Patent Docs

Congressman Berman Is on the Case

    By Kevin E. Noonan --

One of the frustrations of those opposed to actions taken by the Administration over the past eight years has been the lack of Congressional oversight, in view of the congruency of the party in power of the legislative and executive branches.  Although in theory this left the judicial branch to supply a check (or a balance) on public policy, the courts are a blunt and slow tool (and are not above their own type of partisan bias; see Bush v. Gore ).  However, this trend began to turn with the election of the members of the 110th Congress, where the opposition party came to power and, although lacking a sufficient majority to impose its will, maintains the power to police.

One part of the Administration that has suffered mightily as a result of this lack of oversight is the Patent Office, where the current Director and his minions have presided over one of the great adventures in mismanagement in U.S. history.  But it appears that at least some of the Members of Congress are beginning to notice:  at the end of April, Howard Berman (D-CA), Chairman of the Subcommittee on Courts, the Internet, and Intellectual Property of the House Judiciary Committee sent Jon Dudas, Director of the U.S. Patent and Trademark Office, a letter requesting information to supplement Director Dudas' February 27, 2008 testimony before the subcommittee at an oversight hearing (see "House Subcommittee Holds USPTO Oversight Hearing").  Although on its face the letter was a cordial request for additional information, even the most casual perusal of the contents of the letter indicates that Congressman Berman (at right) has something on his mind.

The letter contains eighteen numbered paragraphs covering a wide range of topics.  And the questions are specific, asking Director Dudas (at left) to reconcile or justify his testimony with either Patent Office behavior, statements, or actions.  These topics include:

• Projections as to the number of applications expected to be filed over the next five years.  The Congressman wants to know what methods (including computer programs) the Office uses to make these projections and what considerations are included in its calculations.  The letter specifically references the enjoined continuation and claims rules, and asks to what extent the projections were based on anticipation that the new rules would be implemented.  It also points out that the FY2008 budget projected an 8% per year increase, while the FY2009 budget projects a 5% per year increase.

• In view of the status of the enjoined new rules, the Congressman asks what actions the Office and/or Congress could take to address the pendency backlog, either at a 5% per year or 8% per year patent application increase level.  The letter also cites the GAO Report that claimed the Office could hire 2,000 new examiners per year for the next five years and still not decrease the backlog (the GAO report estimates the backlog would continue to grow, under this scenario, from 260,000 in FY2007 to 953,643 at the end of FY2011).  The letter notes that the source of the GAO's estimates was the PTO, and thus requests Director Dudas to provide all information supporting these estimates.

• Turning to the corps of patent examiners, the letter cites statements in the GAO report alluding to internal Office review of production goals for examiners.  The letter then cites Director Dudas' testimony before the subcommittee that the Office was beginning to review production goals.  Congressman Berman asks Director Dudas to provide a description of the methods being used to perform this review, the personnel involved in the review, and a timetable for its completion.  In this regard, the letter also asks for an accounting of the discrepancy between the GAO report's statements, that most examiners who leave the Office do so in response to management (including the production goals), and Patent Office statements that most examiners leave the Office for "personal reasons."  The letter specifically asks questions regarding putative exit interviews given to departing examiners that Director Dudas used to support his testimony, including the percentage of departing examiners who had participated in said interviews.

• Patent allowance statistics, specifically the decline in allowance rate from 70% in 2000 to 44% in 2007. The letter asks whether the Office included Requests for Continued Examination in its statistics, and if so how.

• The letter requests further information on the progress of plans for regional patent offices, and asks what resources have been used, particularly in view of the failure of the program to be included in the FY2009 budget.

The letter turns more frank with regard to two issues:  the statutory requirements for making changes in the Office's internal management structure, and the behavior of "senior PTO officials" in the RIM v. NTP reexamination.

• The letter also asks for information regarding whether the Office violated Acts of Congress as well as Commerce Department rules when implementing the creation of the Office of Enforcement.  Specifically, the letter reminds Director Dudas that the 2006 Science, Justice, Commerce Appropriations Act requires that, before the Office can "reprogram" funds it must notify Congress fifteen days prior to reprogramming, and that Departmental Administrative Order (DAO) 203-13 defines reorganization ("establishment, consolidation, abolition or 'other significant change'") as "generally considered a reprogramming that triggers the disclosure requirement."  Director Dudas had testified to the subcommittee that elimination of the Office of Enrollment was a "realignment," and the letter requests the Director to inform the subcommittee of the criteria used to distinguish between the two.  In this regard, Congressman Berman asks the Director for an accounting of all other actions taken by the Office that were deemed a "realignment" (and putatively outside the rule requiring Congressional notification) and a "detailed description" of the basis for so doing in each instance.

