Upcoming Patent Law Conferences

November 22, 2005Conference or CLE, PatentClaim ConstructionDennis Crouch

December 5, 16th Annual PTO Day, Washington, DC – IPO

January 3–7, National CLE intellectual Property Law Conference, Aspen Snowmass — ABA-IPL, INTA, FCBA (Skiing + Learning!) (Big names like Dunner, Whealan, McKelvie & Rogan).

February 1–4, Mid-Winter Institute, La Quinta, California — AIPLA (I will be presenting “Patent Law Year in Review.”) (Southern California in February!).

February 17, Modern Patent Claim Construction Practice, Chicago — LSI.

February 27–28, Calculating and Proving Patent Damages, San Francisco — LSI.

April 20–21, Blog Law, San Francisco — LSI (Cathy Kirkman & I are co-chairs).

ITC Claim Construction Vacated — Court Unnecessariliy Limited Claim Scope

November 1, 2005Patent, Patent Cases 2005Claim ConstructionDennis Crouch

Sorensen v. ITC (Fed. Cir. 2005)

Sorensen alleged that Mercedes-Benz imports violated its patented injection molded tail lights. and requested that the ITC institute an investigation under 19 USC 1337. However, after the investigation, the ITC found no infringement based on its interpretation of the claims.

The patent is directed to a multi-layer injection molding with at least two materials having “different characteristics.” The only difference between the accused layers was that they were different colors, and the ITC found that “different characteristics” must refer to different molecular properties and not to color. Under this claim construction, it was easy for the ITC to find no infringement.

On appeal, the CAFC reversed because the claim did not exclude color as a basis for differing characteristics, the specification did not so limit the term, and there was no disavowal of scope in the prosecution history.

Summary judgment vacated.

What Does it Take to Become a Patent Attorney?

April 6, 2005Conference or CLE, PatentDennis Crouch

The Practicing Law Institute is hosting a free audio webcast IP Career Series directed to young lawyers, law students, and people thinking about law school. Their next audio briefing is titled “So You Want to Be a Patent Lawyer…," and will be held on April 18th from 1:00-2:00 p.m. EST. John White (who helped me learn patent law) and Katharine Patterson will present topics that include:

What does it take to become a patent attorney?
What does it mean to say you’re a patent attorney?
What is life like as a patent attorney?

In answering the general questions, White & Patterson expect to delve into how to decide between a prosecution or a litigation career and other sub-topics such as: The distinction between patent agents and patent attorneys; Hot undergraduate technical degrees; Whether and when a PhD is important; Geographical areas; and how to find a firm that wants to hire you.

Registration info:

Via Live Audio Webcast, April 18, 2005;
Via Live Telephone Briefing, April 18, 2005;
Register by Phone: (800) 260-4754. (Priority Code: CRA5-8BLG2).

Supreme Court Briefs: Merck KGaA v. Integra

February 26, 2005Patent, Patent Cases 2005Claim Construction, Enablement, Supreme Court, Venue, Written DescriptionDennis Crouch

Merck KGaA v. Integra (on certiorari at the Supreme Court, 2005).

In 2003 Court of Appeals for the Federal Circuit (CAFC) narrowly interpreted the safe harbor statute that permits a drug manufacturer to perform potentially infringing experiments needed to obtain FDA approval without incurring liability for patent infringement. Integra LifeSciences I, Ltd. v. Merck KGaA, 331 F.3d 860 (Fed. Cir. June 6, 2003) [PDF] (Interpreting 35 U.S.C. §271(e)(1)). In January 2005, the Supreme Court granted certiorari in the case and will hear the appeal on April 20. Cert. granted, No. 03-1237 (U.S. Jan. 7, 2005). The question revolves around what types of experiments are ‘safe’ from liability under the statute.

The party and amicus briefs are summarized below Of course, the length of individual summaries below does not indicate my view of that brief — in fact, my view is often that the length of an argument has an inverse relationship with the quality of the argument.

Merck’s substantive brief was filed on February 15. I split Merck’s arguments into two categories.

The Law: The FDA exemption covering any “use . . . reasonably related to the development and submission of information” to the FDA should be interpreted broadly. Merck argues that any research that is “directed at developing information relevant to an IND application” should fall under the 271(e)(1) safe harbor.
The Facts: The allegedly infringing experiments in this case falls under the safe harbor statute because (i) it was reasonably believed that the compound was a viable drug candidate and (ii) the experiments produced information that is considered in an IND application.

You can download the Merck KGaA brief here [pdf].

Brief of the United States in Support of Merck: The government has already played an important role in this case by filing a brief in support of Merck’s petition for cert. Now, the Government has filed it brief on the merits. Essentially, the U.S. argues that the statutory exemption should protect “all activities that are undertaken in the course of attempting to develop a particular drug and are reasonably related to the development of the types of information that would be relevant to an INDA or NDA.”

The exemption should apply to pre-clinical studies.
The exemption should begin to apply once research “progresses beyond basic research and begins efforts to develop a particular drug.”

The Government brief also discusses the research tool market, saying that the CAFC “erred by artificially narrowing the statutory exemption in an effort to protect research tools.” According to the Government, it is unclear whether the statute even applies to research tools.

You can download the Government brief here [pdf].

AIPLA’s Amicus Brief: The AIPLA brief is officially in support of neither party. However, the brief makes the argument that the Federal Circuit erred on both the facts and the law. Here is a summary of some of the AIPLA arguments:

Limiting the safe harbor protection to only (i) clinical tests that are (ii) related only to the exact drug for which FDA approval is ultimately sought would leave the statute much too narrow.
The road to FDA approval involves much more than clinical tests. The Federal Circuit payed too little attention to the FDA regulatory scheme in its decision.
The earliest stage of experiments do not fall under the safe harbor statute. The brief notes, for instance, that high-throughput screening of drugs for potential activity should not fall within the safe harbor.
Finally, the Supreme Court should not weigh-in on the common-law experimental use exception. [NOTE: Although I understand the AIPLA’s legal reasoning on this point, I do not understand their motivation. If not now, when will the Court look at the common-law experimental use exception]

William McGeveran at Foley Hoag was kind enough to supply a copy of the AIPLA brief. You can download the AIPLA brief here [pdf].

Eli Lilly, Wyeth & Merck as Amicus in Support of Merck: The three big drug manufacturers submitted an eloquently written brief that makes strong practical points:

Virtually Every Experiment is Reasonably Related to FDA Approval: Because the length, risks and costs of innovative drug development are so great, every activity in the development process has a purpose and a clear rationale. Each is designed to generate information that ultimately goes into the decision of whether a potential new drug will progress to the next hurdle. Each is aimed at the same ultimate goal: to gain FDA approval. . . . Innovative new drug development, thus, resembles a funnel. Just as a funnel is widest at the top, so too the early phases of drug development involve many more potential drugs than eventually emerge. The narrowing of the funnel represents the winnowing of less attractive potential new drugs. Blocking the funnel at any point cuts off the entire flow of new drugs. The Federal Circuit in its 1993 decision blocked the funnel.

The decision enables patent holders to prevent others from entering, or moving down the funnel. As a result, drug development will slow and its costs will mount in what is already a lengthy, high risk, high cost process; patients will be deprived of timely access to new, safer, more effective drugs; the entry of generic equivalents will be delayed; promising drugs to treat unmet medical needs will never be developed; and drug development activities along with valuable American jobs will be exported to countries having more favorable legal environments.

You can download the brief here [pdf].

NYIPLA Amicus Brief in Support of Merck: The New York Intellectual Property Law Association is filing an Amicus brief. (The Brief is available here [pdf] ). The NYIPLA’s conclusions parallel many of those outlined by the AIPLA. For instance, the NYIPLA argues that the statutory safe harbor was construed too narrowly and that the experiments performed in this case were “reasonably related” to the process of FDA approval.

