Fish oil and intellectual property: A look at Amarin’s recent clinical success story

Anyone who stays current on topics related to nutrition and human health is well aware of the rampant use of fish oil supplements to reduce risk/susceptibility to everything from cardiovascular disease to cancer, mood disorders and more.  The hype is due to fish oil containing omega-3 fatty acids, including at least docasahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).  

            However, the medical community has debated the efficacy of fish oil supplements for years.  The debate appeared to culminate in July of this year, when a study published in the Cochrane Database of Systemic Reviews that included analysis on more than 112,000 participants over the course of 10 years, reported that omega-3 supplements had essentially no effect on cardiovascular health.

            The conclusion that omega-3 supplements are worthless however, was recently turned on its head with the report that Vascepa, a purified version of EPA produced by the biopharmaceutical company Amarin Corporation, remarkably lowered the risk of heart attacks and strokes in patients with very high levels of a type of fat in the blood called triglycerides.  Specifically, patients on Vascepa who were also on a statin drug for lowering cholesterol showed a 25 percent reduction in the relative risk of a heart attack, stroke, or death due to a cardiovascular event, etc.  Remarkably, the 25 percent reduction in risk is on top of a 25 percent reduction in risk that historically has been associated with taking statins.  Thus, there appears to be enormous potential for this particular drug when taken in combination with conventional statin treatment.

The critical reason for the success appears to lie in the fact that Vascepa lowers triglycerides, without increasing so-called bad cholesterol (low-density lipoprotein-cholesterol, or LDL-cholesterol).  Other supplements previously examined in studies assessing cardiovascular health included DHA along with EPA, and it is thought that because DHA is known to elevate bad cholesterol, that is the reason the previous trials failed.  Alternatively, as mentioned, Vascepa is pure EPA. 

            Upon learning of these incredibly promising results, we were interested in looking into Amarin’s intellectual property holdings regarding this subject matter.  Certainly with the overwhelming amount of information out there pertaining to the relationship between statins, cholesterol, triglycerides and omega-3 supplements including EPA and DHA, the prosecution history would provide valuable lessons from which to glean how to overcome Examiner rejections in this space.

            Thus, we looked into patents filed in this space by Amarin.  Specifically, United States Patent Application No. 14/411815 assigned to Amarin was directed to:

 A method of reducing a risk of cardiovascular death, coronary revascularization, and unstable angina in a subject on statin therapy, the method comprising:

Administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of ethyl icosapentate per day, wherein the subject has a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL and optionally has established cardiovascular disease.

            The primary rejection during prosecution included a 35 U.S.C. 102 rejection based on prior art teachings of US 2012/0121698, which included all the elements of the method claim of US 14/411815, but which failed to specifically teach the limitations related to “reducing a risk of cardiovascular death, coronary revascularization, and unstable angina in subjects having a baseline triglyceride level of about 135 mg/dL to about 500 mg/dL”, even though methods for treating a cardiovascular-related disease were disclosed.  This fact was argued by the Applicant, and was enough to persuade the Office to allow the claims without any further rejections.  We were surprised that no further rejections were applied in this case, given the frequency with which the KSR decision (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) has been recently readily applied to claims simply by an Examiner finding all the elements in a particular claim in one or more pieces of prior art, and then asserting the claim as being obvious to one skilled in the art.

            At any rate, the take-home message is that method of treatment claims directed to specific aspects of disease can in some cases be sufficient to overcome close prior art.  The success of Amarin’s trial is good news for investors, as well as patients with high triglyceride levels, which Amarin estimates to be over 50 million adults in the United States alone.  More good news is the current list price of Vascepa, which is around $2400 per year, as compared to much higher pricing for other drugs that reduce cardiovascular events in high-risk populations.

Paul FockeComment