Patent Baristas

The United States Patent and Trademark Office (USPTO) will publish (tomorrow) in the Federal Register new rules that will allow the agency to continue to make the patent examination process more effective and efficient by encouraging applicants to use greater precision in describing the scope of their inventions. The new rules will be effective on November 1, 2007.

Under the new rules, applicants may file two new continuing applications and one request for continued examination as a matter of right. Also, under the new rules, each application may contain up to 25 claims, with no more than five of them independent claims, without any additional effort on the part of the applicant. Beyond these thresholds, however, the new rules require applicants to show why an additional continuation is necessary or to provide supplementary information relevant to the claimed invention to present additional claims.

The USPTO beleives that application quality will be improved, enhancing the quality and timeliness of both the examination process and issued patents. We shall see.

The new rules are available tomorrow, August 21, 2007, no later than noon, in the Federal Register. A webinar on the new rules is scheduled for Thursday, August 23, 2007. See Rule Changes to Focus the Patent Process in the 21st Century.

Previous News:

Another USPTO Rule Package Slowly Boxing In Applicants

OMB Approves Patent Changes, But to What Result?

Patent Holders Express Budget Concerns Over Proposed Patent Rule Changes

USPTO Proposes Limiting Continuations

I received a note from the USPTO asking if I could post a notice about needing volunteers for a Complex Work Units Pilot Program.  This is mainly for those that deal with complex chemical or mathmatical formulae.

The United States Patent and Trademark Office (USPTO) is seeking participants for a Complex Work Units (CWUs) Pilot Program scheduled for late 2007.  CWUs are chemical structure drawings, mathematical formulae, protein crystal data, and table data, which often add significant complexity and cost to the examination and publication of patent applications in which they are contained.  

The CWU Pilot Program will be conducted in an effort to:

• Investigate filing practice options for CWUs
• Gather information about existing CWU formats and their use in the Intellectual Property community
• Evaluate rule changes to allow applicants to submit CWU files
• Determine other acceptable file types

The pilot will allow applicants to submit original source files for CWUs through EFS-Web or on a CD, supplementing the traditionally-filed application parts.  The CWU source file submissions will not be considered when calculating the application size fee, which will reduce the cost of filing for pilot participants.

The USPTO is requesting participants in an effort to gather more information about CWUs from the intellectual property community.  If you have any questions or would like to participate in CWU Pilot activities, please send an e-mail to cwupilotsupport@uspto.gov today!

It’s nice that they’ve asked for feedback, though.

As further evidence that the United States Patent and Trademark Office (Office) hates the chemical/pharma/biotech arts, the Office is proposing to revise the rules of practice pertaining to any claim using alternative language to claim one or more species. That is, if the claims use Markush or other forms of alternative language. This is all part of the Master 21st Century Strategic Plan where the PTO is trying desperately to reduce its workload by any means necessary. According to the USPTO, the search and examination of such claims consume a disproportionate amount of Office resources as compared to other types of claims.

In Ex parte Markush, 1925 Dec. Comm’r Pat. 126, 128 (1924), the Office officially sanctioned a claim drafting technique, already in use for some time, wherein the phrase ‘‘selected from the group consisting of’’ is followed by a closed listing of specific members of the group. Claims including such language became known as ‘‘Markush claims.’’ For example, if a claim to a chemical composition requires a particular alcohol, that alcohol could be defined via Markush language such as ‘‘an alcohol selected from the group consisting of methanol, ethanol, and isopropanol;’’ or ‘‘an alcohol of the formula R-OH, wherein R is selected from the group consisting of CH3-, CH3CH2-, and (CH3)2CH-.’’

In addition to the indefiniteness issue, another factor giving rise to claims using Markush language was the change from claims based on the central type of definition to those based on the peripheral definition. With the peripheral- type claims came the necessity of avoiding invalidity by reason of inoperative species which might be included within the metes and bounds of the claim. In mechanical cases, this problem is overcome by the use of elements defined as ‘‘means’’ but chemical claims do not lend themselves well to such a solution due to the fact that equivalence in chemical cases is difficult to establish. The Markush claim may be regarded as a partial solution to this problem, since it permits an applicant to claim a subgeneric group containing those materials which have been actually tested and known by applicant to be operable.

Most of the court decisions concerning claims that recite alternatives involve Markush practice and reflect problems associated with claiming compounds by their chemical structure. Current Office practice is that compounds that are defined by Markush language are directed to a single invention (i.e., have ‘‘unity of invention’’) when they ‘‘(1) share a common utility, and (2) share a substantial structural feature essential to that utility.’’

