February 2010

False Marking and Patent Reform

Marking Products as Patented: Many manufacturers mark their products as patented by listing the associated patent number on the product or its packaging. The marking serves as constructive notice to potential infringers — allowing a patentee to collect damages for infringement even if the infringer had no actual knowledge of the patent. There have also been a few cases where marking was important to support a plaintiff’s willful infringement allegations. From a non-rights-based perspective, marking a product as patented may create additional consumer goodwill by suggesting that the marked product is innovative and that the design is the valuable property of the manufacturer. The markings may also tend to deter would-be competitors.

Marking is not without risk. The Patent Act provides a cause of action against those who “falsely claim that their products are patented.” The false-marking cause of action is termed a qui tam action because the action may be taken by any private individual on behalf of the government. A successful false-marking claimant must prove two elements: first, that an unpatented article has been marked as patented; and second that the marking was done with intent to deceive the public. Clontech Labs. Inc. v. Invitrogen Corp., 406 F.3d 1347, 1352 (Fed. Cir. 2005).

Rather than calling for damages or compensation, the false-marking statute calls for a fine of “not more than $500 for every … offense.” 35 U.S.C. 292. In the recent case of Forest Group v. Bon Tool, the Federal Circuit held that the “offense” relates to each article that has been falsely-marked. Thus, the fine against a manufacturer that sells a batch of 1,000 tubes of lip-gloss would have an upper limit of $500,000.

Patent Reform: In her recent article, Professor Winston (Catholic U) has argued that the rules of false-marking should be shifted to place more of a burden onto the patentee to avoid false marking. Winston would ease the proof necessary for to prove “intent to deceive the public.” Some manufacturers are requesting patent reform that goes the other way. I have heard of three potential changes being suggested: (1) clarifying that the listing of expired patents is not actionable; (2) limiting the standing to only particular individuals who have been harmed (such as competitors) or otherwise eliminating qui tam enforcement; and (3) overruling the Forest Group decision as a way to limit damages.

The Harm of False-Marking: I am working on a project to understand how the false-marking fine should be calculated. Notably, the fine could be based on any of (1) compensation for the harm caused to the public by the false-marking; (2) disgorgement of the false-marker’s profits due to the false-marking; or (3) punitive damages based on the culpability.

Related Posts:

Patent Law Professors on the Move

Every year March-Madness hits a handful of law professors as they lateral to other law schools. This year is no different.

Moves:

  • Josh Sarnoff is moving from American University to De Paul. Professor Sarnoff has been a champion of applying classic legal theory in his arguments for "shaking the foundations" of our current patent law system. The slot at De Paul opened when Katherine Strandburg left for NYU
  • Michael Risch is moving from West Virginia to Villanova. In addition to patent law, Professor Risch has considerable experience litigating trade secret and copyright cases.
  • Sean Seymore is moving from Washington and Lee to Vanderbilt. Professor Seymore has a PhD in chemistry and likes to focus on issues involving patenting by academic institutions.
  • Ed Lee is moving from Ohio-State to Chicago-Kent (IIT). Professor Lee's scholarship has focused primarily on copyright and internet law.

Many leading law schools still lack a full time faculty members with a patent law focus.

False Marking False Marking False Marking False Marking all at up to $500 per offense

pic-86.jpgSimonian v. Blistex, Ciba, Pfizer, 3M, Edgecraft, Darex, Cisco, Bunn-O-Matic, Oreck, Novartis, Merck, etc. (N.D. Ill. 2010)

Thomas Simonian is a self-described “individual living in Geneva, Illinois.” In a series of at least 27 complaints filed in the past few days, Simonian has raised the stakes of the Federal Circuit’s false marking jurisprudence. Most of the complaints assert false marking claims based on the continued marking of products with now-expired patents. However, a few cases focus on marked products that are allegedly not covered by the patent rights. For instance, in Simonian v. 3M, the plaintiff asserts that the 3M patent requires a “hook portion” but that the marked 3M “Command Strips” do not include that feature.

The cases were filed by the Chicago-based law firm of Vanek, Vickers & Masini.

  • Simonian Cases: Simonian v. Blistex, Inc.(Blistex); Simonian v. Ciba Vision Corporation (Clear Care); Simonian v. Hunter Fan Company (thermostat); Simonian v. Mead Westvaco Corporation (envelopes); Simonian v. Fiskars Brands, Inc. (Fiskars scissors); Simonian v. Pfizer, Inc. (Pfizer); Simonian v. Pella Corporation (Pella windows); Simonian v. 3M Company; Simonian v. The Quigley Corporation; Simonian v. Edgecraft, Corp.; Simonian v. Tru Fire Corporation; Simonian v. Darex, LLC; Simonian v. Cisco Systems, Inc.; Simonian v. Novartis Pharmaceuticals Corp.; Simonian v. Bunn-O-Matic Corporation; Simonian v. Kimberly-Clark Corporation et al; Simonian v. Merial L.L.C. et al; Simonian v. Weber-Stephen Products Co.; Simonian v. Oreck Corporation et al; Simonian v. BP Lubricants USA, Inc.; Simonian v. Irwin Industrial Tool Company; Simonian v. Novartis Animal Health US, Inc.; Simonian v. Novartis Consumer Health, Inc.; Simonian v. Monster Cable Products, Inc.; Simonian v. Global Instruments, Ltd. et al (Riddex); Simonian v. Merck & Co., Inc. et al; Simonian v. Advanced Vision Research, Inc.
  • Other Recent False Marking Cases: O’Neill v. Roche Diagnostics Corporation; Akbar v. Proctor & Gamble Co.; Josephs v. Federal-Mogul Corporation; Josephs v. Sigma-Aldrich Corporation; Seirus Innovative Accessories, Inc. v. Cabela’s, Inc.; Yarbough v. S.C. Johnson & Son, Inc. et al.

