Tag Archives: Federal Circuit En Banc

Federal Circuit En Banc Patent Decisions

Patent

By Jason Rantanen

A few weeks ago a commenter asked about a list of Federal Circuit en banc patent law decisions.  Despite the seeming importance of such a list, I was unable to find one through either online searching or consulting my favorite treatises.  After sorting through several sources, however, I was able to assemble the following list.  While a handful of the opinions are of limited substance, the bulk of the list consists of seminal patent rulings.  Note that this is only a first pass, and any corrections are welcome.

  1. Hyatt v. Kappos, 625 F.3d 1320 (Fed. Cir. 2010 (en banc)
  2. Princo Corp. v. Int'l Trade Comm'n, 616 F.3d 1318 (Fed. Cir. 2010) (en banc)
  3. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc)
  4. Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 576 F.3d 1348 (Fed. Cir. 2009) (en banc in part)
  5. Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009) (en banc in part)
  6. Tafas v. Doll, 559 F.3d 1345 (Fed. Cir. 2009) (en banc)
  7. In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc)
  8. Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665 (Fed. Cir. 2008) (en banc)
  9. In re Seagate Tech., LLC, 497 F. 3d 1360 ( Fed. Cir. 2007) (en banc)
  10. DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) (en banc in part)
  11. SmithKline Beecham Corp. v. Apotex Corp., 453 F.3d 1346 (Fed. Cir. 2006) (en banc)
  12. Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc);
  13. Knorr-Bremse Systeme Fuer Nutzfahrzeuge GmbH v. Dana Corp., 383 F.3d 1337 (Fed. Cir. 2004) (en banc)
  14. Honeywell Int'l Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131 (Fed. Cir. 2004) (en banc)
  15. Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 344 F.3d 1359 (Fed. Cir. 2003) (en banc)
  16. Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046 (Fed. Cir. 2002) (en banc)
  17. Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed. Cir. 2000) (en banc)
  18. Midwest Indus., Inc. v. Karavan Trailers, Inc., 175 F.3d 1356 (Fed. Cir. 1999) (en banc)
  19. Nobelpharma Ab v. Implant Innovations, 141 F.3d 1059 (1998) (en banc in part)
  20. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)
  21. In re Zurko, 142 F.3d 1447 (Fed. Cir. 1998) (en banc)
  22. Hilton Davis Chem. Co. v. Warner-Jenkinson Co., 114 F.3d 1161 (Fed. Cir. 1997) (en banc)
  23. Hilton Davis Chem. Co. v. Warner-Jenkinson Co., 62 F.3d 1512 (Fed. Cir. 1995) (en banc)
  24. In re Trovato, 60 F.3d 807 (Fed. Cir. 1995) (en banc)
  25. Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538 (Fed. Cir. 1995) (en banc)
  26. Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (en banc)
  27. In re Alappat, 33 F.3d 1526 (Fed. Cir. 1994) (en banc)
  28. In re Donaldson Co., 16 F.3d 1189 (Fed. Cir. 1994) (en banc)
  29. A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc)
  30. In re Dillon, 919 F.2d 688 (Fed. Cir. 1990) (en banc)
  31. Beatrice Foods Co. v. New England Printing & Lithographing Co., 899 F.2d 1171 (Fed. Cir. 1990) (en banc)
  32. Aerojet-Gen. Corp. v. Mach. Tool Works,  Oerlikon-Buehrle Ltd., 895 F.2d 736 (Fed. Cir. 1990) (en banc)
  33. Racing Strollers, Inc. v. TRI Indus., Inc., 878 F.2d 1418 (Fed. Cir. 1989) (en banc)
  34. Gavin v. Star Brite Corp.,865 F.2d 269 (Fed. Cir. 1988) (en banc) (nonprecedential)
  35. Kingsdown Med. Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc)
  36. In re Roberts, 846 F.2d 1360 (Fed. Cir. 1988) (en banc)
  37. Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931 (Fed. Cir. 1987) (en banc)
  38. Woodard v. Sage Prods., Inc., 818 F.2d 841 (Fed. Cir. 1987) (en banc)
  39. Wyden v. Comm'r of Patents & Trademarks, 807 F.2d 934 (Fed. Cir. 1986) (en banc)
  40. SRI Int'l v. Matsushita Elec. Corp., 775 F.2d 1107 (Fed. Cir. 1985) (en banc)
  41. In re Bennett, 766 F.2d 524 (Fed. Cir. 1985) (en banc)
  42. Paulik v. Rizkalla, 760 F.2d 1270 (Fed. Cir. 1985) (en banc)
  43. In re Etter, 756 F.2d 852 (Fed. Cir. 1985) (en banc)
  44. Atari, Inc. v. JS & A Group, Inc., 747 F.2d 1422 (Fed. Cir. 1984) (en banc)
  45. Gardner v. TEC Systems, Inc., 725 F.2d 1338 (Fed. Cir. 1984) (en banc)
  46. South Corp. v. U.S., 690 F. 2d 1368 (Fed. Cir. 1982) (en banc)

Sources: Chisum on Patents; Lee Petherbridge, "Patent Law Uniformity," 22 Harv. J.L. & Tech. 421 (2009); WESTLAW.  Those interested in further reading on en banc Federal Circuit decisions may want to check out Christopher Cotropia's article "Determining Uniformity Within the Federal Circuit By Measuring Dissent and En Banc Review," 43 Loy. L.A. L. Rev. 801 (2010).

Update: Shortly after publishing this post, I learned that Professor Ryan Vacca at the University of Akron School of Law has drafted an article on the Federal Circuit's en banc practice, which he recently presented at the Missouri Law Review Symposium.  Professor Vacca argues that these practices make the court look much like that of an administrative agency engaging in substantive rulemaking, a role that he suggests is beneficial in shaping patent policy as a whole.  Along with the substantive analysis, the article includes an appendix listing the court's en banc decisions.  A draft of the piece, entitled "Acting Like an Administrative Agency: The Federal Circuit En Banc" is available on ssrn, and I recommend that anyone interested in the CAFC's en banc practices should take a look at it.

CAFC Declines to Take Prosecution Laches En Banc

Patent,

By Jason Rantanen

Cancer Research Technology Ltd. v. Barr Laboratories, Inc. (Fed. Cir. 2011) (Precedential Order) Download 10-1204 enbanc order

This morning the CAFC denied Barr Laboratories' request for rehearing en banc.  Review was barely denied: the judges split 5-5, just short of the 6-judge majority currently required for rehearing en banc.  Dissenting from the denial, both Judges Prost and Dyk expressed opinions on the issue of prosecution laches.

I previously wrote about Cancer Research Technology here.  In a nutshell, the panel majority reversed the district court's finding of prosecution laches on the ground that no prejudice was shown due to the lack of any evidence of intervening rights arising during the prosecution period.  Judge Prost dissented from that ruling, rejecting the idea that prosecution laches requires either prejudice or intervening rights. 

Judge Prost's dissent from the denial of rehearing en banc, joined by Judges Gajarsa, Moore, and O'Malley, reiterates and bolsters that view.  Drawing on Supreme Court precedent, Judge Prost again argues that the Supreme Court's test for prosecution laches does not require evidence of intervening rights:

This narrowing of the doctrine is not only unnecessary, it is contrary to Supreme Court precedent.  It is true that in both Woodbridge and Webster the Court refused to enforce the patent where both unreasonable delay and intervening rights existed. Woodbridge, 263 U.S. at 53, 56-57; Webster, 264 U.S. at 465-66. In each of these cases, however, the Court made clear that both unreasonable delay and intervening rights were not required to support a finding of prosecution laches.

Prost dissent at 3-4.  In Judge Prost's view, this precedent instead requires the court to favor flexibility over rigidity as the Supreme Court instructed in decisions such as Bilski, KSR, and eBay.

Judge Dyk wrote separately, commenting that while he agrees with Judge Prost that evidence of intervening rights should not be required, he disagrees with the use of a "totality of the circumstances" test, "which is really no test at all." Dyk dissent at 1.

Is Woodridge Applicable? In his IP newsletter, Hal Wegner takes issue with Judge Prost's characterization of a Supreme Court "doctrine" of prosecution laches based on Woodridge, pointing out that the case had nothing to do with a granted patent.  As explained in an amicus brief filed in Symbol Technologies:

Woodbridge v. United States, 263 U.S. 50 (1923), does not provide any guidance regarding prosecution laches because Woodbridge never received a patent. Rather, the Woodbridge case involved a statutory compensation act for private relief for an unpatented invention of Woodbridge. Woodbridge, 263 U.S. at 51. The statute's language required the trial court to deny relief to Woodbridge because there had been laches in his patent procurement process. Id. This statutory laches in a private law therefore had nothing to do with laches in the patent law.

