by Dennis Crouch
Par Pharm., Inc. v. Eagle Pharm., Inc., No. 2021-2342, — F.4th — (Fed. Cir. Aug. 18, 2022)
In 2018, Eagle filed its Abbreviated New Drug Application (ANDA) with the FDA seeking to market a generic version of Par’s vasopressin injection product (Vasostrict) used for emergency blood pressure treatment. Par had listed two patents in the Orange Book as covering its product and so, as required, Eagle’s ANDA included a Paragraph IV certification that the two patents were either (1) invalid or (2) would not be infringed. 35 U.S.C. § 355(j)(2)(A)(vii)(IV).
In order to facilitate resolution of brand-generic patent conflict, the Patent Laws include a form of paper infringement–a legal fiction that simply filing an ANDA and Paragraph IV certification counts as a form of patent infringement. This gives the branded drug maker (here PAR) the ability to immediately sue to keep the generic off the market (if the patent turns out to be enforceable). But, these Hatch-Waxman lawsuits are considered a form of declaratory relief and no actual damages are available. This setup also means that these cases are not “Suits at common law” and so the Seventh Amendment right to a jury trial does not apply. Thus, ANDA patent lawsuits are ordinarily decided by bench trial–and typically by one of the Delaware district court judges. In patent law, injunctive relief has been difficult to obtain, but under the Hatch-Waxman law, the FDA will automatically delay any market approval by 30 months if the brand-patentee sued.
Vasopressin is a naturally occurring mammalian hormone and been generally known for decades. As its name suggests the chemical has always been known since its naming for its ability to constrict blood vessels — the same use that Par’s patents claim. Par’s two patents here cover a particular vasopressin composition (9,750,785) and a method of treatment using the composition (9,744,209).
Both Par patents include a pH requirement: “wherein the unit dosage form has a pH of 3.7-3.9.” In its ANDA, Eagle was careful to specify that its product would have a slightly different pH range: 3.4–3.6. Eagle then argued that this difference was enough to avoid infringement.
Despite its nominal specifications, Par presented evidence that (it claims) Eagle’s product pH would “drift up” while sitting on the shelf. It coupled that evidence with the very slight difference between Eagle’s product and Par’s patent to make the argument that Eagle’s product “would inevitably drift into Par’s claimed range.” Slip Op. The district court (Judge Connolly) held a three-day bench trial and ultimately issued a judgment of noninfringement. In particular, Judge Connolly concluded that the evidence failed to prove any upward drift of pH, but rather simply “minor fluctuations” without “any discernable trend.” Id. On appeal, the Federal Circuit has affirmed–seeing no “clear error” in the district court’s factual findings.
I mentioned above that this form of ANDA-filing infringement is a legal fiction created by Congress to facilitate a more competitive marketplace. One problem then is that there is no actual product to inspect. We have the ANDA filing, but there are always substantial design choices before final release. The prophetic inquiry thus looks to what is the “probable ANDA product” and asks whether that probable product would be infringing if actually made.
Still, the primary guide is the ANDA documents as the source of infringement in this highly regulated area. At times, a court can look to other relevant evidence, but only when the ANDA filing fails to “speak clearly and directly to the question of infringement.” Rather, the court assumes that the ANDA filer will “act in full compliance with its representations to the FDA.” In re Brimonidine Patent Litig., 643 F.3d 1366, 1378 (Fed. Cir. 2011).
Here, the ANDA documents are clear that the product does not infringe. The pH range in Eagle’s ANDA document is different than that claimed by Par. And, the ANDA filings also indicate that the pH range will remain stable throughout the shelf life of the product. Thus, the ANDA documents indicate no drift into Par’s protected space.
No Declaratory Judgment of Infringement. (Neither court decision discusses the doctrine of equivalents.)
I have not thought through all the claim preclusion issues. But, once the product is released Par may be precluded from suing again based upon res judicata and the Kessler Doctrine.
= = =
Judges: Moore, Prost, Hughes
Opinion by: Moore
Attorneys: Martin Black (Dechert) for the patentee Par along with Sharon Gagliardi, Brian Goldberg, Luke Reilly, Robert Rhoad, Daniel Roberts, and Jonathan Loeb. John O’Quinn (Kirkland) for Eagle along with Bill Burgess, Bryan Hales, Benjamin Lasky, and Jenna Wacker.
“35 U.S.C. § 355(j)(2)(A)(vii)(IV).” — don’t you mean 21 not 35? link to law.cornell.edu
It’s surprising why Par has not bring up the DOE element.
Hatch-Waxman lawsuits are… ordinarily decided by… one of the Delaware district court judges.
