Will this Limit on Patent Term Extension Drive a Rewriting of Hatch-Waxman?

The court today denied two en banc petitions:

Biogen International GmbH v. Banner Life Sciences LLC, 20-1373 (Fed. Cir. 2020)

The law allows for a limited extension of patent term based upon regulatory delays – such as FDA delay in approving a drug for sale.  The statute is unfortunately complex and poorly written. 35 U.S.C. 156.

In this case, Biogen received a patent term extension for its Patent US7619001 associated with using the drug Tecfidera (MS treatment). By the time of the litigation, the patent would have expired, but for the term extension.

Banner’s proposed version of the drug is a bit different than Biogen’s Tecfidera — although apparently bioequivalent. The court included the following diagram showing the differences with the Biogen’s version is DMF and Banner’s is MMF (both versions were covered by the asserted claim):

In the case, the Federal Circuit held that the term extension did not apply in this situation.  The court limited limiting PTE to only situations where the same drug (active ingredient) is being accused of infringement, even if the alternative is covered by the patent claims and includes the same active portion.  The court wrote:

Because the scope of a patent term extension under 35 U.S.C. § 156 only includes the active ingredient of an approved product, or an ester or salt of that active ingredient, and the product at issue does not fall within one of those categories, we affirm the judgment of the district court.

In its petition for rehearing, Biogen asked two questions:

  1. Whether the panel’s decision allows an infringer to avoid an innovator’s patent term extension by using the claimed and bioequivalent active moiety of the compound in the patentee’s approved drug product.
  2. Whether patent term extension under 35 U.S.C. § 156(b)(2) for method claims is limited to the “approved product” only, where the only limit that Congress imposed on patent term extension for method claims is “any use claimed by the patent and approved for the product,” and Congress further provided that “[a]s used in this subsection, the term ‘product’ includes an approved product” (i.e., is not “limited” to an approved product). 35 U.S.C. § 156(b) (emphases added).

PhRMA also filed an en banc petition in support. The PhRMA brief argues that this decision will allow generic companies skirt the Hatch-Waxman generic-innovator compromise. In particular, generic companies will be able to rely upon innovator data to gain market entry since the active portion of the drug product is the same, while not being subject to the term extension.

The Federal Circuit has denied the en banc petition without further opinion.

[BiogenCAFCDecision] [Discussion by Kevin Noonan]
[Biogen en banc petition] [Biogen PhRMA Amicus]

= = = = =

Dragon Intellectual Property v. DISH Network LLC, 19-1283 (Fed. Cir. 2020).

This is a common setup: Patentee sues for infringement; Defendant collaterally attacks patent via IPR and claims are cancelled; District court then dismisses case as moot – void ab initio. The petition questions whether the defendant can be considered a “prevailing party” for attorney fees in such a situation. “When, if ever, can a litigant be deemed the ‘prevailing party’ in a case terminated as a result of mootness?”

In the case, the district court found no prevailing party in this situation. On appeal, the Federal Circuit rejected that approach – holding that the defendant could be considered a prevailing party because it rebuffed the claims.  The Federal Circuit has now denied the en banc petition — meaning that its rule sticks.

DragonIP en banc petition



28 thoughts on “Will this Limit on Patent Term Extension Drive a Rewriting of Hatch-Waxman?

  1. 3

    The Dragon IP “nah, we are not going to bother with your arguments” is a bit surprising given the simple and direct brief.

  2. 2

    Haven’t read the briefs: Did Biogen argue (pre-patent-expire?) DoE?

    If not, could they (possibly) have prevailed on such an arg?

    1. 2.1

      They did not argue the DOE. There has never been a case where the DOE has been used with respect to a patent term extension, nor it is clear that such an argument would work. To the best of my knowledge (freely admitted that it’s not perfect), the DOE applies only in situations that necessitate the interpretation of a patent, such as infringement allegations and (rarely) during prosecution. I don’t know if the FDA could make such a decision, or even if they have the authority to suggest they are equivalent. The approved drug is what gets taken by the patient; how it metabolizes in vivo is another question entirely.

    2. 2.2

      As I understood this situation, direct infringement of generic claims of the patent was not in dispute, but the drug species for which FDA approval was obtained by the patent owner was not that of the defendant, and the terms of the patent extension provision of this statute are not based on patent infringement. [Dvan can correct this if not.]

      1. 2.2.1

        This specific case was only about the patent term for this specific patent and whether or not the asserted patent was eligible for a patent term extension under 35 USC 156 (not patent term adjustment under 35 USC 154). There are other cases that address infringement issues. So you are correct in that the patent term extension is not based on any allegations of infringement. They are entirely separate and usually decided long before any possible infringement occurs. Whether or not infringement occurs obvious requires (at the minimum) a valid patent whose term has not yet expired. That is what this case was specifically about – when did the patent at issue expire. Unfortunately, that’s not always a simple question.

        This particular case is unusual because one compound (DMF) metabolizes almost instantly into the active compound (MMF) after a patient takes it, but it is DMF that received FDA approval. The best comparison is that of a pro-drug that metabolizes into the drug after being taken by a patient. There is debate in pharma circles as to how the PTE issue could apply because it is often possible to make many different pro-drugs of the same drug molecule. Does the PTE attach to the drug or the pro-drug? As you would expect, it divides between the branded and generic manufacturers. Based on this case, the PTE attaches to the pro-drug which is what is physically in the (for example) tablet or capsule the patient takes.


