Purpose of Best Mode The sole purpose of the best mode requirement is to restrain inventors from applying for patents while at the same time concealing from the public preferred embodiments of their inventions which they have in fact conceived Bayer AG v. Schein Pharmaceuticals, Inc., 301 F.3d 1306 (Fed. Cir. 2002) You can’t have your patent (cake) and trade secret too! Trade Secret Cake
5 Effective date of Best Mode Change Sept. 16, 2011 35 USC 112 retains best mode requirement “and shall set forth the best mode contemplated by the inventor of carrying out his invention” 35 USC 282 removes best mode from invalidity defence “Invalidity for failure to comply with … any requirement of section 112, except that the failure to disclose the best mode shall not be a basis on which any claim of a patent may be canceled or held invalid or otherwise unenforceable”
6 USPTO view of Best Mode The best mode is still required after AIA: [The examiner is to] Assume best mode is disclosed unless there is evidence to the contrary. MPEP § 2165.02 (The information that is necessary to form the basis for a rejection…is rarely accessible to the examiner….) BUT, the failure to disclose a better method will not be an issue if the inventor, at the time of filing the application, did not know of the better method OR did not appreciate that it was the best method. MPEP § 2165 http://www.uspto.gov/aia_implementation/faq.jsp
7 Test for Best Mode Prong 1 – Subjective test: whether the inventor, at the time of filing, “knew of a mode of practicing ‘the claimed invention that ‘the inventor’ considered to be better than any other.” See DeGeorge and Christianson Trying to figure out what was in someone’s mind frequently more than a decade ago is hard if not impossible Prong 2 – Objective test: whether what the inventor knew under the first prong was adequately disclosed so as to enable one skilled in the art to practice the best mode. See Randomex and Solomsen article The best mode is for the claimed invention Chemcast BUT see also Bayer, where the best mode did not fall within the scope of the claims!
8 What if there are several modes disclosed? Best Mode needs to be present but not “pointed out” However, this is one issue many complain about
9 When were patents invalidated for lack of best mode? See Bayer (1) Intentional concealment See Consolidated (2) Partial concealment: failed to disclose a preference that materially affected making or using the invention See Spectra - failure to provide the details of a 6-stage braze cycle and oven specifics resulted in the failure to provide best mode – where the materials/specifics affect making / using
10 Types of cases for Best Mode issues? Product-by-Process claims Stem cells Biological extracts Process claims for making compounds Making biologics, industrial enzymes / proteins, etc. Failure to provide details on materials (manufacturers) when those materials are relevant to the ability to make / use the invention
11 Best Mode v. Enablement There is no statutory requirement for the disclosure of a specific working example In re Gay, 309 BUT, “the absence of a specific working example is not necessarily evidence that best mode has not been disclosed, nor is the presence of one evidence that it has.” In re Honn, MPEP §2165.01 So how does that work?
12 Biological Deposit A deposit can serve to meet the best mode requirement Ex parte C; Scripps Clinic Note that Lundak raised the possibility that a deposit can be dispensed with if biotechnology progresses during pendency of the application such that it is no longer required In re Lundak Also note that in the US, deposits could be made after filing, but if the deposit is made after filing but required for Best Mode, there is a problem
13 The Joint Inventorship Nightmare Inventor problem of non-joinder and an inventor is later added – how can best mode have been contemplated at the time of filing? Melissa N. McDonough, 80 S. Cal. Law Rev. 151 (2006) How does the impact duty of candor? Joint inventors can’t decide what the best mode is? Union Carbide Corp. v. Dow Chem. Co., (S.D. Tex. 1981) One joint inventor identifies a mistake, but the other doesn’t agree, and the case is filed with the mistake? Pittway Corp. v. Maple Chase Co., (N.D. Ill. 1992) BUT, one cannot impute a patent attorney’s knowledge of a best mode to the inventor for purposes of finding a best mode violation Glaxo Inc. v. Novopharm Ltd.
14 Fixing Best Mode Attempts to fix best mode if not originally present in the application at filing will be treated as new matter under 35 USC §§ 132 and 251 Remember biological deposits – don’t let it trip you up!