Current Office policy requires examination of all species of a claim that recites a Markush group when the alternatives are sufficiently few in number or so closely related that search and examination can be made without serious burden. That is, the Office cannot refuse to examine what applicants regard as their invention unless the subject matter in a claim lacks unity of invention.

In such case, however, the examiner may require applicant to elect a single species under 37 CFR 1.146 for initial search and examination to facilitate examination on the merits. If the elected species is not allowable, examination of the Markush claim will be limited to the elected species and any species not patentably distinct therefrom, and any separate claims to the elected species and any species not patentably distinct therefrom. Claims drawn to species patentably distinct from the elected species are held withdrawn from further consideration. If the elected species is allowable, then the search and examination of the Markush claim will be extended to non-elected species to the extent necessary to determine patentability of the claim. This may require a separate search and examination of each alternative.

The proposed rules are intended to provide a mechanism by which the Office can require a single claim to be limited to a single invention.

1. Each claim must be limited to a single invention.

A claim that is directed to multiple independent and distinct inventions would meet the statutory eligibility requirement for restriction set forth in 35 U.S.C. 121:

If two or more independent and distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions.

Through the use of the word ‘‘may,’’ the statute is permissive, not mandatory, and gives the Director discretion to require restriction.

In addition to proposing a requirement limiting a claim to a single invention, the Office is proposing to specify that when subject matter that reads on multiple species is defined in a single claim using alternative language, the claim is limited to a single invention when at least one of the following two conditions is met: (1) All of the species encompassed by the claim share a substantial feature essential for a common utility, or (2) all of the species are prima facie obvious over each other.

The Office proposes to encourage applicants, when filing a claim that employs alternative language, to provide an explanation as to why the claim is directed to a single invention. (WARNING: Prosecution Estoppel Ahead!)

The Notice claims that when an applicant submits an explanation in a timely manner, the examiner will fully consider it (and then summarily reject it).

The Office also proposes that if an application seeks the benefit under title 35, United States Code, of a prior-filed application and discloses subject matter that was not disclosed in the prior-filed application (a continuation-in-part), the applicant must identify which claim or claims in the application are disclosed in the manner provided by the first paragraph of 35 U.S.C. 112 in the prior-filed application.

2. Claims with alternatives will require a new format.

The Office proposes to require a simplified format for the presentation of such claims and to set forth conditions that must be met by any claim that uses alternative language by adopting language similar to that in the PCT Guidelines, specifically requiring that the number and presentation of alternatives in the claim not make the claim difficult to construe, and requiring that each alternative within a list of alternatives must be substitutable one for another. In addition, to reduce the complexity of determining whether a claim is directed to a single invention, the Office proposes to specify that no alternative may itself be defined as a set of further alternatives.

Finally, the Office proposes to specify that no alternative may be encompassed by any other alternative within a list of alternatives, unless there is no other practical way to define the invention. When alternatives partially overlap in scope, it is more difficult to determine whether a single claim encompasses more than one invention. Thus, a single claim that includes alternatives that either fully overlap (e.g., ‘‘selected from the group consisting of an adhesive agent, tape, and glue’’) or partially overlap (e.g., ‘‘selected from the group consisting of citrus fruits and tropical fruits’’) in scope may be subject to an objection.

The Office states that Applicants should file a series of individual claims from the broadest scope that they feel they are entitled to the narrowest scope they are willing to accept. Put differently, applicant should narrow the scope of protection sought via separate claims and not via nested sets of overlapping alternatives.

Couple this with the proposed rules on claim limits (see Changes to Practice for the Examination of Claims in Patent Applications, 71 Fed. Reg. 61) and this adds up to a skyrocketing increase in costs.

If you want to (try to) make your voice heard, written comments must be received on or before October 9, 2007. No public hearing will be held. Comments should be sent to

markush.comments@uspto.gov.

Comments may also be submitted by mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, or by facsimile to (571) 273–7754, marked to the attention of Kathleen Kahler Fonda, Legal Advisor, Office of the Deputy Commissioner for Patent Examination Policy.

In addition to comments on the proposed rules, the Office welcomes further suggestions for changes that would improve the examination of claims that recite Markush or other alternative language while appropriately balancing the interests of the Office with those of applicants and the public.

Sheryl Sisk Schelin, a solo practitioner living and working in North Myrtle Beach, South Carolina (yes, we hate her already), brings an inspired version of Blawg Review this week in Blawg Review #121 over at the Inspired Solo.

We especially enjoyed David Lat’s post on Above the Law regarding a counsel’s motion to reschedule oral arguments “for no other reason than to please his wife.” While we disagree about the lawyers claimed nonenjoyment of said 350-mile bicycle trip, it’s still puzzling to see the comments get out of control.

