Court Publicly Reprimands Ed Reines, Recipient of Email from then-Chief Judge Rader (to be updated)

By David Hricik

(Note:  yesterday when writing this, it struck me as odd that this was en banc (I don’t think that’s procedurally proper and it surely deprives Reines of any “appeal,”)  and some of the facts, upon critical thought, don’t make a lot of sense. I’m going to read the source documents.  Click on “ethics” above to keep reading.)

In early June, 2014, the Federal Circuit in an unusual per curiam order ordered Ed Reines to show cause as to why he should not be sanctioned for forwarding an email sent to him by then-Chief Judge Rader.  The Federal Circuit today issued an en banc per curiam decision publicly reprimanding Mr. Reines for his actions.  The opinion, In Re Edward R. Reines, is here.

The email from Chief Judge Rader that began the events reads:

Ed,

On Wednesday, as you know, the judges meet for a strictly social lunch. We usually discuss poli- tics and pay raises. Today, in the midst of the general banter, one of my female colleagues inter- rupted and addressed herself to me. She said that she was vastly impressed with the advocacy of “my friend, Ed.” She said that you had handled two very complex cases, back to back. In one case, you were opposed by Seth Waxman. She said Seth had a whole battery of assistants passing him notes and keeping him on track. You were alone and IMPRESSIVE in every way. In both cases, you knew the record cold and handled every question with confidence and grace. She said that she was really impressed with your performance. Two of my other colleagues immediately echoed her en- thusiasm over your performance.

I, of course, pointed out that I had taught you everything you know in our recent class at Berkeley together . . . NOT! I added the little enhancement that you can do the same thing with almost any topic of policy: mastering the facts and law without the slightest hesitation or pause!

In sum, I was really proud to be your friend today! You bring great credit on yourself and all associated with you!

And actually I not only do not mind, but encourage you to let others see this message.

Your friend for life, rrr

Consistent with his encouragement to let others see the email, Reines forwarded it to clients and potential clients.

The decision analyzed whether Reines’ conduct violated Model Rule of Professional Conduct 8.4(e). That rule states that “[i]t is professional misconduct for a lawyer to . . . state or imply an ability to influence improperly a government agency or official to achieve results by means that violate the Rules of Professional Conduct or other law.” The court noted that the ABA has stated that “a lawyer who suggests that he or another lawyer is able to influence a judge or other public official because of a personal relationship violates Rule 8.4(e).” Id. (quoting Lawyers’ Manual on Prof’l Conduct (ABA/BNA), at 101:703 (Mar. 30, 2011)).

The court held that Reines had violated the rule.  Specifically, it reasoned:

First, the email both explicitly describes and implies a special relationship between respondent and then-Chief Judge Rader. The text of the email describes a close friendship between the two. The email included the language, “[i]n sum, I was really proud to be your friend today,” and closed with “[y]our friend for life.” The very fact that the email was a private communication rather than a public document implies a special relationship, and then-Chief Judge Rader’s sharing of internal court discussions (which would be ordinarily treated as confidential) about the lawyer’s performance in a pending case implies an unusually close relationship between respondent and the then-Chief Judge. Respondent’s comments transmitting the email also convey a special relationship with then-Chief Judge Rader and the Federal Circuit. Respondent described the email as “unusual” or “quite unusual” in some of his accompanying comments, Reines Ex. 4; Ex. 8; Ex. 44; Ex. 45, and referenced his “stature” within the court and his role as chair of the Federal Circuit’s Advisory Council, Reines Ex. 38.

Second, recipients of the email also viewed it as suggesting the existence of a special relationship between respondent and then-Chief Judge Rader and perhaps other judges of the court. Several responses referred to the high opinion then-Chief Judge Rader and judges in general had for Mr. Reines. 5 Other responses specifically referenced the friendship between respondent and then- Chief Judge Rader.

Third, the transmission of the email did more than suggest that respondent should be retained because of his superior advocacy skills. It suggested that his special relationship with the court should be taken into account. Respondent touted his role as chair of this court’s Advisory Council, and stated that his “stature” within the court had helped “flip” a $52 million judgment in favor of his client and that he “would love to help [the recipient of his message] do the same.” Reines Ex. 38. Another lawyer in respondent’s firm in forwarding the email stated that respondent “knows the judges extremely well.” Reines Ex. 49. Albeit respondent noted that he did not approve of the communication, he took no steps to advise the recipient of his disapproval. Decl. of Edward R. Reines ¶ 21.

Fourth, in sending the email to clients and prospec- tive clients, respondent sought to directly influence their decisions about retaining counsel. He typically stated, “[a]s you continue to consider us for your Federal Circuit needs, I thought the below email from Chief Judge Rader might be helpful.” Reines Ex. 11.7 Prospective clients likewise stated that they would consider it in making retention decisions.8

Finally, the email itself and respondent’s comments accompanying the sending of the email suggested that Federal Circuit judges would look favorably on the retention of respondent. Then-Chief Judge Rader invited respondent to distribute the email to others. Respondent suggested that clients should “listen[] to . . . the Federal Circuit judges[.]” Reines Ex. 30.

Id.  Based upon this analysis, the court stated that it would “blink reality” to pretend that forwarding the email did not imply a special relationship with the judge.  Id.

The court then determined that the penalty would be a public reprimand.  Not only had Reines acknowledged he had erred by forwarding the email, the court found mitigation in the fact that he had been encouraged to do so, and, further, because it was not an express but was an implicit statement that he could influence the court.

After rejecting a First Amendment challenge, the court ended with two somewhat curious observations. First it stated there was a separate issue that it was referring to the California bar concerning an exchange of gifts:

On Mr. Reines’s side, he provided a ticket for one concert, at another concert arranged for upgrading to a standing area near the stage, and arranged for backstage access for then-Chief Judge Rader at both. Then-Chief Judge Rader paid for accommodations. This occurred while Mr. Reines had cases pending before this court.

