IP. Patentes y Open Science (1). El caso Sangamo.

En la entrada anterior hemos rozado de manera anecdótica la siguiente  cuestión:

¿ está el movimiento Open Science en contra de las Patentes ?

En esta entrada quiero tratarla de manera más sistemática presentando un caso en concreto proveniente de la biología (de proteínas), la plataforma de investigación del Sangamo. Primero presentamos de manera sucinta y abstracta la problemática.

1. Patentes.

La caracterización más clara de lo que es un patente es la siguiente:  es la concesión de un derecho de propiedad a cambio de la publicación de una invención. La clave aquí está en la publicación.  La alternativa a las patentes es o la publicación gratuita del mismo resultado o el secreto  comercial. El tener un derecho de propiedad sobre una invención significa que cualquiera que quiera utilizarla tiene que pedir permiso al propietario que se lo podrá conceder bien gratuitamente, bien vía el pago de una licencia (esto es exactamente lo  mismo que alquilar una casa).

2.  Open Science.

El objetivo del movimiento Open Science es promover el acceso gratuito por cualquiera al conocimiento científico, sobre todo al conocimiento científico producido con fondos públicos.

Tener esto en cuenta es importante dado que los conflictos actuales tienen que ver con el hecho de que resultados obtenidos con fondos públicos se publican en revistas privadas, que cobran sus servicios posteriormente a a las bibliotecas públicas o a los ciudadanos que quieran comprar el acceso a esta información. Esta forma de organización ha funcionado así desde hace siglos o al menos décadas y nadie se había quejado hasta que las nuevas tecnologías (básicamente Internet) han hecho muchos más barato la gestión y difusión del conocimiento.

Por otra parte es importante señalar que el conocimiento científico, una vez publicado por esta vía, sea a través de una publicación de acceso libre sea por una publicación de acceso de pago, aunque se le atribuye una autoría pasa a pertenecer al dominio público, es decir, a diferencia del conocimiento patentado  su uso es gratuito.

A mi personalmente todo esto me parece muy razonable pero, al margen de los problemas organizativos, tiene dos  problemas (uno ya lo hemos  comentado en anteriores entradas):

–gran parte del conocimiento científico financiado por entidades públicas está ahora, legítimamente, en manos privadas. ¿ cómo se resuelve este problema ?.

–¿ Que pasa con el nuevo conocimiento científico que generen partes privadas ?

3. Patente vs. Open science.

Entonces resumiendo, si me he enterado bien del contenido del movimiento  Open Science (sinceramente, el tema está bastante confuso: aquí un blog específico sobre este movimiento):

Patente = publicación y acceso gratuitos a los resultados + pago (opcional, decide el inventor) de licencias por usar los resultados.

Open Science = publicación y acceso gratuitos a los resultados  + uso gratuito (dominio público).

4. El caso Sangamo.

El movimiento Open Science es tan nuevo que hay muy poco publicado. Pero he encontrado un artículo muy interesante, sobre un caso en el campo de la biología de proteínas, que es muy informativo.

Título: Proprietary science, open science and the role of patent disclosure: the case of zinc-finger proteins.

Extractos.

Recent advances in the ability to engineer customized zinc-finger proteins (ZFPs), which can bind virtually any DNA sequence of interest, have generated excitement among both academic and industrial researchers.

These advances have given researchers hope that ZFP- and ZFN-based approaches may help improve both the efficiency and the precision of gene therapy. Other potential commercial applications for ZFPs include plant genetic engineering, the production of biopharmaceutical molecules such as growth factors and antibodies, and the nascent field of synthetic biology. ZFN technology has also been used successfully to make targeted gene modifications in several model organisms such as Drosophila (4), C. elegans (6), plants (7,8) and most recently zebrafish (9,10), illustrating the range of uses for ZFNs in basic research as powerful molecular biology tools.

As might be expected with any research platform that has many potential commercial uses, a large patent estate now covers both the engineering and the use of ZFPs. Notably, the patent estate was initially owned by several different companies and academic institutions, thereby creating the possibility that subsequent users and developers would face prohibitive costs in negotiating multiple licenses—the classic scenario of a patent “anticommons” (11). However, one company, Sangamo, has now consolidated the majority of this patent estate. The dominant patent position held by Sangamo has raised the recurrent question of whether a company’s monopoly control over an important and versatile research platform will ultimately help or hinder optimal development of that platform. Because such development can occur within both the private and public sectors, there is also the subsidiary issue of whether patents will be enforced against academic researchers in the same manner as they might be enforced against private-sector competitors.

Previous studies (12) suggest that academic researchers do not seem concerned about being sued by private-sector patentees. For example, a survey of academic biomedical researchers found that only 5% report checking for patents related to their research (13). These studies further indicate that private-sector patent owners practice “rational forbearance” and do not sue academic researchers because of the difficulties and disadvantages of asserting patent rights in such circumstances (1415). Currently, the conventional view is that academic biomedical research is more likely to be impeded by lack of access to privately held research inputs such as materials, data and know-how than by patents (12131617).