Additionally, the NYIPLA presents a nuanced statutory construction argument that is derived from Professor Janice Mueller’s recent paper on the Experimental Use Exception (56 Baylor L. Rev. 101 (2004)).

The Federal Circuit misused a de minimis maxim to narrowly construe the safe harbor statute.
The statutory FDA exemption arises from Article 1, Section 8 of the Constitution and from the economic principles echoed in numerous Supreme Court cases. See, e.g., Universal Oil Products Co. v. Globe Oil & Refining Co., 322 U.S. 471, 484 (1944). These first principles indicate that the statute should be given a broader interpretation.

Thanks to David Ryan at Fitzpatrick Cella for providing a copy of the brief.

Amicus Brief for PhRMA in Support of Merck: PhRMA is an association of the largest drug development companies in the U.S. Last year PhRMA members spent $38 billion on drug development and have been responsible for almost all innovative new medicines approved during the last ten years. According to PhRMA’s brief, the CAFC 2003 decision in this case “represents a direct and substantial threat to future drug development.” The brief argues that pre-clinical testing is an essential part of drug development and an FDA requirement.

Download the PhRMA brief here [pdf].

Amicus Briefs of Professors Rochelle Dreyfuss, John Duffy, Arti Rai and Katherine Strandburg: The professors argue that the Court should not determine the reach of the common-law experimental use exception in this case. And, in fact, the brief asks that a clear disclaimer be placed in the Supreme Court opinion so that the opinion cannot be used by the Federal Circuit to decide issues on experimental use. In the professors’ view, the disclaimer may encourage litigants to bring the common-law issue to the Supreme Court. Of note, the professors find no “generally applicable relationship between the coverage of” the common-law experimental use exception and the statutory safe harbor.

You can download the Professors’ Brief Here [pdf]. Thanks to Professor Strandburg at DePaul for providing a copy of the brief.

Amicus Brief of The Bar Association of the District of Columbia (BADC): According to the BADC, regardless of a statutory safe harbor under 271(e)(1), the allegedly infringing “development activities are of the type that have traditionally been excluded from infringement liability under the common law experimental use exemption. . . .Failure to recognize this important exemption to infringement will deter research in the United States and encourage companies to conduct their research and development off-shore.”

You can download the BADC Brief Here [pdf]. Thanks to Susan Dadio at Burns Doane for providing a copy of the brief. Lynn Eccleston is the counsel of record.

Brief of EON LABS as Amicus Curiae in Support of Merck KGaA: Shashank Upadhye, VP and Counsel at the Generic Manufacturer Eon Labs has submitted a brief that explicitly supports Merck’s position.

The statute discusses “reasonably related . . . information.” Logically, exemption applies to any information that the FDA would normally request or that it mandates be submitted. For instance, the FDA has promulgated regulations that mandate certain pre-clinical or screening information be submitted.
Generic drug companies often engage in the same kind of screening activities that Merck KGaA did in order to find a bio-equivalent product. This activity is shielded.

Eon also provides a nice description of the two most common types of drug research covered by the safe harbor regime: (i) testing and information collection on brand new drugs and proving safety and efficaciousness; and (ii) testing and information collection related to approving a generic bio-equivalent version of a preapproved drug. Eon argues that the Federal Circuit erred by fixating on policy of safe harbor applying to generic drugs only.

You can download the EON Labs brief here [PDF].

Brief of the Consumer Project and the EFF as Amicus Curiae in Support of Merck KGaA: The consumer brief, filed by professor Joshua Sarnoff, makes the compelling argument that Section 271(e) and the common law experimental use exception provide overlapping protection. Sarnoff asks the Court to “confirm that Congress intended a broad experimental use exception to promote the progress of science and technology.”

It is critically important that the Court take this opportunity to correct the Federal Circuit’s improperly narrow interpretations of the experimental use exception in Roche, Embrex, Madey, and this case. This is likely to be the best (and, given the chill these cases exert, may be the only foreseeable) opportunity to set the historic and statutory record straight and to explain how Section 271(e) and Section 271(a) and its experimental use exception relate to each other.

You can download the Consumer/EFF brief here [pdf].

The Biotechnology Industry Organization (BIO) filed in support of neither party: According to BIO, this “is not a case about whether Section 271(e)(1) is limited to generic drugs and/or required regulatory activity. Instead, it is a case about whether the particular animal and in vitro studies at issue are “reasonably related to the development and submission of information” for regulatory approval and therefore non-infringing under Section 271(e)(1).”

BIO makes four specific arguments:

Section 271(e)(1) is not limited to generic drugs.
Section 271(e)(1) is not limited to required regulatory activity.
Section 271(e)(1) protects “reasonably related” testing activities.
Section 271(e)(1)’s “reasonably related” inquiry must be fact-based. For instance, if a researcher pursues more safety information than what Federal regulators require, the researcher should not be punished for being careful.

Finally, BIO makes the practical point that even the potential for an errant application of Integra could have a great and adverse impact on many avenues of research and funding critical to BIO members. You can download the BIO brief here [pdf].

Amicus Brief for Sepracor in Support of Merck: Michael Dzwonczyk at Sughrue assisted with the Sepracor brief. He also provided a copy of the brief for Patently-O and the following summary [slightly edited]:

The brief for amicus Sepracor takes the position that the federal circuit misinterpreted the scope of the exemption under §271(e)(1) by suggesting that the statutory immunity is limited to clinical activities in furtherance of FDA approval of a generic version of a commercialized drug. Notwithstanding the Supreme Court’s reliance in Eli Lilly on the public policies underlying the Hatch-Waxman Act that the §271(e)(1) infringement exemption and §156 patent term extension remedy symmetrical, yet opposing, patent term distortions imposed by the FDA regulatory process, the scope of the immunity conferred by §271(e)(1) is not limited to subject matter also encompassed by §156, which is far narrower in scope. Because FDA routinely requires pre-clinical data in evaluating INDs and NDAs, activities directed to generating this data should be exempt under §271(e)(1).

You can download Sepracor’s brief here [pdf].

AARP in Support of Merck: The AARP’s brief argues that the Federal Circuit mistakenly focused on generic drug approval rather and mistakenly omitted a discussion of how the statute provides a safe harbor for the development of innovative drugs as well. As would be expected, AARP also argues that a narrow exemption delays medical advancement and increases the costs of prescription drugs.

The Federal Circuit’s unwillingness to allow a broader experimental use exemption to patent infringement as Congress intended will lead to delay of medical advances by hampering the free exchange of scientific knowledge and by postponing competition beyond the patent term. The costs for prescription drugs, which already are so high as to prohibit many people from accessing their benefits, will be driven even higher.

You can download the AARP Brief Here [pdf]. Thanks to Sarah Lens Lock, author of the brief, for providing the PDF copy.

Genentech and Biogen Idec in Support of Merck: The Biologic companies bring out the important point that drug development of biologics is quite different than that of chemically-synthesized drugs, and that those differences alters the FDA approval process. The conclusion is that, perhaps even more than traditional chemical drugs, the FDA requires an incredible amount of pre-clinical research before a new biologic will be approved.

You can download the Biologics Brief here [PDF]. Thanks to Raymond Arner for providing a copy of the brief.

Integra LifeScience’s Brief on the Merits: In their brief, respondents Integra and the Burnham Institute attempt to shift the direction of the argument away from whether certain experimental activities may fall within the scope of FDA requirements to an examination of Merck’s activities and whether they were taken recklessly.