Just to be strictly accurate, Miller (2019) “Venue One Year After TC Heartland: An Early Empirical Assessment of the Major Changes in Patent Filing,” 52 Akron L.R. 763 shows that 40% of ANDA cases are brought in Delaware. In other words, there are more non-Delaware ANDA cases than there are Delaware ANDA cases, although Delaware is the largest single venue.
New Jersey is not far behind Delaware, at 30% of ANDA cases. IN, MD, NY, PA, and WV combine to account for the rest, with only a trivial number of ANDA suits occurring in other states each year.
Thanks!
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August 19, 2022 at 10:32 am
Two thought on the article itself:
1: “and typically by one of the Delaware district court judges.”
What? Where is all the umbrage for concentrating THESE types of cases into one district?
What’s that you say?
“injunctive relief has been difficult to obtain…
But, these Hatch-Waxman lawsuits are considered a form of declaratory relief and no actual damages are available”
Oh, so this appears for less favorable to certain types of patent owners…
No wonder the lack of “A L A R M !!!!!”
(in pieces)
2: “I have not thought through all the claim preclusion issues. But, once the product is released Par may be precluded from suing again based upon res judicata and the Kessler Doctrine.”
No.
Clearly.
IF the actual product infringes then necessarily that product is not the same product that the current suit was brought against.
Not only that, but I can easily see the generic ‘being in trouble” for NOT following through on the very a s sumption you mention (the FDA a s suming that the generic ACTUAL product will be per the ANDA process.
You speak of the surety that a trace of what was done can easily be captured. That’s not as easy as tracking what came and went. What still remains, and why it does. Why a Judge claims he retired but goes back to lawyer. That anyone would see is Prima fascie evidence of a lie.. And then in order to protect himself from harm that even the BOPR can’t hold back,He retires. Why even His backstop retired when there were crumbs that even HE couldn’t explain. But now the reel that carried my SeaSaddle you jus
n’t like fingerprints at a crime, be erased
Two thought on the article itself:
1: “and typically by one of the Delaware district court judges.”
What? Where is all the umbrage for concentrating THESE types of cases into one district?
What’s that you say?
“injunctive relief has been difficult to obtain…
But, these Hatch-Waxman lawsuits are considered a form of declaratory relief and no actual damages are available”
Oh, so this appears for less favorable to certain types of patent owners…
No wonder the lack of “ALARM!!!!!”
2: “I have not thought through all the claim preclusion issues. But, once the product is released Par may be precluded from suing again based upon res judicata and the Kessler Doctrine.”
No.
Clearly.
IF the actual product infringes then necessarily that product is not the same product that the current suit was brought against.
Not only that, but I can easily see the generic ‘being in trouble” for NOT following through on the very assumption you mention (the FDA assuming that the generic ACTUAL product will be per the ANDA process.
Greg, since this subject obviously not within the expertise of most patent attorneys, please review for accuracy this simplified text:
“Generic drugs are chemical and therapeutic equivalents of FDA approved name-brand drugs. Generic drugs are FDA approved to be marketed by the much simpler and faster Abbreviated New Drug Application (ANDA) process. For a pharmaceutical company to gain approval for a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. They normally must have the same dosage, safety, effectiveness, strength, stability, and quality. As of 2012, 80% of all FDA approved drugs are available in generic form.”
As Dennis notes, all patents on the originally FDA approved drug must be listed in the public “Orange Book.” If any, that requires the ANDA application for the generic to additionally include a Paragraph IV certification that the two patents were either (1) invalid or (2) would not be infringed. 35 U.S.C. § 355(j)(2)(A)(vii)(IV). The ANDA applicant may be immediately sued for patent infringement to prevent FTC approval, but if that ANDA applicant wins they are rewarded with a term of generic exclusivity.” [And see Comment 3 below.]
Par should have had samples on stability and also samples used in their pK study. Unless destroyed, samples of Par’s actual product should have been made available to Eagle.
If Congress was really serious about lowering billions in drug costs, would not the statute require generic drug manufacturer ANDA drug patent challenges be decided on a fast-track basis? [noting that this one already took 4 years]
If Congress were really serious about lowering drug costs, it would not bother with adjusting patent law. Every other peer jurisdiction has lower drug costs than ours, but none of them have any material differences in their patent laws that anyone seriously lists as the cause of the price difference. It is not patent law that is driving the cost difference, so fiddling with patent law as a means toward lowering drug prices is like looking for your keys under the street lamp because that is where the light is better.
I have to agree with Greg here.
For MANY issues (especially of the “0h N0es Tr011s” propaganda variety), messing with patent law is exactly the wrong answer.
+1
Off topic – but worth celebrating: after just over a year, there is life on the Ethics side of the blog.
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