**7. Sundry IP protection issues in biotechnology**

In scientific research, openness in sharing foundational research results and tools promptly with the scientific community advances the field more rapidly than otherwise. This requires that synthetic biologists collaboratively create a basic platform where, *e.g.*, standardized biological parts that are safe, ethical, and cost effective are easily accessible to facilitate the development of other inventions needed by society but require an industrial setting, a profit motive, and IPR protection. A shared basic platform will foster less acrimonious market competition. Basic research is curiosity-driven and largely government funded; product development is market-driven and requires huge private funding. The government owns the mint, the private sector does not nor can it crowd-source funds via taxation. IP laws try to bridge this gulf. The task is far from easy as the following two examples indicate.


and small businesses and turned them over to the fund recipients. It also permitted them to grant exclusive licenses thereby creating the needed incentives for private firms to invest. Many countries have since enacted Bayh-Dole type Acts. About the Act, *The Economist* (December 14, 2002) wrote:

Possibly the most inspired piece of legislation to be enacted in America over the past half-century was the Bayh-Dole act of 1980... More than anything, this single policy measure helped reverse America's precipitous slide into industrial irrelevance.

#### **7.1. Limited period monopoly versus dedicated to the public**

The *quid pro quo* of the patenting system is that in exchange for government granted limited period monopoly, the inventor must fully disclose the details of the invention so that further innovation and improvement of the invention by others can continue. On the patent's expiry, the invention falls in the public domain and all patent rights are extinguished. Patent law encourages such inventions where without a patent the incentive to invent products and processes useful to society is unlikely to occur rapidly enough. For example, not having patents may mean not having certain drugs and therapies.

Acquiring patents is expensive; fighting litigation even more so. So the key question in framing a patent system is: "Will concentration of monopoly power in a given technology be detri‐ mental to industrial growth in the long run?" The answer depends on the scale and availability of funding. Only those with deep pockets can afford to acquire a sizable patent portfolio. The second question, "Is the patent office ready to handle this technology?" New technologies that come rapidly to the fore can be a nightmare for any patent office because of lack of examiners, inadequate repository of and access to prior art, inadequate case-law from which they can seek guidance, etc. Not every country has the ability or the resources to cope with such a situation. The third question, "How high should the bar be set for grant of patents in terms of novelty and non-obviousness?" Higher the bar, less will be the cost of enforcing patent law since a great many infringement battles can be eliminated and more inventions will populate the public domain. How the answers to the three questions are dynamically balanced will decide how well the patent system serves society. This balancing act is far from easy given that substantial and rapid technological advancement is not possible if based purely on the innovative capabilities of ordinary people. Only extraordinary people are capable of such feats and many of them require the incentive of government granted and protected privileges in order to be productive, *e.g.*, Galileo. Patents promote trade and commerce and avoid the accumulation of trade secrets.

#### **7.2. Patents common**

PHOSITA, and exact wordings of the patent's claims. In most cases, the issue involves the expansionary scope of the doctrine of equivalents and whether obvious-to-try is the same as obvious from the perspective of the PHOSITA. Some of the trickiest situations involve the opposing tendencies of the doctrine of equivalents and prosecution history estoppel. Such

In scientific research, openness in sharing foundational research results and tools promptly with the scientific community advances the field more rapidly than otherwise. This requires that synthetic biologists collaboratively create a basic platform where, *e.g.*, standardized biological parts that are safe, ethical, and cost effective are easily accessible to facilitate the development of other inventions needed by society but require an industrial setting, a profit motive, and IPR protection. A shared basic platform will foster less acrimonious market competition. Basic research is curiosity-driven and largely government funded; product development is market-driven and requires huge private funding. The government owns the mint, the private sector does not nor can it crowd-source funds via taxation. IP laws try to

**1.** *Galileo seeks IPR*. The Venetian Senate passed the first patent law on March 14, 1474, granting limited duration monopoly for original devices. That same Venice in 1594 granted Galileo a "privilege" (a patent) for 21 years on a machine which he had invented [54] "for raising water and irrigating land with small expense and great convenience," on the condition that it had never before been thought of or made by others. In his petition for the privilege he said, "it not being fit that this invention, which is my own, discovered by me with great labour and expense, be made the common property of everyone" and adding that if he were granted the privilege, "I shall the more attentively apply myself to new inventions for universal benefit." Clearly, even Galileo, the father of modern science, was not willing to divulge his invention only to have it copied for free exploitation by

