The recently enacted Cooperative Research and Technology Enhancement (CREATE) Act of 2004, amends Federal patent law in an effort to promote collaborative research, particularly between scientists at separate universities and between industry and university scientists. This new law provides that sharing of confidential information under a joint research agreement that was in effect on or before the date the claimed invention was made will not be the basis of an obviousness determination under patent law. 

During the course of collaborative research, patent applications may be filed which arise from the research.  The filing of these patent applications can become unforeseen prior art when these patent applications or resulting patents become prior art against subsequent patent applications coming out of the collaborative research.

To take advantage of its provisions, you should take steps to: 

  1. prior to entering into a collaborative agreement, consider whether you are willing to potentially give up the opportunity to separately enforce your patent;
  2. review any pending patent applications which may have come out of a collaborative research agreement;
  3. review all collaborative agreements to determine if the agreement will satisfy the criteria set forth in the Act;
  4. amend any relevant pending patent applications or issued patents to include the names of the parties to the agreement;
  5. consider filing a Certificate of Correction to amend patents that have issued as a result of collaborative works; and
  6. record all collaborative research agreements with the United States Patent and Trademark Office.

More details can be found here.

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Carnegie Mellon University scientists have developed a new way to introduce peptide nucleic acid (PNA) directly into live mammalian cells, including human embryonic stem (ES) cells. The work, published online December 2 in Chemical Communications, holds considerable promise in genetic engineering, diagnostics and therapeutics.

Until now, getting PNAs into living cells has been difficult. While other laboratories have developed ways to shuttle PNAs into cells, these methods remain largely ineffective and limited to small-scale experimental setups. Messenger RNA (mRNA) is the current preferred target of antisense therapy.

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The U.S. Congress passed a bill raising patent-filing fees in the Consolidated Appropriations Act, 2005 enacted on December 8, 2004.  The new system’s basic filing fee, search fee and examination fee add up to more costs for applicants, but the most significant change may be the fee hike for each claim beyond the first 20 claims.  The increase from $18 to $50 for each additional claim will particularly hit biotechnology patent applications since even run-of-the-mill applications are now filed with 100-200 pages and as many as 100 claims.

The maintenance fees during the patent’s lifetime have also increased substantially.  This, on top of current efforts by the U.S. Patent and Trademark Office to step up pressure on applicants to reduce the number of claims and pages.  This does not address the fact the one broad claim can cause more searching work for an Examiner than 50 relatively straight-forward and focused claims.  It is worth noting here that what is disclosed in a patent but not claimed is dedicated to the public.  To get around this limitation in the case of applications having both broad scope and broad disclosure, a patentee will need to file additional applications with terminal disclaimers subjecting themselves to multiple maintenance fees.

Of course, the big issue for patentees is that a lot of the money is going into the general government fund and not staying at the patent office to improve efficiency and the quality of prosecution. According to the Intellectual Property Owners Association in Washington, D.C., the federal government has diverted three-quarters of a billion dollars in fees from the patent office since 1992.

The AIPLA has this nice desciption here.

More from the USPTO here.

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IP management is of strategic importance for universities since they can derive significant benefits from an effectively-managed IP portfolio.  According to a survey published by the Association of University Technology Managers (AUTM), the fiscal year 2002 saw over US$37 billion in sponsored research expenditures at 212 member institutions responding to the survey.  During the same period, over 3,600 US patents were issued bringing in US$1.267 billion in licensing revenue and 450 new companies were formed to develop and commercialise some of these inventions.

I just published an article entitled "Building and managing university patent portfolios," IP Value 2005: Building and Enforcing Intellectual Property Value. An international guide for the boardroom, Ed. Joff Wild, published by Globe White Page Ltd. (London, UK);  www.buildingipvalue.com.

I point out that the great potential for universities to generate revenue from IP is less likely to be realized unless universities adopt an aggressive stance towards exploitation.

My recommendations include:

1.  Develop university seed funds to perform the applied research necessary to bridge the gap for high potential, embryonic technologies.

