The WilmerHale Obviousness Report – A Client Alert Special Edition

The WilmerHale Obviousness Report – A Client Alert Special Edition

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Since the Supreme Court's landmark decision in KSR Int'l v. Teleflex Inc. in April 2007, the Federal Circuit has decided nearly 80 cases (precedential and non-precedential but not including summary affirmances) that substantively address the issue of obviousness. In an effort to shed light on how the Federal Circuit has reacted to KSR's admonishment against rigid application of the TSM test (and its statements concerning the "obvious to try" concept), we have carefully tracked and analyzed the Federal Circuit's post-KSR decisions on the issue of obviousness. The tables that follow provide a breakdown of these cases by holding, affirmance or reversal, and patented subject matter. The cases are divided into three broad categories: (1) Life Sciences and Chemical Arts; (2) Computers, Software, and Electronic Arts; and (3) Mechanical Arts and Miscellaneous Cases. Each major category is further broken down into additional industrial subcategories. Aggregate results follow each table and section.

Although the following tables provide much more industry-specific detail, a number of overall statistics and other trends are worth highlighting:

  • In roughly half of Life Sciences and Chemical Arts Cases (51.2%) and Computers, Software, and Electronic Arts Cases (50%), the validity of the claims was upheld on appeal, whereas in 80% of Mechanical Arts or Miscellaneous Cases, the claims were invalidated as obvious.

  • Within the pharmaceutical subcategory, new chemical entity (NCE) cases were the most likely to result in a non-obviousness holding at 75%; in stark contrast, 71.4% of non-NCE pharmaceutical cases resulted in an obviousness holding.

  • In 45 of 79 cases (57%), the Federal Circuit held the claim(s) at issue obvious versus 34 cases (43%) in which the court held that the claim(s) had not been proven obvious.

  • Of the 79 cases, only 21 decisions (26.6%) were reversals in chief of the district court decision on obviousness, whereas 58 decisions (73.4%) were affirmances.

  • Among the 21 reversals were 14 decisions (66.7%) that held the claim(s) obvious in contravention of the decision below (including each of the six instances in which the Federal Circuit reversed a jury verdict).

WilmerHale will continue to monitor developing trends in the obviousness case law and share those insights with its clients.

Life Sciences and Chemical Arts Cases

Biotechnology Cases

Case Name

Holding

Affirmance/Reversal

Subject Matter

Applera Corp. v. Illumina, Inc., 2010 U.S. App. LEXIS 6250 (Mar. 25, 2010)



Non-obvious



Affirmed

Methods of sequencing DNA

In re Chapman, 595 F.3d 1330 (Feb. 24, 2010)



Non-obvious



Reversed (remanded)

Divalent antibody fragments

In re Kubin, 561 F.3d 1351 (Apr. 3, 2009)



Obvious



Affirmed

DNA molecules encoding NAIL protein

Amgen Inc. v. F. Hoffmann-La Roche, Ltd., 580 F.3d 1340 (Sept. 15, 2009)



Non-obvious
(obviousness-type double patenting)



Affirmed

EPO production using recombinant DNA

Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (June 9, 2009)



Obvious

Reversed

Use of paracetic acid as sanitizer in beef and poultry

In re DBC, 545 F.3d 1373 (Nov. 3, 2008)



Obvious



Affirmed

Neutriceutical compositions comprising rind of the mangosteen fruit

In re Swanson, 540 F.3d 1368 (Sept. 4, 2008)



Obvious



Affirmed

Method for analysis of analytes

Pharmastem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (July 9, 2007)



Obvious (2-1)



Reversed

Compositions and methods for treating persons with compromised blood and immune systems with hematopoietic stem cells




3 Holdings of Non-obviousness (37.5%) 3 Reversals (37.5%, 2 holding obvious)

5 Holdings of Obviousness (62.5%) 5 Affirmances (62.5%)



Medical Device Cases

Case Name

Holding

Affirmance/Reversal

Subject Matter

Spine Solutions, Inc. v. Medtronic Sofamor Danek USA, Inc., 2010 U.S. App. LEXIS 18818 (Fed. Cir. Sept. 9, 2010)



Non-obvious



Affirmed

Intervertebral implants



Trimed, Inc. v. Stryker Corp., 608 F.3d 1333 (June 9, 2010)



Non-obvious



Reversed (remanded)

Implantable device to set bone fractures

Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357 (Apr. 1, 2010)



Non-obvious



Affirmed

Hearing aid components

Pressure Prods. Med. Supplies v. Greatbatch Ltd., 599 F.3d 1308 (Mar. 24, 2010)



Non-obvious



Affirmed

Introducer for catheters

Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1289 (Jan. 25, 2010), reh'g en banc granted (Apr. 26, 2010)



