About Burcu Kilic

Posts by Burcu Kilic:

Reversing the “IP Ratchet”: Global Implications of the U.S. Supreme Court’s Ruling in Myriad

, ,

BRCA gene

Co-authored by Adriana Benedict and Tiffany Jang

The U.S. Patent and Trademark Office (USPTO) and European Patent Office (EPO) have been granting patents on isolated human DNA since the early 1980s.  Many countries have followed their lead.

More than three decades later, the U.S. has become the first country to reject the patent eligibility of isolated DNA following last week’s Supreme Court ruling in Ass’n of Molecular Pathology v. Myriad Genetics.  Will its opinion have any global ripple effects?

The USPTO has promoted harmonization with its standards of patentability through training and technical assistance programs since 1985.  USPTO patent standards have spread in part due to a partnership established between the USPTO, EPO and Japanese Patent Office (JPO) in 1983.  As noted by the Australian Law Reform Commission, in 1988, these Trilateral Offices issued a joint statement explaining that

Purified natural products are not regarded as products of nature or discoveries because they do not in fact exist in nature in an isolated form. Rather, they are regarded for patent purposes as biologically active substances or chemical compounds and eligible for patenting on the same basis as other chemical compounds.

In response to some uncertainty regarding claim drafting for isolated DNA sequences, the USPTO Manual of Patent Examination and Procedures was updated in 1990 to provide clear guidelines to this effect. Similarly, the JPO’s Implementation Guidelines for Inventions in Specific Fields explicitly provides that isolated genes are patentable; and in the E.U., isolated DNA is patentable under Biotechnology Directive 98/44/EC (although patents on isolated DNA may only be issued in the E.U. if the inventor can show that the genetic sequence exhibits surprising or unexpected properties).  Importantly, the European Commission was influenced by the U.S.’s acceptance of gene patents in its deliberations leading up to the directive.  When it proposed the Biotechnology Directive in 1988, it noted:

[W]hereas the two leading nations in biotechnology, the United States of America and Japan, have been able continuously to adapt their patent protection according to the latest needs of industry, science and consumers, the Member States, representing comparable potential of intellectual manpower and capital, are immobilized by a not yet completed and . . . outdated legal framework.

Other countries have followed suit.  Isolated DNA sequences are patent eligible in Canada as biomolecules, and the Intellectual Property Office of Singapore recognizes patents on genes, in accordance with Howard Florey Institute [Relaxin].  In February of this year, the Federal Court of Australia held that isolated DNA is patentable under the Statute of Monopolies because it embodies a chemical compound, and thus is a “manner of manufacture,” rather than genetic information.

But the Supreme Court is forcing the USPTO to reverse course. In the long-awaited Myriad opinion, the U.S Supreme Court ruled late last week that isolated human DNA is not patentable subject matter because it is naturally ocurring, while complementary DNA (cDNA) is patentable subject matter because it is not naturally occurring. cDNA is a synthetic form of DNA that does not contain introns (nucleotide sequences that don’t encode for proteins), while isolated DNA is composed of exons (protein-coding nucleotide sequences) interspersed with introns.  Because both isolated DNA and cDNA have important research applications, the Supreme Court’s decision in Myriad will have an enormous impact on the future of biotechnology, biomedical research, and diagnostic and therapeutic efforts.

Prior to Myriad, the recognition of human genes as patentable subject matter meant that the owners of patents on isolated DNA could hold monopolies on the genetic information embodied in DNA sequences, raising the cost of access to this information for both patients and scientific researchers. This led to a concern that, among other things, exclusively licensed patents on isolated DNA stood in the way of patient access to secondary opinions confirming the results of genetic tests.  To address this concern, the America Invents Act had directed the USPTO to explore this challenge and propose possible solutions to it; the USPTO’s final report, however, was delayed more than a year and has yet to be released.   

Under common law precedent regarding 35 U.S.C. § 101’s definition of patentable subject matter, laws of nature, products of nature and abstract ideas cannot be patented in the U.S.  As explained in Mayo v. Prometheus, laws of nature constitute “the basic tools of scientific and technological work.”  In addition to playing a major role in the Supreme Court’s ruling in Mayo last year, the law of nature exception has a long history of Supreme Court precedent, including Mackay Radio & Telegraph Co. v. Radio Corp. of America, Funk Bros. Seed v. Kalo Inoculant, and Parker v. Flook.  Indeed, even in Diamond v. Chakrabarty, the case considered to have paved the way for gene patents, the Court expressly stated that “laws of nature, physical phenomena, and abstract ideas have been held not patentable.”  Prior to today’s ruling, it was the long-held practice of the U.S. Patent and Trademark Office (USPTO) to grant patents on isolated DNA. It had been widely believed that because human DNA does not exist in nature in isolated form, isolated DNA could be patented on the grounds that it is a product of human ingenuity.

