Patent Law

The following is excerpted from a May 19, 2008 Pharmaceutical Patent Attorneys, LLC press release:

In two separate rulings, The United States Patent & Trademark Office announced that it will revoke both patents on the epilepsy drug felbamate. The rulings are the latest problems for a drug haunted by controversy since its inception.

Since its troubled launch, however, the drug has proven quite profitable for its manufacturer: in 2007, the wholesale cost for a single 960 ml suspension was $1,066.42.  The manufacturer preserved its high pricing by advising the F.D.A. that lower-cost generic products were barred by two patents.

An unremarkable legal dispute between the manufacturer and an ex-employee, however, called the validity of these two patents into question, and has raised concern that the manufacturer knew of the hazards of combination therapy before it began selling the drug.

In the legal dispute, the manufacturer accused the ex-employee, Dr. Walter Kozachuk, of patenting inventions allegedly made by a colleague, Robert Duane Sofia.  The dispute seemed set to be a battle of intellectual titans: the ex-employee is a board-certified neurologist formerly of the National Institutes of Health, while his colleague is an accomplished laboratory scientist with both felbamate patents and close to two hundred published scientific articles to his name. 

In investigating the allegations of idea theft, however, Dr. Kozachuk?s patent lawyers, Pharmaceutical Patent Attorneys LLC of Morristown, New Jersey, uncovered the inverse situation: when filing the patents on felbamate, Dr. Sofia had apparently stolen credit for other scientists? prior work.  The patent lawyers reported their findings to the U.S. Patent Office, who began investigating the matter several years ago.

The Patent Office has just concluded its proceedings, finding that both of Dr. Sofia?s felbamate patents cover other scientists? work.  The Patent Office has thus announced that it will revoke both patents.  Left unanswered in the inquiry is why a scientist as accomplished as Dr. Sofia would have felt pressured to claim credit for other scientists? work.

In investigating the case, however, Dr. Kozachuk?s patent lawyers stumbled on a discovery tangential to the patent dispute, but horrifying: several years before the rash of patient deaths, the manufacturer had specifically studied whether felbamate could be safely combined with other anti-epileptic drugs.  That study found that combining felbamate with other anti-epilepsy medications is extremely dangerous, and produced severe adverse drug interactions in fully one third of the patients tested.

Download 51908_news_release.pdf