**9. Patent law reforms**

Since Galileo (1564-1642), science has dramatically affected society. Industry, transportation, communications and medicine have all undergone such revolutionary changes that most mortals today appear to have semi-divine powers compared to pre-seventeenth century denizens of the world. The common man's focus has shifted from seeking divine favours to diligently acquiring human invented technological gadgets and services. Today,

Western industrial technology has transformed the world more than any leader, religion, revolution, or war. Nowadays only a handful of people in the most remote corners of the earth survive with their lives unaltered by industrial products. The conquest of the non-Western world by Western industrial technol‐ ogy still proceeds unabated. [65].

Yet some of these technological and scientific advances, such as genetically engineered plants and animals, human cloning, electronic surveillance, the use of robots, and now the possibility of genetically engineered humans raise serious moral and ethical issues, which demand legislative solutions and hence political intervention. If the track record of politicians, say, in handling problems related to climate change is any indication, we can expect synthetic biology related calamities to inundate us before they act. Their inadequate understanding of synthetic biology and the legislative process driven by one-person-one-vote electoral dynamics in a knowledge-driven society where knowledge creators and knowledgeable people constitute a miniscule minority creates an anomaly. Intellect-driven legislations require an entirely different legislative process than mass-and-emotion-driven legislations. When laws of Nature and laws of man collide, catastrophe results.

#### **9.1. Challenges**

for wilful infringement of CMU patents [63]. In another case, Varian Medical Sys‐ tems, which allegedly infringed on the University of Pittsburgh patents for a respirato‐ ry device, a judge awarded \$85.8 million. Such cases have made other universities wonder if their technology transfer offices should get more aggressive in protecting patents [62]. Once a patent is infringed the alternatives are litigation or an out-ofcourt settlement. In litigation, the patent will almost certainly be dissected in terms of the doctrine of equivalents, prosecution history estoppel, the subjectively determined profile of the PHOSITA, applicable prior art relative to the patent, clarity of descrip‐ tion of the invention, the breadth and narrowness of claims, etc. Litigation results are often uncertain. In the U.S., *e.g.*, some one-third of district court decisions on claim boundaries are reversed on appeal [64], while a large number of CAFC patent decisions

A commercially successful patent attracting litigation is a fair possibility because a patent's validity is not guaranteed. Post-grant a patent may be found invalid because of erroneous evaluation of the invention by the patent examiner during prosecution, or because he was simply blindsided by undetected prior art, etc. In addition, one must be prepared to deal with intentional predatory moves by patent trolls and the calculated overreach of some patent owners in asserting patent claims against non-infringing entities. Their general aim is to either drag the target into expensive litigation or force it into licensing agreements under the threat

Since Galileo (1564-1642), science has dramatically affected society. Industry, transportation, communications and medicine have all undergone such revolutionary changes that most mortals today appear to have semi-divine powers compared to pre-seventeenth century denizens of the world. The common man's focus has shifted from seeking divine favours to

Western industrial technology has transformed the world more than any leader, religion, revolution, or war. Nowadays only a handful of people in the most remote corners of the earth survive with their lives unaltered by industrial products. The conquest of the non-Western world by Western industrial technol‐

Yet some of these technological and scientific advances, such as genetically engineered plants and animals, human cloning, electronic surveillance, the use of robots, and now the possibility of genetically engineered humans raise serious moral and ethical issues, which demand legislative solutions and hence political intervention. If the track record of politicians, say, in handling problems related to climate change is any indication, we can expect synthetic biology related calamities to inundate us before they act. Their inadequate understanding of synthetic biology and the legislative process driven by one-person-one-vote electoral dynamics in a knowledge-driven society where knowledge creators and knowledgeable people constitute a

diligently acquiring human invented technological gadgets and services. Today,

have been reversed by the SCOTUS on appeal [52].

of litigation, which small and medium enterprises can ill afford.

**9. Patent law reforms**

222 Biotechnology

ogy still proceeds unabated. [65].

For patents to be an effective tool to promote innovation, they should be scarce and hard to obtain, especially in today's knowledge driven world, where the population of university educated people is far larger than it was several centuries ago when the modern patent system was instituted in England during the rule of Queen Elizabeth (reign: 1558 – 1603). An enormous knowledge gulf separates the PHOSITA of the Elizabethan era and of today. The biggest challenge patent examiners face today is the objective profiling of the modern biotechnology PHOSITA whose profile is prone to rapid changes, sometimes within months.

The second challenge is related to patent seeking researchers whose desire is to seek patents in anticipation that their discoveries will eventually, but during the lifetime of a patent, lead to substantial, if not miraculous, benefits to society that truly touches peoples' lives. The challenge patent examiners face here is, whether or not the applicant is claiming a 'law of Nature', or whether granting a patent will be against the interests of society (*e.g.*, patents on nuclear weapons are banned), such as creating obstacles to further research or advancement of the invention.

The third challenge is fulfilling the need for a new patent system that would minimize litigation. When patent offices are inundated with patent applications in highly competitive cutting-edge technology areas populated with extremely well qualified PHOSITAS, deter‐ mining overlapping claims among applications is an incredibly demanding task, and therein lies the source of debilitating and fierce future litigations. Current legal systems are visibly deficient in handling such litigations so remedies may lie elsewhere, *e.g.*, in the form of peacemakers among feuding parties.

