Patent Baristas

The USPTO clarified its position concerning the treatment of petitions to withdraw a holding of abandonment that are not timely filed because the applicant failed to exercise reasonable diligence in monitoring the status of the application. The USPTO receives petitions under 37 CFR 1.181(a) to withdraw holdings of abandonment (based on non-receipt of an Office action, or upon non-receipt or loss of a reply by the applicant). Some of these petitions are filed years after the application is held abandoned, causing extensive prosecution delays. To prevent these delays from inappropriately extending the term of any patent issued from the application, the USPTO is clarifying its position concerning the treatment of petitions to withdraw holdings of abandonment that are not timely filed because the applicant failed to exercise reasonable diligence in monitoring the status of the application.

Utility and Plant Applications Filed on or after May 29, 2000.

The term of a patent issuing from a utility or plant application filed on or after June 8, 1995, ends on the date that is twenty years from the filing date of the application, or the earliest filing date for which a benefit is claimed under 35 U.S.C. 120, 121, or 365(c). Utility and plant applications filed on or after May 29, 2000, however, are eligible for patent term adjustment under the American Inventors Protection Act of 1999 (AIPA). Therefore, if a petition to withdraw a holding of abandonment is not filed within two months from the mailing date of the notice of abandonment, any patent term adjustment will be reduced under the provisions of 37 CFR 1.704(c)(4).

If applicant does not receive the notice of abandonment, any patent term adjustment may be reduced under the provisions of 37 CFR 1.704(a) by a period equal to the period of time during which the applicant "failed to engage in reasonable efforts to conclude prosecution" (processing or examination) of the application, in which case any period of adjustment shall be reduced by the number of days, if any, beginning on the day after the date that is twelve months from the date of applicant’s filing or submission of correspondence with the USPTO for which further action by the USPTO can reasonably be expected and ending on the filing date of a grantable petition to withdraw the holding of abandonment.

Utility and plant applications filed on or after June 8, 1995, but before May 29, 2000

Utility and plant applications filed on or after June 8, 1995, but before May 29, 2000, are eligible for patent term extension under the Uruguay Round Agreements Act (URAA). The URAA provides for patent term extension only if issuance of the patent was delayed due to: (1) an interference proceeding; (2) imposition of a secrecy order; or (3) successful appellate review. See 35 U.S.C. 154(b) (1994). Unless an application is held abandoned during one of these three periods, the untimely filing of a petition to withdraw a holding of abandonment will not operate to extend the term of the patent because the USPTO has no authority to grant patent term extension under the URAA for other administrative delays. If a petition to withdraw a holding of abandonment is not filed within two months from the mailing date of the notice of abandonment during a period of appellate review, any patent term extension accrued under 37 CFR 1.701(a)(3) (extension due to successful appellate review) may be reduced under the "due diligence" provisions of 37 CFR 1.701(d)(2).

Design Applications, Utility Applications Filed Before June 8, 1995, and Plant Applications Filed Before June 8, 1995

(A) Applicant Receives Notice of Abandonment. In any utility or plant application filed before June 8, 1995, and in any design application, if applicant receives a notice of abandonment, any petition to withdraw the holding of abandonment that is not filed within two months of the mail date of the notice of abandonment will not (absent extraordinary circumstances) be treated on its merits unless accompanied by a terminal disclaimer under 37 CFR 1.321(a), and the required fee set forth in 37 CFR 1.20(d). The period to be disclaimed is the terminal part of the term of any patent granted on the application, or of any patent granted on any utility or plant application that claims the benefit of the filing date of the application under 35 U.S.C. 120, 121, or 365(c), equivalent to the period between:

1. the date that is two months after the mail date of the notice of abandonment; and
2. the filing date of a grantable petition to withdraw the holding of abandonment.