Obvious



Affirmed

Glucose measuring device for diabetics

Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325 (Jan. 25, 2010)

Obvious



Affirmed

Glucose measuring device for diabetics

Smith & Nephew, Inc. v. Arthrex, Inc., 355 Fed. Appx. 384 (Dec. 2, 2009)



Non-obvious



Affirmed

Method of placing and securing a suture anchor in bone

Fresenius USA, Inc. v. Baxter Int'l, Inc., 582 F.3d 1288 (Sept. 10, 2009)



Obvious



Reversed

Hemodialysis machine with touchscreen interface

Cordis Corp. v. Boston Sci. Corp., 561 F.3d 1319 (Mar. 31, 2009)



Non-obvious

Affirmed

Intravascular stents

Kinetic Concepts, Inc. v. Blue Sky Med. Group, Inc., 554 F.3d 1010 (Feb. 2, 2009)



Non-obvious (2-1)

Affirmed

Reduced/negative pressure for wound healing

Boston Scientific Scimed, Inc. v. Cordis, Corp., 554 F.3d 982 (Jan. 15, 2009)

Obvious

Reversed

Intravascular stents

Lexion Med., LLC v. Northgate Techs., Inc., 292 Fed. Appx. 42 (Aug. 28, 2008)



Obvious

Affirmed

Method/apparatus for heating and humidifying gas used to inflate abdomen during laparoscopic surgery

Voda v. Cordis Corp., 536 F.3d 1311 (Aug. 18, 2008)



Non-obvious

Affirmed

Catheters

Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307 (Aug. 24, 2007)



Obvious

Affirmed

Computer-aided design and manufacture of custom orthodontic appliances


8 Holdings of Non-obviousness (57.1%) 3 Reversals (21.4%, 2 holding obvious)

6 Holdings of Obviousness (42.9%) 11 Affirmances (78.6%)



Pharmaceutical Cases

Case Name

Holding

Affirmance/Reversal

Subject Matter

Daiichi Sankyo Co., Ltd. v. Matrix Labs., Ltd., 2010 U.S. App. LEXIS 18820 (Fed. Cir. Sept. 9, 2010)



Non-obvious



Affirmed

Olmesartan medoxomil (Benicar®, Benicar HCT®, and Azor®)



Eli Lilly & Co. v. Teva Pharms. USA, Inc., 2010 U.S. App. LEXIS 18236 (Fed. Cir. Sept. 1, 2010)



Non-obvious



Affirmed

Raloxifene (Evista®)

King Pharms., Inc. v. Eon Labs., Inc., 2010 U.S. App. LEXIS 15947 (Aug. 2, 2010)



Obvious



Affirmed

Methods of administration of metaxalone (Skelaxin®)

Sun Pharm. Indus. v. Eli Lilly & Co., 2010 U.S. App. LEXIS 15552 (July 28, 2010)



Obvious
(obviousness-type double patenting)



Affirmed

Method of using gemcitabine (Gemzar®) for treating cancer

Purdue Pharma Prods. L.P. v. Par Pharm., Inc., 2010 U.S. App. LEXIS 11246 (June 3, 2010)



Obvious



Affirmed

Controlled-release tramadol formations for daily dosing (Ultram® ER)

Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., 2010 U.S. App. LEXIS 1624 (Jan. 25, 2010), reh'g en banc denied (May 7, 2010)

Non-obvious (2-1)
(obviousness-type double patenting)

Reversed

Pramipexole (Mirapex®)

Ortho-Mcneil Pharm, Inc. v. Teva Pharms. Indus., Ltd., 344 Fed. Appx. 595 (Aug. 26, 2009)



Obvious



Affirmed

Combination tramadol and acetaminophen (Ultracet®)

Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341 (Aug. 5, 2009)



Obvious (2-1)



Affirmed

Drospirenone formulation for oral contraception (Yasmin®)

Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989 (May 13, 2009)



Non-obvious

Affirmed

Risedronate (Actonel®)

Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Dec. 12, 2008)



Non-obvious

Affirmed

Clopidogrel (Plavix®) – racemate separation

In re Omeprazole Patent Litig. v. Apotex Corp., 536 F.3d 1361 (Aug. 20, 2008)



Non-obvious

Affirmed

Omeprazole (Prilosec®)

Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd, 533 F.3d 1353 (July 21, 2008)



Non-obvious

Affirmed

Rabeprazole (Aciphex®)

Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254 (July 11, 2008)



Obvious

Reversed

Method for treating bacterial ear infections with ofloxacin (Floxin®)

Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Mar. 31, 2008)



Non-obvious

Affirmed

Topiramate (Topamax®)

Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353 (Mar. 7, 2008)



Obvious
(obviousness-type double patenting)