In contrast, Webster Elec. Co. v. Splitdorf Elec. Co., 264 U.S. 463 (1924), did include a discussion of prosecution laches. An examination of the facts in that case, however, reveals that the key issue involved what today would be inequitable conduct. Accordingly, Webster hardly shapes the contours for a well-formed ‘doctrine.’”

Hal Wegner, quoting Symbol Technologies, Inc. v. Lemelson Medical, Educ. & Research Foundation, 422 F.3d 1378 (Fed. Cir. 2005), Brief Amicus Curiae of Takeda Pharmaceutical Co., 2004 Westlaw 3335267, p. 4 (2004)(original emphasis).

Guest Post: Centocor, the Antibody Exception, and Claiming Only What was Invented

Patent, , , , ,

By Oskar Liivak
Assistant Professor, Cornell Law School

As Jason Rantanen’s post describes, Centocor claimed but failed to disclose any fully humanized antibodies.  Abbott consistently pushed this argument and they won.  It was the simplest and most direct way to dispose of the case.  This approach necessarily left other important issues undecided, however.  Both Eli Lilly and I separately filed amicus briefs in favor of Abbott and we both argued for a decidedly more aggressive, alternative argument for written description invalidity.  As the Court in Centocor disposed of this case by simpler means, clear judicial resolution of our arguments will have to wait for another day.

This post highlights those remaining issues, why we should still care about them, and how they are tied to a much larger ongoing struggle in patent law – can a patent claim cover more than what was actually invented (i.e. conceived and disclosed) by the inventor?  I think the answer is clear – it cannot – but not every patent attorney or CAFC judge agrees.  I think this is perhaps the most important ongoing debate in patent law.  § 112 as applied to antibodies is but one battlefront in this larger fight. 

ABANDONING THE ANTIBODY EXCEPTION
The arguments in both of our briefs would have resolved the case in favor of Abbott but would have also resolved a very problematic ambiguity relating to the written description for antibodies generally – the so-called ‘antibody exception.’  The PTO’s written description guidelines seem to suggest that disclosure of an antigen alone can provide § 112 support for any antibody that binds to that antigen.  See U.S.P.T.O., Written Description Training Materials Revision 1 March 25, 2008 at 45-46.  Cases like Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), have cited these guidelines but the guidelines have yet to be really at the center of a case – even here in Centocor the CAFC distinguishes them.  The trouble is that those PTO guidelines are in tension if not complete conflict with written description as described in Ariad v. Eli Lilly, 598 F.3d 1336, 1354 (Fed. Cir. 2010) (en banc).  With the rapid growth of and enormous revenues associated with antibody related therapies, patent law must clarify this issue.

The crux of the argument is simple.  I believe that the disclosure requirements of § 112 limit claims to the subject matter actually invented by the inventor and disclosed by the specification.  Ariad at 1351.  If we consistently applied this rule for disclosure in light of today’s understanding of protein structure, disclosure of a well characterized antigen alone would not provide support for an antibody that binds to that antigen.  And disclosure of one actual antibody provides § 112 support only for that antibody—not the entire genus of antibodies that binds to the antigen.  This view is in direct conflict with the antibody exception.  Here is the argument.    

Ariad reaffirmed that § 112 “requires … that the specification must … show that the inventor actually invented the invention claimed.” Id.  As best I can surmise, to invent something a person must conceive it.  Conception is how patent law decides when something is invented; conception is how patent law decides who invents something; and it should be the way patent law determines what the something is that was invented.  From the perspective of conception (namely a “definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice”) the antibody exception and the broad claims it would allow start to look totally absurd. 

The problem is, as put by Eli Lilly in their amicus brief, “[e]ven with today's most advanced scientific tools, it is impossible to predict the actual structure … of a not-yet-known antibody based on the structure of an antigen or even the structure of another antibody that binds that same antigen.”  Though my own scientific background was not in immunology (it was in the more general field of three dimensional protein structure determination) I agree with Eli Lilly.  Even given the three dimensional structure of an antigen, no person today can conceive (without actually going into the lab and making one) an antibody that will bind to that antigen.  Furthermore, even once we make one antibody that does bind to an antigen, that alone does not allow for the conception of any other antibodies (much less every antibody) that will also bind to that antigen.

As the Federal Circuit determined, Centocor’s “application only provides amino acid sequence information … for a single mouse variable region.”  Slip Op. at 14.  That meager though still useful (see http://en.wikipedia.org/wiki/Infliximab) disclosure pales in comparison to the broad genus of variable regions that were claimed.  Asserted claims 2 and 3 covered any antibody with a human constant region and a human variable region that binds and neutralizes TNFα in a similar location as the deposited antibody.  There is nothing in the specification that evidences conception of any other variable regions beyond the one deposited variable region.  That disparity between the solutions disclosed versus the solutions claimed is why I viewed this case as being nearly identical to the over-reaching patentees in The Incandescent Lamp case, 159 U.S. 465 (1895).  Where a solution to a technical problem is found through trial and error (even sophisticated, elegant trial and error like for antibodies) without further discovering how to extrapolate to other solutions from the one found solution, then claims cannot exceed that one particular solution.  See id. at 472.  As a result I argued that the asserted claims are invalid under § 112 because they claim variable regions (whether humanized or not) that Centocor certainly did not invent or disclose.

From a policy perspective some might worry that this will provide incredibly narrow and worthless claims in a rapidly growing and important field.  I am not so sure.  It will certainly allow others to produce their own antibodies to the same antigen as the other antibodies will likely differ in actual variable region structure.  The narrow claims still prevent outright piracy and copying of your particular antibody but they also leave room for competition.  With tens of thousands of dollars a year for treatment for these drugs, a little fair competition doesn’t sound bad.  Lastly, the big question is the ability for generic biologic producers to piggy back on the testing data for the initial biologic.  I don’t see a problem from narrow claim scope in this regard either.  Though it depends on the details of the generic approval process for biologics, roughly speaking I wouldn’t want safety and efficacy data from one antibody to be used to confirm the safety and efficacy of structurally different antibodies even if they bind to the same antigen.

When § 112 and its usage of ‘the invention’ is rightfully tied to the subject matter actually invented (i.e. conceived and disclosed), then the shortcomings of the antibody exception become quite apparent.  In fact, when viewed in that light (which I think is the only way to interpret the statute) I cannot fathom a scenario by which the PTO could have possibly drafted the antibody related written description guidelines that have led to the antibody exception.

THE INVENTION AS THE EMBODIMENTS CONCEIVED AND DISCLOSED
But therein lies the problem: not everyone in patent law thinks about the statutory appearances of the invention in § 102, § 112, and more importantly § 271, as tied to the subject matter actually invented (i.e. conceived and disclosed).  For some the invention is just a short-hand reference for whatever subject matter the applicant claims because “the claims … define the invention….”  Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004).  The difference between these two views is critically important yet patent law has never confronted this confusion directly.  In fact, ask yourself, how do you conceptually and practically define the ‘invention’ in 35 U.S.C.?  I think some of our most pressing debates are fueled by talking past each other.  We are often thinking differently about the invention without actually being aware of the disagreement. 

The fight over the disclosure requirements evidenced in Ariad and Centocor is just one visible battle between these two world views.  Another important flashpoint is claim interpretation.  Just a month ago on Jan. 24 (as noted here on Patently-O) in IP Frontline, Hal Wegner described the ongoing problems with claim interpretation.  Discussing Arlington Indus. v. Bridgeport Fittings he pointed to the “festering sore” in Federal Circuit jurisprudence over the proper conceptual relationship between the claims and the specification.  He noted that “[u]ntil there is a final resolution of this debate there will never be clarity in claim construction at the Federal Circuit.”  That festering sore is another important instance of this broader fight over the proper conceptual relationship between claims, the invention, and the specification.  In a recent article, I further detail this controversy and its proper resolution.  For those interested in that broader discussion see Oskar Liivak, Rescuing the Invention from the Cult of the Claim (http://ssrn.com/abstract=1769270).

I thank Kevin E. Collins and Jason Rantanen for very helpful and insightful comments.

Dissenting in Patent Cases

Patent

Over the past decade, the Federal Circuit has released thousands of patent case opinions.  For today’s study, I focused on patent opinions released since January 1, 2000. And, I limited my search only to those opinions with Westlaw Headnotes. Westlaw consistently provides Headnotes for published CAFC decisions and for a small number of unpublished opinions that Westlaw deems important. For each opinion, I looked to see whether a dissent was filed and, if so, who filed the dissent.  I also excluded en banc opinions from this particular study and instead focused on three-member panels.

Of the approximately 2000 panel decisions in my sample, 13.5% included a dissent.

For those who follow Federal Circuit decisionmaking, it will not be surprising that Judge Newman filed the most dissenting opinions. Of the 471 decisions in my sample associated with Judge Newman, she dissented in roughly 17%. What may be surprising is that Chief Judge Rader has been the least likely dissenter of the appellate judges.

