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 ten claims of any one patent and no more than 32 claims in total against any one Defendant.
This early election of claims is possible, in part, because of Judge Connolly's new Standing Order requiring the defendant to produce their ANDA or NDA when answering the complaint.
30 days later, the defendant(s) serve their invalidity contentions (along with non-infringement contentions, another new development!) that:
identity of no more than 12 prior art references for any one patent and no more than 30 prior art references in total that Defendant(s) allege(s) anticipates each asserted claim or renders the claim obvious (the "Preliminary Disclosure of Asserted Prior Art").
Fitting with Judge Connolly's usual rule for contentions, these elections of asserted claims and prior art may only be modified upon a showing of good cause. Plaintiffs proceed to serve their formal infringement contentions after receiving the invalidity and noninfringement contentions
Practices in Foreign Lands
More worldly readers will note that this procedure—initial disclosure of claims by plaintiff followed by non-infringement and invalidity contentions from defendant, followed by infringement contentions from plaintiff—is similar to the ANDA rules in the District of New Jersey. I hesitate to speak to much to those procedures, given the frankly hurtful tone of the official New Jersey Twitter account. Ahem.
It should be noted however, that Judge Connolly's procedure diverges from the default New Jersey Rule in that it actually sets numerical limits on the number of claims and references that can be asserted. Hopefully this will cut down on the absolute deluge of disputes regarding claim narrowing.
More Narrowing!
Returning to sweet, sweet Delaware, the new order builds in another stage of narrowing after claim construction, with defendants narrowing first this time:
Unless otherwise agreed to by the parties, no later than 28 days after the Court issues a claim construction order, Defendant(s) shall serve on Plaintiff(s) a "Final Election of Asserted Prior Art" that reduces the number of prior art references that Defendant(s) allege(s) anticipates each asserted claim or renders the claim obvious. Defendant(s) shall identify in the Final Election of Asserted Prior Art no more than six prior art references for any one patent from among the 12 prior art references identified for that patent in the Preliminary Disclosure of Asserted Prior Art and shall identify no more than a total of 20 references from among the references identified in the Preliminary Disclosure of Asserted Prior Art. No later than 14 days after service of the Final Election of Asserted Prior Art, Plaintiff(s) shall serve on Defendant(s) a "Final Election of Asserted Claims" that shall identify for any one patent no more than five asserted claims from among the 10 claims identified for that patent in the Preliminary Disclosure of Asserted Claims and shall identify no more than a total of 16 claims from among the claims identified in the Preliminary Disclosure of Asserted Claims.
This schedule and number is broadly similar to what we've seen when the Court has narrowed cases in the past.
Still further Narrowing?!
In its penultimate paragraph, the order states simply that "The Court will limit the number of claims and prior art references asserted at trial." This has, of course, been the practice on the district for some time (given that that the average ANDA trial is only 3 or 4 days, it could hardly be otherwise), so it comes as no surprise to us at IP/DE.
It will be interesting to see if these new limits will be the end of disputes over narrowing, or if the battlefield will shift to ever more esoteric grounds. We live in interesting times.
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