Pérdida de la oportunidad

Substantial effort, research and study through trial and error is required for making the claim that the reprogrammed cells will function towards the desired application. Non-obviousness to a person skilled in art can be established and the human contribution for the ―inventive step‖ may justify an IP protection.⁴⁹ The non-obviousness requirement is laid down in 35 U.S. Code § 103 as following:

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in

45 35 U.S. Code § 102 (a) states that, ―[a] person shall be entitled to a patent unless—

(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention‖. 35 U.S.C. § 102 (2013).

46 Supra note 40.

47 C-34/10, Judgment of the Court (Grand Chamber) 18 Oct. 2011, also available at http://curia.europa.eu/juris/liste.jsf?language=en&num=C-34/10 (last visited July 25, 2014).

48 Article 6(1) states that, ―[i]nventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality‖; and Article 6(2) states that, ―[o]n the basis of paragraph 1, the following, in particular, shall be considered unpatentable:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes‖.Supra note 40.

49 See ch. 3.1.2.4 ARE THEY SUBSTITUTE OF EACH OTHER OR DIFFERENT FROM EACH OTHER?

50 35 U.S.C. § 103 (2013).

The non-obviousness requirement was applied in the case of Graham v. John Deere Co. (1966) by the U.S. Supreme Court.⁵¹ However, if it (the non-obviousness requirement) is strictly applied for the protection of hSCI, some of the subsequent inventions and second medical applications will not qualify for the patent protection, as they might be insubstantial invention.

However, it cannot be decisively said that novelty and non-obviousness/inventive step apparent in an invention will be adequate to support the patent survive the legal battles. A patent may fail to survive entirely or partially in the post grant proceedings at the patent office or later at Court. The intricate parts of the claims may not contain enough invention/innovation to justify the novelty and non-obviousness in a given case. After the first isolation and derivation of ES cells in non-human primate by the scientist James Thomson in 1995 of Wisconsin Alumni Research Foundation (WARF), the

 The United States Patent No. 6,200,806, issued on March 13, 2001 for ―[p]rimate embryonic stem cells;‖ ⁵³

 The United States Patent No. 7,029,913, issued on April 18, 2006 for ―[p]rimate embryonic stem cells;‖⁵⁴ and

 The United States Patent No. 7,442,548, issued on October 28, 2008 for ―[c]ulturing human embryonic stem cells in medium containing pipecholic acid and gamma amino butyric acid.‖⁵⁵

Although the US Patent No. 5,843,780 and the US Patent No. 6,200,806 survived till date, the US Patent No. 7,029,913, issued on April 18, 2006 has been tangled with oppositions. However, WARF patents generated much debates, arguments and protests. They have faced oppositions from the public interest groups. Nevertheless, they survived as patent keeping the question ―if human embryonic stem cells should be patented to allow exclusive right at all‖ alive. Easy access to these inventions/innovations are very important for the other researchers to be able to develop ―biological drug products‖.⁵⁶ In 2013, the WARF‘s US Patent No. 7,029,913 was challenged in the United States Court of Appeal for the Federal Circuit by the Consumer Watchdog, a nonprofit organization, in the

53 The very patent also claimed to have disclosed the ―know-how‖ for the derivation of human ES cells. United States Patent and Trademark Office, USPTO Patent Full-Text and Image Database, available at

56 FDA‘s ―Compliance Program Guidance Manual Chapter – 45 Biological Drug Products‖ mentions stem cells and cell therapies as ―biological drug products‖ (U.S. Food and Drug Administration: Compliance Program Guidance Manual (CPGM) 2014).

case of Consumer Watchdog v. Wisconsin Alumni Research Foundation (2013) claiming that the inventions are not eligible for patenting, but the appeal was dismissed on June 4, 2014. ⁵⁷ Although the Appellant Consumer Watchdog claimed that the inventions lack novelty and inventive steps, they also indicated that patenting those inventions by WARF resulted to burden on the taxpayers’

money.⁵⁸ But the rejection of Appeal did not highlight any of those (patentability criteria and implications of patenting) issues; rather the absence of locus standi of the Appellant as an ―aggrieved person‖ was shown as the justification for the rejection of Appeal by the US Court of Appeal for the Federal Circuit.⁵⁹ Therefore, those inventions have not yet failed the test of the novelty and inventive step requirement and their justification of patenting being inventions from public funded research⁶⁰ shall remain as a ―debate‖ to be resolved probably by a Supreme Court‘s (US) ruling in future.

Feldman and Furth made the following discussion on the application of non-obviousness standard in the field of iPSC inventions in the USA:

In the years leading up to 2007, the Federal Circuit had been applying the so-called TSM test⁶¹ for determining obviousness. According to the test, an invention would not be ruled patentable as a combination of information available in the prior art unless that art contained a specific teaching, suggestion, or motivation to combine the prior art. In the 2007 case of KSR Int’l Co. v. Teleflex Inc., the U.S. Supreme Court rejected the Federal Circuit‘s application of the TSM test in a case concerning automobile gas pedals. The Supreme Court ruled that the test had been applied too rigidly. The Court also held that the Federal Circuit also erred in concluding that application of the TSM test was mandatory. (2010, 31; footnote added, footnote omitted)

It seems that the U.S. Supreme Court has a softer approach in determining the non-obviousness standard. On the other hand, the EPO or CJEU on patentability issues had been apparently more strict in the recent past. It is more likely that technical intervention involved in reprogramming of the iPSC‘s early inventions may survive the non-obviousness standard in some patent offices very well.

But the downstream inventions in iPSC making small variations in iPSC generation methods and application might not encompass substantial ―inventive step.‖ Therefore, it is necessary that the claim language of each invention is very precise to its inventive aspect. An overly broad claim may block the subsequent inventions to get a patent.

57 Case 13-1377, Fed. Cir. 2013.

58 Consumer Watchdog v. Wisconsin Alumni Research Foundation, supra note 57.

59 Id. (June 4, 2014).

60 The inventions of the US Patent No. 7,029,913, which was challenged by the Consumer Watchdog, was the result of the research sponsored by the US Federal Government (US Patent No. 7,029,913, issued on April 18, 2006). United States Patent and Trademark Office, USPTO Patent Full-Text and Image Database, available at

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s 1=7,029,913.PN.&OS=PN/7,029,913&RS=PN/7,029,913 (last visited Nov. 20, 2014).

61 Teaching-Suggestion-Motivation Test.

Fig. 4.1 Novelty and Inventive Step (Non-obviousness) in hESC (A) (Illustration from Wikipedia:

Inner cell mass 2014), SCNT (Embryo Cloning) (B) and iPSC (C) (Figure 1, Mummery and Roelen 2013, 174)

Novelty and non-obviousness would rely on "isolation"

and "differentiation capacity" of the process and product (derivation

technique and new cell line) patented.

A. hESC:

Derivation from the Inner Cell Mass (ICM) of the blastocyst

Novelty and non-obviousness can be found in the modified protocol of the reprogramming.

B. SCNT (NT-ESC) of Tachibana et

al. (2013)

The successful

reprogramming by the introduction of the transcription factors (Oct3/4, Sox2, c-Myc, and Klf4 genes) is both novel and non-obvious.

C. iPSC of Takahashi and

Yamanaka (2006); Takahashi

et al. (2007)