Garnet BioTherapeutics Files Amicus Brief to Support its Victory Against Athersys in Patent Interference

Jan 28, 2015, 09:00 ET from Garnet BioTherapeutics

MALVERN, Pa., Jan. 28, 2015 /PRNewswire/ -- Garnet BioTherapeutics, a regenerative medicine company developing off-the-shelf allogeneic stromal cell products for tendon repair, filed a friend of the court (amicus) brief last Wednesday to support its victory in a patent interference provoked by Athersys.

In the interference, the U.S. Patent and Trademark Office (PTO) ruled that:

  • Garnet and Athersys claim different inventions and there is no basis for an interference.
  • Athersys's stem cell patents and pending application at issue are not patentable.

Athersys now seeks to overturn the PTO's rulings through a time-consuming action in District Court. A federal district court has already ruled, however, that such actions must be appealed directly to the U.S. Court of Appeals for the Federal Circuit ("Federal Circuit").  The PTO is also on record as agreeing that Congress eliminated the type of action Athersys is now pursuing. 

To protect its rights, Garnet has filed an amicus brief at the Federal Circuit in a separate appeal that may determine the proper appeal forum.  Garnet is confident that the Federal Circuit will confirm that actions such as Athersys's challenge in district court are not proper.  Garnet is also confident that the PTO's decision in the interference will be upheld.

"We are extremely pleased with the decision by the PTO.  It supports our long-standing position that Garnet's stromal cell population and process for obtaining said cells are very different than the MAPC cells purportedly described in the Furcht patents and application.  Garnet's cells have tremendous therapeutic potential and we look forward to advancing our products in the field of regenerative medicine," said Vanessa Ragaglia, PhD, CSO of Garnet.

Garnet BioTherapeutics has developed the first in a series of products capable of reducing inflammation and promoting healing.  In addition, the company has developed proprietary scalable cell manufacturing technology for producing commercial scale patient doses from a single donor source.

The interference proceedings involve patent applications owned by Garnet (Ho et al. U.S. Patent applications 09/960,244 and 10/251,685) against U.S. Patents 7,659,118 and 7,015,037, and U.S. Patent application 11/084,256 (Furcht et al.), owned by ABT Holding Company, a wholly owned subsidiary of Athersys, Inc., and Regents of the University of Minnesota. 

About Garnet BioTherapeutics

Garnet BioTherapeutics is a clinical stage regenerative medicine company located in Malvern, PA.  Garnet's mission is to discover, develop, and deliver new regenerative therapies by leveraging the intrinsic ability of adult somatic cells to repair, regenerate, and remodel tissue in acute and chronic disease settings.  The company's broad technology platform has been set up to maximize success by leveraging the company's expertise in cell manufacture and clinical development.  The challenge of scale-up has been addressed by developing proprietary technology to meet market needs and enable the manufacture of billions of doses from a single donor tissue at low cost.  The company has identified a distinct population of bone marrow-derived stromal cells that, when placed in an area of injury, elaborate many pro-healing and anti-inflammatory factors in the area around them.  The cells have been demonstrated to produce a plethora of factors, which in addition to directly aiding the wound, recruit endogenous cells to the area to aid in repair and regeneration.  Garnet's manufacturing process is also adaptable to other cells types, including chondrocytes, smooth muscle cells, skeletal muscle cells, neural progenitors, and fibroblasts, to name only a few.  Two therapeutic platforms have been developed: a liquid suspension of cells stored in the vapor phase of liquid nitrogen prior to use (GBT009), and bioactive, non-living cell-based devices (GBHT012).

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