[Merck] did not proceed with caution in the face of patent rights held by [Integra]. This case did not arise from a decision by Merck to perform experiments designed to satisfy FDA regulatory requirements. . . This case arose from Merck’s reckless decision to hire [Scripps] to embark on a basic research program to search for new drugs

Integra also asks the High Court to dismiss the case for lack of controversy. “Given that the parties agree that the District Court’s jury instruction applied the correct legal standard, and given that Merck did not seek a sufficiency of the evidence review of the jury’s verdict in its petition for certiorari, there is essentially no controversy for this Court to adjudicate.

Finally, in an attempt to lessen the perceived importance of the case, Integra argues that companies who “seek a safe harbor under the FDA Exemption for preclinical work in their own laboratories in compliance with FDA regulations have nothing to fear. . . . Merck’s problems in this case are of its own making and are unique to it.”

Benitec Australia’s brief in support of Integra: Benitec argues that the safe harbor does not extend to “identifying, characterizing and developing new drugs.” Such a right would interfere substantially and selectively with the rights of certain patentees and undermines the fundamental principles of the patent system.

Interestingly, the counsel for Benitec (in support of Integra) is the same as for BIO (in support of neither party).

Vaccinex brief in support of Integra: Vaccinex makes the important policy point that patented research tools are essential to the development of new drugs. Without patent protection, the development of future tools is at substantial risk. As a rule, Vaccinex argues that the exemption extends “only to infringing activities that are ‘solely for uses reasonably related to the development and submission of information’ to the FDA.”

Applera and ISIS brief in support of Integra: Applera argues that from a textual statutory construction, that the plain meaning of section 271(e)(1) limits the exemption to uses that are “solely for the purposes of regulatory approval,” and that the Petitioner’s interpretation of the meaning treats the word “solely” as mere surplusage.

The statute provides that the exemption applies to making, using, and selling “a patented invention . . . solely for uses reasonably related to development” for FDA approval

Applera’s argument is that the sole pupose of the invention should be for uses related to FDA approval while Merck argues that solely applies to the infringing act.

Invitrogen et al. brief in support of Integra: The research tool makers request a ruling from the Court that expressly states that the 271(e) safe harbor does not extend to patented research tools.

WARF brief in support of Integra: Among other arguments, WARF outlines its position that the Federal Circuit’s decision effectively thwarts the purposes of the Bayh-Dole Act.

STATUTE: The primary statute relevant to this proceeding is the FDA exemption, found at 35 U.S.C. § 271(e)(1) (2000):

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other process involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

Also at issue are various statutory provisions and regulations governing the FDA: 21 U.S.C. § 355 (2000 & Supp. 2001); 21 C.F.R. §§ 58.3, 312.22-312.23, 314.50 (2004).

Links:

Briefs on the Merits:

In Support of Merck:

In Support of Neither Party:

In Support of Integra:

Reference Material:

John F. Duffy, Harmony and Diversity in Global Patent Law, 17 Berkeley Tech. L. J. 685 (2002).
John F. Duffy, Rethinking the Prospect Theory of Patents, 71 U. Chi. L. Rev. 439 (2004).
Rochelle Dreyfuss, Protecting the Public Domain of Science: Has the Time for an Experimental Use Defense Arrived?, 46 Ariz. L. Rev. 457 (2004).
Rebecca S. Eisenberg, Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. Chi. L. Rev. 1017 (1989).
Janice M. Mueller, The Evanescent Experimental Use Exception from United States Patent Infringement Liability: Implications for University/Nonprofit Research and Development, 56 BAYLOR L. REV. 917 (2004).
Katherine J. Strandburg, What Does the Public Get? Experimental Use and the Patent Bargain, 2004 Wisc. L. Rev. (2004).
Noonan, Greenfield, and Zuhn, Paradise Lost: The Uncertain Future of Research Tool Patents, 15 INTELL. PROP. & TECH. L.J. 1 (2003).
Richard Epstein and Bruce Kuhlik, Is There a Biomedical Anticommons?, Regulation, Summer 2004.
Shashank Upadhye, Understanding Patent Infringement Under 35 U.S.C. 271(e): The Collisions Between Patent, Medical Device, and Drug Laws, 17(1) Santa Clara Comp. & High Tech. L.J. 1, 23 2000)(available at http://www.lordbissell.com/Newsstand/UPIUSUpadhye-1999.pdf).

Federal Circuit Gives PTO Free Rein To Demand Information Beyond That Defined By Section 1.56 As Material to Patentability

January 3, 2005Patent, Patent Cases 2004USPTO DirectorDennis Crouch

Star Fruits S.N.C. and Institute of Experimental Botany v. United States and Department of Commerce (Fed. Cir. 2005)

By Alison Baldwin

What appears on its face to be a strictly procedural case actually raises a few interesting policy issues.

Procedurally, Star Fruits filed a U.S. Patent Application directed to a variety of peach tree. In a subsequent office action, the examiner included a "Requirement For Information Under 37 C.F.R. 1.105" that included a request for "any information available regarding the sale or other public distribution of the claimed plant variety anywhere in the world" and "copies of the application, published proposed denomination and published Breeder’s Right grant." Star Fruits declined to provide the information requested under 37 C.F.R. 1.105 on the grounds that the material requested was "not material to patentability of the new variety." Because Star Fruits did not comply with the Examiner’s request, the Office issued a Notice of Abandonment. Star Fruits petitioned the Director pursuant to 37 C.F.R. 1.181 and the petition was denied. Subsequently, Star Fruits appealed to the district court under the Administrative Procedure Act.

In addressing 37 C.F.R. 1.105, the Federal Circuit has interpreted the rule to include "a zone of information beyond that defined by section 1.56 as material to patentability, and beyond that which is directly useful to support a rejection or conclusively decide the issue of patentability." The court held that, so long as the request from the examiner for information is not "arbitrary or capricious," the applicant must comply with the request.

Furthermore, the Federal Circuit noted that if Star Fruits believed that the requested information was going to be used to support a wrongful rejection under 35 U.S.C. 102, it should have provided the information and then subsequently argued against the wrongful use. The court held that Star Fruits had no right to object to the potential use of the information.

Interestingly, in her dissenting opinion, Judge Newman argued that Star Fruits did exactly what it was supposed to do, when faced with an agency’s change in law and practice. Star Fruits was challenging the PTO’s 2001 change in practice holding that a foreign sale or use of a plant that has foreign Breeder’s Rights registration may bar United States patentability of that plant. This information requested by the examiner was for support for a rejection based upon this policy change. This internal change in practice is arguably an attempt by the PTO to broaden 35 U.S.C. 102 without the required notice-and-comment rulemaking procedures. Judge Newman criticized the panel for ignoring the real issue of law underlying this dispute.

NOTE: Alison Baldwin is a partner at McDonnell Boehnen Hulbert & Berghoff. Her patent litigation experience has covered a diverse range of topics, from recombinant DNA technology to digital television. In addition to her law degree, Ms. Baldwin holds degrees in biochemistry and plant pathology and has conducted research on the molecular mechanisms involved in plant disease resistance. [Brief Biography].

Trademarks granted on Mies van der Rohe’s 1929 furniture designs.

October 28, 2004Articles and Publications, PatentLicensesDennis Crouch

Knoll has received trademark registrations on several Mies van der Rohe furniture designs. (NYTimes Article). These pieces, originally designed in 1929, have been increasingly copied by furniture importers. A Knoll spokesman noted that the registration “gives a green light to U.S. customs to stop unauthorized products from reaching this country.” Knoll’s licensed version of the Barcelona Chair retails at just under $5,000. Ernest Beck reported that the registration has the potential to “reduce the availability of replicas of [the] classic modern furniture.”

