Assuring Quality U.S. Patents: Patent Owners’ Perspective Part 3 of a 3 Part Series

In the third and final part of this series, Assuring Quality U.S. Patents: Patent Owners’ Perspective, considerations for quality patent drafting are provided. The first part (interaction between attorney and inventor and preparing a quality patent) of the series can be found here and the second part (satisfying Section 112) of the series can be found here.

PART 3:  Quality Patent Drafting

IV. Considerations for Quality Patent Drafting: Answers May Have Inequitable Conduct/Unclean Hands Implications

A. Are subjective evaluations presented as fact? Are assertions supported by science?

1. Purdue Pharma L.P. v. Endo Pharms., Inc., 438 F.3d 1123 (Fed. Cir. 2006)

B. Do the inventors or persons with a Rule 56 duty know of any prior art, including patents, publications, and possible on-sale or public use information?

1. Transweb, LLC v. 3M Innovative Properties Co., 812 F.3d 1295 (Fed. Cir. 2016)
2. GS CleanTech Corp. v. Adkins Energy LLC, 951 F.3d 1310 (Fed. Cir. 2020)

C. Do the inventors have any articles or publications on the subject matter of the invention?

1. Bristol-Myers Squibb Co. v. Rhône-Poulenc Rorer, Inc., 326 F.3d 1226 (Fed. Cir. 2003)

D. Were all the experiments described performed as described?

1. Hoffmann-LaRoche, Inc. v. Promega Corp., 323 F.3d 1354 (Fed. Cir. 2003)
2. Novo Nordisk Pharmaceuticals, Inc. v. Bio-Technology General Corp., 424 F.3d 1347 (Fed. Cir. 2005)
3. Pharmacia Corp. v. Par Pharmaceutical, Inc., 417 F.3d 1369 (Fed. Cir. 2005)
4. Apotex, Inc. v. UCB, Inc., 763 F.3d 1354 (Fed. Cir. 2014)

E. Are there experiments and/or experiment details that were not included in the specification?

1. Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc., 525 F.3d 1334 (Fed. Cir. 2008)

F. Are there undisclosed data? undisclosed documents?

1. Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359 (Fed. Cir. 2007)
2. Apotex, Inc. v. UCB, Inc., 763 F.3d 1354 (Fed. Cir. 2014)

G. Is there information in the files of those having a Rule 56 duty that is inconsistent with those data submitted? Arguments made in support of patentability?

1. Monsanto Co. v. Bayer Bioscience N.V., 514 F.3d 1229 (Fed. Cir. 2008)
2. Ferring B.V. v. Barr Labs., Inc., 437 F.3d 1181 (Fed. Cir. 2006)
3. Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc)

H. Do they know of any related applications? Office Actions in any related applications? related patents? any litigation on the related patents?

1. McKesson Information Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897 (Fed. Cir. 2007)
2. Nilssen v. Osram Sylvania, Inc., 504 F.3d 1223 (Fed. Cir. 2007)
3. Leviton Mfg. Co., Inc. v. Universal Sec. Instruments, Inc., 606 F.3d 1353 (Fed. Cir. 2010)
4. Masimo Corp. v. Philips Elec. North Am. Corp., C.A. No. 09-80-LPS (D. Del. 2016)
5. Regeneron Pharms., Inc. v. Merus N.V., 864 F.3d 1343 (Fed. Cir. 2017), cert. denied (Oct. 1, 2018)

I. Is there any correspondence, reports, or notes of telephone calls between the patent owner and third parties, such as potential licensors?

1. Gilead Sciences, Inc. v. Merck & Co., Inc., 888 F.3d 1231 (Fed. Cir. 2018)

J. Are there invalidity and/or unpatentability search reports from patent authorities, inventors, patent searchers of the patentee, and/ or private patent searchers outside the patent owner relating to the subject matter?

K. Are there any documents related to world-wide regulatory filings, including, for example, in the U.S., the IND and NDA.

1. Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324 (Fed. Cir. 2012)
2. Merck & Co., Inc. v. Danbury Pharmacal, Inc., 873 F.2d 1418 (Fed. Cir. 1989)

L. Be very careful with declarations submitted for establishing patentability.