A Blog About Intellectual Property Litigation and the District of Delaware


CJB
The Honorable Christopher J. Burke

Is There No Safe Harbor

Nathan R. Hoeschen, Jan. 7, 2021
Safe Harbor

Honestly, it's not a very safe harbor
Honestly, it's not a very safe harbor Youngje Park, Unsplash

Judge Burke faced an interesting hypothetical last week regarding the rarely invoked safe harbor provision of 35 U.S.C. § 271(e)(1). For those unfamiliar, the safe harbor provision provides that:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

The Sole Use Question

The issue in Wilson Wolf Manufacturing Corp. v. Sarepta Therapeutics, Inc., C.A. No. 19-2316-RGA-CJB, …

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Don't Push the Limit on Notices of Subsequent Authority

David M. Fry, Dec. 16, 2020
Subsequent Authority

Speed Limit
Joshua Hoehne, Unsplash

We've all been there: Your motion is fully briefed, you're waiting for a decision, and some new piece of information comes to light. You really want to get it in front of the judge before your motion is decided—what are your options?

In D. Del., not much. Local Rule 7.1.2(b) sets a default schedule for opening, responsive, and reply briefs, and provides that "[e]xcept for the citation of subsequent authorities, no additional papers shall be filed absent Court approval." The text is clear—if your filing isn't a notice of subsequent authority, you need the court's leave to file it.

In practice, however, notices of subsequent authority often lead to an extended back-and-forth between the parties—argumentative notices lead to responses, which lead to replies, which lead to sur-replies. Before you know it, the judge has a stack of mini-briefs to read.

In a recent R&R, Judge Burke issued a stern footnote admonishing the parties for this practice (and striking the offending filings) ...

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We Three Agree — Me, Myself, and I (Or: Court Strikes Expert's Opinion That Secretly Relied On His Own Anonymous Writing)

Emily S. DiBenedetto, Nov. 19, 2020
Rule 37 Sanctions

Mirrored
Mirrored Alex Iby, Unsplash

Last month, Judge Burke struck "a substantial portion" of an expert's infringement report after the expert relied on his own anonymous peer review to prove infringement, without disclosing that he had been the author.

The truth did not come out until the deposition.

The Expert Secretly Relied On His Own Prior Anonymous Writing

Plaintiffs in this action allege infringement only via the doctrine of equivalents, arguing that the differences between the accused drug and the claimed drug are insubstantial. Defendant argues that the differences are substantial, relying in part on a 2016 article showing that the accused drug performs significantly better than the claimed drug.

Plaintiffs' expert reports criticized the 2016 article based on two …

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Discovery Motions, Like Chocolate, Should Not be Kept in Your Back Pocket

Nathan R. Hoeschen, Oct. 29, 2020
Motion to Strike Discovery Dispute

You really have to use it soon
Brown Chocolate, Kaffee Meister, Unsplash

More often than not, when the Court has a hearing on discovery disputes, both sides bring competing issues. No one likes to be totally on defense for an entire hearing, and even bringing a marginal dispute allows you to undermine the opposing party by pointing out their own wrongdoing. And of course, there's always the chance that you'll win.

Judge Burke showed the limits of this calculus earlier this week—it only works if you convince the Court you've got a real dispute. And It's very hard to do that if you admit that you wouldn't have filed your motion if the other side hadn't moved first.

That's what plaintiff did in in …

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If You Do Not Plead Indirect Infringement, You Cannot Argue It (Without Amending)

Andrew E. Russell, Oct. 14, 2020
FRCP 15 Final Infringement Contentions

Judge Burke granted a motion to strike yesterday where the plaintiff attempted to add indirect infringement allegations in final infringement contentions, but had not pled them in the complaint.

Per Judge Burke:

It is undisputed that Plaintiffs have never pleaded indirect infringement of these patents, (D.I. 170 at 1), and so any portion of their [final contentions] that relate to that subject matter are simply about infringement claims that are not a part of this case.