Patent Reform Moving Forward

Senator Patrick Leahy (D-VT) announced this morning that a “tentative agreement” has been reached on the patent reform bill with Senator Jeff Sessions (R-AL). “No one will think this is a perfect bill, but we are close to a comprehensive patent reform bill that benefits all corners of the patent community.” Leahy did not provide any further details except that the compromise will “address” the issues of “runaway damage awards” and patent quality.

The reform bill has already been passed by the House.

Standard for Reviewing BPAI Obviousness Decisions

In re Chapman (Fed. Cir. 2010)

The BPAI rejected Chapman's claimed antibody fragment-polymer invention as obvious and Chapman (UCB Pharma) appealed. The 103/102(e) rejection was based on the teaching of a Genentech patent that had been filed two years before Chapman's application.

The appellate decision provides a concise overview of the standard of review of BPAI decisions on obviousness.  However, it leaves opon questions regarding the "legal-conclusion" of obviousness.

The Patent and Trademark Office ("PTO") is governed by the Administrative Procedure Act ("APA"), and PTO decisions are reviewed under the APA standard. Dickinson v. Zurko, 527 U.S. 150, 152 (1999). Thus, we review Board's legal conclusions without deference, and review its findings of fact to determine if they are supported by substantial evidence. . . .

The judicial review provision of the APA includes a harmless error rule. We have noted that "the harmless error rule applies to appeals from the Board just as it does in cases originating from district courts." . . . [T]he burden of showing that the error is harmful normally falls upon the party attacking the agency's determination. . . .

The government argues that these errors are harmless, but we conclude that these errors are harmful because they increase the likelihood that Chapman was erroneously denied a patent on grounds of obviousness. If the Board based its decision on a misunderstanding of [the prior art], its conclusions regarding obviousness are called into question. . . . Because we cannot say with confidence that the Board would have reached the same conclusion in the absence of these errors, we are persuaded they are indeed harmful.

The interpretation of the harmless error rule did not receive significant attention pre-KSR because the rule-oriented approach of the TSM test left meant that most BPAI errors were harmful. The post-KSR law of obviousness is based more on a contextual whole-picture analysis. As such, the line between harmless error and harmful error is blurred. This case resolves some issues by indicating that a BPAI error is harmful if (1) the error "increase[d] the likelihood" that the BPAI erred in its obviousness conclusion and (2) the court cannot confidently announce that the BPAI would have reached the same conclusion absent the error.

Obviousness as a Matter of Law: Although the ultimate conclusion of obviousness is a matter of law, the appellate panel did not take-on the role of analyzing the law. Rather, after identifying the correct factual interpretation of the prior art, the Federal Circuit remanded to the BPAI with instructions to "only revisit its conclusion of obviousness."

The Rising Stature of Reexaminations (Meet in St. Louis)

WulogoOn Thursday, March 4, 2010, 12:00 noon – 1:00 pm, I will be speaking at the Washington University Law School (Room 305 in Anheuser-Busch Hall) on the topic of patent reexaminations. The talk will be primarily directed toward IP-focused law students and faculty. However, the law school has offered to open its doors to folks from the community (free). Last year, several local patent attorneys attended when I spoke about design patent law and their comments really enriched the program. I look forward to meeting you there!

The title of my talk this year is “the rising stature of patent reexaminations.” That title reflects the reality that reexamination filing has become a default strategy for accused patent infringers.  We will talk about recent statistics involving reexamination quality and timeliness as well as “success rates” (AKA “kill rates”).  Most patents undergoing reexamination are also simultenously involved in patent infringement litigation. Those parallels actions create unique and sometimes problematic cross-links that we will discuss.  The final topic will involve potential reexamination reforms that could further improve (or ruin) the process.

Send questions about the event to MPCooper [at] wulaw.wustl.edu.

Patently-O Bits and Bytes

  • InventorsEye is the PTO’s new publication for the independent inventor community with a goal of bi-monthly publication. Looks good. As expected, the publication provides good information with a solid mix of propaganda. The first InventorsEye article writes hopefully that “we currently offer a 50% discount for independent inventors in virtually every fee category. That fee is further reduced by another 50% for independent inventors who make use of our electronic filing system.” Of course, that statement is misleading because it implies that the 50% reduction for EFS use also applies to “virtually every fee category.” Rather, independent inventors receive a 50% reduction on most fees, and an additional 50% reduction on the $330 filing fee. Thus, to file a utility patent application, large-entities pay $1090 ($330 filing fee + $540 search fee +$220 examination fee); Independent inventors pay $545 ($165 filing fee + $270 search fee + $110 examination fee); and electronic filing independent inventors pay $462 ($82 filing fee + $270 search fee + $110 examination fee).
  • Chicago: For several years, the Northwestern Journal of Technology & Intellectual Property has been staging an annual IP symposium. This year’s speakers for the March 5 event include several law professors, Sharon Barner (PTO Deputy) and three partners from my former law firm (MBHB): Donald Zuhn, Joe Herndon, and Mike Baniak. Cost: Free ($200 for CLE Credit).
  • International IP Litigation Costs: Read the new WIPO Magazine special edition on IP Litigation Costs.