Reversed

Celecoxib (Celebrex®)

Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293 (Sept. 11, 2007)



Obvious

Reversed

Ramipril free of other isomers (Altace®)

Forest Labs., Inc. v. Ivax Pharms., Inc., 501 F.3d 1263 (Sept. 5, 2007)



Non-obvious

Affirmed

(+)-enantiomer of citalopram (Celexa®)

Metoprolol Succinate Patent Litig. v. KV Pharm. Co., 494 F.3d 1011 (July 23, 2007)



Obvious (2-1)
(obviousness-type double patenting)

Affirmed

Metoprolol succinate (Toprol-XL®)

Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (June 28, 2007)



Non-obvious

Affirmed

Pioglitazone (Actos®)




10 Holdings of Non-obviousness (52.6%) 4 Reversals (21.1%, 3 holding obvious)
9 Holdings of Obviousness (47.3%) 15 Affirmances (78.9%)

3 New Chemical Entity Obviousness Holdings (25%)
9 New Chemical Entity Non-Obviousness Holdings (75%)

3 NCE Reversals (25%, 2 holding obvious)
9 NCE Affirmances (75%)

5 Non-NCE Holdings of Obviousness (71.4%)
2 Non-NCE Holdings of Obviousness (28.6%)


Chemical Arts (Non-Pharmaceutical) Cases

Case Name

Holding

Affirmance/Reversal

Subject Matter

Sud-Chemie, Inc. v. Multisorb Techs., 554 F.3d 1001 (Jan. 30, 2009)



Non-obvious



Reversed

Desiccant containers



In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371 (Nov. 13, 2008)



Obvious
(obviousness-type double patenting)



Affirmed

Method for copolymerizing unsaturated hydrocarbons



All Biological/Biomedical/Chemical Arts

22 Holdings of Non-obviousness (51.2%) 11 Reversals (25.6%, 7 holding obvious)

21 Holdings of Obviousness (48.8%) 32 Affirmances (74.4%)



Computers, Software, and Electronic Arts Cases

Computer/Software/Internet Cases

Case Name

Holding

Affirmance/Reversal

Subject Matter

Dow Jones & Co. v. Ablaise Ltd., 606 F.3d 1338 (May 28, 2010)

Obvious



Affirmed

Customized web pages based on signal info

Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325 (Apr. 16, 2010)



Obvious



Affirmed

Packet-switched telephony



i4i L.P. v. Microsoft Corp., 598 F.3d 831 (Mar. 10, 2010), reh'g en banc denied (Apr. 1, 2010)



Non-obvious



Affirmed

Method of editing custom computer language

Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324 (Dec. 2, 2009)



Obvious



Affirmed

E-mail methods

Lucent Techs. v. Gateway, Inc., 580 F.3d 1301 (Sept. 11, 2009)



Non-obvious



Affirmed

Method of entering information without using keyboard

z4 Techs., Inc. v. Microsoft Corp., 507 F.3d 1340 (Nov. 16, 2007)



Non-obvious



Affirmed

Antipiracy software

Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295 (Sept. 26, 2007)

Non-obvious



Affirmed

Telephony-related methods



4 Holdings of Non-obviousness (57.1%) 0 Reversals (0%)

3 Holdings of Obviousness (42.9%) 7 Affirmances (100%)



Electronic Arts Cases

Case Name

Holding

Affirmance/Reversal

Subject Matter

Vizio, Inc. v. ITC, 605 F.3d 1330 (May 26, 2010)

Non-obvious

Affirmed

Digital television technology/MPEG



Honeywell Int'l, Inc. v. United States, 609 F.3d 1292 (May 25, 2010)



Non-obvious



Reversed

Passive night vision goggles/optics



Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343 (Mar. 30, 2010)



Non-obvious



Affirmed

Point-of-load power regulators

Siemens AG v. Seagate Tech., 369 Fed. Appx. 118 (Mar. 9, 2010)



Obvious



Affirmed

Magnetoresistive sensors

Monolithic Power Sys. v. O2 Micro Int'l Ltd., 558 F.3d 1341 (Mar. 5, 2009)



Obvious



Affirmed

Power inverter circuitry for laptop computers

Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310 (Oct. 10, 2008)



Obvious



Affirmed

System for tracking articles

Scanner Techs. Corp. v. Icos Vision Sys. Corp. N.V., 528 F.3d 1365 (June 19, 2008)

Obvious

Affirmed

Processes to inspect electronic components

Black & Decker, Inc. v. Robert Bosch Tool Corp., 260 Fed. Appx. 284 (Jan. 7, 2008)

Non-obvious



Affirmed

Combination of a radio and a battery charger

In re Translogic Tech., Inc., 504 F.3d 1249 (Oct. 12, 2007)

