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St. Jude Children’s Research Hospital Gets Patent for Genetically Modified Human Immune Cells for Cancer Therapy


Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
Zies, Widerman & Malek
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Posted: March 19, 2013 @ 5:13 pm
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St. Jude Children Research Hospital

As the patent community waits to see whether the United States Supreme Court will deal a significant, perhaps fatal blow, to the patenting of many genetic related innovations in Association of Molecular Pathology v. Myriad Genetics, announcement came this morning of a newly issued U.S. patent. This patent — U.S. Patent No. 8,399,645 — was issued to St. Jude Children’s Research Hospital. The invention relates to compositions for genetically modifying human immune cells so they can destroy some of the most common forms of cancer in children and adults.

It seems unthinkable that the Supreme Court could issue a ruling that would call into question the patent eligibility of an innovation that has the potential for curing cancer, but that is what is at stake. The Supreme Court will hear oral arguments in AMP v. Myriad on April 15, 2013, and the issue they will consider only a single question: Are human genes patentable?

While this St. Jude invention is not likely to be directly impacted by any ruling the Supreme Court makes, if the Supreme Court says that human genes are not patentable then what is to stop the march toward a ruling that says genetic modifications are likewise not patentable? Additionally, the Myriad claims relate to isolated DNA sequences, not DNA as it exists in a person or in nature. Some of St. Jude claims to this cure for cancer would seem to fall if the Myriad claims fall because they cover isolated host cells. Indeed, there is a lot at stake.

St. Jude and this Innovation

St. Jude Children’s Research Hospital is internationally recognized for its pioneering research and treatment of children with cancer and other life-threatening diseases. The hospital’s research has helped push overall survival rates for childhood cancer from less than 20 percent when the institution opened to almost 80 percent today. The research that led to this patent was supported in part by a grant from the National Institutes of Health. The patent issued today increased St. Jude’s patent portfolio to more than 100 issued United States patents.

By any measure St. Jude has been enormously successful. And those who think that government shouldn’t be funding research that results in the issuance of patents will absolutely hate the fact that the government and grants have played a role, together with the patent system, to provide the incentive and funding necessary to achieve this remarkable advance.

But what is this particular advance exactly? The invention allows human immune cells to successfully fight the cancer. “This groundbreaking invention enables human immune cells to recognize and attack certain cells that cause leukemia and lymphoma, cancers of the blood and lymphatic tissue,” said James R. Downing , M.D., St. Jude scientific director.

The invention involves genetically modifying human immune cells to enable them to manufacture a large protein molecule called a “chimeric antigen receptor” (CAR). The protein molecule is “chimeric” in that it is made from parts that do not exist together in the same molecule in nature. It is a “receptor” because a portion of it extends outside the surface of the immune cell and can receive signals from external “antigens.” An antigen is a substance capable of stimulating an immune response in the human body. The CAR invented by St. Jude fits and latches onto “CD19″ antigens prevalent on the B cells that cause ALL, CLL and NHL. It then stimulates the human immune cell to attack and kill the B cells.

The patented technology represents a potentially potent new therapeutic weapon against such diseases as B-cell acute lymphoblastic leukemia (ALL), B-cell chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin lymphoma (NHL). Each year approximately 71,650 people in the United States are diagnosed with these diseases.

“This exciting invention provides a new and promising treatment option for children and adults with these life-threatening diseases and sets the stage for treating other forms of cancer with cellular immunotherapy,” Downing said. St. Jude plans to offer patent licenses to those who wish to exploit this important technology.

The Patent Claims

Of course, patent licenses are only as valuable as the claims granted, and those granted that are likely to withstand the challenge of those who seek to circumvent, as well as challenges by those who just don’t like the patent system period. The independent claims issued to St. Jude in the patent are:

1. A polynucleotide encoding a chimeric receptor comprising: (a) an extracellular ligand-binding domain comprising an anti-CD19 single chain variable fragment (scFv) domain; (b) a transmembrane domain; and (c) a cytoplasmic domain comprising a 4-1BB signaling domain and a CD3? signaling domain.

2. A vector comprising a polynucleotide encoding a chimeric receptor comprising: (a) an extracellular ligand-binding domain comprising an anti-CD19 single chain variable fragment (scFv) domain, (b) a transmembrane domain, and (c) a cytoplasmic domain comprising a 4-1BB signaling domain and a CD3? signaling domain, wherein the polynucleotide encoding the chimeric receptor is operatively linked to at least one regulatory element for expression of the chimeric receptor.