Patently-O Bits and Bytes

  • InventorsEye is the PTO’s new publication for the independent inventor community with a goal of bi-monthly publication. Looks good. As expected, the publication provides good information with a solid mix of propaganda. The first InventorsEye article writes hopefully that “we currently offer a 50% discount for independent inventors in virtually every fee category. That fee is further reduced by another 50% for independent inventors who make use of our electronic filing system.” Of course, that statement is misleading because it implies that the 50% reduction for EFS use also applies to “virtually every fee category.” Rather, independent inventors receive a 50% reduction on most fees, and an additional 50% reduction on the $330 filing fee. Thus, to file a utility patent application, large-entities pay $1090 ($330 filing fee + $540 search fee +$220 examination fee); Independent inventors pay $545 ($165 filing fee + $270 search fee + $110 examination fee); and electronic filing independent inventors pay $462 ($82 filing fee + $270 search fee + $110 examination fee).
  • Chicago: For several years, the Northwestern Journal of Technology & Intellectual Property has been staging an annual IP symposium. This year’s speakers for the March 5 event include several law professors, Sharon Barner (PTO Deputy) and three partners from my former law firm (MBHB): Donald Zuhn, Joe Herndon, and Mike Baniak. Cost: Free ($200 for CLE Credit).
  • International IP Litigation Costs: Read the new WIPO Magazine special edition on IP Litigation Costs.

Upcoming Symposium and The Role of Patent Applicant Incentives in Patent Office (PTO) Reform

On February 26, 2010 (Friday), I will be speaking as part of the Stanford Technology Law Review annual Symposium. This year's focus is USPTO Reform.

Topics include:     

  • Quality and Pendency: Drilling Down to Backlog, Deferred Examination, Patent Worksharing and Other Integers to Achieve Primary Goals led by Hal Wegner
  • The Role of Applicant Incentives in Patent Office Reform led by Dennis Crouch
  • Patent Examination Policy and the Social Costs of Examiner Allowance and Rejection Errors led by Ron Katznelson
  • Examiner Characteristics and the Patent Grant Rate led by Mark Lemley & Bhaven Sampat

Other participants include Professors Colleen Chien (SCU), John Duffy (GWU), Jeff Lefstin (Hastings), Roberta Morris (Stanford), Arti Rai (Duke & USPTO), and Brenda Simon (Stanford) as well as Jon Dudas (Foley & Lardner), Leonard Heyman (VMWare), Ed Reines (Weil Gotschal), Robert Sachs (Fenwick & West), Lee Van Pelt (Van Pelt), Janet Xiao (Morrison Foerster), and Mallun Yen (Cisco).

* * * * *

Introduction to My Talk

Applicant Incentives: Although I have been dilatory in providing my materials for the talk (sorry!), my general themes focus on the role of patent applicant and patentee incentives in patent office reform. The incentives conversation is comfortable for intellectual property scholars and practitioners alike. The explicit Constitutional justification for patent and copyright regimes is that an offer of exclusive rights provides an incentive to "promote the progress" in the respective fields. This big-picture incentive award has already been created by the drafters of the Constitution and detailed by Congress and the Courts. Here, l take a narrow approach and consider how applicant incentives should be utilized to achieve the goals of PTO reform. Specific questions include:

  1. To what extent should PTO reforms focus on modifying patent applicant behavior?
  2. Should reforms focused on applicant-behavior lean on rules and requirements or rather employ a softer incentive approach? These "softer incentives" could be in the form of Sunsteinian Nudges or more onerous or strongly beneficial incentives.
  3. Fees: To what extent are patent applicants sensitive to PTO fees? To what extent can (or should) the PTO use its fee structure to modify applicant behavior?

A Dynamic Feedback System: My mental starting point for the topic is Newton's third law of motion: For every action there is an equal and opposite reaction. In the simple case of billiard balls colliding on a table, those reactions are (relatively) easy to predict. In the complex patent system reactions to reforms are less predictable – especially for any particular case. It is also important to recognize that the system is dynamic. Changes in PTO operations lead to changes in patent applicant behavior. These PTO changes may take the form of rules, fees, appeal processes, personnel availability, training, etc.

Provisional patent applications have become increasingly popular since their introduction in 1995. Offering the right to file a provisional application was the first arguably most important step in shifting applicant behavior. However, the low fee, lack of formality, and ease of process in claiming priority all contribute to popularity of the form. While the government has no direct control over applicant behavior, the popularity of provisional applications was likely ensured by these positive incentives. There are many examples of applicant behavior altered by PTO practices. Increasing application fees decreases application filings; offering "free" claims increases claim filings; longer applicant deadlines result in longer waits for applicant responses; etc.

There are two observations that I want to highlight from this discussion thus far – both of which were likely already obvious to most patent folks. (1) The patent office rules & procedures impact patent applicant behavior and therefore have the potential for serving as policy levers. (2) The exerted policy lever need not create a hard-rule to be effective. Rather, non-rights-based policy choices involving fees, procedures, and default rules can also effectively shift applicant behavior. The hard-rule / soft-rule distinction is not always clear. In some situations strong incentives can have the same coercive impact as an absolute rule. (The PTO's recent attempt to limit claim and continuation filings has been described as such.)

Cause of the Problems?: It is typically difficult to pin-down the root cause of problems in dynamic system with multiple independent actors. Take the current PTO backlog problem as an example. One popular explanation accuses the PTO of being too slow and issuing unnecessary rejections. On the flip-side, applicants can be blamed for filing so many applications that are difficult to examine. Both accusations have merit, but neither tells the whole story. (There was no backlog until the first application was filed…) Even while sidestepping the blame-game, this discussion leads to two additional observations. (3) Applicant behavior impacts PTO problems — thus creating the possibility that (4) shifting applicant behavior can help to resolve those problems. In other words, many goals of PTO reform could potentially be met by pushing on applicant incentives.

USPTO Fee Structure: The USPTO has always charged some fee-for-service as a way to avoid directly spending taxpayer monies on the examination and issuance of patents. In 1871, the application fee was $15. By 1952, the fee had doubled to $30 with a surcharge of $1 per additional claim over 20. By 1982, the fees had been raised by a factor of ten to $300 for filing and $10 for excess claims. Today, the filing fee (including the required search and examination fee) is $1090 and additional claims cost $52. Since 1952, the increase averages to a not-too-unreasonable annual rate of 6.4%.