Ludwig Mies van der Rohe was a famous German architect who left for Chicago in the late 1930’s to head the architecture program at the Illinois Institute of Technology. He is known for the International Style of Modernism and for his catch-phrase “less is more.”

Huang v. CIT (Lab Notebook Must be Witnessed)

July 14, 2004Patent, Patent Cases 2004USPTO DirectorDennis Crouch

Huang v. California Institute of Technology (C.D. Cal. 2004)

Dr. Huang sued, alleging that he should be a named inventor of CIT’s automatic DNA sequencing patents. As evidence, Dr. Huang submitted his own testimony and his laboratory notebooks. The Court found that the lab notebooks were insufficient because they were not witnessed or reliably dated.

Only in those instances where Dr. Huang’s lab notebooks were corroborated by independent evidence were they considered at all persuasive.

Find more information here and here.

Director, Codes and Standards – Trade Association – Remote

March 16, 2023- US - Telecommute

The National Propane Gas Association (NPGA) represents every segment of the propane industry. As the Director of Codes and Standards, reporting to the Vice President & Chief Technical Officer, you will have a national and global impact, using your knowledge, technical, and advocacy experience to support us in addressing the complex challenges facing the propane industry today. This is a highly visible and respected role where you will influence future standards, interface with all levels of NPGA staff and board, and connect with organizations across the country.

This role is ideally suited for either a codes & standards professional or for a professional engineer or patent prosecution attorney looking for a career transition.

The Work You’ll Do:

Working closely with the Vice President and Chief Technical Officer and Director of Research and Technology, you will serve as an influential subject matter expert, advocating on behalf of NPGA membership for the development of fair and progressive codes and standards across the energy sector. In representing NPGA, you will:

Advocate before numerous codes- and standards-setting bodies in favor of conventional and renewable propane to ensure energy choice.
Work with NPGA committee members to develop new and revised codes and standards proposals to further the usage and safety of propane and related equipment.
Develop coalitions with like-minded industry associations to work toward common goals and use your deep understanding of the industry to advise NPGA members on nationally recognized codes and standards, including those from the National Fire Protection Association, the International Code Council, and others.
Support the Vice President and Chief Technical Officer with managing committee activities, including preparing and maintaining records, developing technical and advocacy content, and working with members to prepare high-quality documents.
Liaise with our sister organization, the Propane Education & Research Council (PERC), and collaborate on a range of projects, including serving as a resource on the codes and standards related to research and development for end-use, transportation, storage, and handling equipment.

Work Environment, Salary, and Benefits:

You’ll enjoy working primarily from your home office with frequent domestic travel (between 10-15 trips annually) to represent the propane industry in developing nationally recognized codes and standards, meet partners to build coalitions, attend board meetings, visit state and regional member associations, and represent NPGA at industry events.

The budgeted salary range for this position is $115K - $130k with an annual discretionary merit-based bonus and outstanding benefits package including 15 days of PTO + 14 paid holidays, medical/dental/vision plans, a generous retirement plan, a mobile phone subsidy, and more.

You will like who you work with. Your colleagues are highly respected industry experts, and our members are fantastic. Many of our members are family-owned, family-friendly companies that are welcoming and appreciative of our work. Our experienced team will support you as you come up to speed.

Responsibilities:

Advocate for NPGA policy while developing nationally recognized codes and standards, including but not limited to:
- NFPA 58 LP-Gas Code
- NFPA 54/ANSI Z223.1 National Fuel Gas Code
- International Code Council Model Codes
- Z21/83, CSA, ASHRAE, ASTM, and Underwriters Laboratories codes and standards
Work with the 36 regional and state associations that are affiliated with NPGA to advocate for industry-advantageous codes and standards.
Work with NPGA’s other pillars of advocacy (federal legislative, federal regulatory, and state & municipal advocacy) as well as NPGA’s sister organization (PERC) on cross-functional matters where codes and standards expertise is warranted.
Work with related organizations on common interests, including but not limited to the American Gas Association; the Hearth, Patio & Barbecue Association; the American Public Gas Association; the Association of Home Appliance Manufacturers; and the Air-Conditioning, Heating, and Refrigeration Institute.
Review and provide draft material in response to proposals relating to vehicle engines, appliance energy efficiencies, and other technical issues related to propane transportation, storage, and handling.
Represent NPGA and engage members in meetings with the Technology, Standards, and Safety Committee.
Collaborate with the Communications Team to develop informative reports, documents, and other membership materials.
Periodically provide seminars to NPGA members and affiliated state propane gas associations to update them on new editions and changes to codes and standards.

Qualifications:

Bachelor’s degree in engineering (chemical, environmental, or mechanical is ideal) or a related scientific field is required.
MS, PE license, or JD with admittance to the patent bar is preferred.
Experience working in a regulatory environment or a codes and standards development organization or a related field is advantageous but not required.
Familiarity with environmental standards and and safety compliance within the energy industry is advantageous but not required.
Very sharp eye for reviewing and drafting complex written materials.
Keen ability to advocate for a position in writing and orally.
Ability to travel domestically 8-12 times per year.

About Us:

Next to solar and wind, propane—and increasingly, renewable propane—is one of the cleanest fuels approved under the Clean Air Act. The National Propane Gas Association (NPGA) is the national trade association representing the US propane industry. We represent members from 2,500 companies in all 50 states, 36 affiliated state or regional associations, and 19 foreign countries. Our work pushes the propane industry forward by advancing safety and sound public policy.

How to Apply:

Email your resume to Lilly Khan at resumes@staffingadvisors.com with “NPGA – Director, Codes and Standards #2023-2766 PA” as the subject of the email. Staffing Advisors is committed to reducing bias in every aspect of the hiring process. We have long recommended a competency-driven approach to hiring. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other basis protected by law.

Include with your submission a resume in Word or PDF format.

Additional Info
Employer Type: Other
Job Location: Remote

Patent Agent/ Technical Specialist – Small Corporation – Maryland

April 1, 2022- US - MidAtlantic and South, Emp - Corporate (in-house), Tech - Biotech, Tech - Chemical / Pharma, Work - Patent Agent

Vaccitech plc is a fast-growing biotech company. At only five years old we already have a development portfolio of six products, a partnered product that is in commercial production that has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly-listed clinical stage biopharmaceutical company that spun out of the University of Oxford’s Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We have clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.

In December 2021 Vaccitech acquired Avidea Technologies with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us US operational presence in Maryland, complements Vaccitech’s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. From Q3 2022 Vaccitech's US headquarters will be moving to a new facility in Montgomery County. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.

The Role:

The successful candidate will be the interface between internal technical, legal/ IP teams and outside counsel, supporting patent strategy in pursuit of business development and corporate goals. Your key responsibilities will include independently working with R&D staff to understand technical approaches and data output; compiling and curating reports of R&D output to assist invention identification; assisting in-house and external counsel in drafting patent applications and prosecuting a global patent portfolio; managing patent correspondence and document generation in support of global patent prosecution; contributing as part of multi-disciplinary scientific, legal and business development teams to deliver on business-critical projects; working closely with internal and external counsel to help coordinate and manage intellectual property strategy; searching scientific and patent literature and patent document databases to monitor competitor landscape; and presenting updates and guidance to all levels of the company including the senior leadership team and R&D teams.