Petitioners in Myriad challenged the legality of Myriad’s patents on BRCA1 and BRCA2 genes, mutations of which are known to be associated with heightened risk of breast and ovarian cancer. Myriad’s patents on isolated DNA had originally been struck down by the Southern District of New York in a ruling that was later reversed and subsequently affirmed after being remanded by the Supreme Court.  In a unanimous holding (with the exception of some minor concurrences by Justice Scalia on biological explanations), Justice Thomas explained that isolated human DNA is not patent eligible subject matter under § 101 because it constitutes a law of nature.  Specifically, the Court explained that:

  1. Myriad did not invent anything by isolating or locating the BRCA1 and BRCA2 genes, but rather identified what already exists in nature;
  2. the relevant “patent descriptions simply detail the ‘iterative process’ of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought;
  3. the claims at issue cover the information contained in a genetic sequence rather than chemical compositions themselves; and
  4. deference to past USPTO practice was not persuasive in the absence of explicit statutory support for the patentability of isolated genes, which is absent from Title 35 of the U.S. Code.

In contrast, the Court explained that cDNA—with the exception of very short strands free from intervening introns—is patentable because it differs from naturally occurring DNA, which contains both introns and exons.

Myriad paves the way for increased competition in the provision of genetic tests for BRCA1 and BRCA2 mutations because Myriad will no longer have a monopoly on all research and diagnostic methods that use the isolated BRCA1 and BRCA2 nucleotide sequences.  On the coattails of the Court’s ruling, many diagnostic companies and research institutions such as Ambray Genetics and the University of Washington announced their intentions to incorporate BRCA1 and BRCA2 into their next-generation sequencing panels, significantly reducing the cost of BRCA1 and BRCA2 diagnostic testing.  Similarly, GeneDX has announced its plans to launch comprehensive genetic testing for hereditary cancers, and DNATraits has said that it will provide a test for $995, less than a third of the cost of Myriad’s test. There has also been speculation that whole genome sequencing will become easier without Myriad’s patents on isolated BRCA1 and BRCA2 sequences. However, Myriad will retain its monopoly over BRCA Analysis, the only test currently used worldwide for determining susceptibility to hereditary breast and ovarian cancer based on an analysis of BRCA1 and BRCA2 mutations.  Additionally, Myriad will retain a monopoly on all research that involves the cDNA of BRCA1 and BRCA2, which includes many research methods that use a probe to assay for gene expression.

Following in the footsteps of Mayo v. Prometheus and Bilski v. Kappos, Myriad is the third case since 2010 in which the Supreme Court has used subject matter eligibility to limit long-standing practice of the USPTO.  This apparent trend demonstrates the risk in exporting the maximum reach of U.S. law and practice at any given time via the USPTO and trade agreements negotiated by the office of the U.S.  What is clear for now, however, is that the Supreme Court is scaling back on the maximalist tendencies of U.S. patent policy, referred to by some as the global IP ratchet.

Will other countries once again follow suit?

 

 

First SOPA then ACTA, now TAFTA- here we go again

, , , ,

Our Trans-Atlantic Call for Exclusion of Intellectual Property from EU-US Trade Talks

US trade policy is currently focused on the Trans-Pacific Partnership (TPP), for which President Obama hopes to complete negotiations by October. If the agreement is concluded according to plan, the TPP will include the United States, Canada, Mexico, Peru, Chile, New Zealand, Australia, Brunei, Singapore, Malaysia, and Vietnam.  Japan is signaling its interest to join and Korea would possibly follow Japan. The treaty would remain open for other countries to join as well, so long as they meet the required standards.

Meanwhile, along the Atlantic, the US is preparing to launch negotiations for a Transatlantic Free Trade Agreement (TAFTA)—or what is being touted as the Transatlantic Trade and Investment Partnership (TTIP).

The establishment of a Trans-Atlantic partnership is not a new idea; the possibility of creating a Trans-Atlantic Free Trade area had been discussed occasionally in the past, especially during the 1970s and 1980s. However, informal discussions failed to solidify into something more concrete.

The United States and the European Union have both entered into economic partnership agreements across the globe, but never before with each other. In 2011, American and European politicians keen on “shaping globalization” (i.e. setting rules for the 21st century) outside the official global forums set up the High-Level Working Group on Growth and Jobs (HLWG) to assess the feasibility of a comprehensive transatlantic trade agreement.  The deal between the world’s two most important economic powers hopes to be a “game-changer.”

The BRICS countries — Brazil, Russia, India, South Africa and perhaps most notably China – have not been invited to either negotiation. It may be the case that these deals aim to better prepare the EU and the US for an upcoming economic battle with the BRICS and other emerging powers.  The BRICS countries have a combined GDP now equivalent to that of the EU or the US.  “This is about the weight of the western, free world in world economic and political affairs,” declared EU Trade Commissioner De Gucht.