Of course, we could really use Ernie the Attorney’s thoughts on avoiding the stress caused by email.

Our addition this week comes from the Althouse blog via a tip from the Blawg Review editor: Do drug makers invent diseases for their drugs?

“We wouldn’t have invented a disease unless we had something to take for it.”
— a line from a 1960s ad.

Johnson & Johnson has sued the American Red Cross, an indisputably highly regarded charitable organization, over ARC’s “commercial” use of the red cross symbol trademark. It seems that the ARC has been licensing others to use the symbol in connection with first-aid type products sold in retail stores. To raise money, of course. That’s generally what charities do in order to fund their services.

Apparently worried about provoking cries of outrage and denouncements of corporate greed, J&J’s lawyers laced the complaint with interesting but mostly irrelevant historical information about ARC’s charter and the utterances of long-dead public figures, to support a suggestion that ARC should only be permitted to use the symbol in connection with its “chartered” (non-“commercial”) purposes. J&J’s people have been busy issuing press releases, too, about J&J’s efforts to be reasonable and seek amicable resolution of the dispute. The complaint has provoked cries of outrage and denouncements of corporate greed.

The complaint alleges an 1895 agreement between J&J and the ARC in which the ARC acknowledged “the exclusive use [by J&J] of a red cross as a trademark”. The complaint also notes J&J’s federal trademark registration for the symbol. Unless J&J amends its complaint at some time in the future, these things, too, seem irrelevant. Why? Because the complaint doesn’t allege claims for breach of contract or trademark infringement.

Instead, it contains only two counts against ARC: First, it alleges a vague claim of “equitable estoppel”, to the effect that because the ARC allegedly said in the past that it would not use the symbol “commercially”, J&J believed it would not do so in the future. In some if not many jurisdictions this would not even be recognized as a valid cause of action. Second, it alleges violation of a 102-year-old federal criminal statute that makes it a crime for anyone to make use of the Greek red cross on a white background (except the ARC and those who were already lawfully using it at the time of enactment — which allegedly includes J&J).

Assuming the ARC has actually violated the statute in some way (how, it is not clear), violation of a criminal statute does not automatically give anyone who objects a private civil cause of action. There has to be an associated, legally recognized civil tort — like trademark infringement — which is not alleged here. You can’t sue me in civil court for parking my car illegally, unless in doing so I am trespassing on your property.

Confused? I am. First, I hadn’t even known that J&J owns or uses “its famous Red Cross design” trademark. No products come to mind. I went to J&J’s web site to look for evidence of use of the mark, and couldn’t readily find any — it may be there somewhere, but I couldn’t find any after 10 minutes. It doesn’t appear on Band-Aids packages. Apparently J&J does use the mark in connection with consumer first aid kits, sold somewhere. But other sellers of first aid kits use cross symbols of varying colors and configurations.

Additionally, the symbol has been widely used to identify sources of medical care, throughout the world. This suggests the possibility that the symbol has become generic, and therefore, unprotectable as a trademark. Perhaps J&J didn’t allege trademark infringement because it is worried about this, or about its ability to succeed in showing that people in the U.S. associate the red cross symbol with any particular organization . . . other than the ARC.

Coupled with this very unclear situation concerning ownership and violation of rights, in an unfortunately typical showing of heavy-handedness, the complaint seeks relief including an injunction, destruction of all of the defendants’ marked goods, packaging and promotional materials, “all profits, gains and advantages derived by Defendants from their unlawful conduct,” “exemplary and punitive damages,” costs, interest and attorneys’ fees. Granted, attorneys routinely put things like this in their pleadings because they think it will instill fear in their opponents, but did J&J consider the perceptions of non-lawyers reading this? Just take a look at some of the blog postings, for example, here.

What is J&J trying to accomplish? Time will tell, but we wonder whether litigation will be a worthwhile endeavor for anyone but the lawyers.

See Johnson & Johnson’s statement on the issues here.

See the Red Cross response here.

Listen to NPR’s Morning Edition story.

Update:

For a timeline of the trademark and an explanation of the legal reasoning behind the suit, see Professor Froomkin’s discourse at Discourse.net.

For some suggestions on resolution, see Victoria Pynchon’s integrated solutions at the IP ADR Blog.

Today’s post comes from Guest Barista Bill Gallagher, a registered patent attorney in Frost Brown Todd’s Cincinnati office.

The Position:

CincyTechUSA is looking for a Bioscience Executive-in-Residence to identify new technologies that have the potential to be commercialized through the formation of new companies; guide the launch these startups; prepare startups for an investment from CincyTech’s Seed Fund; and work with companies to help them achieve investment milestones and attract a follow on round of capital from other sources.