He also preemptively denied any future request to amend the complaint as coming too late:

Although they have not filed a formal motion seeking to amend their currently operative complaint to include such [indirect infringement] claims, to the extent Plaintiffs suggest they would …
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Substantial Completion Is Really More of a State of Mind

Nathan R. Hoeschen, Oct. 8, 2020
Substantial Completion Sanctions

Typical small production of recent unimportant documents served after substantial completion deadline
Typical small production of recent unimportant documents served after substantial completion deadline Can you find the book you need?, Carles Rabada, Unsplash

"Substantial completion of document production" is not exactly a bright line.

Is it more than half?

More than 90%?

At least in Delaware, cases interpreting the issue are light on the ground. Usually, when presented with a steaming pile of documents after the substantial completion deadline, the parties will work out some modest schedule extension without any court intervention. This is probably for the best, but it means that the parties are usually working from a blank slate when negotiating the necessity and length of any extension.

Luckily for us, Judge Burke issued an Oral Order …

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Court Permits Deposition Questions on Litigation Financing Arrangements

Andrew E. Russell, Oct. 5, 2020
Depositions MTC

I thought this was interesting. Last week Judge Burke granted a motion to compel a plaintiff's witness to respond on questions about the plaintiff's litigation financing arrangements.

Apparently plaintiff's attorneys instructed the witness not to answer at the deposition, but in the discovery dispute they only argued that the information is irrelevant, and did not raise privilege. Since relevance is not a valid justification for an instruction not to answer under FRCP 30, the Court permitted defendant to re-ask the question and held that plaintiff's witness must answer.

About Those Redacted Versions

I say plaintiff "apparently" objected only on reasonableness grounds because plaintiff never filed the redacted version of its sealed letter brief—a common problem.

If parties continue …

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Court: Document Production Two Months Before Trial Sufficient to Avoid Prejudice

Andrew E. Russell, Sept. 14, 2020
Motion to Strike Pennypack

In the holding below, Judge Burke found that, under Pennypack, producing documents just over two months before trial was sufficient to provide time for "Defendants to be able to appropriately respond to Plaintiffs' expert's related position."

This is a shorter timeline than typically comes up. For example, Judge Burke has previously struck late-produced material where there were six months remaining before trial, although in that case the other Pennypack factors also played a role.

The facts here were not terrible for defendants. The documents had been produced by individual defendants in a set of related cases. According to the plaintiff, the expert reports at issue used the documents from various defendants to respond to arguments from those defendants, although …

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New Standard for Striking a Theory from a Rebuttal Expert Report

Andrew E. Russell, Sept. 4, 2020
Pennypack Discovery

Stop Sign
Luke van Zyl, Unsplash

This week, Judge Burke issued an interesting oral order on a discovery dispute about the admissibility of "new" expert opinions in rebuttal reports.

In the order, he sets forth a simple baseline test for what a party has to show to strike purportedly "new" expert opinions in a rebuttal report. To succeed in striking a "new" theory, a party must show at least:

(a) how they clearly disclosed that theory well before final . . . contentions were due . . . ; (b) how the same theory was thereafter found in their opening expert reports . . . ; and (c) how [the opposing party] never provided any substantive response to that theory until …
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Judge Burke: Don't Just Say You're Burdened—Prove It

David M. Fry, Sept. 2, 2020
Discovery Dispute

Burden
Simon Migaj, Unsplash

Yesterday, Judge Burke ordered a plaintiff to collect documents from an additional custodian beyond the limit agreed to by the parties. But he also gave the plaintiff a road map for how they might have won with a little extra effort.

Judge Burke acknowledged that "the parties are not large companies, and that cost and burden were a factor in the parties' agreement to [a] seven-custodian limit in the first place."

But Plaintiff could have provided the Court with a record ... to help the Court conclude that the collection, search, review and production of [the custodian's] documents would be unduly burdensome or costly, or that it would be disproportionate to either the amount in controversy or …
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