Throughout this time, the USPTO has also charged an issue fee that has been roughly equivalent to the filing fee, although the current issue fee is $1510. This historic distribution is not intuitive. The filing and issue fees must all be paid before any patent rights can be asserted, and the actual PTO budget is overwhelmingly directed toward examination costs (primarily examiner salaries). Only a small part of the budget is spent on the ministerial process of issuing the patent. The filing fee / issue fee distribution is a policy lever. A relatively low filing fee encourages applicants to "take a chance" on patenting inventions that are only marginally likely to be financially successful. The prosecution delay prior to payment of the issue fee gives applicant the opportunity to first determine whether a patent is worthwhile. On the other side of the argument, a relatively high filing fee could limit the absolute number of patent applications filed and also operate to encourage patent applicants to file "higher quality" applications. The PTO also charges maintenance fees (previous known as renewal fees). Perhaps more than any other fees, the maintenance fees are "pure profit" because the PTO does not work for that income.

The analysis of fees leads to the following observation: (5) Wittingly or not, the setting of USPTO fees involves policy choices that shift applicant incentives. Still, the agency (with the help of Congress) could attempt to design its fees in a way that most directly cover costs. However, that approach would waste the potential opportunity to use fees to improve the system inputs. At this point it would be a ridiculous approach, but it would not be inconceivable for the PTO to shift its fees for individual applications according to input quality measures with designated "high quality" applications paying a lower fee.

Additional Issues To be Discussed:

  • USPTO Deadlines, Late Fees, and Deferring Examination
  • USPTO Authority: To what extent should the PTO be given authority to use fees and other mechanismsto intentionally shift applicant behavior.

New regime for use claims (dosage regimes) before the European Patent office (EPO)

Guest Post by Paul Cole, visiting professor of IP law at Bournemouth University

Dosage Regime/ABBOTT RESPIRATORY  G 0002/08 – 19 Feburary 2010

Patentability of the present application was governed by EPC 2000 rather than EPC 1973, and the referring Appeal Board considered it an important point of law whether medicaments for use in therapeutic treatments could be considered novel where the only feature of novelty was a dosage regime. The claim before the Board was directed to:

"The use of nicotinic acid or a compound metabolized to nicotinic acid by the body … for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia … "

The Enlarged Board was first asked to consider the general question: when a medicament was known for use to treat an illness could patents subsequently be granted further new and inventive treatments of the same illness. Under EPC 1973, such further patents had been granted with Swiss-form use claims directed to treatment of new patient groups (T 0019/06, T 0383/90 and T 0233/96), new modes of administration (T 0051/93 and T 0138/95) and different technical effects relating to truly new applications (T 0290/86. T 0254/93 and T 1020/03). The Board held that it was not the intention of the legislators in framing EPC 2000 to change the patent protection available for further therapeutic uses.  Use of a composition as a medicament for unspecified therapy was permitted as a first medical indication and for a specified therapy was permitted as a second medical indication.

A second and more specific question was directed to patentability where the only novel feature was a new and inventive dose regime. The Enlarged Board held that this question should be answered in the affirmative provided that there was a new technical effect, see also UK decision Activis v Merck [2008] EWCA Civ. 444 and German decision X ZR 236/01 Carvedilol II, 19 December 2006.   

As to any appropriate change in EPO practice, simple use claims were now permitted under the changes introduced by EPC 2000. Since the reasons for granting Swiss-form use claims had disappeared with the entry into force of EPC 2000, there was no reason to maintain the "praetorian" approach suggested in case G 0005/83, and such claims would no longer be permitted. As to the transitional provisions governing this change in practice:   

"The Enlarged Board of Appeal is aware of the fact that patents have been granted and many applications are still pending seeking patent protection for claims of this type. In order to ensure legal certainty and to protect legitimate interests of applicants, the abolition of this possibility by the interpretation of the new law given by the Enlarged Board in this decision shall therefore have no retroactive effect, and an appropriate time limit of three months after publication of the present decision in the Official Journal of the EPO is set in order for future applications to comply with this new situation. In this respect the relevant date for future applications is their date of filing or, if priority has been claimed, their priority date."   

The present decision can be seen as an uncontroversial but welcome restatement of the law that will give greater certainty both for applications and oppositions before the EPO and for the enforceability of the resulting patents in the EPC contracting states. Connoisseurs of verbal abuse may, however, wonder whether it was wise to attach the label "praetorian" which at least to English readers has implications of dishonesty, corruption and perhaps subversion to the former Swiss form claim practice whose acceptance by the national courts of the EU contracting states was at times grudging. 

When does an Ordinary Order become a Preliminary Injunction?

Duhn Oil Tool, Inc. v. Cooper Cameron Corp (Fed. Cir. 2010) (nonprecedential)

In a rare appeal from the Eastern District of California, the Federal Circuit has vacated the lower court’s order of preliminary injunctive relief. Duhn Oil’s patent covers a “frac mandrel” or tool for isolating the head of an oil or natural gas well. Cooper Cameron’s version is alleged to infringe when its lockscrews are engaged during installation.

Appellate Jurisdiction over Preliminary Injunction Orders: As an initial matter, the parties argued over whether the court held jurisdiction over the interlocutory appeal since the defendant (Cameron) had previously volunteered to halt the uses covered by the preliminary injunction. On appeal, the Federal Circuit found jurisdiction clearly granted by 28 U.S.C. § 1292 as interpreted by the Federal Circuit. “[I]f the district court’s order expressly grants an injunction, the order is appealable under § 1292(a)(1), without regard to whether the appellant is able to demonstrate serious or irreparable consequences.” Quoting Cross Med. v. Medtronic, 424 F.3d 1293 (Fed. Cir. 2005).

When does an order become an injunction?: A court must make particular findings before it can order preliminary injunctive relief. However, the court has much more leeway when making orders that relate more to the court proceedings such as orders for discovery, preservation of evidence, compelling witnesses, etc. This case raises, but does not answer the question of where the line is drawn between ordinary orders and preliminary injunctions.