The court did not decide the issue but referred it “and the underlying relevant documents to the California bar authorities for their consideration.”  Id.

Second, the court stated that it was maintaining certain documents relating to the investigation under seal.  It stated that it was doing so “since this does not concern a matter as to which we have imposed discipline.”  Instead, it was leaving “it to the California bar authorities whether and when such materials should be disclosed.”  Id.

My Comments.

I clerked for Chief Judge Rader ending about 18 months ago. I never perceived him to be influenced by anything other than the merits of a case — period.  I also know he has a tendency to be effusive (that is putting it mildly) in emails.  As a result, the context of Chief’s emails to anyone who knows him discounts some of this.

But, in my view the court’s ruling was correct.  (Well, no it wasn’t.  See the ethics page by clicking above.)

En Banc Federal Circuit to Review ITC’s Power over Induced Infringement

By Dennis Crouch

Suprema, Inc. and Mentalix v. US International Trade Commission and Cross Match Tech (Fed. Cir. 2013/2014)

Although the USITC handles plenty of patent cases, it actually derives its power from the Tariff Act, 19 U.S.C. § 1337(a)(1)(B). That provision indicates that the government agency can prohibit the import or sale-after-import of “articles . . . that (i) infringe a valid and enforceable United States patent” The Tariff Act does not further define patent infringement and so the ITC has generally referred to Section 271 of the Patent Act for guidance.  As with district court patent litigation, ITC merits decisions are also appealed to the Court of Appeals for the Federal Circuit.

Here, Cross Match’s asserted patent covers a fingerprint-scan methodology that includes both hardware and software components. The hardware is manufactured abroad and imported by Suprema and then, once in the US, combined by Mentalix with the software to make a product used to infringe. Of importance, the imported hardware does not – by itself – directly infringe the patent. However, the USITC found that Suprema was liable for inducing infringement under 35 U.S.C. 271(b).

On appeal, the Federal Circuit reversed that judgment — holding instead that the USITC’s power only extends to block articles that are themselves infringing at the point of importation. The result for this case is that the inducement theory of infringement could not stand because it requires both additional steps to complete the infringement as well as a particular mens rea. Oddly, however, the majority did find that the USITC may still have power when the cause of action is contributory infringement rather than inducement. This distinction was based upon the notion that inducement is focused on the “conduct of the inducer” and “is untied to an article.” Judge O’Malley penned the Federal Circuit opinion and was joined by Judge Prost. Judge Reyna wrote in dissent.

The ITC and Patentee both filed petitions for re hearing en banc and the Federal Circuit has now granted those petitions. The questions presented are as follows

Cross Match asks:

Whether the United States International Trade Commission (“ITC”) has authority to find a Section 337 violation—and issue an exclusion or cease and desist order—where it finds that an importer actively induced infringement of a patented invention using its imported articles but the direct infringement occurred post-importation.

Cross Match argues that the question is largely answered by Young Eng’rs, Inc. v. ITC, 721 F.2d 1305 (Fed. Cir. 1983); Vizio, Inc. v. ITC, 605 F.3d 1330 (Fed. Cir. 2010); and Disabled Am. Veterans v. Sec’y of Veterans Affairs, 419 F.3d 1317 (Fed. Cir. 2005).

The USITC asks:

(1) Did the panel contradict Supreme Court precedent in Grokster and precedents of this Court when it held that infringement under 35 U.S.C. § 271(b) “is untied to an article”?

(2) Did the panel contradict Supreme Court precedent in Grokster and this Court’s precedent in Standard Oil when it held that there can be no liability for induced infringement under 35 U.S.C. § 271(b) at the time a product is imported because direct infringement does not occur until a later time?

(3) When the panel determined the phrase “articles that . . . infringe” in 19 U.S.C. § 1337(a)(1)(B)(i) does not extend to articles that infringe under 35 U.S.C. § 271(b), did the panel err by contradicting decades of precedent and by failing to give required deference to the U.S. International Trade Commission (“the Commission”) in its interpretation of its own statute?

(4) Did the panel misinterpret the Commission’s order as a “ban [on the] importation of articles which may or may not later give rise to direct infringement” when the order was issued to remedy inducement of infringement and when the order permits U.S. Customs and Border Protection to allow importation upon certification that the articles are not covered by the order?

The USITC argues that these questions are fully answered (in its favor) by Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 940 n.13 (2005); Standard Oil Co. v. Nippon Shokubai Kagaku Kogyo Co., 754 F.2d 345, 348 (Fed. Cir. 1985) (Rich, J.); Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l, Inc., 246 F.3d 1336, 1351 (Fed. Cir. 2001); Vizio, Inc. v. Int’l Trade Comm’n, 605 F.3d 1330, 1343-44 (Fed. Cir. 2010); The Young Engineers, Inc. v. U.S. Int’l Trade Comm’n, 721 F.2d 1305, 1310, 1317 (Fed. Cir. 1983); Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837, 843 (1984); and Enercon GmbH v. Int’l Trade Comm’n, 151 F.3d 1376, 1381 (Fed. Cir. 1998).

The accused infringers here argued that the fingerprint scanning hardware they are importing are simple staple goods that cannot themselves infringe even if their intended use is infringing.

Documents:

In many ways, this is another divided infringement inducement case. The Supreme Court is currently deciding that issue in Akamai and a decision is expected within the next four weeks.  The Federal Circuit may do well to delay its briefing in this case until Akamai is decided.

= = = = =

Parallel Process: Despite its “international” name, the USITC is actually a branch of the U.S. government charged with protecting U.S. industry and U.S. goals in international trade.  The USITC’s jurisdiction focuses solely on border-crossing issues and, in the patent context, investigates infringing imports.  It turns out that district courts can also block the importation of infringing goods.  There are some differences in remedy and process, but the basic patent policy question is whether the additional parallel procedure offered by the USITC fills an important gap in district court adjudication. And, if so, why does that gap exist?