As the charts below suggest, Chief Judge Rader’s low dissent count does not mean he builds unanimous coalitions. Rather, it appears that Chief Judge Rader is skilled at building majority coalitions. The first chart below shows the percent of panel opinions associated with a particular judge where a dissent was filed.  The final chart just considers opinions with a dissent and reports the percent of those opinions where a particular judge is in the majority.  As the final chart shows, in cases with a split decision, Judge Newman is rarely in the majority while Judge Rader is almost always in the majority. 

In the social dynamic of panel opinions, there are particular structures that tend to lead to dissent.  In Chief Judge Rader’s case, more than 85% of his dissents were filed when at least one of Judges Lourie, Prost, or Bryson was on the three-member panel.

Using a slightly different dataset, Professor Cotropia (Richmond) found that the Federal Circuit is more likely to dissent than are other circuits — especially in patent cases. Christopher A. Cotropia, “Determining Uniformity Within the Federal Circuit By Measuring Dissent and En Banc Review,” 43 LOY. L.A. L. REV. 801, 811 (2010).  Cotropia suggests that “A likely explanation [for the high level of dissent] is that the repeated exposure to the same subject matter results in more diverse viewpoints. The deeper one gets into a particular subject, the more likely they develop their own opinions and the further developed and more nuanced these opinions become.”

Top Twelve Most Read Patently-O Posts over the Past Year

Patent, , , ,
  1. PatentLawImage078Bilski v. Kappos
  2. Court: Essentially All Gene Patents Are Invalid
  3. Patent Reform Act of 2010: An Overview
  4. Therasense v. Becton Dickinson: Federal Cicuit Grants En Banc Request to Rethink the Law of Inequitable Conduct
  5. Dear Patent Attorney and Patent Agent: Consider Joining the PTO
  6. USPTO Guidelines for Determining Obviousness
  7. Patent Absurdity: The Movie
  8. Federal Circuit Confirms that Patents Must Meet Both the Written Description and Enablement Requirements of Section 112.
  9. PatentLawImage079Bilski, Kenny Rogers and Supreme Court Rule 46 (by Prof Ghosh)
  10. Top-Ten Pending Patent Cases (using Hal Wegner's List)
  11. Bilski Watch: Timing of Supreme Court Decisions (Using Prof Miller's Data)
  12. How should a future patent attorney choose a law school?

See the list from 2009.

Survey on Willful Infringement

Infringement, Patent, Patentable Subject Matter, Survey

Prof. David C. Berry (Cooley) is researching how In re Seagate Technology, LLC, 497 F.3d 1360 (Fed. Cir. 2007)(en banc) has altered the practical landscape of willful patent infringement. One goal of the project is to collect data from persons with recent experience evaluating whether an organization's activities create a risk of patent infringement, and deciding how to respond to that risk. Current or recent in-house counsel interested in participating in the research project are invited to complete a confidential, on-line survey at: http://www.novisystems.com/NoviSurvey/n/risksurvey.aspx.

The survey was developed in conjunction with the ABA Section of Intellectual Property Law, Special Committee on Patent Analysis and Opinions of Counsel Post-Seagate. It has approximately 30 questions, and can be completed in less than 15 minutes. The survey link will be open for responses until February 15, 2011.

iLOR v. Google: Rejected Claim Construction Does Not Render Case “Objectively Baseless”

Attorney Fees, CAFC, Claim Construction, Fees, Infringement, Injunctions, Patent, ,

By Jason Rantanen

iLOR, LLC v. Google, Inc. (Fed. Cir. 2011)
Panel: Rader, Linn, Dyk (author)

This case involved a district court exceptional case determination based a finding that the suit was objectively baseless and brought in bad faith.  iLOR, the assignee of Patent No. 7,206,839, sued Google for infringement of the '839 patent by Google's Notebook product.  In denying iLOR's request for a preliminary injunction, the district court rejected iLOR's proposed construction of the only claim term in dispute, subsequently granting summary judgment of noninfringement.  The Federal Circuit affirmed the district court's denial of the preliminary injunction, agreeing that the language of the claim, the specification and the prosecution history supported the district court's construction.  See iLOR, LLC v. Google, Inc., 550 F.3d 1067 (Fed. Cir. 2008).  Following the Federal Circuit's disposition of that appeal, the district court granted Google's request to recover its attorneys' fees and costs and expenses, finding the case exceptional on the ground that it was "not close" on the merits (i.e.: ("objectively baseless") and iLOR had acted in subjective bad faith.  iLOR appealed.

In reversing the district court, the CAFC first likened the exceptional case standard for a suit brought by a patent plaintiff (absent misconduct during patent prosecution or litigation) to that of willful infringement.  "The objective baselessness standard for enhanced damages and attorneys’ fees against a non-prevailing plaintiff under Brooks Furniture is identical to the objective recklessness standard for enhanced damages and attorneys’ fees against an accused infringer for § 284 willful infringement actions under In re Seagate Technology, LLC, 497 F.3d 1360 (Fed. Cir. 2007) (en banc)."  Slip Op. at 8-9.  Thus, just as willfulness requires an assessment of both objective and "subjective" (i.e.: known or so obvious that it should have been known) prongs, so too does the exceptional case determination. And just as for willfulness, the objective assessment "is to be determined based on the record ultimately made in the infringement proceedings."  Id. at 10.

Comment: At some points, the Federal Circuit's opinion is confusingly imprecise in its usage of "objective baselessness."  Although in some instances it refers to the "objective baselessness" standard as being identical to the overall objective recklessness standard for willfulness (which includes, according to the court, both objective and subjective elements), at other times it treats it as being identical to only the "objective" prong of the analysis.  The only reading that makes sense is that when the court indicates that "objective baselessness" is identical to the willfulness "objective recklessness" standard, what it is really referring to is the overall standard for an exceptional case determination based on a meritless case theory, while when it compares it to the "objective" prong of the willfulness analysis, it really is referring to "objective baselessness."

Applying this framework, the CAFC concluded that iLOR's claim construction was not objectively baseless, and thus it was unnecessary to consider the issue of subjective bad faith.  The CAFC pointed to iLOR's arguments supporting its proposed construction, which – although the court disagreed with them – had some merit.  The CAFC also commented on the difficulty of claim construction, "in which the issues are often complex and the resolutions not always predictable."  Id. at 13.  And the court noted that the fact that it "held oral argument and issued a precedential written opinion in the first appeal suggests that we did not regard the case as frivolous."  Id. at 13-14.  In short, "simply being wrong about claim construction should not subject a party to sanctions where the construction is not objectively baseless."  Id. at 14.

The Use of Online Databases for Legal Scholarship

Academic Studies, Patent, Rantanen, , ,

By Jason Rantanen

Many empirical studies of Federal Circuit jurisprudence rely on searches of one of the leading legal databases such as Westlaw or Lexis.1 Relying on a search of a single database is potentially problematic, however, if the substantive content of the databases is not identical – in other words, if Lexis and Westlaw don't contain the same universe of cases, any claims about the results are necessarily limited by the dataset being used. 

In order to avoid this problem in connection with an empirical study of inequitable conduct that I'm working on, I recently performed a comparison of results obtained by a keyword search on Westlaw versus an identical search on Lexis.  This comparison revealed that although the data obtained from the two sources is largely comparable, small differences do exist that certain types of searchers may want to take into account.

The chart below shows the results, by year, produced by searching for the term "inequitable conduct" in the Federal Circuit databases for Lexis and Westlaw.2,3  In large part, the results suggest that there is relatively little variation between the two databases: in the context of this analysis, only 30 out of 681 (4.4%) Westlaw opinions were not found in Lexis and only 6 out of 657 (0.9%) Lexis opinions were not found in Westlaw.  Furthermore, in no instance did a precedential opinion appear in one database but not another.  Rather, all of the single-database hits were nonprecedential opinions.  In addition, nearly all of the nonprecedential opinions appearing in only a single database issued prior to 1991.   That said, there is a significant difference with respect to nonprecedential opinions for the period prior to 1991: nearly all the nonprecedential opinions from this time period are found in only one database.4  Thus, while it may not be efficient for most practitioners to run keyword searches on multiple databases, scholars conducting empirical research on Federal Circuit decisions, or individuals searching for older party-specific nonprecedential opinions, may want to be sensitive to the differences between the two databases.