Experience and qualifications:

Due to the nature of Vaccitech North America’s manufacturing platform and product candidates, the successful applicant candidate must be an expert in chemistry, will holding a graduate degree (PhD preferred) in chemistry or chemical engineering and possessing a deep understanding of the subject. You will also have a minimum of two years’ experience in intellectual property related work (USPTO admission to practice preferred) and a demonstrable experience in patent and claim drafting, in patent prosecution and in technology assessment or invention identification. As an accomplished writer you will have a proven ability to communicate technical information in a clear and concise manner. The successful candidate will have a familiarity with patent database searching methodologies, ideally with competitor landscape analysis. Experience with in-licensing and/ or out-licensing would be a distinct advantage. All applicants must be a US citizen or green card holder as we cannot offer sponsorship.

What we can offer you:

Vaccitech is a great place to work. We encourage an entirely flat structure with an open door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. This role would suit an experienced Patent Agent looking for a broad and varied role in a rapidly accelerating biotech. As part of a fast-growing team they will play a significant part in shaping the future in a global biopharmaceutical company that offers significant opportunities for personal and professional development. We offer employer funded health, dental and vision insurance; a 401k retirement plan; career development opportunities and paid time off (PTO). Salary will be commensurate with experience.

Apply online at:
https://vaccitech.bamboohr.com/jobs/view.php?id=34&source=aWQ9MjA%3D

All applicants are required to submit both a resume and a cover letter.

Additional Info
Employer Type: Small Corporation
Job Location: Maryland

Patent Counsel – Small Corporation – Washington, D.C.

January 12, 2019- US - MidAtlantic and South, Emp - Corporate (in-house), Tech - Computer Science, Tech - Electrical, Work - Admin, Work - Patent Litigation, Work - Patent Prosecution

Unified Patents is again growing its legal department, and seeks experienced, registered, patent attorneys. Applicants must have at least 3 years of law firm or other relevant experience at the Patent Trial and Appeal Board (PTAB) and post-grant petition (IPR, PGR, and CBM), reexamination, and other administrative drafting and litigation experience;

Applicants should have a degree in Electrical Engineering (EE) or Computer Science (SC), as well as experience with video codecs, coding, cryptography, compression, signals, wireless communications, or other algorithmic subject matter. Patent examination experience is a plus; clerking experience is a plus; familiarity with ongoing cases post-SAS Institutes is a plus. Must be willing to work within a team, work well independently, and enjoy writing and editing. Journal and filing experience a plus. Strong preference for candidates located in the Washington, DC area.

DUTIES

Managing patent office proceedings internally
Drafting, filing, and litigating patent office proceedings, e.g., inter partes reviews
Handling calls with decision makers
Preparing for, conducting depositions
Presenting at oral hearings
Drafting motions and briefs
Supporting senior attorneys with management of ongoing matters
Support docketing, e-filing, deposit account, budgeting, and other IP functions
Editing work product of colleagues, outside counsel
Amicus curiae drafting and support; comment drafting and support
Contract, licensing, and other legal support services
Legal writing, support, and other various legal duties

REQUIREMENTS

3 years of PTAB (drafting petitions, filing, litigating, deposition) experience
State and Patent Bar passage
Ability to work independently and in a team
Excellent English written and oral communication skills

PREFERRED

Patent Office examination experience
Algorithmic, codec, and other code-based subject matter experience
Appellate and /or Clerking experience
EE or CS undergraduate degree
Graduate Technical (MS, MA, or PhD) degree
Willing to work from DC strongly preferred

BENEFITS
Aggressive, competitive benefits, with generous vacation and paid-for health insurance; freedom to work from home when appropriate; maternity and paternity leave; and financial support for bar and further education.

Contact
To apply, please visit this website: https://unifiedpatents.workable.com/j/591C80324F. Please provide cover letter showing PTAB filing experience.

Additional Info
Employer Type: Small Corporation
Job Location: Washington, D.C.

Dean – Univ. of New Hampshire School of Law – Durham, N.H.

August 1, 2016- US - Northeast, Emp - Educational

The University of New Hampshire invites applications and nominations for the position of Dean of the University of New Hampshire School of Law.

The only law school in New Hampshire, the UNH School of Law is a national leader in intellectual property law and practice-ready curricula with a commitment to inclusion, diversity and quality engagement for all. The School is ranked number five in intellectual property law and has been among the top ten IP law schools for 25 consecutive years. Overall, UNH Law jumped 55 positions in the US News rankings in the past three years – an unprecedented rise among law schools. UNH Law was founded as the Franklin Pierce Law Center in 1973 in the state capital of Concord. In 2010, the University of New Hampshire and Franklin Pierce agreed to affiliate and eventually merge, resulting in the UNH School of Law. More information about the School of Law may be found at www.law.unh.edu.

The University of New Hampshire School of Law is an intimate, innovative law school, committed to developing students who enjoy challenging dialogue from the first moments of orientation, embrace practice-based learning, and stand ready to join the ranks of alumni who are global leaders in intellectual property, general practice, public interest and social justice, and commerce and technology.

Throughout its history, UNH Law has been a global leader in innovative legal education. Students study in a close-knit, cooperative environment. The curriculum emphasizes an intensive, practice-based approach involving many opportunities for hands-on learning. With a highly productive and engaged full-time faculty of 28 and a student:faculty ratio of 12:1, the School of Law serves 253 students from 31 states and 11 countries across the globe, offering JD, LLM, and Masters degrees, certificates, dual degrees and joint degrees. The school has the third highest placement rate among New England law schools for graduates in non-school funded, bar-required positions. Approximately 97% of the Class of 2015 enrolls in a live-client clinic or completes a legal residency.

The UNH School of Law celebrates over 5,700 alumni currently practicing in over 80 countries who are providing global leadership in the areas of intellectual property, general practice, public policy, commerce and technology. International graduates from Afghanistan to Zambia comprise almost 15 percent of the alumni population, over half of whom practice in the East Asian countries of South Korea, Taiwan and China. Alumni from the Franklin Pierce Center for Intellectual Property have a distinctive presence in senior leadership positions in IP-centric markets in all major east and west coast population centers.

UNH Law features specialized programs that blend innovative legal scholarship, dynamic teaching and hands-on professional development:

The Franklin Pierce Center for Intellectual Property Law
The Warren B. Rudman Center for Justice, Leadership and Public Service
The Daniel Webster Scholar Program
The UNH Law Legal Residency Program
The Sports and Entertainment Law Institute
The Health Law and Policy Program
The UNH Law Clinics

UNH is an Equal Opportunity/Equal Access/Affirmative Action institution. The University seeks excellence through diversity among its administrators, faculty, staff, and students. The University prohibits discrimination on the basis of race, color, religion, sex, age, national origin, sexual orientation, gender identity or expression, disability, veteran status, or marital status. Application by members of all underrepresented groups is encouraged.

Contact
Applications, nominations and inquiries may be directed in confidence to Lucy A. Leske or Sheila Murphy, the Witt/Kieffer consultants assisting UNH Law with this search, at UNHLawDean@wittkieffer.com. Electronic submissions are required and should include a letter of interest, current resume, and a list of at least five references with contact information. Application review will begin on September 15, 2016, and will continue until the position is filled.

Additional Info
Employer Type: Education
Job Location: Durham, New Hampshire

Legal Assistant / Paralegal – Small Corporation – Cambridge, Mass.

July 25, 2013- US - Northeast, Emp - Corporate (in-house), Work - Paralegal / Legal Secretary

Moderna Therapeutics is seeking a skilled para-professional (assistant or paralegal) for in-house legal support with a focus on intellectual property and transactional matters. This talented individual will be instrumental in supporting internal efforts directed at patent preparation, filing, and prosecution. The position will also involve support of transactional work directed to various contracts and agreements including MTAs, CDAs, JDAs, MSAs, research collaborations, and licensing agreements. The IP assistant/paralegal will also provide general support of the company’s legal department as well as special projects as they may arise within the department.

