Re: Stem Cells

From: ainsron (ainsron@sbcglobal.net)
Mon Jun 21 20:02:42 2004


I spoke with my son, who is a clerk to a judge in the Delaware Federal Court and he said that we can actually be sued for patent infringement if we knowingly participate in the collection of blood using a patented technique, even if we aren't directly profiting from the procedure. I had a patient come in today, right after I got the letter. She is going through CBR (actually she is a surrogate mother and the parents are going through CBR). CBR and the other named firms are actively working to overturn the Pharmastem patents and they indicated that the letter is "based upon some very misleading and erroneous statements concerning the law and the facts." I'm sure the truth lies somewhere between the two. They pointed out that Pharmastem's license fee is $225/collection and $25/yr. We're talking about big bucks here if the technology continues to grow.

Ronald E. Ainsworth

-----Original Message----- From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net] On Behalf Of Brickster0@aol.com Sent: Monday, June 21, 2004 3:39 PM To: Multiple recipients of list OB-GYN-L Subject: Re: Stem Cells

I got the same letter; the CBR rep said it was a scare tactic. I agree I don't know how we could be sued for drawing blood.

Brick Bills MD

Alpharetta, GA

In a message dated 6/21/2004 5:46:33 PM Eastern Standard Time, ainsron@sbcglobal.net writes:

Did anyone else get this letter from PharmStem recently, implying that we could be sued for using any stem cell bank not licensed by them?

--------------------------------------------------------------------------- -------------------------------------------------------------------------"We have been asked by concerned colleagues of yours to clarify the

--
-------------------------------------------------------------------------legal implications for Obstetricians regarding the collection of
umbilical cord blood.

The question raised by your colleagues relates to the Obstetrician's leqal liabilitv arising out of infringement of U. S. patents 5,004,681, 5,192,553,6,461,645,6,569,427 and 6,605,275 owned by PharmaStem Therapeutics. Patent infringement occurs when a person or institution practices all or part of a patented process. In the case of umbilical cord blood collection by an Obstetrician, the Court ruled that infringement occurs even if the cryopreservation and storage is performed by a third party.

Sensitive to the delicate position you are confronted with, PharmaaStem wants to assure you that we-have taken all the necessary steps to protect the Obstetricians from any intellectual property infringement liability, provided they work with anyone of the following licensed companies:

Stembanc Cord Blood Family Trust StemCyte Newborn Blood Banking Securacell LifeBank USA Family Link Norton Hospitals Cord Partners HemaStem Therapeutics California Cryobank Lifestor New England Cord Blood Bank Alpha Cord

In its license agreements with these cord blood banks, PharmaStem has extended its license to the health care providers under the condition they work with these licensed Blood banks:

"The license granted shall extend to any medical doctor, nurse, midwife, hospital, clinic,.., (collectively, "Health Care Providers"), ".involved in the Collection, .. .of any Cord Blood, ". that will be Cryopreserved, by the licensed Cord Blood Bank.. ."

This language means that as long as you are collecting cord blood for a PharmaStem licensed blood bank, you are not liable for patent infringement.

In October 2003 a Federal jury in the United States Federal Court, District of Delaware unanimously found that ViaCell / ViaCord, CBR Systems, ("Cord Blood Registry"), Cryo-Cell International and CorCell willfully infringe PharmaStem's patents covering the collection, cryopreservation and storage for future therapeutic use of stem cells derived from umbilical cord blood. Following this verdict, PharmaStem has asked the Court to grant a permanent injunction against these companies. An injunction would prevent the infringing companies from continuing their cord blood storage activities.." -----------------------------------------------------------------------

I emailed back the following to them: ----------------------------------------------------------------------- I received your letter today regarding legal implications of collection ----------------------------------------------------------------------- of umbilical cord blood. I am certainly not a lawyer, but I fail to see how I have any personal liability if a patient chooses one of your unlicensed competitors for stem cell preservation. Certainly, I am the one who collects the blood. However, I am not the one who decides who they use, I don't steer them in a particular direction and I do not charge for the collection. The patient brings the kit to me in the hospital and ask that we honor their request for cord blood collection. It is simply done as a service to my patients who desire it. Even If I were to charge a collection fee, I don't see how this letter applies to the physician in the trenches. Please clarify this to me in plain English.





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