IP STRATEGY


LSIPR that while Cohn’s method was effective, it had “inherent flaws”.


Cohn’s process extracted albumin from blood plasma which, when administered to wounded soldiers, helped expand the volume of blood and led to increased chances of a speedy recovery. Te method has since been used to treat all types of patients.


But, says Schorer, one of the most effective ways for carrying it out is to add alcohol to the plasma pool, a process known as cold alcohol fractionation, or ethanol fractionation.


“Tat creates a denaturing effect that we think affects the molecules, because it’s a harsh environment that causes damage to the protein,” Schorer says.


“Our method uses salt from sodium citrate because it is oſten used as a preservative. It produces a much higher protein yield and less damage to the resulting protein that we pull out of the blood.


“In essence we are removing proteins from source plasma in a unique fashion that allows us to produce a ten-fold increase in protein. In an environment where supply is constrained, this is absolutely revolutionary.”


Protecting IP


One might expect a company that has come up with a “revolutionary” solution to keep its most prized inventions protected, so it comes as no surprise that one of the company’s priorities is ensuring that strong IP protection is in place.


“We have patent protection for all of our key methods,” says Schorer. “On the plasma side there are a number of patents. Probably our most significant—a method process patent—was approved in 2012 and does not expire until 2025.


“We have approval in all key jurisdictions,


including the US, EU and China, and applications are pending in Canada and India.”


Despite the delays in India, known to be a tricky market for IP protection in the pharmaceutical sphere, and in neighbouring Canada, Schorer remains confident.


“We are not expecting issues with that”, he says. “It’s just to do with time. Every other jurisdiction has approved it.”


PlasmaTech’s eagerness to acquire patent protection also applies to its other key area: hydrogel technology, which is used to help the oral and rectal mucosa recover from damage sustained during radiation or chemotherapy.


16 Life Sciences Intellectual Property Review


“ESSENTIALLY THEY WOULD TEST OUR IP AS IF WE WERE GOING INTO LITIGATION WITH A HOSTILE PARTY; ONLY THEN CAN YOU BE REALLY SURE HOW YOU STAND.”


Its ProctiGard product, for which it has trademark protection, is used as a treatment for rectal mucositis, a potentially debilitating side-effect of cancer treatment. Its other product, Mugard, also trademark-protected, is used to provide a protective coating for oral mucosa.


“Mugard is the only technology on the market that has clinical data proving its efficacy and it can be used to treat oral mucositis as well as other cavity disorders,” Schorer says.


“Te hydrogel repairs tissue in the mouth and oesophagus that may have been damaged by radiation or chemotherapy.”


Explaining its “uniqueness”, Schorer adds: “We are the only technology on the market at the moment that can produce something you can swallow, and it is the only one that sticks inside the mouth, not just something you rinse.


“It has statistically shown a reduction of patient discomfort and a nine-day delay to the onset of oral mucositis,” Schorer explains.


Te two main technology areas that PlasmaTech’s products are marketed in seem to be very different for one company.


Until as recently as September, the two focus


areas were developed by separate companies but a partnership between Access Pharmaceuticals, which developed the hydrogel technology, and


Volume 2, Issue 1


PlasmaTech, developer of the plasma fractionation, has created a new company.


According to Schorer, this has strengthened its position as a major player both from the development side and in terms of IP protection.


Like its plasma fractionation model, the hydrogel formula is


also patent-protected in major


jurisdictions and PlasmaTech has the licensing rights to both products.


Although it already has several issued patents for both, Schorer says the possibility of filing new applications is never far from his mind, and in fact the company is already in the process of filing additional patents.


He says he can’t reveal too much about what exactly they entail, but he drops a hint.


“Composition of matter patents are sometimes more powerful and more narrowly focused than a process patent. We feel that we have novel molecules that we could find, so we are looking at novel composition of matter filings as well.


“Tis will happen once we dig into the lab and start characterising the results of our processes more.”


Trade secrets In the highly competitive world of


life sciences,


where many parties are competing to provide the latest breakthrough inventions, keeping certain


www.lifesciencesipreview.com


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