A Blog About Intellectual Property Litigation and the District of Delaware


Entries for tag: ANDA

Four
David Pisnoy, Unsplash

On Friday, Chief Judge Connolly issued an order in the lead-up to an ANDA bench trial compelling the plaintiff to reduce its number of asserted claims by 75% to 4 claims, or face consequences:

ORAL ORDER: WHEREAS, the parties filed the proposed pretrial order (D.I. 225) on May 10, 2022; WHEREAS, the bench trial in this case is 24 days away, and, according to the pretrial order, Plaintiffs are still asserting 15 claims across eight patents . . . ; and WHEREAS, Plaintiffs' assertion of 15 claims across eight patents at this juncture makes clear that Plaintiffs have yet to focus adequately on the relative strength of their various infringement claims, the limited resources of …

Delaware Memorial Bridge
Chintan Jani, Unsplash

Observant readers will have noticed that the new scheduling orders Chief Judge Connolly unveiled last week were specifically for non-Hatch-Waxman cases, and perhaps deduced that further orders for ANDA cases would be forthcoming. Well, the wait is over.

The new Hatch-Waxman case order, released yesterday, contains many of the same updates as the orders from last week, including a procedure for ranking Daubert motions, the tweaks to claim construction procedures, and the requirement for colored covers on courtesy copies. All to be expected given the changes last week.

Early Case Narrowing

The big change was that the new scheduling order includes a staged procedure for narrowing asserted claims and prior art. The first such stage begins just 7 days after the scheduling conference:

No later than seven days after the date of this Order, Plaintiff(s) shall serve Defendant(s) with a "Preliminary Disclosure of Asserted Claims" that lists each claim of each patent alleged to be infringed by Defendant(s), including for each claim the applicable statutory subsections of 35 U.S.C. § 271 asserted. Unless otherwise agreed to by the parties, Plaintiff(s) may assert no more than ...

Standing Stones
Andreas Brunn, Unsplash

Today, Judge Connolly issued four new standing orders. These orders include:

  1. A requirement to disclose third-party litigation funding arrangements on the docket;
  2. A requirement in diversity cases to disclose the name and citizenship of every individual and corporation with a direct or indirect interest in every party;
  3. An order expanding disclosure requirements under Federal Rule of Civil Procedure 7.1 for non-governmental joint ventures, LLCs, partnerships, and LLPs;
  4. A requirement for the defendant in ANDA cases where there was a Paragraph IV certification to produce the ANDA when responding to the complaint;

The above are numbered only for reference below.

Each of these orders explicitly applies only in Chief Judge Connolly cases.

Order 1: Litigation …

On Tuesday, Judge Andrews issued what I believe is the first opinion in the district regarding "skinny labels" since the Federal Circuit issued its decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021).

As anyone immersed enough in patent law to read this blog will know, skinny labeling is the practice of excluding certain indications from the generic drug's label and associated inserts, so as to avoid inducing infringement of method of treatment patents listed in the orange book. In Amarin Pharma, Inc. et al v. Hikma Pharmaceuticals USA Inc., C.A. No. 20-1630-RGA, D.I. 97 (D. Del. Jan. 4, 2022), for instance, the branded drug was indicated for treatment of severe …

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Charting Goals and Progress, Isaac Smith, Unsplash

To give the reader a bit of a peak behind the curtain, it can sometimes be taxing to write 5 blog posts in a week. This is especially true on a week, like this one, where the Court issues fewer decisions than average. All of us at IP/DE have our own strategies for dealing with this -- my preferred method is to dig up some stats that I had always wondered about, but never bothered to figure out.

This week, my focus was on invalidity challenges in ANDA cases. In particular, what are the relative odds of invalidating a composition patent, vs. a method of treatment patent, vs. a formulation patent?

The …

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 . . …

Pills
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 …