Responsibilities:
• Effectively collaborates with in-house attorneys and agents and coordinates with outside counsel/staff
• Supports timely patent preparation, filing and prosecution activities
• Support and manage all contract and transactional work at the company
• Responsible for special projects including, but not limited to; due diligence, assignment projects, interference proceedings, post grant review, sequence listings, re-
examinations, and on-line patent database searches
• Assumes additional responsibilities, as assigned

Minimum Qualifications:
• 3 years of legal administrative or para-professional experience in a corporation or law firm
• Proficient with Microsoft Word, Outlook, searching and docketing software
• Effective collaborator interpersonal skills

Preferred Qualifications:
• A BA/BS degree
• Experience in biotech or pharmaceutical industry or at law firm that supports the same
• Familiarity with technical aspects of biological or chemical sciences
• Notary Public certification

Competencies:
• Detail Orientation (strong attention to detail and high quality work standards)
• Highly Organized (ability to prioritize and perform effectively under pressure)
• Results Orientation
• Operates Independently (works independently and meet deadlines with minimum supervision)
• Excellent analytical, organizational and time management skills
• Effective Communication (oral and written)

Contact:
Apply online at: http://modernatx.com/revolution.

Additional Info:
Employer Type: Small Corporation
Job Location: Cambridge, Massachusetts

Why join Moderna Therapeutics:

Moderna Therapeutics is pioneering messenger RNA therapeutics™, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn active intracellularly or secreted. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate relating to mRNA therapeutic technologies ranging from novel nucleotide chemistries to specific drug compositions. The company plans to develop and commercialize its innovative mRNA drugs—initially for rare diseases and oncology—while partnering drug candidates in other therapeutic areas in order to rapidly deliver this innovation to patients.

Based in Cambridge, Massachusetts, Moderna is privately held and was founded in 2010 by Flagship VentureLabs in association with leading scientists from Harvard University and Massachusetts Institute of Technology.

Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Patent Agent / Attorney – Small Corporation – Cambridge, Mass.

July 25, 2013- US - Northeast, Emp - Corporate (in-house), Tech - Biotech, Work - Patent Agent, Work - Patent Prosecution

Responsibilities:
• Effectively collaborates with in-house attorneys and agents and coordinates with outside counsel/staff
• Supports timely patent preparation, filing and prosecution activities
• Support and manage all contract and transactional work at the company
• Responsible for special projects including, but not limited to; due diligence, assignment projects, interference proceedings, post grant review, sequence listings, re-examinations, and on-line patent database searches
• Assumes additional responsibilities, as assigned

Contact:
Apply online at: http://modernatx.com/revolution.

Additional Info:
Employer Type: Small Corporation
Job Location: Cambridge, Massachusetts

Why join Moderna Therapeutics:

Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

Intellectual Property Specialist – Hong Kong Polytechnic University – Hong Kong

August 10, 2008- Asia, Emp - Educational, Emp - Government, Tech - Any / Other, Work - Licensing / Other Corporate, Work - Patent Litigation

The Hong Kong Polytechnic University (PolyU) seeks an intellectual property specialist to work within its Partnership Development Office. The University is the largest government-funded tertiary institution in Hong Kong, with a total student headcount of about 27,200, of which 13,500 are full-time students, 11,400 are part-time students and 2,300 are mixed-mode students. It offers programmes at Doctorate, Master's, Bachelor's degrees and Higher Diploma levels. The University has 26 academic departments and units grouped under six faculties, as well as 2 independent schools. It has a full-time academic staff strength of around 1,250. The total consolidated expenditure budget of the University is in excess of HK$4 billion per year.

The University's Partnership Development Office is a unit of the Institute for Enterprise at PolyU. It serves as a hub of a network of partners and clients to enable technology transfer and commercialisation. Its mission is to build long-term relationships between internal academic talents and the industrial and business sectors. To tap on the vast capability and resources at PolyU, it serves as the first point of contact for the commercial and industrial sectors. It provides professional services in the areas of Business Development, Management of the University's Intellectual Property, and Marketing Services and Support.

Responsibilities:
Successful candidate required to:
• Advise PolyU’s staff and students on patent applications, strategies and other forms of intellectual property protection
• Conduct patent search, prepare patent applications, professional response to office actions and patent annuity payment, and provide reminding services
• Render patentability and non-infringement opinions
• Provide services on patent litigation and administrative resolution of patent disputes
• Conduct talks/seminars on intellectual property
• Supervise clerical staff.

Requirements:
Applicants should have the following:
• Recognised university degree, preferably in Law and/or Science
• Qualification of being a Registered Patent Attorney by examination
• At least eight years of experience in a related field, including proven experience in the preparation of all forms of intellectual property applications
• Excellent interpersonal and communication skills
• An excellent command of English.

Preference will be given to those with good command of Chinese, including Putonghua.

(Applicants who have responded to the previous advertisement on July 12, 2008 need not re-apply.)

Benefits:
Salary offered will be commensurate with qualifications and experience. Applicants should state their current and expected salary in the application. Remuneration package will be highly competitive.

Contact:
Please submit application form via email to hrstaff@polyu.edu.hk; by fax at (852) 2764 3374; or by mail to Human Resources Office, 13/F, Li Ka Shing Tower, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.

Application forms can be obtained via the above channels or they may be downloaded here. Recruitment will continue until the positions are filled. Details on the University's Personal Information Collection Statement for recruitment can be found here.

Additional Info:
Employer Type: Education Institution
Job Location: Hong Kong

KSR and the Line Between Fact and Law

May 6, 2007Supreme Court

By Professor Chris Cotropia

Well, we have gotten early indications from the major patent players as to how the substantive part of KSR will play out. TSM still has a place in the post-KSR world, at least according to Chief Judge Michel of the Federal Circuit and Deputy Commissioner Focarino of the USPTO. These are preliminary statements. We will not know what the Federal Circuit or USPTO really think until the first precedential opinion or interim guidelines issue. But these early comments make one wonder if KSR changes anything, particularly those like myself who witnessed the Federal Circuit's acceptance of, and reliance on, implicit TSM well before In re Kahn, DyStar, and Alza.

While the substantive impact may turn out to be minimal, KSR could have a significant procedural effect. The Court appears to have shifted the line between factual and legal parts of the nonobviousness analysis, moving what was (is?) the TSM test from being a question of fact to a question of law.

The Supreme Court in Graham established that nonobviousness was ultimately a question of law, but there were recognized underlying factual issues—content of the prior art, scope of the claims, and the level of the PHOSITA. When the CCPA, and then the Federal Circuit, started employing the TSM test, the test became another underlying factual component of the inquiry. As a result, there was not much left at the question of law level, and the Federal Circuit affirmed most appeals from rejections by the USPTO and or trials before district courts on the nonobviousness issue.

The Court in KSR introduces a procedural change, folding the TSM-like inquiry into the question of law level of the analysis. This move is most clearly witnessed in Part IV of the opinion, where Court rejects the existence of a dispute over an issue of material fact. Slip op. at 23. The Court goes out of its way to note that "[t]he ultimate judgment of obviousness is a legal determination," rejects the ability of a "conclusory affidavit[s] addressing the question of nonobviousness" to create a fact issue, and shows concern only to whether the first three Graham factors are "in material dispute." Id. In contrast, the final step, determining whether a PHOSITA would modify the prior art, is identified as a "legal question." Slip op. at 21. The earlier, general discussion of the substantive standard also supports this interpretation. The opinion focuses on what "a court" should analyze when determining whether there is "an apparent reason to combine." Slip op. at 14.