The fourth challenge is providing adequate scientific research support to the judiciary. It needs a permanent science advisory body to enhance its understanding of the scientific basis on which biotechnology patent claims rest and in creating a plausible PHOSITA profile acceptable to the scientific community on a case-by-case basis. This will substantially simplify and accelerate judicial proceedings in biotechnology patent litigation and lead to greater consis‐ tency in judicial decisions. The science advisory body can bring about greater clarity to the vexing question: "When is obvious-to-try the same as obviousness?" in relation to the profiled PHOSITA.

The fifth challenge is integrating introductory IPR courses in science and engineering curricula in universities to bring home to students the paramount economic relevance of their acquired scientific and technical knowledge and skills.

#### **9.2. Questions**

The fact that synthetic biology involves the creation of artificial living matter or modification of living matter through human intervention raises important questions related to biosecurity, biosafety, bioethics, and environmental health and sustainability. Their answers will require consultation with engineers, scientists, attorneys, innovators, teachers, students, policymak‐ ers, and ordinary citizens. However, before doing so society must decide how synthetic biology as a scientific discipline is to be handled. That is, establish rules and regulations of ownership, diffusion, and access to the knowledge the discipline generates and accumulates. Concurrent‐ ly, to further the bio-economy, it must establish global engagement and collaborative models, mentor and nurture young leaders, create next-generation manufacturing facilities, and address standards-related issues. The crucial questions are:


Johnson [66] notes that synthetic biology needs "public policies and collaborative mechanisms that promote broad and robust pre-competitive openness, sharing, and access" and "strong and robust IPR" to enable "later-stage economic value creation, IPR-enabled commercializa‐ tion, and market-based investments". They will indeed help in aligning international invest‐ ments, in framing lab-to-market policies, and in creating global manufacturing and marketing policies to facilitate global commerce.

#### **9.3. Harmonization**

There are serious obstacles to globally harmonizing patent laws [67]. Disparate national laws have caused a number of complicated cross-border IP disputes and multiple infringement suits. For example, software and business method patents are permitted only in some coun‐ tries. Even when patent laws are similar in two countries, their interpretation by the courts may vary widely. Patent laws operate on the principle of territoriality and the needs of individual nations. Thus in a globalized, knowledge-driven economy, technologically advanced nations support strong patent protection to spur innovation, while the less advanced see it as barriers erected to restrict their access to new goods and dilute their welfare programs. Current national patent laws embody premises and concepts that were shaped by the Indus‐ trial Revolution; they are not malleable enough for the knowledge and information-driven age that has given rise to such exotic technologies as nano-technology, information technology, biotechnology, and robotics (and in the future, possibly bio-robotics). Today's inventor is frequently university educated or a researcher or a member of a large R&D team rather than an artisan or a technician. There is thus an acute need for harmonization of patent law and its enforcement. The assumption is that a uniform legal system would reduce legal uncertainties, cost of litigation, and barriers to trade. Other potential benefits include liberalized technology transfer and increased foreign direct investment from developed countries to the developing and underdeveloped countries and thus raise living standards globally. Ideally, harmoniza‐ tion would improve the world's capacity to innovate as a whole, which would be greater than the sum from its parts.

The World Intellectual Property Organization (WIPO) has been leading harmonization efforts. It currently administers the Patent Cooperation Treaty (PCT), the Paris Convention, the Patent Law Treaty, the Budapest Treaty, and the Strasbourg Agreement. However, these are not enough. WIPO's Standing Committee on the Law of Patents (SCP), created in 1998 to spur substantive harmonization efforts, has a wide representation of interested parties. So far, their deliberations have resulted in the Patent Law Treaty in 2000. Its modest aim is to harmonize formal procedures, *e.g*., related to the filing date for a patent application, the form and content of the application, and representation. During 2001-2006, discussions on framing a Substantive Patent Law Treaty generated enough disagreements that they were put on hold in 2006. The SCP has since focused "on building a technical and legal resource base from which to hold informed discussions in order to develop a work program" while larger issues related to exceptions and limitations to patent rights; technology transfer; quality of patents, including opposition systems; confidentiality of communications between patent advisors and their clients; and patents and health hibernate.

Clearly, a bold experiment in universalising IPR governance and rule of law is sorely needed. Present disparities in IP laws and innovation capabilities among nations have created a "creditors and debtors" relationship where creditors appear to impose conditions that would perpetuate their dominance over debtors via institutions such as the WTO. Biotechnology provides strategic socio-economic advantages to creditor nations because of their research universities. This means that flight of capital and talent to countries with top research univer‐ sities coupled with their liberal immigration policies for researchers can quickly deplete the talent pool of debtor countries. Of course, smart creditors know that helping debtors improve their circumstances makes for better, amicable, long-term, diversified, and more profitable business. Helping debtor countries build world-class universities would be one such example.

However, for synthetic biology, there is more to IP protection than just utility patents. Products arising from DNA synthesis and construction may also qualify as human authored original "literary work and artistic works" and hence eligible for copyright protection. Further, DNA is an information carrying molecule much like a computer program, which too is copyrighta‐ ble. Likewise synthetic biology motifs can be used as trademarks and tacit knowledge locked up in a researcher's mind and selectively shared may deserve trade secret protection. And, of course, one can seek design patents for novel DNA designs.