Administrative Law: Moving from patent policy, the issues here also focus on a continued power struggle between the various branches of government. One question here is the level of deference that should be given to the USITC in carrying out its mandate.

– Dennis

Federal Circuit Again Declines to Revisit Cybor

By Jason Rantanen

Retractable Technologies, Inc. v. Becton, Dickinson and Company (Fed. Cir. 2011) (CAFC en banc denial) Download 2010-1402 en banc order
Before Rader (dissenting), Newman, Plager, Lourie, Bryson, Linn, Dyk, Prost, Moore (dissenting), O'Malley (dissenting), and Reyna.

As in the past, the Federal Circuit has again expressly declined an invitation to revisit its 1998 en banc holding in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 that claim construction is reviewed de novo.  Once again, however, that decision was not without dissent.  Both Judge Moore, joined by Chief Judge Rader, and Judge O'Malley wrote to express their view that Cybor should be revisited. Professor Tun-Jeng Chiang expresses his views on this issue below.

In addition to recommending that the court reconsider the issue of deference, Judge Moore's dissent emphasizes the problematic nature of claim construction review by the Federal Circuit itself: on the one hand, "[c]laim construction is the single most important event in the course of a patent litigation"; on the other, "our rules are still ill-defined and inconsistently applied, even by us."  Moore dissent at 1.  This problem is especially acute in Retractable Technologies: "Retractable simply cannot be reconciled with our en banc decision in Phillips."  Id. at 4.  Here, Judge Moore asserts, the majority applied its own approach to claim construction, not that of Phillips, "[c]hanging the plain meaning of a claim term to tailor its scope to what the panel believes was the actual invention."  Id. at 6.  This is not an isolated instance, Judge Moore points out, but is a common practice that points to a fundamental split on the court about the nature of claim construction: a disagreement over whether claim scope should be limited to "what the inventor actually invented" or instead construed according to the plain meaning to one of skill in the art, a meaning that may be informed – but is not dictated – by the specification.

Note: In  support of her view that the Federal Circuit's own claim construction is ill-defined and inconsistently applied, Judge Moore cited the views of several commentators who "have observed that claim construction appeals often lead to frustrating and unpredictable results for both the litigants and trial courts," including Dennis's post on the panel decision and Hal Wegner's post on Arlington Industries v. Bridgeport Fittings on IP Frontline

Guest Post by Tun-Jen Chiang: Functionalism versus Faux Formalism at the Federal Circuit

Guest Post by Tun-Jen Chiang, Assistant Professor of Law, George Mason University School of Law

One of the longstanding myths about the Federal Circuit is that it is formalist.  This is usually levied by academics as a criticism, but no one does more than the Federal Circuit itself to spread the myth.  For judges, being labeled as a jurisprudential machine is a badge of honor.  Thus, even where their true motivation is clearly policy-based, judges invariably couch their opinions in legalistic terms.

The recent dissents from en banc rehearing in Retractable Technologies, Inc. v. Becton, Dickinson & Co. provide perfect examples.  The issue in Retractable is an old one: should the Federal Circuit give deference to district judges on claim construction?  Judge Moore (joined by CJ Rader) and Judge O’Malley both argued the court should.  Their dissents each begin with the assertion that the Supreme Court in Markman held that claim construction is a “mongrel practice” with both legal and factual components, and this counsels for deference to trial judges.

Let me start by debunking this legalistic argument.  The Supreme Court in Markman did not hold that claim construction is a “mongrel practice.”  It started off by observing that claim construction is intrinsically a mongrel practice, and then held that the Court would adopt a legal fiction that claim construction was a pure question of law.

Why do I say this?  If it is correct that Markman held that claim construction has a factual component, then the result under traditional common law principles is not that trial judges get to decide the factual component.  Trial judges do not decide facts; juries do.  Some well-known exceptions are for suits in equity, for jurisdictional facts, and for procedural facts.  But nobody contends that these exceptions apply.  The claim-construction-is-factual line of reasoning is a legalistic and logical dead end.

Rather, the case for deference to district judges on claim construction must succeed, if at all, entirely based on policy-based concerns.  Trial judges have better access to evidence than appellate judges, and yet they are more experienced at dealing with legal documents like patents than juries.  This is a perfectly plausible policy-based argument, and is almost certainly the true reason for Judges Moore and O’Malley to seek deference for trial judges.  Too bad they feel the need to couch the argument in formalist terms.

En Banc Federal Circuit Arguments in TheraSense and TiVo: Update

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.

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

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:

Guest Post: The Great Haste and Less Milling of Beer v. United States

 

Guest Post: The Great Haste and Less Milling of Beer v. United States (Fed. Cir. 2010, cert. pet. pending)

By Andrew Dhuey

When patent litigators hear the term “rocket docket”, they usually think of the U.S. District Court for the Eastern District of Virginia, long-known for its dedication to accelerated justice. The term doesn’t usually call to mind the U.S. Court of Appeals for the Federal Circuit, though its docketing-to-disposition time has averaged a reasonable 9-10 months. The recent case of Beer v. United States, however, shows that it is possible to have the Federal Circuit decide your appeal on the merits and rule on your en banc hearing petition in a mere 85 days, docketing to disposition.

Beer concerns a newsworthy issue dear to the hearts of federal judges: their pay. Eight current and former federal judges seek to recover cost-of-living adjustments Congress promised federal judges in 1989, but failed to deliver in 1995-97, 1999 and 2007. While the Beer parties disagreed on whether this deprivation of COLAs was an unconstitutional diminishing of judicial pay, they all agreed that the Federal Circuit rejected this exact position in Williams v. United States (Fed. Cir. 2001). In 2002, the Supreme Court denied cert. in Williams over the dissent of Justice Breyer, joined by Justices Scalia and Kennedy.

