When are eight 0.5g capsules not equivalent to four 1g capsules?

Orange Book Insights No. 29 – When are eight 0.5g capsules not equivalent to four 1g capsules?

 Amarin is still keeping its patent attorneys busy. The Supplement 10 “What’s New” of my Orange Book Companion showed that they listed two more patents for VASCEPA® (icosapent ethyl). Patents Nos. 11,116,742 and 11,154,526 made it 66 patents listed for VASCEPA 1g, and 63 patents listed for VASCEPA 500mg (“half-gram”). 

While the ‘742 and ‘526 patents were listed for both the 1g and half-gram strengths of VASCEPA, that new listing started me wondering about the three patents that were listed for the 1g strength but were not listed for the half-gram strength. With 63 patents in common, what was so different about those three patents that Amarin did not list them for the half-gram strength? After all, shouldn’t claims that cover a method of treatment by administering a certain dosage of icosapent ethyl cover the use of both the 1g and half-gram strengths of VASCEPA? Just administer the correct number of capsules, right?

What I saw when I looked at the claims of the three patents that were not listed for the half-gram strength was a little surprising. All three patents, 8,431,560, 8,455,472 and 8,618,166, were limited to the administration of four capsules per day that each contain about 1g of icosapent ethyl. That’s right, administering four 1g capsules, not four grams total, of icosapent ethyl per day. For simplicity, I shall refer to the ‘560, ‘472, and ‘166 patents collectively as the “1g capsule patents.”

What this means is that the administration of eight VASCEPA half-gram capsules per day would not fall within the scope of any claim of the 1g capsule patents. That is the case even though the administration of eight half-gram capsules per day is an approved method of using the half-gram capsules.

So why do I think that Amarin did not list the’560, ‘472 and ‘166 patents in the Orange Book for the half-gram strength of VASCEPA? Surely, the administration of eight half-gram capsules on a daily basis, instead of the claimed four 1g capsules, would meet the Graver Tank function/way/result “triple identity” test for equivalence. But that is not the issue. The real issue is eligibility for listing of the 1g capsule patents in the Orange Book under 21 USC 355(b)(1) or (c)(2) for the half-gram strength. Are those three patents whose claims require the administration of four 1g capsules per day eligible for listing in the Orange Book for the VASCEPA half-gram strength? The statute says that the patent must be one that “claims the drug for which the applicant submitted the application or which claims a method of using such drug.” [35 USC 355(b)(1)].

What the patent “claims” is best defined by the words in black and white at the end of the specification, i.e., by the subject matter that we consider to define literal infringement. Should an NDA holder really want to decide on their own that their drug would be “claimed” by their patent (for purposes of Orange Book listing eligibility) if only they could first expand one of the limitations of their claim under the Doctrine of Equivalents? After all, the Doctrine of Equivalents “is a factual matter normally reserved for a fact finder” unless no reasonable fact finder could find equivalence. [See Sage Products v, Devon Industries, 126 F.3d 1420, 1423 (Fed. Cir. 1997)]. So I do not recommend that anyone apply the Doctrine of Equivalents (along with considering file history estoppel) to an element of a claim in one of their patents for Orange Book listing purposes. As a result, I agree with Amarin’s decision to not list the 1g capsule patents in the Orange Book for the half-gram strength of VASCEPA. And now you know how eight half-gram capsules might not be equivalent to four 1g capsules, at least for Orange Book patent listing purposes.

But all may not be lost. In response to an ANDA with a  P. IV requesting approval of the half-gram capsules, there may be a way for Amarin to bring an additional suit against the ANDA applicant for infringing the unlisted 1g capsule patents based upon the Doctrine of Equivalents. For example, in a case that started with a P. IV suit, the Federal Circuit decision in Vanda Pharmaceuticals v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018) affirmed the jurisdiction of the district court under 35 USC 271(e)(2) over an additional infringement suit against the ANDA filer that was based on an unlisted patent.

Similarly, an ANDA with a P. IV certification for Amarin’s half-gram capsules would allow a district court, under the Vanda Pharmaceuticals decision, to have jurisdiction over an additional suit by Amarin alleging that the ANDA filer infringes the unlisted 1g capsule patents under the Doctrine of Equivalents. After all, couldn’t a patent claiming the use of four 1g capsules be infringed under the Doctrine of Equivalents by a drug label directing the patient to take eight half-gram capsules? A better application of Graver Tank’s function/way/result triple identity test would be hard to find.

But wait! Is there anything in the file history of Amarin’s 1g capsule patents that could preclude application of the Doctrine of Equivalents? If the above series of events ever occurs, I leave it to the ANDA applicant to discover if Amarin would have problems with file history estoppel. 

#patents #fda #hatchwaxman  #drugpatents #orangebook #orangebookpatents #orangebookinsights #orangebookcompanion

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