(B) Applicant Does Not Receive Notice of Abandonment. In any utility or plant application filed before June 8, 1995, and in any design application, if applicant never receives the notice of abandonment, any petition to withdraw the holding of abandonment that is not filed within twelve months from the date of applicant’s filing (or date of submission, if the correspondence was never received by the USPTO) of correspondence with the USPTO for which further action by the USPTO can reasonably be expected, will not (absent extraordinary circumstances) be treated on its merits unless accompanied by a terminal disclaimer under 37 CFR 1.321(a), and the required fee set forth in 37 CFR 1.20(d). The period to be disclaimed is the terminal part of the term of any patent granted thereon, or of any patent granted on any utility or plant application that claims the benefit of the filing date of the application under 35 U.S.C. 120, 121, or 365(c), equivalent to the period between:

1. the date that is twelve months from the date of applicant’s filing or submission of correspondence with the USPTO, for which further action by the USPTO can reasonably be expected; and
2. the filing date of a grantable petition to withdraw the holding of abandonment.

Petitions to revive an abandoned application for unavoidable or unintentional delay under 37 CFR 1.137(a) or (b) are also subject to a terminal disclaimer requirement of 37 CFR 1.137(d). According to the USPTO, "Since practitioners and pro se applicants can monitor the status of their applications using the USPTO?s PAIR and IFW systems, the failure to receive a notice of abandonment (or any other USPTO notification) will not excuse an unreasonable delay in filing a petition to withdraw the holding of abandonment. A status inquiry is in order once six months have elapsed with no response from the USPTO."

Read the full document here.

US District Court Judge Mark Wolf dismissed patent claims filed by several biotechnology companies (including Genzyme Corp. and Biogen Idec Inc.) against Columbia University that alleged the New York school was improperly trying to extend its rights to a process widely used to engineer new drugs. Columbia had collected several hundred million dollars over the years from its patents on the drug-making process but the school recently pledged not to seek further royalties, so the judge in the case dismissed firms’ claims.

The patents are based on research from the 1970s by Columbia professor Richard Axel, who this year was co-winner of the Nobel Prize for Medicine. Axel and two colleagues created a way to splice bits of DNA into living cells to create human proteins, a basic technique used to produce many of today’s best-selling biotechnology products such as Genzyme’s Cerezyme for Gaucher disease and Biogen Idec’s multiple-sclerosis drug Avonex.

The patents expired in 2000, but in 2002 Columbia received a new patent derived from its previous patents with 17 more years of protection and Columbia expected continuing royalties based on the new patent. The companies stopped paying and filed various suits against Columbia the next year.

In dismissing the claims, Wolf let stand Columbia’s patent itself, which the school is having reexamined by the US Patent and Trademark Office. David I. Gindler, an attorney at the firm of Irell & Manella LLP in Los Angeles who represents Columbia, said Wolf’s ruling leaves open the possibility of a future decision by the government agency that would extend the school’s rights after all.

A proposal in Arizona to allow universities to enter partnerships with corporations was defeated despite no organized opposition and widespread support from prominent groups and top elected officials from both political parties. The proposition, defeated 52 to 48%, was to amend the Arizona Constitution, which prohibits the state government from becoming a shareholder or joint owner in a company.

Proposition 102 would have allowed the state to license or transfer interests in technology or intellectual property created by the state’s universities. Officials of Arizona’s three universities said most states have no such restrictions.

Only one person submitted a statement of opposition, claiming the proposal could lead to human cloning. Really?  It could lead to human cloning?  While there are some reasons for not wanting a state to get entangled in corporate ownership, e.g., conflicts of interest and fiduciary duty, human cloning isn’t one of them.  This is a good illustration of how the general public doesn’t understand university research or the process of tech transfer.  See more details here.

I’m back from attending the BioOhio 2004: Entrepreneurs & Innovation in Columbus (and I have all our materials back home).  We received many wonderful compliments on our new booth featuring our  "Protect Your Stuff" ad motif and logo "bulldogs".   We gave out plenty of stuffed beanie dogs and chocolate dog bones to attendees.  Thanks to everyone who stopped to see us.  I’ll see everyone at next year’s conference – and I’m sure the bulldogs will make a repeat appearance.   

Some news I always like to hear (being in the wet, allergy-prone Midwest), a new research from the University College London branch of the Ludwig Institute for Cancer Research (LICR), published in this week’s Nature, detail how inactivating a key signalling molecule called p110delta reduced the effect of allergies on mice. In mice lacking the gene for p110delta, the allergic response was reduced substantially; in normal mice that had been treated with an experimental drug inhibiting p110delta, the allergic response was stopped completely.