Based on its opinion, the district court clearly believed that it had not issued a preliminary injunction. The opinion expressly held that “issuance of a preliminary injunction at this time would not be a measured and appropriate exercise of equitable discretion on the present evidentiary record.” Although it generally denied relief, the court did make a series of orders relating to Cooper Cameron’s “accounting practices.” These accounting practices primarily included maintaining specific evidence regarding equipment orders, items sold, and installation instructions given. The order also granted Duhn the right to photograph newly installed equipment. In addition, the court ordered that Cameron “provide instructions to its frac mandrel customers, which unambiguously state that the lockscrews are not to be engaged during installation or use of the frac mandrel.”

The Federal Circuit focused on the final requirement that Cameron provide installation instructions to its customers and classified that requirement as an injunction because it “specifically imposed . . . an affirmative obligation on Cameron . . . to prohibit Cameron from further allegedly infringing uses.”

The lower court had not intended to issue preliminary injunctive relief and had not specifically found either a likelihood of success on the merits nor irreparable harm absent injunctive relief. Therefore, the injunction was vacated on appeal.

In this case, there were insufficient grounds for the court to enjoin Cameron. A preliminary injunction requires the moving party to show both likelihood of success on the merits, and irreparable harm unless the injunction issues. The district court identified “strongly conflicting evidence” about the possible frequency of Cameron’s future infringement, and the absence of “a sufficient showing for injunctive relief of the scope and of the nature, [sic] including the notice requirement that Plaintiffs are seeking.” Duhn identifies no irreparable harm that it would suffer without the court’s order, and does not cross-appeal the denial of the broader injunctive relief it proposed. For these reasons alone, the injunction was improper. Therefore, we decline Cameron’s invitation to address invalidity and noninfringement in the first instance.

Vacated and Remanded.

Notes & Cases On Point:

  • “[F]or purposes of appeal, requiring a party to do or refrain from doing something that is an integral part of the very matter in litigation….” Moore’s Federal Practice, ¶ 65.21 (1989). Quoted in NTN Bearing Corp. of Amer. v. U.S., 892 F.2d 1004, 1005-06 (Fed. Cir. 1989) (ITC’s stoppage of the collection of import duties was an injunction) and Norcal/Crosetti Foods Inc., v. U.S., 963 F.2d 356, 358 (Fed. Cir. 1992) (lower court’s requirement of marking of imported produce was an injunction).
  • Types of non-injunctive orders include for the purposes of Section 1292(a) include “temporary restraining orders, orders regulating procedural matters, and security orders.” Wright & Miller, 16 Fed. Prac. & Proc. Juris. § 3922 (2d ed.) (Orders Not Constituting Injunctions). Wright and Miller reluctantly offer the definition of a Section 1292(a)(1) “injunction” as embracing “orders that are directed to a party, enforceable by contempt, and designed to accord or protect ‘some or all of the substantive relief sought by a complaint’ in more than temporary fashion.”
  • Holmes v. Bendix Corp., 713 F.2d 792 (Fed. Cir. 1983) (“an appellant from an interlocutory adverse Rule 56 decision must point out something he said or did to alert the court that it would be passing indirectly on the availability of injunctive relief. Otherwise, the congressional care in allowing appeals from interlocutory decisions denying injunctive relief, and not allowing them for appeals from summary judgments, or from declaratory judgments (unless disposing of the whole case), is made meaningless.”).
  • Woodard v. Sage Products, Inc., 818 F.2d 841 (Fed. Cir. 1987) (“an interlocutory appeal under section 1292(a)(1) requires (a) that the order be injunctive in nature, (b) that it cause a serious, if not irreparable, consequence, and (c) that the order can be effectually challenged only by immediate appeal.”)

Ariad v. Eli Lilly: Written Description Requirement

My recent study of BPAI written description requirement jurisprudence was prompted by reading the US Government Brief in the en banc case of Ariad v. Eli Lilly. In the brief, the government indicated its continued support for a separate written description requirement as a tool that the agency uses to eliminate claims during patent prosecution. In sometimes bold font, the government makes its position clear: that a separate written description requirement is "essential to the operation of the patent system;" serves an "indispensable role in the administration of the patent system;" is "fundamental to the operation of the patent system;" and is "necessary for USPTO to perform its examination function." According to the brief, these conclusions are grounded in the USPTO's "practical experience" in "appl[ying] the requirements of Section 112, ¶1 to more than 400,000 patent applications each year."

During oral arguments, the government attorney was pressed for specific evidence supporting its contention that the separate written description requirement serves a practical purpose. As in its brief, the government did not point to any evidence supporting the conclusory statements. The following colloquy at oral arguments between Chief Judge Michel and Mr. Freeman emphasize this point:

Chief Judge Michel: Why does the patent office care? How many applications that can’t be rejected on other statutory grounds will fail only if we [retain the current written description requirement]? . . . I’m asking about impact. . . .

Mr. Freeman on Behalf of the Government: I don’t know an absolute number, your honor, but I think that number must be high. . . .

Chief Judge Michel: I can’t remember ever seeing a patent office rejection that was based only on the failure of written description. I’m not saying there aren’t any, but the flow of cases that come through this court at three or four hundred a year, it is exceedingly rare that the patent office hangs its case on written description. I can’t remember a single case.

Mr. Freeman: Your honor, I don’t have a single case in mind . . . .

Chief Judge Michel: . . . It seems like the practical impact is miniscule, negligible.

Mr. Freeman: Your honor, with all respect, one cannot assume away four-hundred-thousand applications where the written description doctrine comes into play in a great many of them.