**2.** *The Bayh-Dole Act*. In the late 1970s the U.S. Government realized with shock that while it held title to approximately 28,000 patents (at the time all patents resulting from federal R&D funding at universities were owned by the government), fewer than 5% were licensed to industry for development of commercial products. Literally, results of billions of dollars of federal R&D investment were under-utilized in commerce. The remedy was the Bayh-Dole Act of 1980. It went against prevailing wisdom that patents resulting from tax-payer funded research should belong to taxpayers and availed by industries under non-exclusive licenses. It turned out that without an exclusive license, companies were wary of investing the huge sums required to turn those inventions into marketable products when the resulting products could easily be appropriated by competitors. The business risks were too high. Therefore, under the Act, the government relinquished its ownership rights to future patents arising from federally funded R&D in the universities

bridge this gulf. The task is far from easy as the following two examples indicate.

others. Galileo's argument pervades the modern patent system.

matters are best left to experienced lawyers.

216 Biotechnology

**7. Sundry IP protection issues in biotechnology**

There is a perennial dilemma: How does one encourage innovation without eroding the vitality of the scientific commons? What is the right balance between philanthropy and profit incen‐ tive? Should the balancing be driven by free market mechanisms or government intervention? Reforms in the patent system are undoubtedly warranted but what they should be are unclear.

The biotechnology industry, recognizing these dilemmas, has funded certain initiatives in the past with the clear aim of placing the resulting research output in the public domain in the larger interests of both industry *and* society via patents-information commons. These initiatives sought a balance between the intellectual property system that quarantines new knowledge and information and the goal of science to put them in the public domain expeditiously [55]. For example, to mitigate debilitating competition, like-minded companies have collaborated to create and share IP among themselves to enhance the scale, scope and speed of innovation; used cross-licensing, patent pools, and patent exchanges to lower the cost of exchanging IP; embraced open standards to enhance inter-operability and encourage collaboration; and invested in pre-competitive information-commons to boost their downstream product development. Some well-known examples of pre-competitive information-commons are *Merck Gene Index* (1995), *Merck sponsored project to create patent-free transgenic mice* (1997), *SNP Consortium* (1999), *International HapMap Project* (2002), and *The Genographic Project* (2005).

The National Institutes of Health (NIH) in the U.S. too has been active in creating information commons. Since 1996, all human genomic DNA sequence information that it funds is placed in the public domain. In December 1999, it adopted a general statement of "Principles and Guidelines for Sharing of Biomedical Research Resources"3 that said:

[T]he use of patents and exclusive licenses is not the only, nor in some cases the most appropriate, means of implementing the [Bayh-Dole] Act. Where the subject invention is useful primarily as a research tool, inappropriate licensing practices are likely to thwart rather than promote utilization, commercialization, and public availability.

In the same spirit, the Guidelines encourage unencumbered transfer of unpatentable research tools to other needy researchers. Of course, in view of the Bayh-Dole Act, the Guidelines could not restrain grantees from filing patent applications.

In August 2014, NIH issued a final policy on genomic data sharing that builds on and replaces its earlier policy issued in 2007 in an effort to promote the sharing of data from genome-wide association studies, and through the creation of the database of Genotypes and Phenotypes (dbGaP), a two-tiered system for distributing data. One tier offers open-access with no restriction and the other provides controlled access that can be used only for research purposes consistent with the original informed consent under which the data were collected. This new policy (available at http://gds.nih.gov/03policy2.html) will go into effect in January 2015. NIH's preference for open access understandably comes from its top leadership which is typically drawn from academia and the basic research community that sanctifies open access. A survey of deals and business models that highlight the more charitable side of the pharmaceutical and biotechnology industry is available at [56].

<sup>3</sup> Available from http://grants.nih.gov/grants/intell-property\_64FR72090.pdf.