The implications of this procedural change are many. Making the TSM-like analysis a question of law facilitates more summary judgments on the issue of nonobviousness (although not as much as one would think, as I determined here). It also gives the Federal Circuit more freedom to reverse both USPTO and district court judgments on nonobviousness. This may lead us down a similar road as Markman has, giving the Federal Circuit so much flexibility that it injects even greater uncertainty into an area that is inherently uncertain, particularly after KSR. We might even end up with KSR hearings.

Admittedly, the Court does not explicitly say it is making this change. And, as the Federal Circuit has done in the past, TSM-like discussions can be framed as part of one of the first three Graham factors that have always been factual issues. However, the main focus of the opinion is on the Federal Circuit's "application" of § 103, and the language and application in KSR strongly suggest a change in the law/fact line in nonobviousness analysis (or maybe this is all just a "common sense" reading).

Chris Cotropia is an Associate Professor of Law at the University of Richmond School of Law and is part of the School's Intellectual Property Institute. Professor Cotropia was counsel of record and a co-author on the Brief of Business and Law Professors as Amici Curiae in Support of the Respondents in KSR.

Nike’s Patent Saga Highlights Controversial PTAB Practices

June 6, 2023PatentDennis Crouch

by Dennis Crouch

The pending petition in Nike v. Adidas asks the Supreme Court whether it is proper for the Patent Trial & Appeal Board (PTAB) to raise sua sponte new grounds of unpatentability against a substitute claim added during an inter partes review proceeding. The government, as a respondent in this case, argues that the PTAB can create its own reasons for rejecting newly-added claims so long as the patent owner is given sufficient notice and a chance to respond.

However, the case intrigue has recently heightened due to a somewhat chaotic saga involving the PTAB. Key figures involved include former PTAB Chief Judge Ruschke, current Chief Judge Boalick, and Judge Michael Fitzpatrick, who was recently justified as a wronged-whistleblower.

The Supreme Court petition was submitted amidst revelations of secretive maneuvers within the Board. These questionable practices include an abrupt panel expansions and judge replacement without notifying involved parties. Specifically, in the Nike v. Adidas IPR, the Board panel was first expanded to include Chief Judge Ruschke and then Deputy Chief Judge Boalick after all parties had finished their arguments and opinion writing had begun. The process also witnessed the replacement of Judge Fitzpatrick after he expressed discontent over the panel’s expansion, prompting his removal from all America Invents Act (AIA) cases.

Judge Fitzpatrick’s ousting ignited a legal battle against the USPTO, which recently concluded with a victory for Fitzpatrick at the Merit Systems Protection Board (MSPB). Fitzpatrick alleged that the USPTO had manipulated the inter partes review process in the Nike v. Adidas case, inappropriately expanding the PTAB review panel and delaying the final decision. Furthermore, Fitzpatrick’s whistleblowing disclosures extended beyond the PTAB, unearthing a misrepresentation by the Solicitor General to the Supreme Court regarding the frequency of expanded panels during the Oil States proceedings. In briefing in the case, the Solicitor General recently apologized to the Supreme Court, expressing regret for the unintended misinformation. The SG’s brief indicates that they only recently learned of the underlying drama.

In light of these troubling revelations, the Solicitor General suggests the Supreme Court grant, vacate, and remand Nike v. Adidas, offering the petitioner a chance to present arguments based on this new information to the Federal Circuit, and allowing the Federal Circuit to consider these points in the first instance.

Interestingly, this practice of unannounced judge replacements parallels the Federal Circuit’s tactics in the infamous Novartis case. Although the Adidas name is still on the case, the company has formally requested not to be involved in the appeal, citing a settlement reached with Nike.

Challenging NHK-FINTIV

February 15, 2022PatentDennis Crouch

Accused patent infringers are fighting to overturn NHK-Fintiv rules that permit the PTAB to deny IPR institution in favor of pending litigation between the parties.

In addition to pending SCOTUS petitions; see a recent letter to the Commerce Sec. https://t.co/DszZkr2RG9 pic.twitter.com/pqOgtrtn73

— Dennis Crouch (@patentlyo) February 15, 2022

Total References Cited

January 29, 2022PatentDennis Crouch

The chart below shows a histogram of the total number of references per patent. (Utility patents issued in 2021) with the mode, median, and average noted.

Guest Post: Fast Examiners; Slow Examiners; and Patent Allowance

August 2, 2020Patentmotivation to combine, Printed PublicationDennis Crouch

Prof. Shine Tu (WVU Law) has been doing interesting work studying patent prosecution and how differences between patent examiners impact the process. I asked him to provide a guest post to help readers get started on his work. – DC

by Shine Tu

Although we know that individual patent examiners can greatly affect an inventor’s chance to (1) get a patent at all and (2) get it in a timely way, there has been very little work determining how examiners are able to either delay or compact prosecution while still maintaining their quotas via the count system. Understanding how examiners work the quota system with very different outcomes can be critical for practitioners trying to understand what sort of responses or claim narrowing they should make. It also has significance for those looking to understand and improve the very process intended to spur invention.

In a previous study, I have shown that there are extreme variations on allowance rates between examiners. For example, in analyzing 10 years of patents from Technology Center 3700 I found that there were approximately 200 examiners from 3700 who had issued over 120,000 patents (approximately 51% of the patents from this Technology Center). In contrast, there was a group of approximately 300 examiners who issued less than 800 patents (less than 1% of the patents from this Technology Center). [See https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1939508]. In this current dataset, I find that not only is there a difference in allowance rates, but there is a significant difference in prosecution times. Fast examiners allow applications in approximately 1.64 years, average examiners in 3.07 years, and slow examiners on average will allow a case in 5.85 years. This delay of over four years (fast versus slow examiners) increases direct costs to applicants in the form of PTO and attorney fees, as well as indirect costs such as reduced growth, sales, and follow-on innovation.

In a set of two articles, I explored how examiners can either: (1) slow down the patent prosecution process by using a strategy of constant rejections [https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3539731] or (2) speed up the patent prosecution process by using a strategy of fast allowances [https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3546944]. To create a sufficiently large sample to be statistically significant, I coded the patent prosecution histories of 300 patents and reviewed 100 patents from slow, average, and fast examiners from workgroup 1610. Every rejection issued by the examiner and every response and traversal argument by the applicant was recorded.

As an initial matter, these data show that examiners in each group have similar amounts of experience at the PTO and similar average current docket sizes. However, the allowance rates of these examiner groups vary dramatically, with 79.55%, 61.65%, and 27.7% allowance rates corresponding with fast, average and slow examiners, respectively. The Office Action to Grant (OGR) score shows that these fast examiners grant a patent for every 1.5 Office Actions written, while it takes average examiners roughly 4 Office Actions and slow examiners a stunning 10.5 Office Actions before they grant one patent.

Fast examiners seem to be using a count maximization strategy based on allowances. A typical applicant who gets a fast examiner will usually have one or two Office Actions before an allowance. Fast examiners do not use many prior art rejections. Additionally, the rejections employed by fast examiners rely heavily on Obviousness-type Double Patenting (ODP) and/or 35 USC 112 rejections. Fast examiners have four times as many ODP rejections compared to slow examiners. Most applicants can (and do) traverse these ODP rejections by simply filing a terminal disclaimer. Interestingly, use of the ODP rejection is a super-efficient way to employ a count maximization strategy. This is because little work is needed to find an ODP rejection, due to the closed universe of patents, and an ODP rejection is relatively easy for the applicant to traverse. Thus, an ODP rejection followed by a terminal disclaimer gets the examiner to maximum counts with minimal effort.