          Only slightly pedantic, but would not the transformation from pro-drug to ANY drug (by way of action of the human body) BE the epitome of “Law of Nature?”


            That may or may not fit (and it’s been debated more than once), but in this instance the actual transformation from pro-drug to drug was not in the claims of the patent at issue.

            As for being a law of nature, in virtually every case, the pro-drug itself is not something found in nature. The argument then follows that it’s not a law of nature (or it adds something more) when you take something that does not occur in nature and subject it to natural conditions. The something more part is based on the non-naturally occurring pro-drug. On the other side of the issue, the way a body transforms the pro-drug into the active drug occurs in nature. It comes down to the scope of the claims, because in most cases, the transformation (the part that could potentially fall under the law of nature) is not included in the claim language.


              The ‘actual transformation not in the claims’ is not the only aspect, as lacking that final transformation, the claims (as is) lack utility under 101.

      2. 2.2.2

        Paul, think of it this way: when a PTE is granted, does that extend the term of ALL of the claims of the patent, each claim across its entire scope? Or does the PTE only extend the term of those claims that cover the specific product for which the patentee received FDA approval, and only extend them with respect to that specific product? The CAFC said the latter.

        Meanwhile, on the other side of the island, FDA law says that a generic drug manufacturer need not make the exact same product, but may make a product that is slightly different, as long as the generic drug manufacturer can show that its product is bioequivalent to the innovator’s approved product.

        In the present case, the generic manufacturer used a slightly different active ingredient, but the generic product was bioequivalent to the innovator/patentee’s product. So under the rule announced by the CAFC, what Banner (the generic drug company) did doesn’t constitute infringement of the PTE.

        Does it make sense now?



          Not sure if this is pertinent, but wouldn’t ‘bio-equivalence’ scream out ‘doctrine of equivalence’ (hence the several comments on DOE)…?


              Linguistically that makes sense, except that both are terms of art with specific legal definitions that do not resemble each other. The difference is like the words “there”, “their”, and “they’re”. They may all sound alike, but that does not reflect their actual meaning.

                1. Evidently not. Every generic drug maker asserts—as a predicate to filing their Abbreviated New Drug Application—that their generic is “bioequivalent” to the patentee’s drug. In other words, the accused infringer always arrives at the lawsuit having stipulated to this sort of “equivalence.” If juries routinely conflated bioequivalence with “doctrine of”-type equivalence, then juries would almost always find for the patentee in generic drug suits.

                  The fact that actual generic drug suits are a very mixed-bag (sometimes the generic win, sometimes the patentee wins) indicates that juries do not routinely conflate these two, legally distinct categories of “equivalent.”

                2. Greg at . . . : Thanks, did (any of) the patentees actually argue DoE; such that the juries were actually faced with such conflation?

                  Have you ever known / heard of a drug-maker patentee to argue DoE against a generic? (I’m not a pharma guy)

                  ’cause if DoE is never argued . . . conflation is not possible.

                3. What Greg does NOT share is that in almost every instance the generic is ‘admitting’ to infringement and when they win (in that ‘mixed bag’) it is often for other reasons (like showing patent invalidity).

                4. Have you ever known / heard of a drug-maker patentee to argue DoE against a generic? (I’m not a pharma guy)

                  Sure. Pharma patentees assert DoE about as often as non-pharma patentees, and they win on DoE grounds about as often as non-pharma patentees (i.e., not all that often).

    3. 2.3

      Thanks for the info and thoughts everyone.

      So now I’m wondering (assuming for a moment that the patent is not expired) wouldn’t the fact that the generic is bioequivalent (as admitted by Banner) mean that Biogen could use the DoE to keep the generic off the market?

      If it has the same effect/s in the body . . . isn’t bioequivalence . . . equivalence?

  3. 1

    The title asks; “Will this Limit on Patent Term Extension Drive a Rewriting of Hatch-Waxman?”
    In this case, that would appear to be a rewriting with the effect of keeping off the market for several more years potentially lower cost, and differently FDA approved, generic drugs for the same patients. The realistic [and self-answering?] question is thus: how appealing will that kind of legislation be to the next Congress to enact?

    1. 1.2

      P.S. Can someone please point out the asserted “bioequivalent” factor in the Hatch-Waxman legislation?

      1. 1.2.1

        This might be what you’re asking about:

        21 USC 355(j)(2)(A) An abbreviated application for a new drug shall contain…(iv) information to show that the new drug is bioequivalent to the listed drug referred to in clause (i)…

      2. 1.2.2

        There is a reasonably good definition of “bioequivalent” in the same section of the statute too.


            But does not an admission of “bioequivalent” coupled with the use of that term in that same statue for “An abbreviated application for a NEW drug..” [emphasis supplied] go against getting a term extension for delayed FDA approval of the “same product.”?



              Is your ‘same’ exactly the same or (in the patent sense), merely ‘equally’ (as in equivalence) the same?

              “Same” as in ‘same product’ is not clearly ‘exactly,’ and isn’t that the question to be answered?

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