Figure 1: Hits Resulting from Search Term "Inequitable Conduct" in Lexis and Westlaw5

 
Search comparison

1 See, e.g., Christopher A. Cotropia, "Determining Uniformity Within the Federal Circuit By Measuring Dissent and En Banc Review," 43 LOY. L.A. L. REV. 801, 811 (2010); Christian E. Mammen, Controlling the "Plague": Reforming the Doctrine of Inequitable Conduct,24 BERKELEY TECH. L.J. 1329, 1348 (2009);  Craig Allen Nard, Toward a Cautious Approach to Obeisance: The Role of Scholarship in Federal Circuit Patent Law Jurisprudence, 39 HOUS. L. REV. 667, 678 fn 40 (2002); Christian A. Chu, Empirical Analysis of The Federal Circuit's Claim Construction Trends, 16 BERK. TECH. L.J. 1075, 1092 (2001); but see R. Polk Wagner and Lee Petherbridge, Is the Federal Circuit Succeeding? An Empirical Assessment of Judicial Performance, 152 U. PA. L. REV. 1105, 1145 (2004) (using results from both Lexis and Westlaw).  In addition, some early empirical studies used the United States Patent Quarterly as their source (see, e.g., John R. Allison & Mark A. Lemley, How Federal Circuit Judges Vote in Patent Validity Cases, 10 FED. CIR. B.J. 435, 436 (2001)), which apparently contains some, but not all, nonprecedential patent decisions.  See e.g., Wirco, Inc. v. Rolock, Inc., 17 U.S.P.Q.2d 1084, 1990 WL 12901 (Fed. Cir. Feb. 14, 1990) as opposed to Mechanical Plastics Corp. v. Unifast Industries, Inc., 1988 WL 25422 (Fed. Cir. March 28, 1988).

2  For purposes of creating this chart, I used the additional limitation "CO(c.a.fed.)" to exclude CCPA and Court of Claims decisions, some of which are included in Westlaw's "ctaf" database.  In addition, I separately compared the results from a keyword search of the entire "ctaf" database to the results from the Lexis search in order to identify any Lexis-only hits that might have been excluded by the Westlaw court limiter.  This process did not reveal any such hits.

3 These results include every search hit that contained the term "inequitable conduct," regardless of the context.  It thus should not be viewed as reflecting any measure of substantive inequitable conduct determinations.  In addition, hits resulting from search terms appearing only in the database-specific casenotes were excluded, as were instances where the database contained duplicate entries of the case opinion or included a copy of a withdrawn opinion.   For more substantive analyses of inequitable conduct jurisprudence, see Lee Petherbridge, Jason Rantanen & Ali Mojibi, The Federal Circuit and Inequitable Conduct: An Empirical Assessment, ssrn id 1686102; Mammen, supra note 1.

4 In addition to double-checking the single-database cases against the search results of the other database, I also spot-checked several decisions against the Lexis/Westlaw case database as a whole by using terms from the parties' names and the Federal Reporter citation, where available.  Although in some instances this resulted in a hit, the contents of those hits were blank.  See, e.g., Air Products & Chemicals, Inc. v. Tanner, 738 F.2d 454 (1984) (nonprecedential) (no opinion in Westlaw; opinion in Lexis).

4 Although the results for 1997 appear equal, each database contained one opinion for that year that is not in the other database.

Judge Moore Weighs In on Vacatur of Invalidity Opinions

CAFC, Inequitable Conduct, Invalidity, Patent, Patent Cases 2011, Rantanen,

By Jason Rantanen

The Ohio Willow Wood Company v. Thermo-Ply, Inc. (Fed. Cir. Order 2011)
Panel: Rader (author), Newman (additional views), Moore (concurrence)

When a patentee is faced with an judgment of invalidity or inequitable conduct, it is a relatively common tactic to settle with the accused infringer who, as a condition of the settlement agreement, then joins the patentee in a joint motion for vacatur of the adverse decision.  Although vacatur requires exceptional circumstances, it is sometimes granted by the district court.  See e.g., Gracenote, Inc. v. MusicMatch, Inc.; Block Financial v. LendingTree; New Medium v. Barco.

The situation becomes more complex, however, when settlement occurs while the case is on appeal. Willow Wood involves an appeal of an Eastern District of Texas judgment invalidating the asserted claims of Patent No. 7,291,182.  While the appeal was pending, the parties settled and filed a motion for remand to the district court for consideration of a motion for vacatur.  In July 2010, the CAFC issued an order pointing out the high standard for vacatur and ordered the parties to explain what extraordinary circumstances would be presented to the district court that would justify vacatur.  Ohio Willow Wood Co. v. Thermo-Ply, Inc., (Fed. Cir. Order July 29, 2010) (nonprecedential). 

After considering the parties' response, along with an intervention request by a third party also being sued for infringement of the patent, the panel granted the request for "the limited purpose of the district court's consideration of the parties' motion for vacatur."  Ohio Willow Wood Co. v. Thermo-Play, Inc. (Fed. Cir. Order 2011) (Willow Wood II). The CAFC retained jurisdiction, however, "so that any of the parties may seek appellate review by notifying the Clerk of the Court within thirty days of entry of the district court’s decision on remand."  Id. at 3.

Concerned about the remand's potential imprimatur on the joint vacatur motion, Judge Moore, writing in concurrence, expressed the opinion that vacatur of existing invalidity opinions should be a rare and disfavored event, particularly in the patent context.  Citing U.S. Bancorp Mortgate Co. v. Bonner Mall Partnership, 513 U.S. 18, 29 (1994), the judge reiterated the high threshold for justifying vacatur following settlement: "[o]nly in 'exceptional circumstances' should a district court grant vacatur at the request of the litigants."  Willow Wood II concurrence at 2.  This is particularly true with respect to patents:

In this case, for example, the patentee has already sued another party on the patent in question. If the decision that invalidated the patent at issue is not vacated, then the patentee will be collaterally estopped from asserting this patent in this and other suits, thereby saving courts and litigants the time and money it takes to proceed with patent litigation. Patent litigations are among the longest, most time-consuming types of civil actions. As of 2009, 384 patent cases had been pending in the district courts for three years or more. 2009 Admin. Off. U.S. Cts. Ann. Rep., at Table S-11. Moreover, the costs of patent litigation are enormous with an average patent case costing upwards of $3 million for each side. See American Intellectual Property Law Association, Report of the Economic Survey 2009 I-129 (2009). If the district court vacates its invalidity judgment then other defendants and other district courts will be forced to proceed with infringement suits, as there would likely be no collateral estoppel. Even if there were no other suits pending, these concerns should still weigh heavily against vacatur, as the only reason the patentee would want an invalidity judgment vacated is to potentially enforce the patent against others.

Concurrence at 3-4.

Judge Moore's decision to weigh in on the merits of the vacatur issue was criticized by Judge Newman, however, who wrote separately "to point out that the views of our colleague in separate concurrence are not the court’s remand order." Willow Wood II, additional views at 2.  Although favoring the remand on the basis that the district court is in the better position to rule on the issue of vacatur, Judge Newman declined to endorse Judge Moore's proffer of judicial advice, commenting that "[o]ur remand should be unencumbered by even the appearance of prejudgment or of the weight to be given to various considerations. Indeed, the issues on which our colleague in concurrence offers judicial advice are more complex than is here recognized."  Id.

In re Vistaprint Ltd.: Venue Transfer Denied

CAFC, Jurisdiction, Patent, Patent Cases 2010, Rantanen,

By Jason Rantanen

In re Vistaprint Ltd. (Fed. Cir. 2010)
Panel: Gajarsa, Schall (author), and Moore

In a counterpoint to its recent decision in In re Acer, this morning the Federal Circuit denied a request for a writ of mandamus seeking transfer of venue out of the Eastern District of Texas.  The underlying action was bought by ColorQuick, LLC, which holds a patent relating to the preparation of production data for printing, against Vistaprint Limited and OfficeMax Incorporated.  As in Acer, none of the parties resided in Texas: Vistaprint, a foreign corporation, has a wholly-owned subsidiary in Massachusetts; OfficeMax is a Delaware corporation with its principal place of business in Illinois; and ColorQuick is a New Jersey corporation.  Both the panel and author in this appeal were identical to the panel and author that granted the writ in In re Acer.

In denying the request for a writ, the CAFC acknowledged the lack of residency, but ruled that the district court did not abuse its discretion in denying transfer.  The panel first noted that although a trial court has broad discretion in transfer decisions pursuant to 28 U.S.C. § 1404(a), "that is not the same as saying that it may accord weight simply as it pleases."  Slip Op. at 4.  Applying that standard, the panel concluded the district court's weighing of factors in this case did not amount to a "patently erroneous result."  Id. (quoting In re Volkswagen of Am., Inc., 545 F.3d 304, 310 (5th Cir. 2008) (en banc)). Specifically, the CAFC concluded that the district court had not abused its discretion in weighing two factors relating to judicial economy: that the trial court had gained substantial experience in construing the claims of the same patent during a prior litigation and that there was a related case currently pending before the same court.

