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Replies to #94789 on Biotech Values
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DewDiligence

04/26/10 6:18 PM

#94791 RE: iOwnSomeBio #94789

Fortunately for MNTA, the Lovenox patent case can’t be re-litigated based on a change in the standards for inequitable conduct. SNY already appealed its case to the US Supreme Court and, last time I checked, that was the highest court in the land.
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north40000

04/27/10 10:36 AM

#94812 RE: iOwnSomeBio #94789

Therasense[Abbott] v. Becton Dickinson order

http://www.cafc.uscourts.gov/opinions/08-1511o.pdf

>>.....A poll was requested, taken, and the court has decided that the appeal warrants en banc consideration.
Upon consideration thereof,
IT IS ORDERED THAT:
(1) The petition of Plaintiffs-Appellants Abbott Diabetes Care, et al. for panel rehearing is denied.
(2) The petition of Plaintiffs-Appellants Abbott Diabetes Care, et al. for rehearing en banc is granted.
(3) The court’s January 25, 2010 opinion is vacated, and the appeal is reinstated.
(4) The parties are requested to file new briefs addressing the following issues:
1.
Should the materiality-intent-balancing framework for inequitable conduct be modified or replaced?
2.
If so, how? In particular, should the standard be tied directly to fraud or unclean hands? See Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238 (1944), overruled on other grounds by Standard Oil Co. v. United States, 429 U.S. 17 (1976); Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240 (1933). If so, what is the appropriate standard for fraud or unclean hands?

3.
What is the proper standard for materiality? What role should the United States Patent and Trademark Office’s rules play in defining materiality? Should a finding of materiality require that but for the alleged misconduct, one or more claims would not have issued?
4.
Under what circumstances is it proper to infer intent from materiality? See Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc).
5.
Should the balancing inquiry (balancing materiality and intent) be abandoned?
6.
Whether the standards for materiality and intent in other federal agency contexts or at common law shed light on the appropriate standards to be applied in the patent context.

(5) This appeal will be heard en banc on the basis of the original filed briefs, additional briefing ordered herein, and oral argument. An original and thirty copies of all originally-filed briefs shall be filed within 20 days from the date of filing of this order. An original and thirty copies of new en banc briefs shall be filed, and two copies of each en banc brief shall be served on opposing counsel. Appellants’ en banc brief is due 45 days from the date of this order. The en banc response brief is due within 30 days of service of the appellants’ new en banc brief, and the reply brief within 10 days of service of the response brief. Briefs shall adhere to the type-volume limitations set forth in Federal Rule of Appellate Procedure 32 and Federal Circuit Rule 32.
(6) Briefs of amici curiae will be entertained, and any such amicus briefs may be filed without leave of court but otherwise must comply with Federal Rule of Appellate Procedure 29 and Federal Circuit Rule 29.

(7) The United States Patent and Trademark Office is invited to participate as amicus curiae.
(8) Oral argument will be held at a time and date to be announced later.

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Court's original opinion[I am mildly surprised it is still here]:

http://www.cafc.uscourts.gov/opinions/08-1511.pdf

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After ~40-45 years experience is this arena, the court is apparently willing to take on the formidable task of at least thinking about reshaping this issue in the face of acknowledged
precedent of the Supreme Court, its own predecessor courts and its own previous and countless opinions, including an earlier en banc opinion. There are times I wonder whether this occasion is just another illustration epitomizing the notion that we live today in a government of rule of men and women, not rule of law
normally focused on long-standing stare decisis.