the subject of trade-marks and a complete collection of the trade-mark classifications in force in the various countries are also included. cf. Pref.

Foreign direct investment in the United States : report of the Secretary of Commerce to the Congress in compliance with the Foreign investment study act of 1974, Public law 93-479.

Vol. 1 includes full text of the Foreign investment study act of 1974.

A study of two commercial film badge services /

"U.S. Atomic Energy Commission Contract AT(29-1)-1106."

Report of the Law Revision Commission.

Report for 1954 includes Record of hearings on the Uniform commercial code; 1955, Study of the Uniform commercial code; 1956, Report relating to the Uniform commercial code.

Party of workmen at work at rear of the temple [Excavation at Antioch of Pisidia in Turkey]

George R. Swain photograph no.1550 Near East Research