Experts estimate that, in the UK alone, one in three people will suffer from some form of allergy during their lifetime; some nine million people suffer from hay fever, six million from eczema and five million from asthma each year. In the most extreme circumstances, an allergic reaction can be life-threatening or even fatal. The p110delta could also play a role in certain tumours, like leukemia, and that targeting the p110delta pathway may one day also be useful in the treatment of cancer.

See details here.

A movement has started called the Biological Innovation for an Open Society (BIOS) initiative by molecular geneticist Dr. Richard Jefferson, founder and CEO of the CAMBIA (Centre for the Application of Molecular Biology to International Agriculture) in Canberra. BIOS is an attempt to establish an open-source technology movement in the biotechnology industry, similar to the computing industry’s open-source software movement.

BIOS provides biotechnology with its own free ‘operating system’: a public-domain toolkit and associated patents, aimed at freeing researchers worldwide to innovate without restriction, and without being forced into partnerships or unfavorable royalty agreements. They have developed a core toolkit of patented techniques that will expand into a protected ‘commons’, protected by licenses and other contracts, as biotechnology researchers and agencies around the world contribute new ideas and refinements.

Jefferson is concerned about the lack of sustainable food production, fragile rural economies, poor nutrition, environmental degradation, and poor public health practices and given insufficient attention to diseases and medical conditions of poor people in marginalized communities. He argues that BIOS will facilitate a bottom-up, rather than a top-down, approach to biotechnology innovation. He argues that the tools for innovation should be a shared, public resource, freely accessible to all researchers and businesses, with everyone contributing to their improvement.

The BIOS project does not address the question of whether this could lead to increased or decreased innovation. More importantly, would such tools be commercialized? Typically, in a regulation-ladened industry like biotech, it is difficult to imagine that companies would be willing to expend the resources it would take to get a product to market. Generally, broad patent protection is essential to the development of biotechnology. Biotechnology companies consume large amounts of capital and resources to develop new therapeutics even while the failure rates in the biotechnology industry are extraordinary. For illustration, in order to get just one new drug approved by the Food and Drug Administration, companies will typically screen 5,000 to 10,000 compounds, spending $800 million over the course of 14 years from initial screening to FDA approval.

While it sounds good in principle, I’ll be interested in seeing how BIOS progresses. It may be that we need to bear the short-term cost (a 20-year patent monopoly) in order to gain the benefit of the innovation provided for all time. Read more here.

The IP Department of Frost Brown Todd LLC will once again be a sponsor of BioOhio 2004: Entrepreneurs & Innovation.  We’ll be attending at our booth featuring our new "Protect Your Stuff" ad motif. 

Omeris, Ohio’s bioscience development organization, will host its 17th annual statewide conference on October 21-22 at the Hilton Columbus.

The conference will feature two of the nation’s premier cancer researchers, both of whom also have succeeded as bioscience entrepreneurs.  The BioOhio agenda also includes some of Ohio’s most successful bioscience entrepreneurs, research leaders of state-funded collaborations, and experts on financing technology start-ups. During Thursday’s opening remarks, Ohio Governor Bob Taft will discuss the impact of Ohio’s continuing investment in bioscience research and commercialization.

BioOhio brings together Ohio’s best in the biosciences-eminent researchers, CEOs of Ohio’s leading bioscience companies, state officials and legislators, top venture capitalists, and enterprising students.  This year’s conference will focus on how to fuel Ohio’s pipeline of bioscience companies and jobs through entrepreneurship and research commercialization.

For more information on BioOhio 2004, contact Omeris Director of Corporate Communications Matt Schutte at 614/675-3686.  See a full agenda or to register online.

See you in Columbus!

As many know, I have started publishing a newsletter back in 1997 when I was still in-house patent counsel at the University of Cincinnati.  Basically, I wrote a collection of news items and updates on intellectual property and licensing issues and, when I collected 10 or 12 or so, I emailed it out in the form of a newsletter to the IP Office list of about 700 people.  After moving to private practice, I wrote few but more substantial articles and continued with the "push" technology of emailing these out to friends and clients.  I have now changed to using a passive "blog" system so that I don’t have to wait to send out emails when I think I’ve collected enough items.  I think this more immediate format will prove better in providing more immediate updates on IP law in biotech, pharma and chemical arts as well as licensing and technology transfer.  We shall see.