15 Examples of Best Mode Cases No Best Mode (invalid) Consolidated Aluminum Corp. v. Foseco Int’l - hit entire family of patents Chemcast Corp. v. Arco Indus. Corp. Dana Corp. v. IPC Spectra-Physics, Inc., Inc. v. Coherent, Inc. USG Co. v. Nat’ Gypsum Co. Best Mode (valid) Pfizer Inc v. Teva Pharmaceuticals USA, Scripps Clinic v. Genentech Amgen v. Chugai Cardiac Pacemakers v. St. Jude Glaxo Inc. v. Novopharm Ltd. In re Bundy In re Gay In re Honn In re Sims In re Sichert Weil v. Fritz Hester v. Allgeier Hybritech Inc. v. Monoclonal Antibodies Inc. Bayer AG v. Schein Pharmaceuticals Inc. Bigham v. Godtfredsen Ajinomoto Co., Inc. v. Archer-Daniels-Midland Co. Eli Lilly & Co. v. Barr Laboratories, Inc. Evans Medical Ltd. v. American Cynamid Co. Teleflex, Inc. v. Ficosa North America Corp. No Best Mode is hard to prove, BUT when it’s there, it can be ugly!
17 After the AIA The discussion had been that we had gotten rid of Best Mode, but we didn’t!!! CONCERN: Malpractice issues for failing to provide a Best Mode Amendment to 35 USC § 282 eliminated best mode as a defense in patent infringement But, does inequitable conduct remain via other routes???
18 The Future How the court interprets the continued presence of BM in 35 USC 112, P1 is one only time will tell Ethics – oh yeah…that Inequitable Conduct Post-Therasense??? False Statements Statute 18 USC §1001 Preissuance Submissions under § 1.290 Spontaneous § 1.105 Requirement of Information
19 PTO Ethics Rules Proposed ethics rules issued 10/18/2012 (77 FR 64189) A practitioner shall not: conceal or knowingly fail to disclose that which the practitioner is required by law to reveal (10.85(a)(3)) A practitioner shall not engage in conduct involving dishonesty, fraud, deceit or misrepresentation (10.23(b)) Knowingly giving false or misleading information to the Office or any employee of the Office (10.23(c)) BUT REMEMBER (12) Knowingly filing, or causing to be filed, a frivolous complaint alleging a violation by a practitioner of the Patent and Trademark Office Code of Professional Responsibility
20 Inequitable Conduct: Therasense & Consolidated Aluminum Failure to disclose Best Mode is inherently material and reaches the minimum level of materiality necessary for finding inequitable conduct BUT, IC requires a threshold level of intent Consolidated was found to have disclosed a fictitious and inoperable mode in addition to failing to have disclosed the best mode, thus the unclean hands doctrine of Keystone Driller, spread unenforceability from the ‘917 to also the ‘081, ‘212 and ‘303 patents Unclear how Consolidated & Therasense would apply given the definition of a patent “proceeding” – PTO says no – BUT how will the courts interpret this?
21 False Statements Statute 18 U.S.C. § 1001(a)(2) Whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully…makes any materially false, fictitious, or fraudulent statement or representation…shall be fined under this title, imprisoned not more than 5 years,…or both.
Preissuance Submissions Now available (9/16/12) Think inventorship squabble Think best mode squabble Think joint venture gone bad Keep going….and I am sure you will think up some more… 22
23 37 CFR 1.105 Allows the patent examiner to require the applicant / patent attorney / patent agent to submit such information as may be reasonably necessary to properly examine or treat the matter
24 Scary Hypothetical 1 In a derivation proceeding involving an application and a patent, where the inventor of the application claims the inventor of the patent stole his idea, could the defending inventor argue that the patent application of the inventor asserting derivation failed to provide the best mode?