My study is essentially directed to the particular questions asked by Chief Judge Michel — How often does the separate written description requirement actually make a difference in patent prosecution? As the data reveals, Chief Judge Michel’s notional recollections from the bench are much more accurate than are the government contentions. I.e., "the practical impact is miniscule, negligible."

[Download the Study]

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).

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).

The Timeliness of the En Banc Rehearing of Hyatt v. Kappos

The pending en banc case of Hyatt v. Kappos is more important now than ever before because the Board of Patent Appeals and Interferences (BPAI or Board) is deciding more appeals than ever before.  The chart below reflects the number of applications with completed appellate briefing that are pending resolution at the BPAI. As active patent prosecutors are well aware, this chart only reveals a small portion of a complex problem.  Appeal briefing has largely become an ordinary part of patent prosecution practice. Most cases where appeal briefs are filed do not actually reach a BPAI decision.  Rather, in most cases the examiner withdraws the standing rejection rather than pursue the appeal.  In this system, appeal briefs have largely become a priced commodity rather than an all-out factual and legal effort.

PatentLawPic928

In Hyatt v. Kappos, the en banc Federal Circuit is focusing on the amount of new evidence that can be presented when challenging a BPAI decision in Federal District Court under 35 USC 145.  The panel decision held that the district court properly refused to allow Hyatt to submit additional expert testimony that went beyond the arguments presented to the BPAI.  Judge Moore dissented from that holding and instead argued that the right to a “civil action” under Section 145 includes a right for a de novo consideration of patentability.

The issues raised in Hyatt v. Kappos are now important for many patent applicants because of the cost-pressures of appeal briefs and the high-likelihood that rejections will be withdrawn based on the briefing.  Typical Applicants do not submit substantial additional evidence of patentability during the appeal process.  However, under Hyatt, the applicant would be barred from substantially adding to the record in a subsequent civil action.

Appealing a BPAI Rejection: Can the Applicant Present New Arguments and New Evidence to the District Court?

Hyatt v. Kappos (Fed. Cir. 2010)

The Federal Circuit has ordered an en banc rehearing of its August 14 decision. The appeal focuses on evidentiary and procedural limits of an appeal of a BPAI decisions to a District Court under 35 USC 145. The Court framed the en banc issues as follows:

(a) Are there any limitations on the admissibility of evidence in section 145 proceedings? In particular—

(i) Does the Administrative Procedure Act require review on the agency record in proceedings pursuant to section 145?
(ii) Does section 145 provide for a de novo proceeding in the district court?
(iii) If section 145 does not provide for a de novo proceeding in the district court, what limitations exist on the presentation of new evidence before the district court?

(b) Did the district court properly exclude the Hyatt declaration?

Background: Hyatt's district court action was originally filed in 2003 as Hyatt v. Rogan after the BPAI sustained written description and enablement rejections for seventy-nine of Hyatt's claims. The examiner had issued 45 separate rejections of Hyatt's claims based on the doctrines of inadequate "written description, lack of enablement, double patenting, anticipation, and obviousness." Complicating the case is the fact that the application's claimed priority date is 1975.

The issues in this appeal case arose when Hyatt filed a civil action in DC District Court to challenge the BPAI decision. In the civil action, Hyatt submitted a new declaration offering additional evidence of enablement and written description. However, the district court excluded that inventor-declaration from evidence based on Hyatt's "negligence" in failing to previously submit the information to the PTO.

Writing for the majority in the original panel opinion, Judge Michel affirmed the exclusion of evidence – holding that the district court may properly exclude evidence that Hyatt should have produced to the PTO. Judge Moore penned a compelling dissent in support of the patent applicant's right to a full civil action including the right to submit additional evidence when challenging a PTO decision.

Briefing: Hyatt's en banc brief will be due around March 31 and the USPTO's response due 28-days later. Briefs of amici curiae may be filed without leave of the court, but must otherwise comply with FRAP 29 and Fed Cir R 29.

* * * * *

35 U.S.C. 145 Civil action to obtain patent.

An applicant dissatisfied with the decision of the Board of Patent Appeals and Interferences in an appeal under section 134(a) of this title may, unless appeal has been taken to the United States Court of Appeals for the Federal Circuit, have remedy by civil action against the Director in the United States District Court for the District of Columbia if commenced within such time after such decision, not less than sixty days, as the Director appoints. The court may adjudge that such applicant is entitled to receive a patent for his invention, as specified in any of his claims involved in the decision of the Board of Patent Appeals and Interferences, as the facts in the case may appear, and such adjudication shall authorize the Director to issue such patent on compliance with the requirements of law. All the expenses of the proceedings shall be paid by the applicant.

Dear Patent Attorney and Patent Agent: Consider Joining to the PTO

The following letter has been sent to many patent attorneys and patent agents asking them to consider joining the USPTO examiner corps.

* * * * *

February 5, 2010

Dear ______

Deputy Under Secretary Sharon Barner and I wanted to contact you directly to let you know about an exciting opportunity for a career as a USPTO patent examiner. The USPTO has recently announced a targeted hiring initiative for experienced IP professionals. We ask that you consider applying for these openings at the USPTO to become a patent examiner.

A career as a patent examiner is both challenging and rewarding. As you consider this opportunity, you should know that USPTO management has undertaken a myriad of initiatives to make the USPTO an outstanding professional work environment. In addition, our modern campus in Alexandria, Virginia, has world-class facilities, including a gym, child-care center, excellent dining and recreational activities nearby. We also have extensive Hoteling programs, where qualified examiners may telework from home.

If you are interested in being considered as a patent examiner, we encourage you to apply to the open USPTO vacancy announcement at http://tiny.cc/ls8j7. Or if you know someone who is interested, please let them know about our open opportunities. If you have questions, please call (800) 786-9757, or send an e-mail to Recruitment@uspto.gov. We hope that you will give serious consideration to applying for our open vacancies. There has never been a more important or promising time to work at the USPTO.