The HLWG released its interim report in 2012 identifying policies and measures to increase EU-US trade and investment. The interim report noted that, “it would not be feasible in negotiations to seek to reconcile across the board differences in the IPR obligations that each typically includes in its comprehensive trade agreements.”

However, industry groups soon realized that the so-called Trans-Atlantic Free Trade Agreement presents a perfect opportunity to set “golden standards” for IP regulation and enforcement, which emerging markets like China and India could then be pushed to accept. Groups like PhRMA urged the EU and US to include IP to further strengthen the international regime. Eventually, the HLWG changed its position and is now recommending the inclusion of an IP chapter, although a “limited” one. The Final Report issued by the HLWG recommends that TAFTA negotiations “address a limited number of significant IPR issues of interest to either side, without prejudice to the outcome.”

It is not clear what the HLWG is trying to say. The US and EU regimes are not alike. Geographical indications, for instance, continue to create a transatlantic trade conflict between the US and EU. They have fundamentally different philosophies on the issue.  The EU is committed to enhancing its vast gastronomic heritage of excellence, and pushes for more restrictive rules. The US wants to maintain the status quo to help giant companies like Kraft sell items like “parmesan” cheese around the world.

Any attempt to boost patent or copyright rules in favor of rights holders and against the interests of consumers would be a significant mistake and invite major public resistance. The defeat of ACTA in the EU and the overnight death of SOPA in the US were no accidents. They should serve as a stark reminder to policymakers on either side of the Atlantic.

It goes without saying we will not hold back from raising our voices once again in defense of our fundamental rights to free speech and health, and to uphold the benefits of an open knowledge economy.

To read the declaration of  transatlantic coalition of 45 consumer, public health and Internet freedom groups, visit http://www.citizen.org/ip-out-of-tafta.

We Can End AIDS: Join Us this Tuesday in Washington, D.C.

, , ,

Acquired immune deficiency syndrome (AIDS) was first recognized in the United States in 1981. The Human Immunodeficiency Virus (HIV) was identified soon after in 1983. By the mid-1980’s, the disease was recognized as an international epidemic which had spread throughout most of the world. Millions have lost their lives since.

Three decades later, we may finally have an opportunity to end AIDS."We Can End AIDS 2012"

This year, new science demonstrated that treatment can also be effective as HIV prevention.  For the first time it is becoming possible to model an end to the epidemic. Activists’ calls for an AIDS-free generation have been echoed worldwide.

But ending AIDS will depend in part on massively scaling up access to treatment. A major obstacle is the monopoly power of the giant pharmaceutical companies.

In 2000, basic HIV treatment cost up to $15,000 per person, per year (ppy). In developing countries, treatment was out of reach for all but the very wealthy, and HIV was a death sentence.

Then, activists working together across borders and increasing availability of generic medicines facilitated a treatment revolution, eventually driving basic HIV medicine prices to under $150 ppy – a 99% cost reduction.  Today, antiretroviral (ARV) medicines provide eight million people in low- and middle-income countries with long term hope for a healthy and long living future.

But millions more still await access, and lifelong AIDS treatment requires access to newer and more potent drug regimens, due to drug resistance.

Unfortunately, most newer ARVs are under the monopoly control of multinational pharmaceutical companies. The high treatment costs for these medicines threaten to block the remarkable progress already achieved and impede the goal of “getting to zero.”

To continue the treatment revolution and seek an end to AIDS, we need competition and access not only for off-patent ARVs but also for the patent-protected and very expensive second- and third-line ARVs. Public Citizen’s Global Access to Medicines Program is working with partners in more than one dozen countries to challenge Big Pharma’s monopoly abuses and realize this vision.

We are also fighting to protect access to medicines in the proposed Trans-Pacific Partnership (TPP), a free trade agreement under negotiation now between the United States and countries in Latin America and Asia. The Office of the United States Trade Representative (USTR) has advanced a Big Pharma wish list that would lengthen, strengthen and broaden pharmaceutical monopolies throughout the region. We are inspiring governments and health advocates fight back.

We envision a very different Asia-Pacific region partnership–one that advances pharmaceutical access and innovation simultaneously.  We believe better public policy is possible. We firmly hold to the promise of an “AIDS-free generation”. Getting there requires standing up to Big Pharma, promoting competition, and expanding access to medicines.

That’s why, this Tuesday Public Citizen’s Global Access to Medicines Program will join the We Can End AIDS March and ask for “accountability from Big Pharma and government officials around the world”.

We need your support to create a future free of AIDS. Please join us on Tuesday and let’s raise our voices against Big Pharma.

