PlasmaTech: two strings to its bow

During World War II, as soldiers struggled to cope with injuries sustained in battle, a man called Edwin Cohn created a solution to help them recover.

The scientist invented the first practical method of what is known as blood plasma fractionation, where the conditions of pooled plasma (for example, temperature or acidity) are changed so that proteins that are normally dissolved become insoluble, aiding a speedy recovery.

At the time, the method, known as the Cohn process, was hailed as revolutionary. But fast-forward 70 years and a US company thinks it has found a new solution that will be a game-changer, and has patented it.

PlasmaTech Biopharmaceuticals develops plasma-derived therapeutics, including its own plasma fractionation process, as well as hydrogel products used for treating the side effects of cancer.

Explaining its new fractionation system, PlasmaTech’s chief executive Scott Schorer tells 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. The 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.

“That 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 often 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.

"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."

“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.

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.

“The 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.

The 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 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.

“This 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 inventions under wraps, at least for a short period, is a necessity.

It is this which brings Schorer on to the subject of trade secret protection.

“Trade secrets are key to how we work”, he says. “Clearly we want to protect confidential information.

“As you practise technology you develop new information that you want to keep confidential, so it’s a constant cycle. But, in the future, some of the information we develop may be patentable. Eventually this could extend the life of our patent protection as well.”

For a company that takes IP protection seriously, it could perhaps be expected to have appointed an in-house counsel to administer its IP policies.

But this is where PlasmaTech differs.

Schorer explains that the company does not have an internal counsel, although he is confident that the combination of himself, Gene Zurlow (chair of the scientific advisory board at PlasmaTech) and David Nowotnik (the company’s senior vice president) can provide more than enough experience.

“We are each considered the inventor of around 30 issued patents and 25 pending patents worldwide, so there are easily 50 to 75 pending patent applications between us,” he says.

“We very much enjoy the IP process and are very involved in it,” he adds.

Schorer explains that his keenness to develop IP also extends, perhaps unusually, to interacting with examiners during the examination process.

“I’m a big fan of this. It cuts through all the limited communication you have through email and you can also explain a little bit about the market and in turn the patent examiners get to understand you.

“Often they enjoy meeting the lead inventor of a patent because it makes it a bit more personal.”

Potential litigation

Given PlasmaTech’s “revolutionary” methods, it is perhaps surprising that the company has yet to experience any IP disputes and has not needed to take direct action against rivals.

“So far we are not aware of any infringements on our IP or that we are infringing another’s,” Schorer tells LSIPR.

Despite this, he is conscious that the company should remain prepared for potential litigation.

“As soon as we raise the capital I would like to hire an external firm that would act as a mock litigator,” he explains.

“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.

“Usually an in-house counsel would be responsible for filing and looking after your IP, but they are very close to the subject and may not see some of the issues that a new party would notice. For example, they may find little things that could be tack-ons to a patent or find holes that you can shore up.”

In an age where IP has to be watertight to ensure infringements are kept to a minimum it’s reassuring to a see a company with an impressive invention putting protection at the forefront of its concerns.

As with any merger between two companies, managing different products from each could prove problematic. But PlasmaTech certainly seems to have a grip on IP matters and, if it carries on the same way, it could have a long lasting hold in its core fields as well.