Sincerely,

PatentLawPic927

David J. Kappos

* * * * *

[File Attachment: KapposRecruitingLetter.pdf (33 KB)]

Note: The text above is created by my OCR software which created some errors.

Appealing BPAI Rejections in Ex Parte Reexaminations

I have to admit some prior confusion as to the rules governing appeals from adverse BPAI decisions during an ex parte reexamination. My confusion stems from three potentially conflicting provisions in the Patent Act.

35 U.S.C. 145 indicates that “[a]n applicant dissatisfied with the decision of the Board of Patent Appeals and Interferences in an appeal under section 134(a) of this title may, unless appeal has been taken to the United States Court of Appeals for the Federal Circuit, have remedy by civil action against the Director in the United States District Court for the District of Columbia . . . .

35 U.S.C. 306 indicates that “[t]he patent owner involved in a reexamination proceeding . . . may seek court review under the provisions of sections 141 to 145 of this title, with respect to any decision adverse to the patentability of any original or proposed amended or new claim of the patent.

35 U.S.C. 141 indicates that “[a] patent owner, or a third-party requester in an inter partes reexamination proceeding, who is in any reexamination proceeding dissatisfied with the final decision in an appeal to the Board of Patent Appeals and Interferences under section 134 may appeal the decision only to the United States Court of Appeals for the Federal Circuit.”

§145 was part of the original 1952 Patent Act. §306 was added to the Patent Act in 1980 when ex parte reexaminations were introduced. In 1999, §141 was amended to add the limitation that “[a] patent owner in any reexamination proceeding dissatisfied with the final decision in an appeal to the Board of Patent Appeals and Interferences under §134 may appeal the decision only to the United States Court of Appeals for the Federal Circuit.” In 2002, the portion regarding “inter partes reexaminations” was added to §141.

Conflicting: §141 indicates that a patent owner in reexam may only appeal a BPAI decision to the CAFC; Section 306 indicates that the patent owner in reexam may appeal under either §141 or §145; §145 indicates the availability of an appeal in district court.  Of course, §145 focuses on an “applicant” rather than a patent owner, but pre 1999–cases held that patent owners whose patents are undergoing reexamination are “applicants” for the purposes of §145.

Solution: The PTO interpretation found in 37 C.F.R. § 1.303 and in MPEP § 2279 is that §145 controls and that reexaminations may only be appealed to the Federal Circuit. The caveat is that reexaminations filed prior to the 1999 amendment of §145 may also be appealed to a district court  under §141.

In a 2009 decision, an Eastern District of Virginia court recognized the statutory tension but substantially agreed with the PTO interpretation:

[T]he fact that § 306 continues to cross-reference §§ 141 to 145 following the AIPA’s enactment appears to be in tension with the AIPA amendment to § 141: Although § 145 authorizes a patent applicant–and thus a patent owner under the plain terms of § 306–to file a civil action in the D.C. District Court, § 141 was specifically amended to allow patent owners dissatisfied with a BPAI decision to “appeal the decision only to the United States Court of Appeals for the Federal Circuit.” Id. § 141 (emphasis added). Despite this tension, the statutory provisions continue to make clear that a patent owner’s right to seek court review of a BPAI decision accrues only after the BPAI renders a “decision adverse to the patentability of any original or proposed amended or new claim of the patent.” Id. § 306; see also id. §§ 141-145. Sigram Schindler v. Kappos, 2009 WL 4981473 (E.D. Va. Dec. 18, 2009).

Charles Miller of Dickstein Shapiro has worked on this issue and directed me to the statutory problem. In a forthcoming article, Miller and Daniel Archibald argue that the PTO’s interpretation is wrong and constitutes an unlawful extension of the agency’s authority. In particular, they argue that “Congress did not entrust the PTO with administering, nor did it authorize the agency to enact rules interpreting § 141, § 145, and § 306 of the Patent Act . . . these statutes pertain only to rights in proceedings outside the PTO’s jurisdiction and operational domain, and are exclusively for the courts to interpret and apply in cases that they decide.”

Notes:

  • Read the Sigram Schindler Opinion [File Attachment: SigramSchindlerMemo.pdf (1522 KB)]
  • Read the (losing) arguments by Sigram Schindler [File Attachment: SigramSchindlerBrief.pdf (86 KB)]
  • Reexam Center discusses the Sigram Schindler decision [Link]
  • Note, the Sigram Schindler decision was filed in E.D.Va. because the patentee was challenging the USPTO interpretation of the statutes rather than actually attempting to appeal BPAI decision.
  • The Schindler reexamination was filed by Cisco on US Patent No. 6,954,453. Cisco and Schindler (Teles) are currently litigating an infringement suit over the patent.

 

Viagra, Cialis, & Levitra: Board of Patent Appeals Affirms Rejection of Pfizer’s Broad Patent over ED Treatment

Ex parte Pfizer (BPAI 2010)

Pfizer’s broadest patent covering its bestselling drug Viagra is in the midst of an ex parte reexamination. See Patent 6,469,012. The reexamination was separately requested by Lilly & ICOS (makers of Cialis) and Bayer (maker of Levitra). In addition, the PTO director (then James Rogan) independently ordered reexamination. These separate actions were all merged into one proceeding before the PTO. In parallel, Pfizer has sued Lilly & ICOS – asserting that Cialis infringes the Viagra patent. See Pfizer Inc., et al. v. Lilly ICOS LLC et al, Civil Action No. 02-1561 (D. Del. Oct. 22, 2002). The litigation has been stayed pending reexamination since 2003.

The broad claim (that is said to cover both Levitra and Cialis) is claim 24:

24. A method of treating erectile dysfunction in a male human, comprising orally administering to a male human in need of such treatment an effective amount of a selective cGMP PDEv inhibitor, or a pharmaceutically acceptable salt thereof, of a pharmaceutical composition containing either entity.