The CAFC also rejected the petitioners' argument that it is always improper for a district court to deny transfer based on judicial economy when all of the convenience factors clearly favor transfer.  While the court noted the importance of the convenience factors, it also recognized that "§ 1404(a) commits the balancing determination to the sound discretion of the trial court based not on per se rules but rather on an 'individualized, case-by-case consideration of convenience and fairness.'"  Slip Op. at 6-7 (quoting Van Dusen v. Barrack, 376 U.S. 612, 622 (1964)).  In this specific case, the CAFC could not conclude that "the trial court's balancing was so unreasonable as to warrant the extraordinary relief of mandamus."  Id. at 8.

Note: The opinion's final footnote appears to summarize the panel's overarching view on mandamus petitions directed to the venue transfer issue.  It states:

Our holding today does not mean that, once a patent is litigated in a particular venue the patent owner will necessarily have a free pass to maintain all future litigation involving that patent in that venue. However, where, as here, the trial court performed a detailed analysis explaining that it is very familiar with the only asserted patent and the related technology, and where there is a co-pending litigation before the trial court involving the same patent-in-suit, and pertaining to the same underly-ing technology and accusing similar services, we cannot say the trial court clearly abused its discretion in denying transfer.

En Banc Federal Circuit Arguments in TheraSense and TiVo: Update

En Banc, Patent, Rantanen,

By Jason Rantanen

Update: Binal Patel from Banner & Witcoff was kind enough to provide Patently-O with a transcript that the firm prepared of the TheraSense oral argument.  It can be obtained here: Download Therasense v Becton – transcription

* * *

Today the en banc Federal Circuit heard arguments in TheraSense v. BD and Bayer (Inequitable Conduct) and TiVo v. Echostar (post-injunction infringement proceedings).  Audio of both arguments is now available via the Federal Circuit's website, and Bruce Wexler of Paul Hastings has written a summary of the TheraSense argument.

Cancer Research Technology v. Barr Laboratories: Prosecution Laches and Inequitable Conduct

Inequitable Conduct, Infringement, Ownership, Patent, Patent Cases 2010, Patent Prosecution, Pharma, , ,

By Jason Rantanen

Cancer Research Technology Ltd. v. Barr Laboratories, Inc. (Fed. Cir. 2010)
Panel: Newman, Lourie (author), Prost (dissenting)

Although overshadowed by the en banc Federal Circuit arguments in TheraSense v. Becton Dickinson this morning, Cancer Research Technology v. Barr Laboratories may provide a preview of what the opinions in TheraSense could look like – although it doesn't necessarily indicate which view of inequitable conduct will ultimately prevail.  In Cancer Research, Judges Lourie and Newman reversed a district court finding of prosecution laches and inequitable conduct, while dissenting Judge Prost would have reached the opposite result.

The patent at issue (the '291 patent) involved a set of thirteen tetrazine derivatives that the original 1982 specification identified as possessing anticancer activities based on animal studies.  During the first nine years of prosecution, the examiner repeatedly rejected the claims due to lack of utility; rather than file a response to the office actions, the applicant instead filed continuation after continuation.  In 1991, Cancer Research obtained ownership of the patent application and shortly thereafter responded to the examiner's arguments.  The patent issued in 1993 and expires in 2014. 

Following Cancer Research's clinical testing, the FDA approved one of the compounds covered by the '291 patent (marketed as TEMODAR) for the treatment of one type of cancer in 1999 and a second in 2005.  In 2007, Barr Laboratories filed an Abbreviated New Drug Application ("ANDA") for a generic form of TEMODAR.  Cancer Research sued Barr for infringement four months later.  During the district court proceedings, the parties stipulated to validity and infringement and, after a bench trial, the court found that the patent was unenforceable due to prosecution laches and inequitable conduct. 

Prosecution Laches
Given the nearly ten-year delay before any meaningful response to the examiner's rejection was filed, Barr contended that the patent was unenforceable due to prosecution laches.  The district agreed, concluding that the delay in prosecution was unreasonable and unexplained.

On appeal, the majority reversed the finding of prosecution laches, holding that the doctrine requires not just unreasonable delay, but also a showing of prejudice.  The majority further held that "to establish prejudice, an accused infringer must show evidence of intervening rights, i.e., that either the accused infringer or others invested in, worked on, or used the claimed technology during the period of delay."  (Slip Op. at 9).  Here, there was no evidence of intervening rights during the prosecution period, such as evidence showing that someone other than the patent holder attempted to develop the claimed compounds.  Even Barr itself waited until 2007 – four years later than required – before filing its ANDA.  The majority also noted that there was no public harm: in the absence of the patent, Cancer Research likely would not have been incentivized to develop TEMODAR at all. 

Writing in dissent, Judge Prost rejected the notion that prosecution laches requires prejudice, let alone intervening rights; rather, under her reading of the precedent such a requirement is not part of the laches determination.  Furthermore, in her opinion, both Barr and the public were harmed by Barr's inability to market a generic version of TEMODOR.

Comment: I'm unconvinced by Judge Prost's argument on this point.  If she is correct, then the '291 patent was never enforceable – be it in 2007, when Barr filed its ANDA, or 1993, when it issued.  Yet without an enforceable patent, Cancer Research would never have developed TEMODOR, let alone engaged in the expensive Phase III clinical studies necessary to demonstrate its safety and efficacy.  Thus, the "harm" to the public would been greater in the absence of the '291 patent, not less.

Inequitable Conduct
The majority also rejected the district court's finding of inequitable conduct, while the dissent reached the opposite conclusion.  Both opinions focused on the subject of intent to deceive. 

The inequitable conduct issue in this case revolved around an extensive series of articles by an inventor on the '291 patent that presented data from post-application clinical trials of the claimed compounds.  These articles included conclusions indicating that some of the claimed compounds demonstrated high toxicity and low anticancer activity, which the district court found to be highly material to the patent claims because it directly contradicted statements in the '291 patent regarding the compounds' utility in treating cancers, as well as the patentability of a broadly written claim.

The majority, following the "intent cannot be inferred from materiality" line of thought, concluded that the district court's only basis for finding intent was its determination that the withheld articles were highly material.  "Because the district court did not rely on any other evidence to support its finding of deceptive intent beyond that used to find the withheld data material, the court in effect relied solely on its materiality finding to infer intent to deceive."  Slip Op. at 17.  The majority also concluded that the inference of deceptive drawn by the district court about the inventor's publication of data was not the only reasonable inference; rather, the broad publication of this data in multiple articles is inconsistent with an inference of intent to deceive.  Thus, an equally reasonable inference is that the inventor did not appreciate the potential importance of the published data to the patentability of the patent claims.

Judge Prost, again writing in dissent, would have affirmed the district court's determinations.  In contrast to the majority, which required independent evidence of intent, her view of inequitable conduct is that it does not require separate evidentiary bases for materiality and intent; rather it is appropriate to cite to the same evidence for materiality and intent.  Furthermore, here there was additional evidence of intent in the form of the district court's credibility findings, "which are virtually unreviewable by this court."  Thus, under her approach to intent in inequitable conduct, "[w]e should not draw inference that the district court has already excluded based on its own credibility findings."

Comment: The majority and dissent's views on intent can be partially reconciled under the position that, although an intent to deceive may be partially based on evidence of materiality, materiality cannot be the sole basis for the finding of intent to deceive.  Here, in the majority's opinion, the finding of materiality was the sole basis for the intent to deceive determination, because the only additional factor – the credibility determination – was based on an erroneous inference.  On the other hand, in the dissent's view credibility determinations are unreviewable and are sufficient to provide the "beyond the materiality" support for an intent to deceive finding.

Hyatt v. Kappos: Federal Circuit Opens Door to Post-BPAI Civil Actions

BPAI, En Banc, Enablement, Patent, Patent Cases 2010, , , , , , , , ,

By Dennis Crouch

Hyatt v. Kappos (Fed. Cir. 2010) (en banc)

Summary: In a 6-2-1 en banc decision, the Federal Circuit has reversed its prior precedent and held that a patent applicant must be allowed to introduce new evidence in a Section 145 civil action filed to challenge a USPTO refusal to grant patent rights and that the issues implicated by the new facts must be considered de novo.

[W]e hold that the only limitations on the admissibility of evidence applicable to a § 145 proceeding are the limitations imposed by the Federal Rules of Evidence and Federal Rules of Civil Procedure. Therefore, we hold that the district court applied the wrong legal standard for the admissibility of evidence in a § 145 proceeding and abused its discretion when it excluded Mr. Hyatt's declaration. . . .

The particular significance of a § 145 civil action is that it affords an applicant the opportunity to introduce new evidence after the close of the administra-tive proceedings—and once an applicant introduces new evidence on an issue, the district court reviews that issue de novo.

However, the Court also wrote that an applicant may still be barred from presenting new "issues" in the civil action and that, when no new evidence is presented, that BPAI findings and rulings should be given deference under the Administrative Procedures Act.