3. An isolated host cell comprising a polynucleotide encoding a chimeric receptor comprising: (a) an extracellular ligand-binding domain comprising an anti-CD19 single chain variable fragment (scFv) domain; (b) a transmembrane domain; and (c) a cytoplasmic domain comprising a 4-1BB signaling domain and a CD3? signaling domain.

As you can see, the isolated host cell claim, claim 3, could be on a very slippery slope if the Supreme Court decides that the isolation step in the Myriad patent is insufficient to establish patent eligibility.

The Irony

How strange would it be if the cure for cancer has been achieved only for society to take the position that it is not patentable? If innovations of this importance are not patent eligible then why would anyone spend the amount of time and money necessary to bring them into being? Spending millions, or billions, of dollars makes no sense unless there is an opportunity to more than recoup the investment. Without patents those who spend research and development money will be handing over the invention to those who free-ride and then commercialize and distribute for less because they don’t have to recoup the research and development money.

So the next time you speak with some “enlightened” anti-patent advocate you might want to ask them what their position is on the cure for cancer. In my opinion the cure for cancer is something that we ought to be pursuing, and placing road blocks in the path of innovation at the front door by saying certain innovations are patent ineligible is ridiculous.

The anti-patent zealots will be remembered in history in the same way that we today view those who persecuted the likes of Galileo. Standing in the way of scientific advance and innovation is regressive, shortsighted and irresponsible. Only those with a special phobia against science and innovation, as well as a healthy disregard for reality, would ever stand in the way of the march of health related innovations.

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Posted in: Biotechnology, Gene Patents, Gene Quinn, IP News, IPWatchdog.com Articles, Patents, Technology & Innovation

About the Author

is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.

 

3 comments
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  1. Gene,

    Even if SCOTUS holds that’s Myriad’s isolated DNA sequences are patent-ineligible under 35 USC 101, St. Judes claimed subject matter should survive unless SCOTUS decides to overrule or greatly modify its prior holding in Chakrabarty (if SCOTUS does that, we’ll have a disaster in terms of any real incentive to do research and development on therapeutic genetics). Because St. Judes is genetically modifying the human immune cells, that’s much closer to what Chakrabarty did when inserting 4 plasmids into a host bacteria cell.

  2. EG-

    I would agree that the thrust of the invention is much closer to Chakrabarty, but I don’t really see how a principled distinction can exist. For example, if SCOTUS does what many thinks they will and says human genes are not patentable period, that would seriously bring into question what St. Jude is doing here.

    My personal view is that SCOTUS took this question to set large general boundaries. They will say either “No… unless…” or “Yes… but only if…” Then kick it back to the CAFC for more.

    If Myriad loses ultimately it will be because SCOTUS says isolation is not enough. That would impact claim 3 above directly it seems.

    -Gene

  3. “If Myriad loses ultimately it will be because SCOTUS says isolation is not enough. That would impact claim 3 above directly it seem.”

    Gene,

    Not necessarily unless SCOTUS rules that human gene material generally is patent-ineligible. By definition, a chimeric genetic material must come from two different genetic sources which means you can’t simply “snip” it off from the native DNA. BTW, you can have chimerics created by nature crossing the two sources of genetic material but that would be happenstance. Again, what St. Judes is doing here is strictly “man-made”‘ genetic material.

    If SCOTUS does rule that human gene material generally is patent-ineligible, that would undermine not only medical diagnostic testing for genetic disorders, but would also render the way we get certain human biological materials unprotectable. For example, it’s very common to take a section of genetic material that expresses a protein like insulin and to insert into the genetic material of a host organism (e.g., bacteria) to replicate that genetically engineered organism by cell culturing (think of it as a “living” insulin generation factory); that’s why SCOTUS better understand the science and especially the “reaility” of denying patent-eligibility based on the material being derived from human genetic material, or we’re going to end of up either with vital human materials/drug being scarcer (analogous to what has happened to the scarcity of certain common vaccines because of the significant products liabiility risk), or else it will all become “hidden” as trade secrets (if possible) in which case our commercial information database on such stuff will start to dwindle.