During the reexamination, the examiner rejected Claim 24 as anticipated by each of five different references and also issued an obviousness-type double patenting rejection based on three other Pfizer patents. In a 56-page opinion, the BPAI rejected some of the examiner’s reasoning, but affirmed the decision as a whole.

In particular, the Board agreed that prior art descriptions of oral administration of the herb Yin Yang Huo (AKA Horny Goat Weed) serve as anticipatory prior art:

It is undisputed that the herb is orally administered, that icariin is an active component of the herb and that icariin is a selective PDEv inhibitor. Thus, the issue is whether the Yin Yang Huo references describe oral administration of the selective PDEV inhibitor icariin in an amount effective to treat ED. . . .

Appellant argues that a single dosage of Yin Yang Huo fails to provide an amount of icariin sufficient to treat ED . . . However, the selective PDEv inhibitor of claim 24 is not required to have a minimum % inhibition. . . . or a maximum Ki or other enzyme kinetics inhibition value or other defined parameter that would exclude Yin Yang Huo from the claimed method. Moreover, Yin Yang Huo is not administered as a single daily dosage when treating ED. Yin expressly defines one course of treatment as comprising administering 2.5 grams Yin Yang Huo 3 times per day for 20 days (FF 51). Therefore, this rebuttal evidence is insufficient to establish by a preponderance of the evidence that the Yin Yang Huo references fail to disclose oral administration of icariin in an amount effective to treat ED, particularly in view of [the prior art's] disclosed successful treatment of 50 cases of impotence.

Examiner Rejection Affirmed.

Notes

  • [Updated based on Jon's comment below] Pfizer has the opportunity to request a re-hearing and may also appeal the BPAI decision. Regarding a further appeal, the pertinent portion of 35 U.S.C. § 141 reads as follows: A patent owner, or a third-party requester in an inter partes reexamination proceeding, who is in any reexamination proceeding dissatisfied with the final decision in an appeal to the Board of Patent Appeals and Interferences under section 134 may appeal the decision only to the United States Court of Appeals for the Federal Circuit. Although the language is amenable to multiple interpretations, the best interpretation of this is that a patent owner undergoing an ex parte reexamination may only appeal to the CAFC.
  • The re-examination file history is quite long and includes over seventy-three-thousand pages (this total does not include the USPTO patent-documents cited as prior art).
  • What is the expiration date of this patent? Its earliest priority date is a Great Britain from June 9, 1993. A European PCT was then filed on May 13, 1994 which was published on December 22, 1994. The US National Stage application was filed March 4, 1996 and the patent issued October 22, 2002. There is no terminal disclaimer apparent from the file history and the PTO does not indicate any patent term extension due to FDA regulatory delay. [Patent][Granted FDA Extensions][FDA Orange Book Listing]

Top-Ten Pending Patent Cases

Foley attorney Hal Wegner regularly updates his list of the top-ten most important pending patent cases ranked according to their likely impact on the law. The list follows with my own annotations.

  1. Ariad v. Eli Lilly: This en banc case is fully briefed and pending decision on the question of whether the written description requirement of Section 112 should be considered separate and distinct from the enablement requirement. In many ways, the case is about how the law should define the inventor’s “possession” of the invention.
  2. I4i v. Microsoft: A petition for en banc rehearing has been filed on issues of damages and injunctive relief.
  3. Mayo v. Prometheus: This case is on petition for certiorari to the Supreme Court on the question of patentable subject matter for medical diagnostic methods. It has the potential to be a Bilski follow-on.
  4. Bilski v. Kappos: This patentable subject matter case is pending decision at the Supreme Court.
  5. Pequignot v. Solo Cup: Question of intent necessary for false marking charges.
  6. Microsoft v. Lucent: Microsoft is expected to file a petition for certiorari on the “clear and convincing” standard required for invalidating a patent. Microsoft argues that the standard should be lowered when the most pertinent prior art was not considered during patent prosecution.
  7. Arkansas Carpenters: [UPDATED AND CORRECTED] The Second Circuit is considering whether a “reverse payment” from a patentee to an ANDA generic challenger to settle a patent challenge should be considered an antitrust violation.
  8. Costco v. Omega: This case is pending certiorari with an outstanding request for the views of the Obama administration. The case raises an important question of copyright exhaustion in the context of authorized sales of copyrighted material on foreign soil. If decided by the Supreme Court, the case will likely impact patent doctrine.
  9. Princo v. ITC: En banc argument is scheduled for March 3, 2010 on the contours of antitrust and patent misuse in the standard-setting processes.
  10. Acushnet v. Callaway: Whether the legal determination of obviousness should be made by a judge – rendering a jury’s conclusion on that question “entirely advisory.”

Broadening Federal Circuit Jurisprudence: Moving Beyond Federal Circuit Patent Cases

[Update — SSRN Link Now Works] Download my five-page essay that forms the newest entry in the Patently-O Patent Law Journal: Broadening Federal Circuit Jurisprudence: Moving Beyond Federal Circuit Patent Cases, 2010 Patently-O Patent Law Journal 19 (2010). The essay is an expansion of my prior post on the SEB v. Montgomery Ward.

Abstract: Federal Circuit patent jurisprudence has typically focused on Federal Circuit law and Federal Circuit precedent. However, recent Supreme Court decisions such as eBay v. MercExchange, MedImmune v. Genentech, MGM v. Grokster, and KSR Intl. v. Teleflex cases have challenged that default position. These cases represent a directive from the Supreme Court that the interpretation of patent law doctrine requires a consideration of history and doctrines that arise from other areas of law. In this essay, I examine the recent Federal Circuit decision of SEB v. Montgomery Ward and consider whether that case represents a shift in Federal Circuit jurisprudence toward an increased influence of non-patent considerations when deciding patent cases and patent issues.