Biotech Seminar: Aligning IP with the Growth of a Biopharmaceutical Company

A biotechnology seminar entitled “Aligning IP with the Growth of a Biopharmaceutical Company: the FibroGen Experience” was organized by Hong Kong Institute of Patent Agents (HIPA) and Hong Kong Biotechnology Organization (HKBIO), supported by Hong Kong Science and Technology Parks, on 7 May 2010. I would like to summarize the seminar as follows.

Dr. Jacqueline Lui (President of HIPA) gave an opening speech and she introduced the mission of HIPA that it is a non-profit organization established to promote and support Hong Kong as an international hub for the acquisition and commercialization of and respect for rights in technology, inventions, patents and other intellectual assets by acting as a professional governing body for training and recognizing patent practitioners in Hong Kong. Then she introduced two speakers from FibroGen.


The first speaker was Dr. James E. Nesbitt (Director of Intellectual Property at FibroGen, Inc.).

Dr. Nesbitt briefed the background of FibroGen, Inc.

He took that the company founded on 2 core platforms which were:
i) Recombinant human collagens as replacement for animal-derived materials;
ii) Therapeutics in tissue fibrosis (including collagen prolyl hydroxylase inhibitors and connective tissue growth factor (CTGF) (人類結締組織生長因子))

The following photo showed the recombinant collagen expression.

Then he also compared FibroGen Recombinant Human Gelatins and Animal-derived Gelatins. Some applications included pharmaceutical stabilizers, vaccine stabilizers, hard/soft gelatin capsules and plasma expanders.

They are developing a portfolio of powerful, selective product candidates for the treatment of life-threatening diseases affecting the kidneys, lungs, eyes, skin, heart, and liver. CTGF worked as central mediator of tissue remodeling and fibrosis.

Dr. Nesbitt said several clinical trials had being performed such as Diabetic Nephropathy (Phase 2), Pancreatic Cancer (Phases 1), Liver Fibrosis and Cardiovascular Disease.


The second speaker was Dr. Christopher Turner (Direct of IP Team at FibroGen, Inc.). His talk was focused on Prolyl Hydroxylase inhibitors and Hypoxia-Inducible Factor (HIF) (缺氧誘發因子).

A new target of prolyl hydroxylase was identified in 2001 (i.e. HIF).
HIF modulates transcription of numerous genes associated with tissure response to hypoxia including Erythropoietin (EPO) (紅血球生成素), Vascular Endothelial Growth Factor (VEGF) (血管內皮細胞生長因子), Iron regulatory genes (鐵質吸收之調節基因) and Glycolytic enzymes (醣酵解脢).

Regulation of Hypoxia-Inducible Factor (HIF) stability and activity was mentioned.

The comparison of current therapy using rhEPO supplemented with iron and FG-4592 HIF-PHI treatment was discussed.

Finally, Dr. James Nesbitt mentioned FibroGen Intellectual Property worldwide patent portfolio including US patents (30+), Foreign patents (70+) and 200+ pending applications.

The development of IP Portfolio was concluded as follows.
i) Identify and work closely with foreign counsel
ii) Develop territory-specific filing and prosecution strategies
iii) Understanding of territory-specific procedures
iv) Consistent integration of strategy worldwide


For more information:
Hong Kong Institute of Patent Agents (http://www.hipa.org.hk/)
Hong Kong Biotechnology Organization (http://www.hkbio.org.hk/)
Hong Kong Science and Technology Parks (http://www.hkstp.org/)
FibroGen, Inc. (http://www.fibrogen.com/)