To explore the impact of ZFP patents, and specifically Sangamo’s dominant patent position, on academic and commercial research and development, we systematically created a map of existing patents in the ZFP arena, presented here for the first time. We also conducted interviews with academic researchers in the field to develop a nuanced understanding of the complex interactions between private and public ZFP research endeavors. Our findings are consistent with the view that, for academics, lack of access to information and materials is a greater problem than the threat of patent lawsuits. However, because some of the access problems would have been alleviated if statutory obligations regarding patent disclosure had been met, our research also suggests the heretofore unrecognized possibility of an overlap between patents and access to information and research materials. More complete patent disclosure might also have obviated the need to generate various open-science alternatives to the Sangamo platform.

From the pool of patents generated by our search query, patents that directly pertain to the engineering and use of engineered zinc-finger proteins were identified through analysis of the claims (seeSupplementary Table 1). The 42 patents owned by Sangamo include 8 patents on rules and libraries for constructing sets of ‘two-zinc-finger’ domains, each of which can bind to a specific sequence of six nucleotides. These were previously owned by UK-based Gendaq Ltd., which was acquired by Sangamo in July 2001 (18).

Sangamo has also actively licensed intellectual property (IP) from a number of academic institutions. This IP includes five patents from MIT, three from the Scripps Institute, two from Harvard University and six from Johns Hopkins University (JHU) (18).

An analysis of the different categories of patents (see Supplementary Table 1 and Supplementary Table 2) reveals that at least 24 of the 55 patents owned by or licensed exclusively to Sangamo cover technologies for the design, selection and optimization of engineered ZFPs. Our analysis also indicates that several patents owned by Sangamo are foundational for the ZFP field, with limited possibilities for a ‘workaround’. Perhaps most salient is a trio of patents (US Patent nos. 71777766, 6785613 and 6453242) that broadly claim the dominant ‘modular’ strategy for ZFP design (at least with respect to three-finger ZFPs that bind to sequences containing nine nucleotides). This modular strategy relies on assembling a multifinger protein from individual zinc-finger modules where each module has been determined to bind specifically to a particular three-nucleotide subunit and, ideally, to the subunit as further specified by its location within the sequence of nine nucleotides. Also significant is US Patent no. 6794136, which covers “iterative optimization in the design of binding proteins”: this patent broadly covers methods for further improving binding specificity once a ZFP candidate for a particular nucleotide sequence has been identified.

More than three-quarters of the patents owned by or licensed to Sangamo (44 of 55) concern inventions that could be categorized as research methods and tools, with 24 patents covering methods for the design and selection of ZFPs and another 20 patents covering methods to regulate or modify endogenous gene expression using engineered ZFPs and/or ZFP transcription factors. The earliest issued patent in this set will not expire until 2018, making it unlikely that academic or commercial researchers will be able to wait for the technologies to pass into the public domain.

The ZFP patent landscape that we have created confirms Sangamo’s dominant position in ownership of patents covering relevant research tools and methods, including foundational patents on enabling technologies. This position could have at least two benefits. First, a dominant patent position facilitates Sangamo’s ability to attract private capital (20). Given Sangamo’s considerable R&D expenses (21) and lack of marketable products, this private capital is necessary even though Sangamo has also received some federal funding, including two grants totaling nearly $4 million from National Institute of Standards and Technology. Not surprisingly, Sangamo executives have repeatedly stated that a strong patent portfolio has been vital to the company’s success (2223).

Sangamo’s out-licensing strategies provide support for both the optimistic and the pessimistic views of monopoly control. For application areas outside Sangamo’s main focus on ZFP-based medical therapeutics, the company has granted several companies access to its IP. For example, through its “Enabling Technology Program,” Sangamo has longstanding collaborations with Pfizer, Amgen and NovoNordisk for more efficient pharmaceutical production of proteins (18). More recently, Sangamo granted Dow AgroSciences exclusive rights (including sublicensing rights) to ZFP and ZFN technologies for modifying plant genomes and altering plant gene expression (2).

In contrast, several reports indicate that the inability to conclude a licensing arrangement with Sangamo played a crucial role in the failure of the plant biotechnology start-up Phytodyne, founded by researchers at Iowa State University.

Las conclusiones: 

Sangamo’s strategic acquisition of patents has given the company a powerful monopoly over an important platform technology. As economic theory would predict, Sangamo has often (but not always) licensed its platform technology in a manner that is both profit maximizing and likely to enhance social benefit. To date, Sangamo has also tolerated an open-science alternative to its proprietary platform. The coexistence of open and proprietary alternatives may be productive or, at a minimum, peaceful.

Two features of the ZFP/ZFN case are particularly noteworthy. First, because of problems with patent disclosure, patents may effectively be posing a barrier to academic research in this field. Second, resolving deficiencies in patent disclosure could mitigate the problem of academic access to physical materials and know-how, perhaps even obviating the need to develop open-science alternatives. Thus our study raises the possibility that even when academics are not defendants in patent suits, and enjoy a de facto (if not de jure) exemption from patent infringement liability, the patent system may nonetheless be failing to fulfill the constitutional mandate that patents “promote the progress of…the useful Arts.”

Puedes leer el paper completo aquí. Muy interesante.

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