2.  Encourage faculty start-ups to take research outputs closer to market, thereby reducing the risk attached to its exploitation.

3.  Manage IP costs by developing an IP management plan that includes an explicit review process for all inventions, under which technical and business managers, along with outside patent counsel, periodically evaluate each invention to determine if patent protection is cost-effective.

4.  Manage IP donations by requiring, if applicable, the financial resources necessary to maintain the patent(s) for a period of at least two years following the donation as well as financial support for further research and development of the donated IP.

5.  Watch your own IP use since the recent case Madey v Duke University, 307 R 3d 1351 (Fed Cir 2002), has set off a debate about research at federally-funded universities and their right to conduct research without the worry of infringing the IP rights of others.

6.  Continually evaluate performance to demonstrate to external organizations that the university is capable of managing IP effectively and to assist university managers to identify problems and opportunities relating to IP management.

You can see the entire article here.  If you need assistance with University licensing, you can contact me at salbainyjenei@fbtlaw.com.

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An article in the IEEE publication, Spectrum, calls for "a radical cure for the ailing U.S. patent system." As proof, they cite the fact that a small grocery and catering company in Michigan received cease and desist letter from the J.M. Smucker Co. The letter accused Albie’s of violating Smucker’s U.S. Patent No. 6,004,596 by selling crustless peanut butter and jelly sandwiches.

The article takes the "big, bad corporations and their high-paid lawyers" against the "sweet, friendly mom-and-pop store" tact.  You can almost smell the apple pie baking in the background.   It goes on to state that the "beginning of the end" occurred when the U.S. Congress, in 1982, made the U.S. Patent and Trademark Office (PTO) fund itself through application and maintenance fees.

The article argues that this makes it easier to obtain patents, to enforce patents against others, and to extract large financial awards from such enforcement but harder for those accused of infringing patents to challenge the patents’ validity.

The authors go on to stat the our "patent system costs companies and individuals billions of dollars and millions of man-hours annually to obtain patents and fight frivolous lawsuits." Huh?  Isn’t the patent system designed so that companies and individuals can get patents, exploit the technology and make money? 

While I agree that patents are being more actively sought and vigorously enforced, this has more to do with our economy shifting to an intellectual property-based system over a traditional manufacturing base.

The article provides three suggestions to "fix" the system:

First, create incentives and opportunities for parties to challenge the novelty and nonobviousness of an invention before the PTO grants a patent.

Didn’t the American Inventors Protection Act of 1999 (AIPA) provide for this in third-party submissions and Inter Partes Reexamination?

Second, provide multiple levels of application review, with examiners devoting successively more time and effort as an application proceeds to higher levels. The goal would be to avoid wasting money to meticulously examine unimportant patents, while taking sufficient care to avoid mistakes where the stakes are high.

I’d like to see who gets the job of deciding which patents are the "unimportant" ones!

Finally, in cases involving claims of patent invalidity based on the existence of prior art?that is, previously issued patents or public disclosures covering the invention at issue?replace juries with judges who could call on experts, called special masters, for guidance. The change would give parties threatened by invalid patents a better opportunity to make their cases to the court.

Every legal specialty could argue the same thing but it is difficult to reconcile with the jury of ones peers system we have in place.

I think everyone would agree that it is a good ideal to strive for improving the quality of patents, reducing uncertainty surrounding the process of innovation, and limiting patent application, maintenance, and litigation costs. But arguing that the entire system is broken because someone obtained a patent on a watch for "keeping animal time" for dogs where it runs seven times as fast as an ordinary watch (U.S. Patent No. 5,023,850), does not prove anything other than the applicant met the minimum requirements for patentability (new, useful and nonobvious).