25 Scary Hypothetical 2 A third party demonstrates to the Office of Enrollment and Discipline that a practitioner violated 10.23/10.85 in obtaining patent 9,000,001. What happens to the patent legally? Practically does the patent still have value? Could such a finding be used as evidence in an inequitable conduct defense in a civil litigation? Interesting Video Example of the above at: http://farmprod.content.xtranormal.com/2011-11-04/publish/2474a52a-0726-11e1-a7a4-12313b12d0a2.mp4
26 Scary Hypothetical 3 A disenfranchised ex-employee finds out that his old boss has filed a patent application on something he worked on. After reviewing the application, he realizes that key methods of making and using the invention are not disclosed, and files a pre-issuance submission under 35 USC § 122 (37 CFR 1.290) providing a published reference and a statement explaining it. Can the application be rejected because BM is not shown? Substitute a disenfranchised JV partner
Scary Hypothetical 4 Party submits an application with claims that recite a biological deposit. Party makes the deposit and the statement that restrictions will be removed when the patent issues. The restrictions are intentionally put in place when the patent grants. Now what? Don’t forget the rest of 35 USC § 112, ¶1 27
28 What to do? Business as usual (before 9/16/11) – include the best mode in your patent specification – Gaming the system – not recommended – Remind your foreign colleagues that you still need BM – Pay attention inventorship and certain invention classes Watch for ways to attack others during prosecution? Think about BM in JVs & for best practices Watch for future legislation removing BM from Section §112
29 Thank You Neil Henderson Borden Ladner Gervais LLP firstname.lastname@example.org 519.747.6160 With Generous Assistance from: Mercedes Meyer! Drinker Biddle & Reath LLP email@example.com
30 List of Cases Ajinomoto Co., Inc. v. Archer-Daniels-Midland Co., 228 F.3d 1338 (Fed. Cir. 2000) Allvoice Computing PLC v. Nuance Communications., Inc., 504 F.3d 1236 (Fed. Cir. 2007) Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200 (Fed. Cir. 1991) Bayer AG v. Schein Pharmaceuticals, Inc., 301 F.3d 1306 (Fed. Cir. 2002) Bigham v. Godtfredsen, 857 F.2d 1415 (Fed. Cir. 1988) Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 381 F.3d 1371 (Fed. Cir. 2004) Chemcast Corp. v. Arco Industries Corp., 913 F.2d 923 (Fed. Cir. 1990) Consolidated Aluminum Corp. v. Foseco Int’l Limited, 910 F.2d 804 (Fed. Cir. 1990) Dana Corp. v. IPC Limited Partnership & Int’l Packing Corp., 860 F.2d 415 (Fed. Cir. 1988) DeGeorge v. Bernier, 768 F2d 1318 (Fed. Cir. 1985) Eli Lilly & Co., v. Barr Laboratories, Inc. 222 F.3d 973 (Fed. Cir. 2000) Evans Medical Ltd. v. American Cynamid Co., 52 USPQ2d 1455 (Fed. Cir. 1999) Ex parte C, 27 USPQ2d 1492 (BPAI 1992) Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043 (Fed. Cir. 1995) Hester v. Allgeier, 646 F.2d 513 (CCPA 1981) Hoffmann-La Roche, Inc. v. Promega Corp., 323 F.3d 1354 (2003) Hybridtech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367 (Fed. Cir. 1986)
32 List of Articles Dale L. Carlson, “Patent Linchpin for the 21 st Century?- Best Mode Revisited,” 45 IDEA 267 (2005) Donald S. Chisum, “Best Mode Concealment and Inequitable Conduct in Patent Procurement: A Nutshell, A Review of Recent Federal Circuit Cases and a Please for Modest Reform,” 13 Comp. & High Tech. L.J. 277 (1996) Bron D’Angelo, “The America Invents Act: What Remains of Best Mode?” Melissa N. McDonough, “To Agree, or Not to Agree: That is the Question When Evaluating The Best Mode Preferences of Joint Inventors After Pannu V. Iolab Corp.,” 80 S. Cal. L.R. 151 (2006) Jerry R. Selinger, “In Defense of ‘Best Mode’: Preserving the Benefit of the Bargain for the Public,” 43 Cath. Univ. L.R. 1071 (1994) Matthew H. Solomson, “Patently Confusing: The Federal Circuit’s Inconsistent Treatment of Claim Scope as a Limit on the Best Mode Disclosure Requirement,” 45 IDEA 383 (2005) Ryan G. Vacca “Patent Reform and Best Mode: A Signal to the Patent Office or a Step Toward Elimination?” 2011 Kenneth J. Burchfiel, Chapter 9 “Best Mode” in Biotechnology and the Federal Circuit (1997)