Impact: This decision could be seen as relieving some pressure on applicants to ensure that their cases for patentability are exhaustively presented to the USPTO's internal Board of Patent Appeals and Interferences (BPAI). The decision is especially important in light of the growing role of BPAI appeals in the ordinary course of patent prosecution. In its argument, the USPTO suggests that a strategic applicant may now choose hold-back some evidence from the BPAI appeal in order to overcome the APA deference if the case goes to the District Court.

Statute in Question: 35 U.S.C. § 145 creates a right to a "civil action" in Federal District Court against the USPTO Director whenever an applicant is "dissatisfied with the decision of the Board of Patent Appeals and Interferences in an appeal under section 134(a)." In the alternative, an applicant may appeal directly to the Court of Appeals for the Federal Circuit.

Background: Gil Hyatt is a well-known inventor and successful patentee. Hyatt filed a civil action in 2003 after the BPAI sustained written description and enablement rejections for seventy-nine of Hyatt's claims. The examiner had issued "2546 separate rejections of Mr. Hyatt's 117 claims" based on the doctrines of inadequate "written description, lack of enablement, double patenting, anticipation, and obviousness." The Board reversed all of the examiner rejections except for the § 112 p1 arguments. Complicating this case is the fact that the application's claimed priority date is 1975. Hyatt has aggressively pushed the bounds of USPTO practice. This decision is one of more than a dozen Federal Circuit decisions focusing on Hyatt's patent rights. When California pursued Hyatt for tax revenue for his patent licenses, Hyatt took the case to the Supreme Court and eventually won a $388 million judgment against the state of California for invasion of privacy.

After the Board affirmed a set of written description and enablement rejections, Hyatt filed a Section 145 civil action and included a declaration offering new evidence of enablement and written description. The district court excluded that inventor-declaration from evidence based on Hyatt's "negligence" in failing to previously submit the information to the PTO. In a 2009 panel decision, the Federal Circuit held that the district court had properly excluded the new evidence – holding that the district court may properly exclude evidence that Hyatt should have produced to the PTO. That opinion was penned by former Chief Judge Michel and Joined by Judge Dyk. Judge Moore wrote a vigorous dissent that supported a patent applicant's right to a full civil action including the right to submit additional evidence when challenging a PTO decision.

Judge Moore wrote the en banc decision that was joined by Chief Judge Rader and Judges Lourie, Bryson, Linn, and Prost. Judge Dyk dissented and was joined by Judge Gajarsa. Judge Newman Concurred-in-Part – arguing that the civil action should not give deference to PTO factual determinations.

A key to the majority decision is the notion that a Section 145 civil action is not an appeal, but rather a new, separate lawsuit filed to force the PTO to act. In its analysis, the court began with a focus on the 150-year history of the civil action right (and its predecessor Bill in Equity) and the reality that new evidence has always a part of those remedies. See, e.g., Gandy v. Marble, 122 U.S. 432 (1887) (explaining that the [predecessor] § 4915 suit in equity was "not a technical appeal from the Patent Office, nor confined to the case as made in the record on that office"). The court then reviewed the current text of the statute, implications of the APA, and various policy arguments before reaching its conclusions.

In a 37-page dissent, Judge Dyk argued that the majority made an improper leap from (1) the correct premise that new evidence should be admissible in the civil action to (2) the incorrect conclusion that the law provides no meaningful limits on the introduction of new evidence regardless of what was presented at the BPAI.

Notes:

Split Court Denies Rehearing En Banc in Sun Pharmaceuticals v. Eli Lilly

Obviousness, Patent, Patent Cases 2010, Rantanen,

By Jason Rantanen

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. 2010) (denial of rehearing and rehearing en banc)

In Sun Pharmaceutical, a Federal Circuit panel affirmed a district court determination that Eli Lilly's patent for a method of using gemcitabine to treat cancer was invalid due for obviousness-type double patenting based on another application, filed the same day, claiming the compound gemcitabine and disclosing its use for treating cancer.  (The previous Patently-O write-up is here).  This morning the Federal Circuit issued an order denying Eli Lilly's petition for rehearing and rehearing en banc.  The court was closely split on the latter, with four of the nine currently sitting judges dissenting on the decision not to rehear the decision en banc.

The dissent's principal concern was that, in its view, the panel opinion involved a departure from precedent, thus creating an intra-circuit split.  According to the dissent,

the panel held the claims to the anticancer use to be invalid for double patenting because the anticancer use was mentioned (but not claimed) in the continuation-in-part specification that is not prior art, stating that “[t]he asserted claims of the later ’826 patent simply claim the anticancer use disclosed in the specification of the ’614 patent,” reported at 611 F.3d at 1389.

The dissent pointed out that this approach, which focused on the disclosure of the simultaneously filed patent, not its claims, was contrary to precedent:

Uniformly, unlike examination for obviousness based on prior art, the issue of obviousness-type double patenting is directed to whether the invention claimed in a later patent is an obvious variant of the invention claimed in an earlier patent. The panel opinion violates a vast body of precedent.

Furthermore, according to the dissent, expanding the doctrine of obviousness-type double patenting to the facts of this case serves no good policy purpose and creates a schism in the law – a schism that should be addressed by the court en banc:

A change of law “in ways that negatively impact the patentability of important later-discovered uses” serves no public purpose in areas in which commercial development requires patent protection. Id. If the majority of the court now believes, as a matter of policy, that the law should be changed in this new direction, en banc treatment is particu-larly appropriate, for the court’s rule is that the earlier precedent prevails unless overruled en banc. A situation in which the court ignores this rule, and applies whatever law the panel prefers, is an indictment of the ability of this court to provide stable law in the areas entrusted to us.

Comment: Given that there are currently only nine sitting Federal Circuit judges, it seems unlikely that the court will grant a rehearing en banc absent extraordinary circumstances – especially in cases where the panel decision was unanimous.  In that situation, in order for an appeal to be reheard en banc, at least five of the six judges who did not participate on the panel would need to vote to rehear the decision en banc.  Of course, there are instances when this would not apply, as senior judges and visiting judges frequently participate in panel determinations, but it is something to keep in mind for the near future.

Patently-O Bits and Bytes

Bits and Bytes, Patent
  • Professor Lichtman has introduced a new IPColloquium podcast: A chat between the UCLA law professor and Chief Judge Rader. The podcast is setup to provide free CLE for many states. [Link]
  • 10% discount for Patently-O readers at the IBC Legal Conference in London on “Standards & Patents.”  Nov. 16–17, 2010. Discount Code: KW8099PTBG. [Link]
  • Upcoming Hearings:
    • Nov 8: Supreme Court will hear oral arguments in Costco v. Omega. The case involves the concept of copyright exhaustion in the international context.  The decision will likely directly impact the parallel patent law doctrine.
    • Nov 9: The Federal Circuit will hear en banc oral arguments on two cases: (1) Therasense v. BD (rethinking the law of inequitale conduct); and (2) TiVo v. EchoStar (post-judgment treatment of modified product-lines).
  • Satellite Offices are currently under consideration at the USPTO.  In some recent statements, Commerce Secretary Locke suggested that Detroit may a chosen spot. [Link] I contacted PTO officials who indicated that no final decisions had been made, but that some announcement may be forthcoming this calendar year.  I expect that some cities are seriously lobbying at this point.

The Federal Circuit and Inequitable Conduct: Part I

CAFC, Inequitable Conduct, Patent, Rantanen,

By Jason Rantanen

Professor Lee Petherbridge, Ali Mojibi and myself are circulating a draft of our paper Inequitable Conduct and the Federal Circuit: An Empirical Analysis for comment.  The underlying study examines the content of the entire body of Federal Circuit inequitable conduct jurisprudence, and the paper offers several interpretations of the reported data.

Among the most interesting are: that the Federal Circuit seems to apply a stricter standard for inequitable conduct than a substantial number of the tribunals it reviews; that the Federal Circuit’s inequitable conduct standard is applied primarily through the intent to deceive component of the analysis; and that while the apparent lack of clarity in the inequitable conduct standard may be a result of judicial variation on the court, it may also represent a preference by the Federal Circuit to effect a jurisprudential design, the purpose of which is to encourage good faith behavior on the part of patent applicants while only rarely finding inequitable conduct. 

The abstract reads as follows:

Inequitable conduct is unique judicially created doctrine designed to punish patent applicants who behave inequitably toward the public in the course of patent acquisition.  Its name alone strikes fear into the hearts of patent prosecutors, and justly so – for when successfully asserted, inequitable conduct can have devastating consequences that reach far beyond a patentee’s case.  The need for a systematic empirical study of inequitable conduct jurisprudence has become especially pressing now that the Federal Circuit is reviewing inequitable conduct en banc – in terms so broad as to be unprecedented in the history of the doctrine.  This Article reports such a study. 

