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Sunday, 05/25/2014 10:01:27 PM

Sunday, May 25, 2014 10:01:27 PM

Post# of 106837
"Risks Related to Our Intellectual Property

We hold limited patent and other intellectual property rights, and our success will be dependent in large part on safeguarding our existing intellectual property rights and obtaining patent and other proprietary protection for our product candidates.

We hold limited patent rights in our product candidates. Our MyoCath product candidate is protected by a patent, expiring in September 2017, in which we have an irrevocable co-exclusive license. Our MyoCell product candidate is no longer protected by patents, which means that competitors will be free to sell products that incorporate the same or similar technologies that are used in MyoCell without infringing our patent rights. As a result, MyoCell, if approved for use, may be vulnerable to competition in the form of products that use the same or similar technologies. We have previously licensed certain patents and patent applications relating to our MyoCell product candidate. These licenses have all lapsed as of the date of this report, although we have had discussions with the relevant licensor regarding a potential reinstatement of our rights in such licenses.

Our commercial success will depend to a significant degree on our ability to:

·
compel the owners of the patents licensed to us to defend and enforce such patents, to the extent such patents may be applicable to our products and material to their commercialization;
·
obtain new patent and other proprietary protection for MyoCell and our other product candidates;
·
obtain and/or maintain appropriate licenses to patents, patent applications or other proprietary rights held by others with respect to our technology, both in the United States and other countries;
·
preserve intellectual property rights relating to our product candidates; and
·
operate without infringing the patents and proprietary rights of third parties.

Failure to obtain adequate patent protection for our product candidates, or the failure to protect our existing patent rights, may impair our ability to be competitive. The availability of infringing products in markets where we have patent protection, or the availability of competing products in markets where we do not have adequate patent protection, could erode the market for our product candidates, negatively impact the prices we can charge for our product candidates, and harm our reputation if infringing or competing products are manufactured to inferior standards.

Our most important license agreement with respect to MyoCath is co-exclusive and the co-licensor of the intellectual property, a division of Abbott Laboratories, may also seek to commercialize MyoCath.

In June 2003, we assigned our exclusive license to the primary patent protecting MyoCath to ACS, originally a subsidiary of Guidant Corporation and now d/b/a Abbott Vascular, a division of Abbott Laboratories. In connection with this agreement, ACS granted to us a co-exclusive, irrevocable, fully paid-up license to this patent for the life of the patent. Because our license is co-exclusive with ACS, ACS may, parallel to our efforts, seek to commercialize MyoCath if MyoCath secures regulatory approval."

Most recently filed, BHRT, 10-K report, yr ended 2013, PAGE 40.

BHRT is in potential co-competion with ABBOTT labs for Myocath, and their patent expires in 2017, only about 3 yrs away. Their "flagship product", "Myocell", their only product to ever reach significant progress, IMO, via phase II or III level, FDA type trials (those trials have been stalled, gone nowhere since about 2009/2010) is no longer under patent protection.

ABBOTT market cap $59 BILLION on NYSE. ABBOTT share price is about $40 per share, 1.5 BILLION shares outstanding (less shares than BHRT has now authorized to be available at 2 BILLION shares on a 2 cent stock), ABBOTT has $3.2 BILLION in operating cash flow and net income of about $2 BILLION on sales (revenues) of about $22 BILLION a yr.