Obvious

Affirmed

Multiplexers



4 Holdings of Non-obviousness (44.4%) 1 Reversal (11.1%)

5 Holdings of Obviousness (55.6%) 8 Affirmances (88.9%)



All Computer/Software/Internet/Electronic Arts

8 Holdings of Non-obviousness (50%) 1 Reversal (6.3%)

8 Holdings of Obviousness (50%) 15 Affirmances (93.6%)



Mechanical Arts and Miscellaneous Cases

Mechanical Arts Cases

Case Name

Holding

Affirmance/Reversal

Subject Matter

Lucky Litter LLC v. ITC, 2010 U.S. App. LEXIS 20621 (Fed. Cir. Oct. 6, 2010)

Obvious

Reversed

Self-cleaning cat litter box



Geo M. Martin Co. v. Alliance Mach. Sys. Int'l LLC, 2010 U.S. App. LEXIS 17377 (Fed. Cir. Aug. 20, 2010)



Obvious



Affirmed

Bundle breaker with compliance structures



Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contrs. USA, Inc., 2010 U.S. App. LEXIS 17181 (Aug. 18, 2010)



Non-obvious



Reversed (remanded)

Apparatus for conducting offshore drilling

Wyers v. Master Lock Co., 2010 U.S. App. LEXIS 15271 (July 22, 2010)

Obvious

Reversed

Hitch pin locks to secure trailers to automobiles

Rolls-Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (May 5, 2010)

Non-obvious

Affirmed

Swept fan blades for turbofan jet engine

B-K Lighting, Inc. v. Fresno Valves & Castings, Inc., 2010 U.S. App. LEXIS 8770 (Apr. 28, 2010)



Obvious



Affirmed

Adjustable mount for sealed light fixtures

Alloc, Inc. v. Pergo, Inc., 366 Fed. Appx. 173 (Feb. 18, 2010)

Obvious



Affirmed

Mechanical joints for flooring panels

Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d 1371 (July 20, 2009)



Non-obvious

Affirmed

Refrigerator shelves

Sundance, Inc. v. Demonte Fabricating Ltd., 550 F.3d 1356 (Dec. 24, 2008)



Obvious



Reversed

Retractable segmented covering systems

In re Icon Health & Fitness, Inc., 496 F.3d 1374 (Aug. 1, 2007)

Obvious

Affirmed

Treadmill with folding base

Frazier v. Layne Christensen Co., 239 Fed. Appx. 604 (June 29, 2007)

Obvious

Affirmed

Method for improved water well production



3 Holdings of Non-obviousness (27.3%) 4 Reversals (36.4%, 3 holding obvious)

8 Holdings of Obviousness (72.7%) 7 Affirmances (63.6%)



Miscellaneous Cases

Case Name

Holding

Affirmance/Reversal

Subject Matter

Media Techs. Licensing, LLC v. Upper Deck Co., 596 F.3d 1334 (Mar. 1, 2010)

Obvious (2-1)

Affirmed

Sports memorabilia card



Crocs, Inc. v. ITC, 598 F.3d 1294 (Feb. 24, 2010)



Non-obvious



Reversed

Breathable footwear pieces

Ritchie v. Vast Res., Inc., 563 F.3d 1334 (Apr. 24, 2009)



Obvious



Reversed

Borosilicate rods

Rothman v. Target Corp., 556 F.3d 1310 (Feb. 13, 2009)

Obvious

Affirmed

Nursing garment with invisible breast support for nursing mothers

Ball Aerosol & Specialty Container, Inc. v. Ltd. Brands, Inc., 555 F.3d 984 (Feb. 9, 2009)

Obvious

Reversed

Candles

Leggett & Platt, Inc. v. VUTEk, Inc., 537 F.3d 1349 (Aug. 21, 2008)



Obvious



Affirmed

Method and apparatus for printing ink on a rigid, deformable substrate

Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (July 14, 2008)

Obvious



Reversed

Electronic (business) methods for conducting original issuer auctions of financial instruments

Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337 (Mar. 28, 2008)



Obvious

Reversed

Method and apparatus for electrocuting pests

In re Trans Tex. Holdings Corp., 498 F.3d 1290 (Aug. 22, 2007)



Obvious

Affirmed

System of inflation-adjusted deposit and loan accounts


1 Holding of Non-obviousness (11.1%) 5 Reversals (55.6%, 4 holding obvious)

8 Holdings of Obviousness (88.9%) 4 Affirmances (44.4%)



All Mechanical Arts and Miscellaneous Cases

4 Holdings of Non-obviousness (20%) 9 Reversals (56.3%, 7 holding obvious)

16 Holdings of Obviousness (80%) 7 Affirmances (43.7%)


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