With the issue resolved in Williams, why did these federal judges raise the same pay issue again in a 2009 U.S. Court of Federal Claims case? The answer rests not with any changes in the law, but instead with changes in the makeup of the Supreme Court. All four justices who joined the court since 2002 (Chief Justice Roberts and Justices Alito, Sotomayor and Kagan) replaced justices who voted to deny cert. in Williams. Assuming the Beer judges still have the three Williams dissenters on their side, they can win on the merits with two of the four newest justices.  

Of course, before they could even file their cert. petition, the Beer judges needed to work their way through the Claims and Federal Circuit courts. To expedite that process, the judges conceded that both the Claims court and the Federal Circuit panel were bound to follow Williams. Their purpose was to overturn Williams, which could only be done by the Federal Circuit sitting en banc, or by the Supreme Court.

On Nov. 3, 2009, thirteen days after filing their notice of appeal at the Federal Circuit, the Beer appellants filed a Petition for Initial Hearing En Banc or, in the Alternative, Motion for Summary Affirmance. Alas, the clerk’s office rejected this filing since the appellants included a copy of their trial court complaint, and that apparently is not okay. [Side note to Judge Beer, et al: none of your court clerks can hold a candle to Federal Circuit clerks when it comes to finding a way to reject a filing]. Appellants’ counsel, Christopher Landau of Kirkland & Ellis, resolved this problem the following day, and the case was then before all 12 active Federal Circuit Judges.

On Jan. 15, 2010, the court denied the petition for initial hearing en banc over the dissent of then-Chief Judge Michel, joined by Judges Lourie and Moore, and the separate dissent of Judge Newman. With that denial of the en banc petition, a three-judge panel granted the Beer appellants’ motion for summary affirmance, with a concurrence by Judge Mayer, who reiterated his previous view that Williams was wrongly decided, but that “neither Congress nor the Supreme Court has done anything in the interim that would warrant this court taking the matter up again.” The Federal Circuit had thus resolved Beer on the merits, en banc, only 85 days after docketing.  

So what, you ask? How could this possibly be of interest to you, a patent litigator? Well, you have a point – you probably won’t have occasion to stipulate at the district court or the BPIA, and on appeal, that your client is toast due to applicable, binding Federal Circuit case law. But some patent litigants are out to make a big, precedential splash (e.g. ,the ACLU in its challenges to the BRCA gene patents). Perhaps in some of these “big picture” cases, a litigant has no realistic hope on the merits, absent the overruling of a Federal Circuit panel decision. [This was not the case for the ACLU, which actually won at the district court].  Or perhaps obliterating a binding precedent would be so valuable to a litigant (e.g., a “frequent defendant”) that it would be willing to concede away weak but non-frivolous arguments on the merits in order to directly attack the harmful precedent, post haste.

Maybe you’ll never have a Beer, but in the right, highly-exceptional patent case, you might want to use the Beer strategy.

Andrew Dhuey is an appellate lawyer last seen being chased by a flower-carrying guy in a dress.

TheraSense v. BD: Briefs on the Merits

By Dennis Crouch

Briefing continues in the en banc appeal of TheraSense (Abbott) v. BD and Bayer. That case stems from a district court finding that the TheraSense patent was unenforceable due to inequitable conduct during prosecution of the patent. The Federal Circuit is taking the case as a vehicle for re-evaluating the judge-made-law of inequitable conduct. I have collected the majority of merits briefs filed thus far in the en banc rehearing.  Becton Dickinson & Bayer’s opposing brief is due October 8, 2010.  Amici-briefs in support of BD/Bayer are due the following week. Oral arguments are scheduled for November 9, 2010 in Washington DC.  (This post merely provides briefs. Analysis to follow.)

Court Decisions:

Party Briefs:

Amicus Brief filed in Support of TheraSense

Amici Briefs filed in Support of Neither Party

Changing the Law of Inequitable Conduct: Abbot Briefs its Case

TheraSense, Inc. (Abbott Labs.) v. Becton, Dickinson and Co. (Fed. Cir. 2010)(En Banc Rehearing)

In TheraSense v. BD, an en banc Federal Circuit is reconsidering the doctrinal structure that it has created to handle allegations of inequitable conduct. Abbott (the patent holder) has filed its opening merits brief arguing that the current law of inequitable conduct over-extends its proper bounds.  In an eloquent opening statement, Abbott writes:

The question in this case is not whether to reform the doctrine of inequitable conduct, but whether to restore it—to its origins in Supreme Court precedent; to the confines Congress intended in the 1952 Patent Act; to the standards this Court articulated en banc in Kingsdown Medical Consultants v. Hollister, Inc., 863 F.2d 867 (Fed. Cir. 1988); and to the standards that govern in other areas of law. This Court has expanded the inequitable conduct doctrine well beyond those boundaries, and the result has been an “ongoing pandemic” of inequitable conduct charges. Taltech Ltd. v. Esquel Enters. Ltd., 604 F.3d 1324, 1335 (Fed. Cir. 2010) (Gajarsa, J., dissenting). The expansion has rendered valuable patents unenforceable based on minor omissions far afield from the doctrine’s purposes. And it has converted the federal courts into roving commissions to enforce standards of conduct before the PTO without regard to whether the alleged infractions had any impact. . . .

Supreme Court precedent and the legal principles embodied in the Patent Act reserve those extreme consequences for the most egregious circumstances—cases where a party “obtained its patent by fraud.” Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172, 175, 176 (1965). As this Court has recognized, the Supreme Court has held patents unenforceable “only in cases of ‘fraud on the Patent Office.’” Star Scientific, 537 F.3d at 1365-66 (quoting Hazel–Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238, 250-51 (1944)); see Larson Mfg. Co. of S.D., Inc. v. Aluminart Prods. Ltd., 559 F.3d 1317, 1343 (Fed. Cir. 2009) (Linn, J., concurring). A party seeking to invalidate a trademark or copyright based on misconduct before the agency must prove it was the product of fraud. The standard should be no less stringent here.

