Photocure ASA v. Kappos (Fed. Cir. 2010)

    By Andrew Williams --

Last month, in Photocure ASA v. Kappos, the Federal Circuit affirmed the decision by the U.S. District Court for the Eastern District of Virginia that methyl aminolevulinate hydrochloride ("MAL hydrochloride"), brand name Metvixia®, is entitled to patent term extension pursuant to 35 U.S.C. § 156.  Metvixia® was approved by the FDA for use in photochemistry or photodynamic therapy to treat actinic keratoses -- precancerous cell growths on the skin.  MAL hydrochloride is the methyl ester of aminolevulinic acid hydrochloride ("ALA hydrochloride").  However, MAL hydrochloride received patent protection (U.S. Patent No. 6,034,267 ("the '267 patent")), in part because the patentees demonstrated its improved therapeutic properties as compared to ALA hydrochloride.  In addition, even though the FDA had previously approved ALA hydrochloride for the same use, MAL hydrochloride was considered a "new drug," and therefore required full FDA approval.

After receiving FDA approval of MAL hydrochloride, Photocure applied for patent term extension of the '267 patent pursuant to 35 U.S.C. § 156(a).  In pertinent part, the statue reads:

35 U.S.C. §156(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section . . . , if--

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    (a)(4) the product has been subject to a regulatory review period before its commercial marketing or use;
    (a)(5)(A) except as provided in subparagraph (B) or (C) [not here relevant], the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred . . .  .

The FDA pointed out that the MAL hydrochloride is an ester of ALA hydrochloride, and proposed that 35 U.S.C. § 156(a)(5)(A) was not met.  The PTO, in turn, denied the requested term extension on the basis that the two molecules are the same product, because the underlying molecule (ALA) is the same.  Therefore, according to the Patent Office, the molecule was simply formulated differently in the two drugs.  And, because the "product" had previously been approved by the FDA, the '267 patent, claiming MAL hydrochloride, was not entitled to patent term extension.

35 U.S.C. § 156 further defines "product" as:

§156(f) For purposes of this section:
    (1) The term "product" means:
        (A) A drug product.

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    (2) The term "drug product" means the active ingredient of—
        (A) a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), . . . including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.

(emphasis added).  Therefore, to understand what "products" are eligible for patent term extension, it is useful to look at 35 U.S.C. § 156(a)(5)(A) with the definition substituted for the term "product":

35 U.S.C. §156(a)(5)(A): except as provided in subparagraph (B) or (C) [not here relevant], the permission for the commercial marketing or use of the [new drug, including any salt or ester of the active ingredient,] after such regulatory review period is the first permitted commercial marketing or use of the [new drug, including any salt or ester of the active ingredient,] under the provision of law under which such regulatory review period occurred . . . .

The Patent Office interpreted "active ingredient" to mean "active moiety" -- in this case, the same underlying molecule ALA.  Therefore, because MAL hydrochloride is an ester of an active ingredient/moiety that had already been approved, it was not entitled to the patent term extension provisions of § 156.

The Federal Circuit rejected this interpretation, stating that the statute is unambiguous.  The Federal Circuit found that the active ingredient was MAL, and because ALA hydrochloride is not a salt or ester of MAL hydrochloride, the '267 patent coving MAL hydrochloride was entitled to term extension.  In truth, however, MAL hydrochloride is the ester of ALA hydrochloride.  Nevertheless, this decision was not entirely surprising, because in 1990, the Federal Circuit had an almost identical case in Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392 (Fed. Cir. 1990).

Interestingly, even though the Federal Circuit relied entirely on statutory interpretation, the Court appeared persuaded by the fact that MAL hydrochloride was both separately patentable and required separate regulatory approval.  Of course, in these cases, the second approved drug is always going to be separately patentable -- otherwise there will be no patent whose term would need to be extended.  So, how important was the fact that separate regulatory approval was required.  It is perhaps telling to analyze this case from the hypothetical situation where the ester was instead the first approved product.  For example, using the present case, if MAL hydrochloride had first obtained FDA approval, could Photocure have obtained patent term extension for claims to ALA hydrochloride upon FDA approval?  Applying the calculus of the Photocure case, the second active ingredient would be ALA.  MAL hydrochloride is an ester of ALA hydrochloride.  Therefore, substituting these terms into 35 U.S.C § 156 (in pertinent part):

The term of a patent . . . shall be extended . . . if . . . the permission for the commercial marketing or use of ALA hydrochloride, including MAL hydrochloride (the ester of ALA hydrochloride) . . . is the first permitted commercial marketing or use of ALA hydrochloride, including MAL hydrochloride (the ester of ALA hydrochloride) . . .  .

And because, according to this hypothetical, MAL hydrochloride had already been approved by the FDA, no patent covering ALA hydrochloride would be entitled to patent term extension.  In other words, in the present case, the '267 patent was entitled to term extension because ALA hydrochloride is not an ester of MAL hydrochloride, but, in reverse situation, MAL hydrochloride is an ester of ALA hydrochloride, and therefore the patent would not be entitled to term extension.  It would logically appear from this decision that no one should be able to obtain term extension for a patent covering a drug product if the ester of that drug product had been approved first.  And, this should be true even if separate regulatory review was required for the second product.

Of course, it is not entirely clear that this makes sense.  Nor is it clear that the Federal Circuit would actually arrive at such a conclusion because it is unclear if they would ignore the fact that such a drug underwent separate regulatory approval.  One possible out would be if the active ingredient in the hypothetical was determined to be ALA, not ALA hydrochloride.  Thus, MAL hydrochloride would be the ester and the salt of the active ingredient.  The statute clearly reads "ester or salt," so the patent would be eligible for term extension.  Still, it will be interesting to see what happens if, and/or when, such a situation occurs.

Photocure ASA v. Kappos (Fed. Cir. 2010)
Panel: Circuit Judges Newman, Rader, and Linn
Opinion by Circuit Judge Newman

Comments

[EG]

Andrew,

Very interesting. What I find somewhat surprising is that the later Ortho-McNeil Pharm v. Lupin Pharm case doesn't cite Photocure even though Judge Newman authored both opinions. Photocure seems to raise similar issue to that decided in Ortho-McNeil, namely what is the "active ingredient" in the drug for which patent term extension is being sought.

[Andrew Williams]

EG,

Good point. Obviously Ortho-McNeil and Photocure are consistent with each other, and in fact Ortho-McNeil supports the position that what is important for determine whether something is a "new drug" is the requirement for separate patentability and separate regulatory approval. In the end, I worry that the Federal Circuit may have gotten themselves into a logical trap with Photocure that they will need distinguish (or ignore) the next time this issue comes up. Thanks for your comment.

Andrew

[Joe]

More interesting: How will/should Photocure and the Court's application and interpretation of 156(a)/156(f) influence its application of 156(b) After all, the same statutory term 'product' is employed in both subsections, suggesting that Congress meant to link the scope of rights provisions with and the availability of the PTE.

[6]

They shouldn't be too worried about taking on Kappos and company. He obviously just rolls over everytime someone files against him.

[Kevin E. Noonan]

Hm . . . the PTO accepts the FDA's position, argues and loses in the District Court, and then appeals (and loses again) before the Federal Circuit.

What wouldn't constitute "rolling over" for you, 6? Do you think the Office should file a petition for cert?