Daño a la vida de relación

Takahashi et al. (2007) published ―Induction of Pluripotent Stem Cells from Adult Human Fibroblasts by Defined Factors‖ in 2007. The clinical trial in human for this iPSC invention started in 2014. At the Institute for Biomedical Research and Innovation, Kobe, Japan, a 70 years old woman as the participant of this clinical trial received the first graft of iPSCs on September 12, 2014 (Stem Cells Portal: AMD Patient Receives First Induced Pluripotent Stem Cell Graft 2014). The industrial and commercial application of this technology will be in the market after the safety and efficacy is proven by this clinical trial. The observation period of this study is 3 years. (Stem Cells Portal:

World‘s First Induced Pluripotent Stem Cells Clinical Study on Humans Launches in Japan, 2014).

The patent shall last 20 years from the invention was first proclaimed in mouse in 2006 Takahashi ( and Yamanaka 2006) and in human in 2007 (Takahashi et al. 2007). The year in which ―human‖

received the transplant for the first time is 2014 (clinical trial). The industrial and commercial application may begin after the safety and efficacy of the transplant is proved. The study has estimated observation period of 3 years. Therefore, the technology will have very short time for commercial exploitation after it enters the clinic for-profit basis. Mathews, Deegan, and Bubela (2013, 508) wrote: ―Therapies may take between 10 and 15 years to reach the clinic—a timespan that will likely be even longer for cell-based interventions— while patent terms extend for 20 years plus marginal extensions to account for regulatory approval processes and necessary clinical studies.‖

Many of the ES cell derivation patents by the WARF will be useful for the other stem cell and biomedical researches. As product to arrive in the clinic, many of the hESC based inventions will have to wait long time. While the process patents already in existence for the ES cell isolation and derivation, those inventions remain useful for the downstream researchers. But those patents will make them (the downstream researchers) to take a license for their commercial exploitation, if they (the downstream researchers) are successful in making any disease specific inventions. Therefore, the meaning of ―industrial application‖ of the patents on the primary (first generation) hSCI is yet not the strict application as cure for a condition or disease; rather many of them are inventions having utility for further research targeted to product development. However, it is worth reiterating that the derivation of embryonic stem cell is possible through various methods.

Steven D Schwartz et al. (2012, 713) mentioned in their publication on the trial of ESC⁶² for the macular degeneration:⁶³ ―It has been 13 years since the discovery of human embryonic stem cells (hESCs). Our report provides the first description of hESC-derived cells transplanted into human patients.‖

62 Advanced Cell Technology (substituted corporate name Ocata Therapeutics, Inc.), who has funded this study, patented (e.g., United States Patent No. 8,742,200, issued on June 3, 2014) derivation of ES cells from the blastomere cell of the pre-implantation stage embryo (ES cells from biopsied embryo).

63 Macular degeneration is a major cause of blindness.

Fig. 4.2 ―Images of the hESC-RPE transplantation site in the patient with Stargardt‘s macular dystrophy‖ (Figure 4, Schwartz et al. 2012, 718)

In all cases, patent succeeds the claimed invention, but precedes the clinical trial. The time lost in clinical trial, is lost from the term of protection of the patent.

Fig. 4.3 Term of protection continues towards its end, beginning from the date of patent filing

The apprehension of losing time also can push the companies to hurry up to reach to the market. The diverse industrial applications may not all fit the ideal interpretation of ―industrial application‖ of the patentable inventions.

The patented technique of production of retinal pigment epithelium (RPE) cells from human embryonic stem cells by Advanced Cell Technology (Ocata Therapeutics, Inc.) was given orphan drug status for the RPE cells in 2010 (American Macular Degeneration Foundation: Stargardt Disease 2014).⁶⁴ There are two implications of this ―orphan drug status‖, i.e., (a) availing the benefits of the tax reductions; and (b) in the phase III clinical trial, FDA may recognize that the number of 1000 participants may not be available/possible due to the lower number of population affected by the disease (American Macular Degeneration Foundation: What is Orphan Drug Status? 2014).

The age relatedMacular Degeneration is currently ―affecting more than 10 million Americans‖ and a major cause of vision loss in the population over the age of 55 (American Macular Degeneration Foundation: What is Macular Degeneration? 2014). With the growing number of aging population in the industrialized world, the number of population affected by the Age-related Macular Degeneration (AMD) will dramatically increase. The Archives of Ophthalmology of National Eye Institute (NEI), USA documented in the Vol. 122, dated April 2004, that the prevalence of Advanced AMD is witnessed in a total of 1,749,000 (1.5%) persons and Intermediate AMD in 7,311,000 (6.1%) persons (among the age group of 40 and above) (National Eye Institute (NEI): Statistics and Data, Prevalence

64 Their initial study report on safety and efficacy by Schwartz et al. (2014, 2--3) admitted a low sample size of the 18 patients as the participants.

Invention Claimed:

Ready for Patent

Patent Filing

Clinical trial for Proving

Safety and Efficacy

Clinic/

Hospital (Commercial Exploitation)

20 Years (TRIPS)

Term of protection for the patent begins counting from the date of the filing and ends at 20 years

The time spent for the clinical trial will be the ―time lost‖ from the total span of time for the commercial exploitation

of Blindness Data 2014). In 10 years‘ time, from then (2004), the disease has by now affected more American lives. Needless to mention that it has affected population in other parts of the world too.

Industrial application of the invention is a requirement of the patent and it is possible to fulfill this requirement. But how the investors are transforming their invention into the ―industrial application‖

has completely pulled the ―incentive for innovation‖ and ―health care‖ to the back seat and pushed the commercial character of the companies forward. Are the companies giving new look and meaning to the patent itself? Having just an ―industrial application‖ to get a patent is not enough, for diseases affecting lives. The patent law also need to take into account ―how the industrial application‖ is materialized/translated by the patentee. A new meaning of ―industrial application‖ is needed.

Therefore, the hSCI will have less difficulty to fit into the patentability requirements in the present conditions. But a lot more concerns remain on how the patented technology will affect the health care receivers. Shall patent monopoly allow access to the therapy or restrict it? Shall patent bring enough incentive for the inventors and assignee, if the therapy reach to the market after the substantial term of protection is lapsed in the last phase of clinical trial? Will patent not hinder downstream research? Will the health care tourism increase as a result of divergent legal framework having differing interpretation of ―ethical‖ issues on patentability? Therefore, these questions remain the challenge for the IP protection of hSCI under the umbrella of patent, rather than satisfying the patentability requirement for those inventions/innovations. However, the patentability has also been questioned in some cases.