Briefs Filed Thus Far:

Prometheus v. Mayo: En Banc Petition on Patentability of Medical Methods

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)(on petition en banc)

by Dennis Crouch

In the wake of the Supreme Court ruling in Bilski v. Kappos, Mayo has petitioned the Court of Appeals for the Federal Circuit to sit en banc to re-hear its statutory subject matter challenge to the Prometheus  patents. (U.S. Patents 6,355,623 and 6,680,302).

The Prometheus Claims are directed toward an iterative approach of dosing an active drug ingredient (6-thioguanine).  Most of the claims are centered around three ordered-steps of:

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

A broader claim (claim 46 of the ‘632 patent) does not require the administering step of claim 1 above.

In its 2006 decision, The district court held the Prometheus patents invalid under Section 101 — holding that the claims preempt all practical uses of a natural phenomenon.  On appeal, the Federal Circuit reversed that decision — that the claims satisfied the Machine-or-Transformation test. Namely, the Federal Circuit panel held 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.”

The transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined. Because the claimed methods meet the transformation prong under Bilski, we do not consider whether they also meet the machine prong. . . . [C]laims to methods of treatment . . . are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition. . . .

[T]he determining step, which is present in each of the asserted claims, is also transformative and central to the claimed methods. Determining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection. Some form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or other modification of the substances to be measured, is necessary to extract the metabolites from a bodily sample and determine their concentration.

Preemption: The original appellate panel addressed preemption issue somewhat indirectly — holding that the claims could not preempt a fundamental principle because they passed the machine-or-transformation test: “Regardless, because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle.”

Following its Bilski decision, the Supreme Court vacated the Federal Circuit’s Prometheus holding and remanded for further proceedings. 

Not Concentric: Some have described the Supreme Court’s Bilski v. Kappos holding as situated somewhere between the broad State Street decision and the narrow machine-or-transformation test. (See Joe Mullin’s article quoting Mark Lemley as saying “Now we're halfway in between.”).  However, Supreme Court’s vacatur in Prometheus suggests that there are cases that would have been patentable under the strict machine-or-transformation test but that are no longer patentable.  (Otherwise, the court could have simply denied Mayo’s petition for a writ of certiorari as it did in Fergusun.

Roadmap: The machine-or-transformation test offers a clue to the existence of Section 101 qualifying subject matter. However, Prometheus may well present a situation where the claims satisfy MoT, but fail because of their preemptive nature. In its brief, Mayo argues that the three-justice opinion dissenting from the dismissal (DIG) provides a “roadmap” for this case.

Avid ID v. Crystal Import: En Banc Request Denied On Issue of Inequitable Conduct by Non-Inventor CEO

By Dennis Crouch

In Avid ID, the Federal Circuit denied Avid's motion for en banc rehearing on the issue of whether inequitable conduct exists when the non-inventor, non-attorney CEO of a company applying for a patent failed to submit information to the USPTO about pre-filing but non-invalidating trade-show exhibit of a prior version of the patented product. Judge Newman dissented.   

* * *

Avid Identification Systems v. Crystal Import Corp. (Fed. Cir. 2010).

In its original decision in this case, the Federal Circuit held that the president of Avid ID Systems was "substantially involved" with the prosecution of the asserted patent and therefore was subject to the duty of disclosure. The court went on to find that the president had failed that duty by failing to advise the PTO of a trade-show demonstration that occurred more than one-year before the patent application was filed. The inequitable conduct decision was important to the case because the trade-show demonstration of a prior product did not leave the patent invalid under the statutory bar of 102(b)/103(a).   

Avid requested rehearing en banc and that its case join with the pending TheraSense en banc case or, in the alternative, to stay the rehearing decision until after Therasense is decided. The Federal Circuit has denied Avid's motion for rehearing en banc.

Judge Newman dissented from the rehearing denial and would have stayed the case to await changes in the law of inequitable conduct:

The law as applied in Avid is subject to conflicting precedent, a conflict whose resolution is reasonably likely to alter the result. Thus it is prudent, and just, to hold Avid’s petition while the law is clarified. The court today has declined to do so, rendering the subject patent permanently unenforceable, although the patent was found valid on the same prior art that is the basis for its unenforceability.

. . .

This court held that Dr. Stoddard’s demonstration during the Livestock Committee trade show of what the panel calls “some of Avid’s technology,” and Avid calls a “precursor product,” was material to patentability and that Dr. Stoddard was required to assure that the patent examiner was informed. According to the panel opinion, the district court “found that the precursor product, while not invalidating, reflected the closest prior art, and thus was highly material to patentability.” Avid Identification Sys., Inc. v. Crystal Import Corp., 603 F.3d 967, 973 (Fed. Cir. 2010)(“Avid II”). While “closest prior art” has been discussed in the context of whether certain information is cumulative of that already presented to an examiner, see, e.g., AstraZeneca Pharms. LP v. Teva Pharms. USA, 583 F.3d 766, 773-75 (Fed. Cir. 2009), it has never been the law that information is “highly material” simply because it is “closest.” It is not disputed that whatever was demonstrated was not an invalidating disclosure of the patented invention, and not a sale or offer to sell the patented invention, for the jury found that the demonstration at the Livestock Committee was not invalidating. See Avid I, 2007 WL 2901415, at *1.

Dr. Stoddard, who is the president of Avid, is a veterinarian whose principal occupation is running an animal hospital; he is not an electronics engineer and not a chip designer and not an inventor of the patented device and not a lawyer. See Avid II, 603 F.3d at 970. On the undisputed fact that the challenged information is not invalidating, the court’s holding of inequitable conduct is sufficiently questionable to warrant a stay until this court resolves the larger issues before us, including the en banc Order’s query: “Should a finding of materiality require that but for the alleged misconduct, one or more claims would not have issued?” Order, 2010 WL 1655391, at *1. It is at least possible that the court will answer this question in the affirmative. Although I do not venture to guess how Therasense will fare overall, it is not unreasonable to expect that it may affect the Avid decision.