In contrast, slow examiners seem to be using a strategy based on rejections. First, slow examiners have a much higher restriction rate (almost twice) and encounter three times as many traversals to these restriction requirements. These data are consistent with a rejection strategy because examiners can create a large patent family and cycle through rejections with less work, especially since they should already be familiar with the specification from the other restricted family members. Furthermore, slow examiners may not be able to avail themselves of the ODP rejection strategy employed by fast examiners because of the safe harbor created by 35 USC 121.

Not only do slow examiners use more prior art, the sources of prior art differ for slow examiners versus fast and average examiners. Slow examiners employ a rejection strategy based on prior art, with five times as many 102(a/e) rejections and six times as many 103 rejections compared to fast examiners. For 102(a/e) rejections, slow examiners rely on both US patents as well as printed publications, while fast and average examiners rely on US patent applications. Interestingly, for 102(b) rejections all examiners rely more on printed publications and secondarily on US patents. With 103 rejections, examiners also all mainly rely on US patents and, secondarily, on printed publications. Thus, all examiners search and employ prior art from different databases, however, they use the prior art that they find in different ways.

Unsurprisingly, applicants traverse prior rejections from slow examiners at a much higher rate than fast examiners. Specifically, with 102 and 103 rejections, applicants will push back against slow examiners most commonly with a missing elements argument. In contrast, most applicants respond to fast examiner 102 and 103 prior art rejections by simply filing claim amendments. Interestingly, applicants will also push back against 103 rejections from slow examiners by making a “no motivation to combine” argument. This may be because slow examiners use seven times as many references as fast examiners.

Slow examiners also put the brakes on prosecution by filing multiple 112 rejections. Specifically, slow examiners utilize three times as many 112 second rejections, four times as many enablement rejections and seven times as many written description rejections. With slow examiners, applicants use arguments to traverse enablement and written description rejections. In contrast, applicants with fast examiners usually only make claim amendments to traverse enablement or written description rejections.

Practitioners need to understand what type of examiner they have. Understanding and using this data is paramount to help manage client expectations as well as to help create a rational prosecution strategy. I note that all of these data can be accessed through services such as LexisNexis PatentAdvisor® to help determine which examiner you may encounter. This may also be important for patent prosecution strategy since slow examiners may require a strategy that involves an appeal. While fast examiners may require a strategy that involves fewer amendments and more arguments.

Although I do not make any definitive judgements about the quality of the claims passed by different examiners nor even if there is an “optimal” or “ideal” allowance rate, these varying trends indicate a wide discrepancy in examiners’ methodology that may be affecting the overall quality and number of patents created. By analyzing the differences, my studies suggest how the counts system might be modified to ensure a more efficient and balanced process where all examiners apply the rules of patentability fairly and consistently. One possible solution, for example, would be to review applications from both fast and slow examiners at a higher rate. Another solution may be to deduct counts from examiners who make too many erroneous rejections. Conversely, adding counts for examiners who dealt with difficult applicants could also be in order. Alternatively, we could completely reform the count system and create an examiner incentive structure that focuses more on quality and less on quantity. Only by looking in-depth at examiner behaviors will we be able to (1) better understand and navigate the current system and (2) make reforms to the current process that will truly encourage innovation.

Certified Questions on Appeal under 1292(b)

January 31, 2020PatentinventorshipDennis Crouch

by Dennis Crouch

In civil procedure, I just finished teaching appeals of interlocutory orders under 28 U.S.C. § 1292(b).

The normal rule in patent cases (and in federal litigation generally) is that the parties have to wait until the case is complete — final judgment — before having a right to appeal. Under this “final judgment rule,” interlocutory orders — orders that do not end the case — are generally not immediately appealable. Rather, parties have to wait for final judgment. There are, however, a number of exceptions to the final judgment rule.

Appealing Injunction Orders: Because injunctions are often requested in patent cases, § 1292(a) is regularly invoked. That section creates a right to appeal district court decisions “granting, continuing, modifying, refusing or dissolving injunctions, or refusing to dissolve or modify injunctions.” Thus, even if an injunction order is interlocutory (such as denying preliminary injunctive relief), that order can be automatically appealed.

Certified Questions: Section 1292(b) provides the Courts of Appeals with discretionary authority to review of interlocutory issues of law that are “certified” for appeal by a district court:

When a district judge … shall be of the opinion that [an otherwise non-appealable] order involves a controlling question of law as to which there is substantial ground for difference of opinion and that an immediate appeal from the order may materially advance the ultimate termination of the litigation, he shall so state in writing in such order. The Court of Appeals … may thereupon, in its discretion, permit an appeal to be taken from such order.

28 U.S.C. § 1292(b).

This week in MLC Intellectual Property v. Micron Tech (Fed. Cir. 2019), the Federal Circuit decided a 1292(b) issue — allowing MLC (the patentee) to appeal a set of interlocutory orders excluding MLC’s expert testimony. The Federal Circuit opinion is short on detail and analysis — explaining (1) that the Federal Circuit has discretion to exercise interlocutory review in this situation; and (2) review here appears appropriate to “avoid an expensive trial solely on liability” since the patentee was left with a very weak damages case and no injunction case (since the patents are expired). [1292(b) Decision]. The case is now placed on the regular docket with full briefing of the issues.

In its certification order, the district court explained the situation as follows:

In the Damages Orders, the Court excluded [MLC’s expert] Mr. Milani’s damages opinion under Daubert because the Court concluded that his comparative license analysis did not comport with Federal Circuit jurisprudence. These deficiencies included, inter alia, Mr. Milani’s failure to apportion the revenue base to include only the revenue attributable to the patented technology and Mr. Milani’s calculation of a royalty rate that was not supported by the evidence. In addition, the Court held that MLC had failed to disclose the factual underpinnings of its reasonable royalty claim in discovery, and excluded much of Mr. Milani’s opinion on that ground. MLC asserts that it was not required to disclose those facts because the determination of a reasonable royalty is the province of expert opinion. All of these questions are controlling questions of law as to which there is substantial ground for difference of opinion. … Absent interlocutory review, the parties and the Court will be required to proceed with an expensive trial focused solely on liability, as MLC concedes that it has no damages case to present at trial.

Interlocutory review of the Damages Orders will result in either the ultimate conclusion of this case (if the Federal Circuit affirms) or a single trial on liability and damages (in the event of reversal); either way, interlocutory review is in the interest of judicial economy and will save the parties a considerable amount of time and expense.

Dct Opinion.

The parties have jointly requested and have now been granted a stay in the district court litigation pending the outcome of the appeal (as well as the outcome of an appeal in a parallel reexamination). 1292(b) indicates that the appeal does not automatically stay proceedings, but suggests that a stay is available if ordered by “the district judge or Court of Appeals.” Id.

MLC’s claimed invention is a method of calibrating a camera-laser-unit using the Tsai algorithm.

Other Recent 1292(b) Cases: The Federal Circuit decided one other 1292(b) cases over the past year. In Heat Techs., Inc. v. Papierfabrik August Koehler Se, 2019 WL 3430477 (Fed. Cir. July 18, 2019), the court denied the petition to hear an interlocutory appeal on the question of whether a “§ 256 claim for correction of inventorship can proceed not-withstanding other potential challenges to the patent’s validity.” In Heat Techs, the appellate panel found several faults with the district court certification order — most notably was the reality that there was not “substantial ground for difference of opinion.” Rather, the answer was a simple “yes” – inventorship and ownership are separate from validity and there are important implications that can flow from owning a patent – even if invalid.

The Court of Appeals also decided a 28 U.S.C. § 1292(d)(2) case. Laturner v. U.S., 933 F.3d 1354 (Fed. Cir. 2019). 1292(d)(2) is substantially parallel to 1292(b) — difference being that (d)(2) allows for interlocutory appeals from the Court of Federal Claims whereas (b) is focused on district court orders.