Patentable Subject Matter” nurture or neglect innovation? A case study based rational analysis Dara Ajay (Cheers Interactive, India) Patentable Subject matter, list out the controversial inventions ineligible for patent registration. These inventions are related to genetic modification, software patents and business methods etc. which have been debated on national, international levels at various conventions. Currently, there are multiple patent litigation reported under patentable subject matter and are prosecuted at scientific, social and ethical perspectives. However, these inventions despite meeting the criteria of novelty, inventive step and commercial application are still been prosecuted based on patentable subject matter. The presentation would discuss some of the famous case studies in the area of genetic modification, software patents and business methods and logically compare various patent value under three special categories. Further, more emphasis is focused toward the recent patent litigation cases on genetically modified inventions in terms of plants, animals and humans. There by address the critical question whether “patentable subject matter” is actually satisfying the current upcoming technologies assessment or acting as an impediment for future innovations. In other words, dose patentable subject matter stifle the growth of latest upcoming technologies which could emerge as future breakthrough innovations!

1. NURTURE NEGLECT
Dara Ajay (PhD, LLM)
Cheers Interactive.
II-PIC: International Indian Patent Information Conference for Patent Information Professionals
Disclaimer: The views and opinions expressed in this presentation are those
of the authors and do not necessarily reflect the official policy or position of
any governing body including Cheers Interactive.

2. ❖Some of the related articles and
sections from Patent Act and TRIPS
India under Section 3
USA under Section 101 of Title 35 U.S.C.
Australia under section 18
Malaysia under Section 13
China Article 25
European Patent Convention Article 52, 53
TRIPS Article 27.2
2
➢what are not patentable
• Frivolous/ obvious inventions
• Contrary to well established natural laws
• Contrary to public order or morality
• Mere discovery of a scientific principle
• Formulation of an abstract theory
• Discovery of any living thing or non–living substance
occurring in nature
• Process for medicinal, surgical, curative,
prophylactic, diagnostic, therapeutic or other
treatment
• Method of agriculture or horticulture
• Plants & animals in whole or any part thereof
• Method of performing mental act or method of
playing game
• Mathematical method or business method or
algorithms or computer programme per se
http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_31_1_patent-act-1970-11march2015.pdf

3. 3
▪ The landmark case for Gene patenting is the Myriad Genetics, Inc.,
▪ Developed a diagnostic kit which detect gene sequence BRCA1 and BRCA2 genes
▪ Unfortunately, Myriads high price (USD $3000-4000)
https://en.wikipedia.org/wiki/BRCA_mutation

4. 4
13th June 2013, US5747282, US5837492, US5693473,
US5709999, US5710001, US5753441 and US6033857
Invalidate the claims of isolated gene under 35 U.S.C. §101
5 September 2014, AU686004 based on manner of
manufacture indicating DNA and RNA as natural
products and invention as artificial state of affairs
November 2008 EP0705902, EP0705903, EP0699754,
EP0785216 “natural law or natural product but
ultimately whether it is for a mere discovery”

5. 5

6. 6
Petty Patents
Moore, Kimberly A. "Worthless patents." George Mason Law & Economics Research Paper 04-29 (2004).
Vancleave, Ted. Totally Absurd Inventions: America's Goofiest Patents. Andrews McMeel Publishing, 2001
http://www.freepatentsonline.com/crazy.html
http://www.lightlink.com/bbm/weird.html

7. 7
http://www.crainsnewyork.com/article/20111228/HEALTH_CARE/111229902/lipitor-becomes-worlds-top-selling-drug
https://www.theverge.com/2016/7/18/12211484/arm-holdings-softbank-acquisition-intellectual-property-patents-value

8. 8
Patentable
Subject Matter

9. 9
https://www.mysciencework.com/omniscience/dna-patenting-forbidden-in-the-usa-the-end-of-an-era
https://ghr.nlm.nih.gov/primer/testing/genepatents
More than 4,300 human genes are patented.

10. 10
1. In Myriad case plaintiff failed to identify the anticompetitive practices
2. Weather gene isolation is mere discovery or invention ?
BRCA1-17q21
BRCA2- 13q12.3
http://www.scinexx.de/dossier-bild-15-6-21210.html

11. 11
CANCER
The Cancer Statistics
✓~1.6 million new cases got registered with 35% dead rate
✓~ 14.1 million new cases reported with 8.2 million deaths
✓2020 prediction ~ 15 million new cases diagnosed, 12 million deaths
✓GLOBOCAN, 2025 estimation >19.3 million new cancer cases every year

12. 12
https://www.myriadpro.com/ovarian-cancer-testing/bracanalysis-cdx-overview/

13. Feng Zhang
@
Broad/MIT
Jennifer
Doudna @
Berkeley
/HHMI
CRISPR/
Cas9
Emmanuelle
Charpentie
@
Helmholtz
MIMS/MHH
13http://www.brandeis.edu/now/2014/october/gabbay-award-2104.html
http://blogs.plos.org/synbio/2017/10/05/when-will-crispr-get-a-nobel-prize/
“The discovery’s impact on medicine could be
huge. Imagine being able to delete BRCA 1,
the closely linked to breast cancer, or the that
causes Huntington’s disease. The
CRISPR/cas9 system puts scientists one step
closer to being able to cure genetic disorders”
CRISPRs, first observed in the 1980s
2014 Breakthrough Prize in Life Sciences ($3 million)
2015 Massry Prize ( $40,000)
2016 Canada Gairdner International Award ($100,000)
2016 Tang Prize in Biopharmaceutical Science ($1.34
million cash and $1.67 million grant shared)
2016 Warren Alpert Foundation Prize ($500,000).
2017 Albany Medical Center Prize in Medicine and
Biomedical Research ($500,000)

14. 14

15. 1515
Mary-Claire King, University of California,
(1990)."Linkage of early-onset familial breast
cancer to chromosome 17q21".Science.250(4988):
1684–1689

16. ✓ Patentable subject matter should Not Predetermine but evolve with the technology today
✓ Invalidating Gene technologies based on patentable subject matter have directly and indirectly
adverse effect on global health care innovation
✓ Therefore, Gene technology should be excluded from patentable subject matter
1616

17. 17