The Avid panel applied the former Rule 56 standard of materiality as stated in J.P. Stevens & Co. v. Lex Tex Ltd., 747 F.2d 1553, 1559 (Fed. Cir. 1984), although this standard was abandoned by the PTO in 1992. The information here criticized does not appear to violate the current Rule 56 standard, and Dr. Stoddard is not within the cadre upon whom is placed the obligation of understanding the patent law, as Judge Linn explained in his dissent. I must, respectfully, dissent from the court’s refusal to stay this appeal in view of the en banc proceeding in Therasense.

Documents:

Statutory Guidelines for Inequitable Conduct

In TheraSense, the en banc Federal Circuit is looking to rewrite the rules of inequitable conduct. By both its name and historic precedent, inequitable conduct appears to stem from non-statutory doctrines of equity. However, as with other equitable doctrines (such as injunctive relief), inequitable conduct could be somewhat tamed by the language of the Patent Act. In his TheraSense amicus brief, Professor Hricik is taking a useful approach by focusing on the statutory basis for holding claims unenforceable.

Two provisions of the Patent Act come to mind. One is general and the other specific. The general statute is 35 USC 282(1). That portion of Section 282 identifies "unenforceability" as a defense to patent infringement. In TheraSense, the court's first goal should be to interpret the meaning of unenforceability as found in that statute.

The more specific provision is Section 288. It is Section 288 that allows a patentee to assert infringement of remaining claims even after some of the claims are found invalid. Section 288 sets a specific limit on this separability principle. Namely, separability of claims does not apply when an invalidated claim was obtained through deceptive intent.

Whenever, without deceptive intention, a claim of a patent is invalid, an action may be maintained for the infringement of a claim of the patent which may be valid. 35 U.S.C. §288.

Section 288 is not exhaustive in its approach. Rather, the statute is only explicit that the remaining claims of a patent can be asserted even after one of the claims was found invalid, so long as that invalid claim was not obtained with deceptive intent. The statute does not explicitly indicate the result when an invalid claim was obtained with deceptive intent or, for that matter, when a valid claim was obtained with deceptive intent. In his brief, however, Professor Hricik concludes that these statutes should be read to – at times – limit the Court’s ability to automatically render all claims of a patent unenforceable after a finding of inequitable conduct.

Contact Professor Hricik if you (or your firm / company) are interested in joining the brief.

An Empirical Study of the Role of The Written Description Requirement in Patent Prosecution

Table 3[Download the Draft Essay]

Essay Overview: In the pending case of Ariad v. Eli Lilly, an en banc Federal Circuit is considering whether Section 112 of the Patent Act as properly interpreted includes a written description requirement that is separate and distinct from the enablement requirement. Although the USPTO has no direct role in the infringement dispute, the government submitted an amicus curiae brief arguing that a separate written description requirement is “necessary to permit the USPTO to perform its basic examination function.” However, when pressed during oral arguments the government could not point to any direct evidence supporting its contention.

This essay presents the results of a retrospective empirical study of the role of the written description requirement in patent office practice. It is narrowly focused on rebutting the USPTO’s claim that the separate written description requirement serves an important role in the patent examination process. To the contrary, my results support the conclusion suggested by Chief Judge Michel during oral arguments that it is indeed “exceedingly rare that the patent office hangs its case on written description.”

For the study, I analyzed 2858 Board of Patent Appeals and Interference (BPAI) patent opinions decided January-June 2009. Written description issues were decided in 123 (4.3%) of the decisions in my sample. Perhaps surprisingly, I found that none of the outcomes of those decisions would have been impacted by a legal change that entirely eliminated the written description requirement of Section 112 so long as the USPTO would still be allowed to reject claims based on the addition of “new matter” (perhaps under 35 U.S.C. Section 132). New-matter style written description requirement rejections were outcome-determinative in 20 of the 2858 cases – about 1.0% of the cases in my sample. (I am very confident that the PTO will retain its ability to make new matter rejections even if the separate written description requirement is eliminated.)

Although there may be valid reasons for retaining a separate written description requirement, this study safely leads to the conclusion that the government’s conclusory statements regarding the doctrine’s critical importance for patent examination lack a factual basis.

Continue reading the essay. [PDF]

These results fit well with those of UMKC professor Christopher Holman that he reported in his 2007 article, Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and its Progeny in the Courts and PTO , 17 ALB. L.J. SCI. & TECH. 1, 62 (2007).

Bits and Bytes No. 127: Patentability shall not be negatived by the manner in which the invention was made.

Upcoming Conferences:

  • World Research Group, a Patently-O job board sponsor, will be holding a TechNet Patents Forum in New York on November 5-6. Patently-O readers will receive a $300 discount by using the promo code EAG476.

Federal Circuit En Banc:

  • On September 18, the Court of Appeals for the Federal Circuit will sit en banc to hear two non-patent cases.
  • Nebraska Public Power v. US:

    • The Nebraska case is one of several dozen Federal Claims actions against the US Government for breach of contract and takings for the Government’s failure to begin removing spent nuclear fuel.
    • Question: Does the mandamus order issued by the United States Court of Appeals for the District of Columbia Circuit in Northern States Power Co. v. United States Dep’t of Energy, 128 F.3d 754 (D.C. Cir. 1997) preclude the United States from pleading the “unavoidable delay” defense to the breach of contract claim pending in the United States Court of Federal Claims, and if so, does the order exceed the jurisdiction of the District of Columbia Circuit?
  • Henderson v. Dep’t of Veteran Affairs:

    • Equitable tolling of claims for veteran’s benefits
    • Question: Does the Supreme Court’s decision in Bowles v. Russell, 127 S. Ct. 2360 (2007), require or suggest that this court should overrule its decisions in Bailey v. West, 160 F.3d 1360 (Fed. Cir. 1998) (en banc), and Jaquay v. Principi, 304 F.3d 1276 (Fed. Cir. 2002) (en banc), holding that 38 U.S.C. § 7266 is subject to equitable tolling?.

