Technology transfer - comparison of American and Turkish realities and

scientific issues in intellectual property rights

Ali Osmay GüreBilkent UniversityAnkara, Turkey

Highest number of patent applications in the EC are in the medical technology field

Matthews et al. Cell Stem Cell 12:508 (2013)

Patent applications are rising

Matthews et al. Cell Stem Cell 12:508 (2013)

Most patent applications are in the developed countries

Provisional application

Non-provisional appl.

PCT

National applications (148 PCT members)

Extension applications

EPO appl.

PCT (non-EC)

National applications (non-PCT members)

Extension applications

USA Europe

$130-250

$2000

$200

$2000 x n

$500 x n / year

License your patent:

Exclusive

Some exclusivity

Non-exclusive

The “patenting pipeline”

SACGHS report 2010 (http://osp.od.nih.gov/sites/default/files/SACGHS_patents_report_2010.pdf)

Secretary’s Advisory Committee on Genetics, Health, and Society (Department of health and human services - USA):

Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests

“One cannot necessarily expect that a small number of patents may be indicative that the applicant behind

these patents is an SME.”

E.C. PATLICE Survey on patent licensing activities by patenting firms (2013)

The most important financial use for firms is to use patents in negotiating R&D collaboration agreements

E.C. PATLICE Survey on patent licensing activities by patenting firms (2013)

Intermediaries and technology/licensing exchange platforms hardly seem to play a role for matching licensees with licensors

E.C. PATLICE Survey on patent licensing activities by patenting firms (2013)

The growing significance of patent and technology licensing is not due to sectorial effects

E.C. PATLICE Survey on patent licensing activities by patenting firms (2013)

Long development times, expiry of patent protection for key technologies/drugs or negative results in later clinical stage trials hamper

revenues in the Health care industry

E.C. PATLICE Survey on patent licensing activities by patenting firms (2013)

Most exclusive licensing takes place in the Health Care sector

E.C. PATLICE Survey on patent licensing activities by patenting firms (2013)

“The Committee found that the prospect of patent protection of a genetic research discovery does not play a significant role in motivating scientists to conduct genetic research. Scientists typically are driven instead by factors such as the desire to advance understanding, the hope of improving patient care through new discoveries, and concerns for their own career advancement.”

“..this prospect does stimulate some private investment in basic genetic research..”

”The Committee found that, although a patent or exclusive license may at times stimulate its holder to develop a genetic test, SACGHS found no cases in which possession of exclusive rights was necessary for the development of a particular genetic test, including test kits and tests for both common and rare genetic diseases.”

”Furthermore, exclusive rights do not result in faster test development.”

SACGHS report 2010 (http://osp.od.nih.gov/sites/default/files/SACGHS_patents_report_2010.pdf)

Report of the Secretary’s Advisory Committee on Genetics, Health, and Society

“..there is evidence to suggest that patents on genes discourage follow-on research.”

“..the Committee and public commenters were concerned about the future of genetic testing, which will certainly depend on the growing capacity to analyze multiple genes simultaneously. As such, the Committee considered how patents and licensing practices will affect the development of these technologies and found that patents on genes and associations threaten the development of new and promising testing technologies—in particular, multiplex tests, parallel sequencing, and whole-genome sequencing. Because a substantial number of patents claim gene molecules or methods of associating the gene with a phenotype, developing multiplex tests and parallel sequencing will depend on acquiring rights to multiple patents on genes and associations.”

SACGHS report 2010 (http://osp.od.nih.gov/sites/default/files/SACGHS_patents_report_2010.pdf)

Report of the Secretary’s Advisory Committee on Genetics, Health, and Society

SACGHS report 2010 (http://osp.od.nih.gov/sites/default/files/SACGHS_patents_report_2010.pdf)

“..non-exclusive licensing does not reduce the sale price of the final product”

1st Patent priority date to product availability (median years)

AI Nonexclusive 4.66

NIH Nonexclusive 9.5

AI Some exclusivity 4.14

NIH Some exclusivity 6.41

SACGHS report 2010 (http://osp.od.nih.gov/sites/default/files/SACGHS_patents_report_2010.pdf)

Report of the Secretary’s Advisory Committee on Genetics, Health, and Society

SACGHS report 2010 (http://osp.od.nih.gov/sites/default/files/SACGHS_patents_report_2010.pdf)

“License contracts can be drafted so that meeting diligence requirements expands the scope of rights granted therein, and/or so that failure to meet the diligence requirements results in loss of rights under the contract.”

Report of the Secretary’s Advisory Committee on Genetics, Health, and Society

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An example to IPR management:LICR (NY branch); NY-ESO-1

US patent/PCT filed

NY-ESO-1 paper

EP filed

US patent issued

EP issued

98 00 02 04 06 08 10 12 14 16 18 1996

Therion

Sigma-Aldrich

Immunofrontiers, CELLDEX

GSK Upstate

Santa Cruz

US Pat.Exp.

EP Exp.

An example to IPR management:LICR (NY branch); NY-ESO-1

Licensing fee ($) Royalty income ($)

Therion >175,000 (over 10 years) -

Sigma-Aldrich 5,000 x 1 -

Immunofrontiers 30,000 x 1 -

CELLDEX >9,500 (over 7 years) -

GSK >78,000 (over 8 years) >270,000 (over 8 years)

Santa Cruz 5,000 x 1 -

Upstate 4,000 x 1 2,135 (over 3 years)

Distribution strategy

100% LICR 40% LICR 80% Inst. #2 30% Investigators 20% Investigator #1: 25%Inst. #3 15% Investigator #2: 2.5%Inst. #4 15% ..

Thank you !