The Executive-in-Residence will provide assessment for seed and pre-seed investment, coaching, mentoring and networking with capital sources.

The Qualifications:

3+ years experience as a senior executive in a established medical device, diagnostic or therapeutics company.

The Place:

CincyTechUSA is a not-for-profit venture development organization working through management assistance, seed capital investments, and connections to regional partners.

The Rest:

Submit a résumé to admin@cincytechusa.com by August 31, 2007 for consideration.

Kurt Karst of the FDA Law Blog ran a nice update on patent term extension (PTE) legislation. The legislation, known as the “Dog Ate My Homework Act,” would permit the U.S. Patent and Trademark Office to exercise discretion to accept untimely filed Patent Term Extension (PTE) applications has been added to the Patent Reform Act of 2007 (S. 1145) by Senator Edward Kennedy (D-MA).

Representative William Delahunt (D-MA), who introduced a stand-alone bill earlier this year in the House, H.R. 1778, is trying to get the legislation added to the House version of the Patent Reform Act of 2007” (H.R. 1908).

This has been bounced around for several years now, and is intended (very specifically) to help Massachusetts-based The Medicines Company, which submitted its PTE application for U.S. Pat. No. 5,196,404 for ANGIOMAX (bivalirudin) 61 days after FDA approved its New Drug Application (NDA) .

In case you haven’t already guessed, the patent term extension law requires the submission within 60-days of the date of NDA approval. You can just hear the “Doh!”

A copy of Sen. Kennedy’s amendment agreed to at the Senate Judiciary Committee Executive Business Meeting is available here.

What a Diff’rence a Day Makes!

In a follow-up on our earlier discussion regarding the Supreme Court’s broad scope of the research exemption to the Integra case, the question came up asking if a patented delivery formulation — say, a sustained release formulation as opposed to a therapeutic itself — would fall within the exemption from infringement under the Food and Drug Administration (“FDA”) Exemption.

This “safe harbor” under 35 U.S.C. ‘271(e)(1) states:

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 . . . 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 (emphasis added).

It’s very clear that the Supreme Court recently gave pharmaceutical companies broad latitude to study and experiment with compounds covered by other companies’ patents in its recent decision, Merck KGaA v. Integra Lifesciences I, Ltd., 125 S. Ct. 2372, No. 03-1237. The operative effect of the decision is that, in certain circumstances, drug companies can now conduct preclinical research (laboratory and animal testing) using patented compounds without risk of infringement.

The Supreme Court decided, unanimously, that such use in preclinical studies is protected as long as there is a reasonable basis to believe that the experiments will produce types of information relevant to an Investigational New Drug Application (“IND”) or New Drug Application (“NDA”) filed with the FDA.

But what if it is not the active agent that is subject to patent protection but a specific formulation or controlled release invention for use with the active agent?

Writing for a unanimous Court, Justice Scalia found that:

“As an initial matter, we think it apparent from the statutory text that §271(e)(1)’s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA.” (emphasis added).

The use of the term “patented inventions” seems to indicate that the Court very much intended for the §271(e)(1) exemption to apply to any patented technologies that are used in drug development as long as they are reasonably related to the development and submission of information under the FDCA. The Supreme Court therefore ruled that the exemption applies broadly to all the aspects of when researchers seek out new compounds having pharmaceutical safety and efficacy, and is not limited to situations in which a pharmaceutical candidate has already been identified and is being tested in order to obtain FDA approval.

That would seem to include patented methods of making compounds, patented formulations and any other patented technologies related to the drug including tableting systems, coating and encapsulation technologies and even the machinery for manufacturing the drug.

Relying heavily on the language of the statute, Justice Scalia states that “there is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included.”

Critical to triggering the exemption is that experiments be “reasonably related” to FDA submissions; the parameters of this standard are set forth by the Supreme Court:

At least where a drug maker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is ‘reasonably related’ to the ‘development and submission of information under…Federal law.’ 125 S. Ct. at 2382, No. 03-1237, slip op. at 13.

In view of the Merck decision, it appears that many preclinical studies using patented inventions will be exempt from infringement under § 271(e)(1). They may include:

Clinical and Preclinical studies of patented compounds that are appropriate for submission to the FDA;

Studies intended to generate pharmacological, toxicological, pharmacokinetic, and biological qualities of the drug in animals;

Studies intended to generate information regarding a risk-benefit assessment of the appropriateness of [a proposed clinical] trial; and

Safety related tests even if not compliant with FDA regulations.

Unfortunately, the Supreme Court explicitly declined to express a view about whether § 271(e)(1) exempts from infringement the use of research tool patents in furtherance of research for regulatory approval.