Relevance of the “manner in which the invention was made:”

  • 35 U.S.C. 103(a) makes clear that “[p]atentability shall not be negatived by the manner in which the invention was made.” That final sentence of the paragraph was apparently intended to contrast the 1952 law from the Supreme Court’s loose statement in Cuno that a patentable invention must “reveal the flash of creative genius.” 314 U.S. 84 (1941).
  • Should this statement be interpreted to mean that the inventor’s actual process has no relevance to the questions of novelty and nonobviousness? Or, is there still room for a jury to consider the actual creativity and genius of the inventor and the process used. (This question was suggested by a comment on the blog).

Bits and Bytes No. 127: Patentability shall not be negatived by the manner in which the invention was made.

Upcoming Conferences:

  • World Research Group, a Patently-O job board sponsor, will be holding a TechNet Patents Forum in New York on November 5-6. Patently-O readers will receive a $300 discount by using the promo code EAG476.

Federal Circuit En Banc:

  • On September 18, the Court of Appeals for the Federal Circuit will sit en banc to hear two non-patent cases.
  • Nebraska Public Power v. US:
    • The Nebraska case is one of several dozen Federal Claims actions against the US Government for breach of contract and takings for the Government’s failure to begin removing spent nuclear fuel.
    • Question: Does the mandamus order issued by the United States Court of Appeals for the District of Columbia Circuit in Northern States Power Co. v. United States Dep’t of Energy, 128 F.3d 754 (D.C. Cir. 1997) preclude the United States from pleading the “unavoidable delay” defense to the breach of contract claim pending in the United States Court of Federal Claims, and if so, does the order exceed the jurisdiction of the District of Columbia Circuit?
  • Henderson v. Dep’t of Veteran Affairs:
    • Equitable tolling of claims for veteran’s benefits
    • Question: Does the Supreme Court’s decision in Bowles v. Russell, 127 S. Ct. 2360 (2007), require or suggest that this court should overrule its decisions in Bailey v. West, 160 F.3d 1360 (Fed. Cir. 1998) (en banc), and Jaquay v. Principi, 304 F.3d 1276 (Fed. Cir. 2002) (en banc), holding that 38 U.S.C. § 7266 is subject to equitable tolling?.

Relevance of the “manner in which the invention was made:”

  • 35 U.S.C. 103(a) makes clear that “[p]atentability shall not be negatived by the manner in which the invention was made.” That final sentence of the paragraph was apparently intended to contrast the 1952 law from the Supreme Court’s loose statement in Cuno that a patentable invention must “reveal the flash of creative genius.” 314 U.S. 84 (1941).
  • Should this statement be interpreted to mean that the inventor’s actual process has no relevance to the questions of novelty and nonobviousness? Or, is there still room for a jury to consider the actual creativity and genius of the inventor and the process used. (This question was suggested by a comment on the blog).

Bits and Bytes No. 127: Patentability shall not be negatived by the manner in which the invention was made.

Upcoming Conferences:

  • World Research Group, a Patently-O job board sponsor, will be holding a TechNet Patents Forum in New York on November 5-6. Patently-O readers will receive a $300 discount by using the promo code EAG476.

Federal Circuit En Banc:

  • On September 18, the Court of Appeals for the Federal Circuit will sit en banc to hear two non-patent cases.
  • Nebraska Public Power v. US:
    • The Nebraska case is one of several dozen Federal Claims actions against the US Government for breach of contract and takings for the Government’s failure to begin removing spent nuclear fuel.
    • Question: Does the mandamus order issued by the United States Court of Appeals for the District of Columbia Circuit in Northern States Power Co. v. United States Dep’t of Energy, 128 F.3d 754 (D.C. Cir. 1997) preclude the United States from pleading the “unavoidable delay” defense to the breach of contract claim pending in the United States Court of Federal Claims, and if so, does the order exceed the jurisdiction of the District of Columbia Circuit?
  • Henderson v. Dep’t of Veteran Affairs:
    • Equitable tolling of claims for veteran’s benefits
    • Question: Does the Supreme Court’s decision in Bowles v. Russell, 127 S. Ct. 2360 (2007), require or suggest that this court should overrule its decisions in Bailey v. West, 160 F.3d 1360 (Fed. Cir. 1998) (en banc), and Jaquay v. Principi, 304 F.3d 1276 (Fed. Cir. 2002) (en banc), holding that 38 U.S.C. § 7266 is subject to equitable tolling?.

Relevance of the “manner in which the invention was made:”

  • 35 U.S.C. 103(a) makes clear that “[p]atentability shall not be negatived by the manner in which the invention was made.” That final sentence of the paragraph was apparently intended to contrast the 1952 law from the Supreme Court’s loose statement in Cuno that a patentable invention must “reveal the flash of creative genius.” 314 U.S. 84 (1941).
  • Should this statement be interpreted to mean that the inventor’s actual process has no relevance to the questions of novelty and nonobviousness? Or, is there still room for a jury to consider the actual creativity and genius of the inventor and the process used. (This question was suggested by a comment on the blog).

Ariad v. Lilly: Federal Circuit Grants En Banc Request to Challenge Written Description Requirement

Ariad Pharmaceuticals, MIT, and Harvard v. Eli Lilly (Fed. Cir. 2009) (en banc)

The Federal Circuit has granted Ariad's motion for an en banc rehearing of its case. The motion boldly asks whether the written description requirement should be eliminated as a doctrine that is separate and distinct from enablement. The questions:

a. Whether 35 U.S.C. ? 112, paragraph 1, contains a written description requirement separate from an enablement requirement? and

b. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

Ariad's brief is due within 45 days, and Lilly's brief is then due within thirty days of that.

