A Blog About Intellectual Property Litigation and the District of Delaware


Entries for tag: anda

In a post-trial Hatch-Waxman opinion issued this week, Chief Judge Connolly sided with the defendant regarding the sole infringement dispute: whether the defendant's ANDA product had an infringing pH. The plaintiffs' patents required that the claimed compositions have a pH of between 3.7 and 3.9. The defendant's ANDA undisputedly required that the defendant's generic product have a pH between 3.4 and 3.6. Importantly, the ANDA required that the product stay within the 3.4-3.6 range both upon release and during the stability testing period (24 months).

Given that the ANDA's requirements are binding on the manufacturer of the generic product, and given that the ANDA is the operative document for the purposes of the infringement inquiry in Hatch-Waxman cases, you might think that would be the end of the inquiry. Indeed, Judge Connolly noted that in these circumstances, a judgment of noninfringement "must necessarily ensue."

However, the plaintiffs challenged this conclusion...

ANDA litigation can be an odd beast. You file a case based on a product that a defendant has only applied to manufacture—what then, when the FDA requires an amendment? What of the litigation that may be years in the making and heading into the home stretch?

The somewhat tortured history of Biodelivery Sciences International, Inc. et al. v. Chemo Research, S.L., C.A. No. 19-444-CFC-CJB, gives us several examples of exactly how the Court deals with this situation.

An Early Change to an ANDA Does Not Warrant a New Trial Date

Early on in that case (about 6 months after the scheduling order was entered) one of the defendants—Chemo—received a complete response letter ("CRL") from the FDA requiring them …

Pills
Christina Victoria Craft, Unsplash

Magistrate Judge Hall issued an R&R today recommending that the Court deny a motion to dismiss an inducement claim against a health insurer relating to a method-of-use claim for a generic drug.

The complaint alleges that, despite knowing that the plaintiff had a method-of-use claim for a specific treatment, the insurer nonetheless covered the patented treatment at a lower cost to patients than treatment with the name-brand drug:

The thrust of the allegations against [the insurer] Health Net are (1) that it provides coverage and payment for [co-defendant] Hikma’s generic product even in cases where Health Net actually knows that a particular beneficiary is using the generic version for an unapproved—and allegedly infringing . . …

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HalGatewood.com, Unsplash

Judge Hall today issued an R&R on attorneys fees in In Re Kerydin (Tavaborole) Topical Solution 5% Patent Litigation, MDL No. 19-md-2884-RGA (D. Del. June 23, 2021), an ANDA case.

There, the plaintiff filed suit on four patents even though the PTAB had previously found an earlier patent in the family invalid in an IPR, and even though IPRs were pending on each of the four patents-in-suit.

Filing suit triggered the 30-month stay of FDA approval. Shortly after the suit was filed, one of the defendants moved to stay; plaintiff did not oppose, and actually filed a cross-motion to stay its own action against the other defendants (who opposed).

The Court granted the …

Earlier today, Judge Burke unsealed an interesting order addressing the applicability of the common-interest doctrine to communications between a generic pharmaceutical company and its API manufacturer.

No attorneys directly participated in most of the underlying communications, but the defendants argued that they shared "a common legal interest" with their API manufacturer in avoiding a lawsuit "and that their communications furthered that interest." Although Judge Burke found that this "argument has some initial, superficial appeal[,]" in that "the subject of these communications is in some sense legal in nature[,]" he concluded that any shared legal interest came too late:

when one contextualizes the communications with regard to what was happening in the relevant time period, Defendants have not met …

Pigs
Kenneth Schipper Vera, Unsplash

Judge Andrews recently rejected the requests of several defendants in a Hatch-Waxman (or "ANDA") case to file an early motion for summary judgment, calling the request a "pig in a poke."

Judge Andrews, like most judges in this District, does not as a matter of course permit dispositive motions in ANDA cases or early dispositive motions in general. Nonetheless, two defendants in Astrazeneca AB v. Alembic Pharms. Ltd., C.A. No. 20-202-RGA, sought leave to file an early motion for summary judgment of no infringement under the doctrine of equivalents (plaintiff's only infringement theory).

Judge Andrews made short work of the request, first noting that the

defendants do not make a …

Somewhere between the filing of the pretrial order and the pretrial conference, Judge Stark typically issues an order resolving pretrial disputes and allocating trial time. These orders - while usually short - provide a wealth of insight into his trial practices and preferences, and (often) his views on substantive evidentiary issues. They also serve to remind litigants of longstanding trial management practices (including those codified in his form pretrial order).

On Friday, Judge Stark issued a 3-page pretrial memorandum order in a set of consolidated Hatch-Waxman ("ANDA") actions, Silvergate Pharmaceuticals, Inc. v. Bionpharma, Inc. et al., C.A. Nos. 18-1962, 19-1067, 19-678. The order contained decisions on sealing the courtroom during the bench trial, obviousness proofs, disclosure of exhibits to be used on cross examination, and others.

Trials in ANDA cases (also known as Hatch-Waxman cases) are usually very efficient matters. There is no jury, and the judges, lawyers, and witnesses that regularly try and participate in ANDA cases are well-practiced at maximizing the amount of evidence presented in each trial day (even where the issues are quite complicated and the parties numerous). So ANDA trials are often short, sometimes just a few days from start to finish.

Occasionally, however, even ANDA cases are too complicated to fit into a one-week-or-less trial. For example, Judge Stark recently stated that he may allocate up to 25 hours per side in an ANDA case set to go to trial later this week.

Judge Stark today dismissed an ANDA claim after the defendant converted their ANDA in such a way that it simply did not infringe, and plaintiff was left with no claim and no remedy.

What Is an ANDA? (The Short Short Version)

ANDA cases make up a fair portion of the Court's docket. If you're not already familiar, ANDA cases are brought by patent holders after a drug manufacturer files an ANDA seeking approval to manufacture a generic version of a drug.

As part of the ANDA, if there are unexpired patents listed with the FDA as covering the drug, the manufacturer may certify either that the patents are invalid, unenforceable, or won't be infringed (paragraph IV), or …

Pill Bottle
Sharon McCutcheon, Unsplash

Judge Andrews today granted a rare Rule 12(c) motion in an ANDA action, entering judgment against the plaintiffs on their inducement claim based on the pleadings alone.

The method claim at issue requires administering a drug "from about 3 hours to about 1 hour" before a colonoscopy.

The accused product's label includes instructions to administer the drug "start[ing] approximately 5 hours prior to [a] colonoscopy," and then to "drink at least three 8-ounce cups . . . of clear liquids . . . at least 2 hours before" the procedure.

Judge Andrews held that those allegations—even if true—cannot show inducement of infringement, even if in practice some amount of infringement would occur. …