SPECIAL FOCUSINTELLECTUAL

Defending Stem CellsMark Ellinger talks about stem cells, intellectual property, and the biosciences industry.

by Dave Zielinski

is been 10 years since the discov-ery of human embryonic stem cellsby researchers at the University ofWisconsin-Madison, and despite theefforts of scientists, no FDA-approvedstem cell-based therapies have yetemerged to treat diseases such asdiabetes and cancer. But stem-cell dis-coveries are enhancing human health.Adult and embryonic stem cells areincreasingly used to test experimentaldrugs, often as alternatives to usinganimals as subjects. Pharmaceuticalcompanies, regularly use heart stemcells to test new drugs for toxicity to

Mark Ellinger, Fish & Richardson

the cardiovascular system.Those growing applications have

made the protection of stem cellpatents at all stages of the cells' lifecycle-from discovery to commercialuse-vital, says Mark Ellinger, man-aging principal of Fish & Richardsonin Minneapolis and an expert inpatent law. Ellinger, who was a ten-ured professor in cell and molecularbiology at Southern Illinois Univer-sity before getting his law degree atHarvard, says recent court cases, aswell as rulings from the U.S. Patentand Trademark Office, have alteredthe playing field for obtaining andprotecting stem cell patents.

Patents Under Pressure

Intellectual property issues weighheavily in attracting private sectorinvestment in stem cells, Ellingersays. Patents are among the mostimportant assets organizations likethe University of Minnesota or theMayo Clinic have for luring venturecapitalists seeking to create com-mercial enterprises from researchbreakthroughs. Biomedical com-panies such as BioE, a St. Paul basedorganization that provides umbili-cal-cord-blood stem cell products,painstakingly pursue patents for theirtools and technologies, knowing howvital they are to attracting investmentand building future revenues.

Investors want to know patentshave been acquired, or where theystand in the lengthy patent applica-tion process, before committing dol-lars to what are still, in many cases,high-risk investments. In particular,therapies that are designed to repairor regenerate damaged cells in spinalcord injuries, Parkinson's disease, andother intractable medical problems,are still in the experimental phase.They are both highly attractive andhighly risky investments.

"Patent applications themselvesare heavily scrutinized by the in-vestment community, since in thebiotech industry it can take years andyears to get a patent approved by thepatent office:' Ellinger says.

The Wisconsin Alumni ResearchFoundation (WARF) continues tohold important patents relating toembryonic stem cells-a kind ofcell that can be turned into any type

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of cell or tissue in the body-basedon the discoveries of UW-Madisonprofessor Jamie Thomson in thelate 1990s. WARF struck a licensingagreement with Geron Corpora-tion, a biotechnology company inCalifornia, based on three types ofcells Thomson discovered at the time:heart cells, pancreatic cells, and neuralcells. Geron had originally financedThomson's work to isolate the cellsand then gained exclusive rights tosell any commercial treatments.

WARF later had those patentschallenged by a California-basedconsumer organization on the chargethat the discoveries were "obvious"in light of what was publicly knownat the time. Though the patentswere upheld, the "obviousness" testremains one of the biggest hurdlesfacing stem-cell-related patent ap-plicants. A patent must be a "new andnon-obvious useful and functionalfeature of a product or process." Toreceive a patent, an invention mustnot be obvious in terms of what was

CCV09.002

known when it was created.One of the few stem-cell-patent

court cases involved PharmastemTherapeutics bringing an infringe-ment suit against ViaCell, Inc.Pharmastem claimed that a ViaCellproduct-which enables families topreserve their babies' umbilical cordblood to repair compromised im-mune systems, caused by, say, chemo-therapy to treat cancer-infringed ona Pharmastem patent. Blood from anewborn infant's cord is an abundantsource of hematopoietic stem cells,useful for rebuilding damaged bloodor immune systems.

In 2007, the court ruled in favor ofViaCell, Ellinger says. "PharmaStem'sclaimed invention was found to beobvious, so ViaCell was off the hook,"he says. The court also was not per-suaded by Pharmastem evidence thatit was "unknown in prior art" thatcord blood contained hematopoieticstem cells. The court said it was in-ferred by prior art or other informa-tion available at the time.

Future of Therapies

Ellinger believes researchers are "justout of the starting gate" when it comesto finding therapeutic applicationsfor stem cells. He estimates there are700 to 1,000 clinical trials of varioussizes underway around the world oftherapies to treat various diseases.

"Several of those companies aredoing very controlled trials underFDA direction, and many others haveapplied to do the same," he says.

The trials range from treatment ofcardiovascular problems to repair ofspinal cord injuries to less-publicizedapplications such as using stem cellsto boost immune system responses.Ellinger says one ongoing trial is usingadult stem cells in attempts to reducea traumatic immune response expe-rienced by bone marrow transplantrecipients. Called graft versus hostdisease, it occurs when a stem cellgraft provided from a healthy donorto a cancer patient attacks rather thanaids the patient's immune system.

In 2007 and 2008, multiple uni-

versities confirmed they were doingresearch to reprogram adult stem cellsback to their original or "primordial"stem cell state, Ellinger says. Research-ers created pluripotent stem cellsfrom the skin of people with specificdiseases, which will allow them to growand study those defective cells in thelaboratory. Such work is difficult todo with embryonic cells, because thehealth of an unborn embryo is hardto establish. The technique also avoidsdestroying human embryos, which hasethical implications that have causedcontroversy and barriers to research.

At the same time research break-

throughs revolutionize the stem cell

field, a more uncertain legal envi-

ronment promises to make it more

difficult for stem cell scientists and

commercial organizations to win new

patents or even protect old ones. It

will remain a challenging paradox, to

say the least. TCB

Dave Zielinski lis a freelance writer liv-ing in Bloomington.

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