Briefs of amici curiae will be entertained, and any such amicus briefs may be filed without leave of court but otherwise must comply with Federal Rule of Appellate Procedure 29 and Federal Circuit Rule 29. The United States is invited to submit an amicus brief.

Value of Amicus Briefs: In its recent Cardiac Pacemaker decision, the Federal Circuit expressly indicated that it was "appreciative of these [amicus] contributions." To make one particular point in the decision, the court emphasized that Cardiac's extreme position was "not even supported by the lone amicus brief we have received in favor of including method patents within Section 271(f)'s reach."

Although the written description requirement is primarily raised in pharmaceutical and biotechnology cases, it is an increasing aspect of software patent litigation. This decision could have a significant impact both on how patents are litigated and on how they are prosecuted. The inventors here discovered an important biochemical pathway and broadly claimed uses of that pathway.

Notes:

Written Description: Araid Petitions en banc Federal Circuit to Eliminate Separate Written Description Requirement

Ariad v. Eli Lilly (en banc suggestion 2009)

Ariad has petitioned the Federal Circuit for an en banc rehearing – boldly asking the court to eliminate the written description test as a distinct requirement of patentability under 35 USC Section 112, paragraph 1. The petition – drafted by Professors Duffy and Whealan – is essentially a well-formed collage of quotations from Federal Circuit dissents and 19th Century Supreme Court decisions.

The petition raises the following two questions:

(1) Whether this Court has erred by “engrafting . . . a separate written description requirement onto section 112, paragraph 1 …. ” Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d 1366, 1380 (Fed. Cir. 2009) (Linn, J., concurring).

(2) What is the proper test to satisfy the requirement in Section 112, paragraph 1, that a patent specification contain “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same”?

Apart from the merits of this case, the brief notes that half of the Federal Circuit judges “have either voted to grant en banc review of this Court’s written description jurisprudence (Newman, Rader, Bryson, Gajarsa, and Linn, JJ.), or have expressly noted that future en banc review may be appropriate because this Court’s written description standards are unsatisfactory. (Dyk, J.).

Notes:

  • Ariad Brief: ariadrehearingpetition.pdf
  • Federal Circuit Decision
  • The original opinion was written by Judge Moore and joined by Judge Prost. Judge Linn wrote a concurring opinion as a reminder of his belief that the written description requirement should be eliminated and enablement be allowed to do its job.
  • Patent Docs has more.

Tafas v. Doll (En Banc Suggestion)

Tafas v. Doll (En Banc Suggestion)

Both Tafas and GlaxoSmithKline (GSK) have filed petitions for en banc rehearing asking the Federal Circuit to stop the US Patent & Trademark Office (PTO) from implementing any of its proposed rules on continuations and claims.

The proposed rules can be split into two major categories: Rule 75 (requiring applicants to submit Examination Support Documents (ESD) to accompany any application that includes more than five independent or 25 total claims); Rule 78 (limiting applicants to two continuation applications absent a showing of need for more).

In a split decision, the Federal Circuit held that the limitations on continuations improperly conflict with 35 U.S.C. § 120, but that the remaining limits are "within the scope of the USPTO's rulemaking authority." (Limitations on RCEs do not create a problem).

In the motion for en banc rehearing, GSK raises the the questions of:

  1. Whether the Panel majority erred in rejecting the test for determining whether a Patent and Trademark Office ("PTO") rule is "substantive," as set forth in the controlling precedent of Chrysler, supra; Animal Legal Defense Fund, supra; and Cooper Technologies, supra.
  2. Whether the Panel majority erred in holding that the challenged Final Rules, 72 Fed. Reg. 46,716 (Aug. 21, 2007), fall within the PTO's limited, non-substantive rulemaking authority.

Tafas raises similar questions of whether the Federal Circuit:

  1. misapplied significant binding Supreme Court and Federal Circuit precedent concerning the correct standard for classifying administrative rules as "substantive" versus "non-substantive";
  2. failed, contrary to Supreme Court and Federal Circuit precedent, to fully consider evidence that the Final Rules significantly and adversely affect individual rights and obligations under the law;
  3. failed to correctly address, as required by Supreme Court precedent, the threshold question of whether the PTO has the jurisdictional authority under 35 U.S.C. § 2(b)(2) to enact the Final Rules; and
  4. misapplied Chevron deference to its improper determination that Final Rules 75, 265 and 114 were not "inconsistent with existing law".

The federal circuit majority opinion by Judge Prost included a dissent by Judge Rader (arguing that the rules are substantive) and a concurring opinion by Judge Bryson (arguing that the conflict with Section 120 only applies to continuations that are co-pending with the first-filed application).

The diversity of opinion here gives this case an excellent chance at being heard by the full 12-member court. The important administrative law issues will also be appealing to the Supreme Court when it comes time to petition for certiorari.

En Banc Federal Circuit: Infringement of Product-by-Process Claim Requires Practicing the Process

Abbott Labs v. Sandoz (Fed. Cir. 2009) (en banc) 07-1400.pdf

The Federal Circuit had developed two opposing lines of cases for interpreting the scope of a product-by-process claim. Acting en banc sua sponte sub secretum, the appellate body sided with the Atlantic Thermoplatics line in holding that infringement of a product-by-process claim requires practicing the claimed process steps. This decision makes Judge Newman’s 1991 Scripps decision no longer good law. (Note, the en banc portion is only Section III.A.2).

[T]his court now restates that “process terms in product-by-process claims serve as limitations in determining infringement.”

The holding here explicitly focuses on claim construction for the purposes of infringement. Based on my first-pass, it appears that the court has left undecided whether this rule applies for validity purposes. I.e., can a product-by-process claim now cover a well known product made through a new process?

Notes

  • This is a very interesting decision and more analysis will be forthcoming.
  • Perhaps the most interesting portion of the decision is Judge Newman’s 39 page dissent.
  • Based on this Decision, generic Omnicef will continue to be available.