The study reported here provides evidence, inter alia, that the Federal Circuit applies an inequitable conduct standard stricter than that applied by a substantial number of the tribunals it reviews.  The Federal Circuit’s stricter standard manifests primarily through the intent to deceive component of inequitable conduct doctrine.  For all intents and purposes the Federal Circuit has no substantive jurisprudence around the balancing component, and the materiality component is comparatively less impactful then intent to deceive.  The court appears to have trouble communicating its stricter standard to lower tribunals.  We offer some explanations for why this might be so, and offer some modest suggestions that might advance inequitable conduct doctrine.

The complete Article can be downloaded here.   As this is a work in progress, we are particularly interested in any comments, including alternate explanations for the results we discuss.  In addition to responding below, comments can be sent to us directly or to prm.icpaper@gmail.com.

Guest Post: An Interesting Preview of Myriad?

Patent, Patent Cases 2010, ,

By Professor Paul M. Janicke, University of Houston Law Center

The Myriad case from the Southern District of New York, involving patent eligibility of DNA isolates derived from naturally occurring DNA, drew a great deal of attention. The court basically held such isolates ineligible for patent coverage as being too similar to the natural substances, and hence barred by the product-of-nature case law. In the district court Myriad drew twenty-three amici briefs and a great deal of press attention. It is now on appeal at the Federal Circuit, where the first brief is due to be filed October 22. However, in a little-noticed partial dissenting opinion in another case, Circuit Judge Timothy Dyk has given a preview of his likely views on this important question.

The appellate case was Intervet Inc. v. Merial Ltd., decided by a Federal Circuit panel on August 4. The case involved DNA sequences encoding viruses harmful to pigs. According to the patent involved, knowledge of such sequences facilitates detection methods and production of vaccines against the harmful viruses. The patent specification gave full-length DNA sequences for five strains of these types of viruses, and a sequence for a similar but harmless pig virus for comparison purposes. The issues raised below and on appeal were: (i) whether the district court’s constructions of certain claim terms were correct; and (ii) whether a narrowing amendment made in the PTO while a claim was under prior art rejection foreclosed all access to the doctrine of equivalents for the territory between the original language and the amended language or left some of it open. No statutory subject matter issue was raised below or in the appeal.

The Intervet panel majority, consisting of Judges Prost and Bryson, decided those issues largely in favor of the patentee, Merial. Judge Dyk issued an opinion concurring in part and dissenting in part on the appealed questions. However, he also took the occasion to caution that the court’s decision in the case did not mean the court was acquiescing in the patent-eligibility of DNA, even in isolate form: “I write separately primarily to make clear that in construing the claims, we are not deciding that the claims as construed are limited to patentable subject matter.” He proceeded to address the main issue pending in Myriad, namely, whether isolates of DNA similar to DNA found in natural sources like humans or animals are eligible for patenting, or whether they run afoul of the Supreme Court’s pronouncements about products of nature in cases such as Funk Bros., Chakrabarty, and the recent Bilski decision. Judge Dyk indicated he did not think claiming the DNA in its isolated form was sufficient to distinguish it, for eligibility purposes, from the naturally occurring substance. He read the Supreme Court cases to require subject matter that is “qualitatively different” from the naturally occurring substance, and said it was “far from clear” that DNA isolates as claimed here met that test.[8] Perhaps foreshadowing his position in Myriad, he stated:  

The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.

The impact of Judge Dyk’s views is difficult to predict. His is certainly an important judicial voice. However, he may not be on the panel drawn to hear the Myriad appeal, and the case may never be heard en banc. Moreover, these might not be Judge Dyk’s final positions on the issues. Only time will tell how this important case plays out. 

* * * * *

[1] Association for Molecular Pathology v. United States Patent & Trademark Office, 2010 U.S. Dist. LEXIS 35418 (S.D.N.Y. April 2, 2010). Myriad Genetics was a co-defendant and co-owner of at least one of the patents in this declaratory action and exclusive licensee under others, hence Myriad has become the popular name of the case.

[2] 2010 WL 3064311 (Fed. Cir. 2010).

[3] See U.S. Patent 6,368,601, col. 1, lines 6-10.

[4] Id. at *9.

[5] Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948).
[6] Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). 

[7] Bilski v. Kappos, 130 S.Ct. 3218 (2010).

[8] Intervet, 2010 WL 3064311 at *11.

[9] Id.

Prometheus v. Mayo: Patenting Medical Methods

Method Claims, Patent, Patent Cases 2010, Patentable Subject Matter

Prometheus Labs. v. Mayo Collaborative Services (Mayo Clinic) (Fed. Cir. 2010)

This case is one of several pending Federal Circuit appeals that are questioning whether medical diagnostic and treatment methods are the proper subject of patent protection.

The claims asserted by Prometheus are directed toward a method of “optimizing therapeutic efficacy” by first administering an active drug (6-thioguanine) to a subject and then using the subject’s metabolite blood-level to adjust future doses of the drug.  (U.S. Patents 6,355,623 and 6,680,302). Thus, most of the claims are centered around three ordered-steps of:

  1. administering the drug to the subject;
  2. determining the amount of drug in the subject’s blood; and
  3. re-calibrating the drug dosage based on step-2.

A broader claim (claim 46 of the ‘632 patent) eliminates the administering step of claim 1 above.

The district court found the claims invalid as lacking patentable subject matter under 35 U.S.C. 101.  On appeal, the Federal Circuit reversed — holding that the steps of “administering a drug” and “determining the level of 6-thioguanine” were both sufficiently transformative of “a particular article into a different state or thing.”  That Federal Circut decision was based on the court’s machine-or-transformation test that was subsequently discredited by the Supreme Court in Bilski v. Kappos (2010).  In the wake of its Bilski decision, the Supreme Court vacated the Federal Circuit’s Prometheus decision and remanded for a new opinion.  Seeing this as a potential watershed case, Mayo immediately requested that the Federal Circuit hear the case en banc.

Briefing by October 1: The Federal Circuit has apparently denied the en banc request and has moved-forward with a rapid briefing schedule: By October 1, 2010, both parties are scheduled to submit 20–page briefs “addressing the effect of the Supreme Court’s Bilski decision on the disposition of this case. No additional briefing or oral argument is contemplated at this time.”  The scheduling order was signed by the court clerk Jan Horbaly.

Judges in Charge: The scheduling order suggests that the remand will be taken as a supplement to the original decision. A quirk of that original decision is that the three-member panel included two judges who are not on the Federal Circuit (Chief Judge Paul Michel (Ret.) and E.D. Texas District Court Judge Ron Clark). The third member of the panel is Judge Lourie.  Federal Circuit rules indicate that Judge Clark can retain on the panel on remand, but would not be part of any en banc hearing.

Related cases include Classen Immunotherapies Inc. v. Biogen Idec (method of determining an immunization schedule) and Association for Molecular Pathology v. Myriad Genetics (gene patents). 

Preambles as Limitations

Claim Construction, Patent, Patent Cases 2010,

By Jason Rantanen

American Medical Systems, Inc. v. Biolitec, Inc. (Fed. Cir. 2010)
Panel: Bryson (author), Dyk (dissenting), and Prost

It may come as no surprise that the law on whether claim preambles can serve as limitations is unclear.  The Federal Circuit is aware of this issue, and at least one judge suggests that it may be time for the court to address this issue en banc.

The patent in this case, No. 6,986,764, relates to technology for vaporizing tissue using laser radiation.  The invention can be used to treat Benign Prostatic Hyperplasia, a condition in which growth of the prostate gland restricts the passage of urine out of the bladder and through the urethra.  By vaporizing or ablating some tissue, the size of the prostate is reduced, thus reducing bladder outlet obstructions.  Although laser radiation was known in the art, various problems were associated with its use.

The inventors of the '764 patent determined that by using high "volumetric power density" (a high amount of energy delivered to a given volume of tissue) they could produce increased vaporization efficiency while minimizing one of the problems associated with the procedure, residual coagulation.  The patent is directed to various methods and devices for achieving this high volumetric power density by manipulating variables such as wavelength, output power, beam quality, irrigant composition, and distance between the optical fiber and the tissue.

The dispute on appeal hinged on whether the preamble constituted a limitation.  Claim 31 is representative of the method claims. (The apparatus claims are similar, but recite "[a]n apparatus for photoselective vaporization of tissue.")  It recites:

A method for photoselective vaporization of tissue, comprising:

delivering laser radiation to a treatment area on the tissue, the laser radiation having a wavelength and having irradiance in the treatment area sufficient to cause vaporization of a substantially greater volume of tissue than a volume of residual coagulated tissue caused by the laser radiation, wherein the delivered laser radiation has an average irradiance in the treatment area greater than 10 kiloWatts/cm2 in a spot size at least 0.05 mm2.