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The USPTO posted an update on the TC1600 Restriction Practice Action Plan announced on October 6, 2003.  This plan is to improve quality and respond to customer needs by establishing best practices related to restrictions on the number of inventions and/or claim sets in biotechnology, pharmaceutical and organic chemistry patent applications examined in Technology Center 1600 (TC 1600).  A first phase of examiner training has been completed that focused on the basic principles of restriction requirements, and included a review of linking claims, Markush practice, and rejoinder issues.  The training material included sample claim sets and corresponding restriction requirements.  The training materials have been posted on the USPTO web site .  Questions or comments concerning the training examples may be addressed to Deborah Reynolds by phone at 571-272-0734

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The Business First of Columbus news publication reported that Ohio was ranked No. 11 in biopharmaceutical venture capital funding in an October study by the Milken Institute.  The study noted Ohio’s Third Frontier Project, a 10-year plan to spur the state’s high-tech economy, for increasing money spent on biotech.  Massachusetts ranked No. 1 in the overall ranking, with Wyoming bringing coming in last.

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If you haven’t seen it, the USPTO offers a little guide on filing a provisional application for a patent. Besides giving a brief overview of the history, purpose and filing date requirements, it offers a nice list of cautions about their use.  As patent attorneys soon find out, inventors hear about provisional patent applications and then come to you asking for one of those $100 applications.

I’m thinking of keeping the list of cautions as a stock document to send to prospective patentees so that I ensure they are duly warned.  See below:

Cautions

Provisional applications are not examined on their merits.

The benefits of the provisional application cannot be claimed if the one-year deadline for filing a non-provisional application has expired.

Provisional applications cannot claim the benefit of a previously-filed application, either foreign or domestic.

It is recommended that the disclosure of the invention in the provisional application be as complete as possible. In order to obtain the benefit of the filing date of a provisional application the claimed subject matter in the later filed non-provisional application must have support in the provisional application.

If there are multiple inventors, each inventor must be named in the application.

The inventor(s) named in the provisional application must have made a contribution to the invention as described.  If multiple inventors are named, each inventor named must have made a contribution individually or jointly to the subject matter disclosed in the application.

The non-provisional application must have one inventor in common with the inventor(s) named in the provisional application to claim benefit of the provisional application filing date.

A provisional application must be entitled to a filing date and include the basic filing fee in order for a non-provisional application to claim benefit of that provisional application.

There is a surcharge for filing the basic filing fee or the cover sheet on a date later than filing the provisional application.

Provisional applications for patent may not be filed for design inventions.

Amendments are not permitted in provisional applications after filing, other than those to make the provisional application comply with applicable regulations.

No information disclosure statement may be filed in a provisional application.

A provisional application cannot result in a U. S. patent unless one of the following two events occur within 12 months of the provisional application filing date:

  1. a corresponding non-provisional application for patent entitled to a filing date is filed that claims the benefit of the earlier filed provisional application; or
  2. a grantable petition under 37 CFR 1.53(c)(3) to convert the provisional application into a non-provisional application is filed.

Warnings

A provisional application automatically becomes abandoned when its pendency expires 12 months after the provisional application filing date by operation of law. Applicants must file a non-provisional application claiming benefit of the earlier provisional application filing date in the USPTO before the provisional application pendency period expires in order to preserve any benefit from the provisional-application filing.

Beware that an applicant whose invention is "in use" or "on sale" (see 35 U.S.C. ?102(b)) in the United States during the one-year provisional-application pendency period may lose more than the benefit of the provisional application filing date if the one-year provisional-application pendency period expires before a corresponding non-provisional application is filed. Such an applicant may also lose the right to ever patent the invention (see 35 U.S.C. ?102(b)).

Effective November 29, 2000, a claim under 35 U.S.C. 119(e) for the benefit of a prior provisional application must be filed during the pendency of the non-provisional application, and within four months of the non-provisional application filing date or within sixteen months of the provisional application filing date (whichever is later). See 37 CFR 1.78 as amended effective November 29, 2000.

Independent inventors should fully understand that a provisional application will not mature into a granted patent without further submissions by the inventor.  Some invention promotion firms misuse the provisional application process leaving the inventor with no patent.

I would just add that "you get what you pay for" still applies.

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