Les Nouvelles de Bruxelles : The Changing Politics of the Knowledge Economy

, , , , ,

The politics of the global knowledge economy are shifting: from mercantilism to co-operation, from closed commercial regimes toward open source. Last week, the European Parliament Committee on International Trade (INTA) passed a report recommending the rejection of the controversial Anti-Counterfeiting Trade Agreement (ACTA). Since the European Union (EU) and its 22 member states signed ACTA in January 2012, ACTA has caused nothing but consternation in Europe. Citizens of Poland, Bulgaria and the Germany took to the streets to show their opposition. These protests initiated a pan-European movement awakening the spirit of 1968. Young Europeans asked policy makers and politicians in Brussels to respect their rights, privacy and freedom on the Internet.

The ‘old continent’ woke up to what people in the global South have known and fought for over many years. Intellectual property (IP) is not merely a commercial or trade-related issue or something we can allow to be monopolized by corporations. It’s about us. It touches human life. IP rules can dictate how we access, disseminate and share knowledge, technology and information. They are not only about corporations and their interests. They are also about our internet freedom, privacy, scientific research, textbooks and journals, traditional and cultural knowledge, stewardship of biodiversity, arts and literature. The current orthodox IP standards, largely imposed by corporations, create exclusive controls over knowledge and information and have proved to be inadequate and frequently inappropriate in today’s knowledge-based economy.

What ACTA did – albeit inadvertently – was provide an impetus for a new vision of prioritizing people’s rights over IP fundamentalism in the 21st century. In recent decades, there has been a rush to over-regulate this relatively new and rather conceptually confusing form of property. The IP maximalist perspectives create modern juridical bureaucracies; monstrous, absurd legal procedures and protocols. From the perspective of people, the over-aggressive rules pushed through agreements like ACTA and the Trans-Pacific Partnership (TPP) are understood as a declaration of war threatening personal rights and freedoms on the Internet and in our daily lives. This is why the people of Europe raised their voice to warn policy makers in Brussels about the inadequacy of the current IP maximalist model, which places IP monopolies at its heart instead of sharing or disseminating knowledge, technology or information.

The ‘war against piracy’ turned into a revolution against the corporate internet. Brussels could not stay indifferent to the outcry. First, the Committee on Legal Affairs (Juri), Committee on Civil Liberties (LIBE) and the Committee on Industry, Research and Energy (ITRE) voted to express “opinions against ACTA”. If three strikes weren’t enough, a vote in the Development Committee gave a fourth. Finally, on June 21 the trade committee (INTA) dealt a serious blow to ACTA. The INTA vote shows that European politicians increasingly understand we, the people, will not let healthcare and internet policy be dictated by a very few outdated corporate interests. Rather, we need forward-looking, flexible policies for technology, knowledge and creative works that unleash our human genius. ACTA is a retrograde policing approach to the knowledge economy: it promotes IP fundamentalism, it treats competition like criminality and the internet as a threat.

We cannot count ACTA out yet. The final voting in the European Parliament will be held on the 4th of July. The Fourth of July is an important day for Americans, which honors the birthday of the United States of America and the adoption of the Declaration of Independence. But it seems that it would also be a memorable day for the Europeans, honoring the sense of European citizenship in today’s knowledge economy based on the values of individual freedom, equality, tolerance, privacy and democracy .

Thanks to Peter Maybarduk for his contributions to this post.

Read more here

Follow us on twitter: @PCMedsAccess

 

Global Access to Medicines: Celebrating the 10th Anniversary of the Doha Declaration

, , , , ,

Ten years ago, on Nov. 14, 2001, the member states of the World Trade Organization (WTO) gathered in Doha, Qatar, and adopted a declaration aiming to establish a balance between WTO pharmaceutical patent rules and public health. Patent-based drug monopolies and high prices keep lifesaving medicines out of the hands of millions of people who need them worldwide. WTO rules requiring developing countries to grant pharmaceutical patents have been subject to substantial criticism for favoring the multinational pharmaceutical companies. The Doha Declaration recognized countries’ rights to “promote access to medicines for all” and represented a significant victory for developing countries and global health.

Ever since, health advocates have worked to live up to Doha’s promise. Perhaps the most significant obstacle is the political and economic power of the patent-based pharmaceutical industry. This week marks the Doha Declaration’s 10th anniversary – and people everywhere who care about access to affordable medicines are fighting back.

Over the last 10 years, generic competition has reduced the price of basic HIV/AIDS treatment by 99 percent, from more than $10,000 per person per year to under $100 today. This has facilitated a global revolution in treatment access, with six million people in low and middle income countries on lifesaving medicines as a result.

Nevertheless, newer AIDS medicines are patent-protected, monopolized and vastly more expensive. The same is true of many newer medicines for non-communicable diseases, including cancer and heart disease. High prices force health agencies to make impossible choices about allocating scarce resources – and the global financial crisis has made matters worse. Patients pay the cost.

More