During claim construction, the district court determined that the preamble phrase "photoselective vaporization" was a "fundamental characteristic" of the invention, and construed the term to mean "using a wavelength that is highly absorptive in the tissue, while being absorbed only to a negligible degree by water or other irrigant."  Based on this construction, the court granted summary judgment in favor of the accused infringer.

On appeal, the majority disagreed, concluding that the preamble phrase "photoselective vaporization of tissue" does not limit the claims of the '764 patent.  The court first noted the limited circumstances in which the preamble may limit claim scope:

“Generally,” we have said, “the preamble does not limit the claims.”  Nonetheless, the preamble may be construed as limiting “if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” A preamble is not regarded as limiting, however, “when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.”  If the preamble “is reasonably susceptible to being construed to be merely duplicative of the limitations in the body of the claim (and was not clearly added to overcome a [prior art] rejection), we do not construe it to be a separate limitation.”  We have held that the preamble has no separate limiting effect if, for example, “the preamble merely gives a descriptive name to the set of limitations in the body of the claim that completely set forth the invention.”

Slip Op. at 8-9 (internal citations omitted).  After rejecting a prosecution history-based argument and the argument that the preamble phrase provided a necessary antecedent basis, the court determined that the phrase "does not embody an essential component of the invention":

Instead, the term “photoselective vaporization” is simply a descriptive name for the invention that is fully set forth in the bodies of the claims….The bodies of the asserted apparatus claims (claims 63-64) describe a structurally complete device, including a laser adapted to deliver “radiation at a wavelength and irradiance . . . sufficient to cause [tissue] vaporization[.]” The bodies of those claims identify the covered wavelengths by function (“sufficient to cause vaporization”), and nothing in the claim language suggests that the term “photoselective” further limits those wavelengths.

Slip Op. at 10 (internal citations omitted).

Judge Dyk disagreed.  After first noting the confusing and unclear nature of the court's jurisprudence on this issue, he suggested that the court should dispense with the current articulation and instead apply the rule that preambles always limit claims:

It seems to me that a rule recognizing that all preambles are limiting would make better sense and would better serve the interests of all concerned. There is, after all, little to be said in favor of allowing an applicant, in the claim drafting process, to include material in the claims that is not binding. If patentees are allowed to include material in the claim definitions that is not bind-ing, patentees can suggest or imply one position before the U.S. Patent & Trademark Office (“PTO”) to secure allowance of the patent on the theory that the preamble is limiting and another, inconsistent position in infringe-ment litigation on the theory that it is not limiting. Principles of fairness thus dictate that the patentee should be required to clearly define the claimed inven-tion’s scope. By creating a uniform rule that all pream-bles are limiting, we would ensure the patentee has the burden of drafting a patent that avoids confusion as to the scope of the claims….Neither the Supreme Court nor our court sitting en banc has ever addressed the preamble limitation issue. I think the time may have come for us to eliminate this vague and confusing rule.

Dissent at 3-4.  He then turned to the issue of whether the preamble phrase in this case limited the scope of the patent, and concluded that it did based on the prosecution history and what he viewed as a definition of the term in the Summary of the Invention.  He also disagreed with the majority that the district court's construction would be inconsistent with the specification. 

GPG v. ITC: Federal Circuit Review of ITC Determinations

Infringement, Patent, Patent Cases 2010,

By Jason Rantanen

General Protecht Group v. International Trade Commission (Fed. Cir. 2010)
Majority opinion authored by Judge Dyk, joined by Judge Prost.  Dissenting opinion by Judge Newman.

ITC determinations are subject to review by the Federal Circuit under the standards of the Administrative Procedure Act, which allows for de novo review of legal determinations and review of factual findings for substantial evidence.  Although the parties in this appeal largely agreed on the meanings of the relevant claim terms, the majority concluded that the ITC's infringement finding lacked substantial evidence.  Writing in dissent, Judge Newman asserted that the majority's conclusion was based on issues never raised by the appellants.  

* * * *

The three appellants in this appeal, GPG, Trimone, and ELE, import ground fault circuit interrupters ("GFCIs") into the United States.  Pass & Seymour, Inc. obtained an exclusion order from the ITC following the Commission's finding that the devices infringed three patents: 7,283,340; 5,594,398; and 7,164,564. 

On appeal, although the appellants raised "numerous issues" challenging the Commission's determination of infringement, the panel found most of them unpersuasive.  Nevertheless, the majority did conclude that the Commission had erred in some respects, finding that (1) GPG's 2003 and 2006 GFCIs and ELE's 2006 GFCIs do not infringe the '340 patent because they lack a "detection circuit; (2) Trimone's 2006 GFCI's and ELE's 2006 GFCIs do not infringe the '340 patent because they lack the "load terminals" of the patent; and (3) GPG's 2006 GFCI's do not infringe the '398 patent because they perform the function of the "latching means" in a substantially different way than the structure disclosed in the patent.  In all other respects, the court affirmed the lower tribunal's determination.

The disagreement between the majority and dissent is illustrated by their positions on the "detection circuit" claim term, although it permeates the determinations on the other two terms as well.  The Administrative Law Judge construed "detection circuit" to mean "at least one detection circuit having a circuit segment connected between the line terminals and configured to generate a predetermined signal in response to detecting a proper wiring condition, which occurs when the line terminals are connected to a source of AC power.”  Neither ELE nor GPG challenged the construction on appeal; however, they argued that the Commission erred in adopting the ALJ's infringement finding.  The majority agreed that this element was not infringed: 

The construed claims require the “detection circuit” to “generate a predetermined signal in response to detecting a proper wiring condition.” Initial Determination, slip op. at 85 (emphasis added). But as Dr. Harman’s own testimony makes clear, his “predetermined signal” is merely the “current flow” originating from the hot line terminal. J.A. 40,396. The identified circuit does not generate this current; it is the current that comes from the AC power connection. So instead of detecting a proper wiring condition and generating a signal in response, as the properly construed claim requires, the accused GFCIs simply have power to operate, or not. Dr. Harman’s testimony is not substantial evidence to support a finding that ELE’s 2006 GFCIs infringe claims 14, 18, and 30 of the ’340 patent.

(Slip Op. at 9).  The majority applied similar reasoning with respect to GLG. 

In describing both ELE and GPG's arguments, the majority paid particular attention to the dissent's assertion that the appellants did not raise this issue, responding in a footnote that:

The dissent suggests that the parties did not raise this argument, but ELE clearly argued that “[b]y treating the ‘predetermined signal’ as including whatever AC power happens to arrive at a building from the local power plant, the Commission has broadened this limitation beyond all recognition and effectively reads it out of the claim.”

(Slip Op. at 8, fn. 3).

In a strident dissent, Judge Newman took a significantly different view of the ITC decision and majority opinion on appeal:

The Initial Decision of 170 pages and the Commission’s supplemental rulings of 32 pages present a full understanding of the technology, with rigorous discussion of the evidence and extensive analysis, findings, and conclusions. This court now finds its own facts, applies theories that were not raised by any party, uses incorrect standards of review, and creates its own electrical technology contrary to the uniform and unchallenged expert testimony.

(Dissent at 2).  With respect to the majority's "detection circuit" reasoning, after an extensive discussion of the Commission findings, Judge Newman concluded that:

[t]he court creates a theory not proposed by any party, and rules that a signal that originates from the line terminal is not generated by the detection circuit and thus is not “generated.” See Maj. Op. at 9 (“The identified circuit does not generate this current; it is the current that comes from the AC power connection.”). There is no support for this theory. The only signal generated in response to proper wiring as described in the ’340 patent is “generated” in the same way as in the accused devices, that is, the detection circuit uses power from the properly wired line terminals to supply a signal (claim 14) or response (claim 30) that allows the device to be reset. That is how the Commission, and the parties, interpreted the term. The court’s new interpretation of “generate” was not debated and is not briefed.

(Dissent at 8-9).

Notes:

  • I understand that Pass & Seymour is seeking a rehearing and rehearing en banc on the ground that the majority's approach is in conflict with the APA, and intends to raise the argument that the court based its determination on issues not preserved or presented by the parties, thus unfairly prejudicing the party against whom the issues were decided and wasting the resources of the parties and ITC.
  • The Federal Circuit also issued a companion opinion addressing Pass & Seymour's appeal from the ITC's determination that GPG's 2003 devices and Trimone's 2006 devices do not infringe the '398 patent, and that ELE's 2003 and 2006 devices, GPG's 2003 and 2006 devices, and Trimone's 2006 devices do not infringe Patent No. 7,212,386.  The appeal turned on questions of claim construction, with the majority opinion affirming the ITC's constructions largely by applying a "plain meaning" approach.  Judge Newman concurred in the result, but took the position that, with respect to the '386 patent, the majority should have adhered to the Commission's construction, rather then adopting its own construction.