• The letter cites an article in Time magazine from 2006 and an e-mail from James Toupin that "senior Administration officials" met with RIM's CEO Jim Balsillie during the pendency of the NTP reexamination.  Calling it "ex parte activity," the letter asks Director Dudas to identify all senior Patent Office personnel involved in such meetings, and for the Office's policy regarding these contacts.

The answers to these questions should be interesting indeed.  Also included in the letter are even more pointed questions posed by Congressman Darrell Issa (R-CA), a subcommitee member:

• Congressman Issa (at right) wants to know the policy basis for the Office to eschew implementing a "request for examination" requirement, as a way to reduce the backlog based on the experience in other countries that "10% to 40%" of all applications are allowed to lapse for failure to request examination.

The letter gives Director Dudas until May 19, 2008 to provide answers to these questions, pointedly including the subcommitee's address (B-352 Rayburn House Office Building, Washington, D.C. 20515).

While these actions are to be applauded, they carry with them the feeling of being too little, too late.  The same "senior Patent Office officials" responsible for the ineffectiveness of the Office to address its problems will be leaving in less than twelve months, and those who willingly and enthusiastically fell into step behind their misguided proposals may be expected to leave as well.  The legacy of these officials, like so much of the rest of the current administration, will be of opportunities lost, squandered by an appeal to authoritarian rulemaking rather than consensus building with Patent Office stakeholders.  In view of the current parlous state of the USPTO, Inauguration Day 2009 (fittingly, a PTO holiday) can't get here soon enough.

ADDENDUM:  For a chilling set of allegations of misconduct in the NTP patent reexaminations (the subject of one of Congressman Berman'’s inquiries to Director Dudas), we direct our readers to the last twenty pages or so of NTP'’s response, filed April 24, 2006 in Re-examination Control No. 90/007,731, 90/006,675, and 90/006,533 (consolidated) (see Patently-O link).  NTP alleges multiple acts of misconduct against senior administration officials (including Director Dudas and Commissioner Doll), based on e-mail correspondence and other documents obtained under a Freedom of Information Act request.  (Thanks for Peter Zura's 271 Patent Blog for alerting us to these allegations.)

Neuralstem Accusation Touches Nerve with StemCells

    By Donald Zuhn --

Earlier this week, we reported on two recently filed patent cases:  the first by StemCells, Inc. against Neuralstem, Inc., asserting infringement of U.S. Patent Nos. 7,115,418 and 7,361,505, and the second being filed by Neuralstem, seeking a declaratory judgment of noninfringement, unenforceability, and invalidity of the '505 patent.  The '505 patent, which is directed to multipotent neural stem cell compositions, was issued on April 22, 2008.

In a May 7th press release concerning its declaratory judgment filing, Neuralstem stated that StemCells "intentionally withheld crucial information highly material to the patentability of StemCells' 'new' patent," and did so with an intent to deceive the USPTO.  In particular, Neuralstem asserts in its complaint that StemCells failed to disclose "pending litigation with Neuralstem, the reexaminations filed by Neuralstem, and the prior art cited in those reexaminations" (the litigation and reexaminations are discussed below).  With respect to the prior art cited in the reexaminations, Neuralstem contended that the art was cited, but only after the issue fee for the '505 patent had been paid.  Neuralstem President and CEO Richard Garr contended that while "it is clear that we are not infringing this patent, . . . the threatening statements in [StemCells'] press release of April 23rd leave the misleading impression that we would require a license from them as a result of the issuance of this patent," and "[n]othing could be further from the truth."

The newly filed cases do not mark the first time that the two companies have squared off in court.  In 2006, StemCells filed suit against Neuralstem, asserting infringement of four other neural stem cell patents.  Neuralstem responded to that suit by filing requests for ex parte reexamination of all four of the asserted patents.  Last month, the U.S. Patent and Trademark Office issued a Notice of Intent to Issue an Ex Parte Reexamination Certificate for two of the four StemCells patents.  The two companies quickly issued competing press releases asserting that the USPTO had upheld the patents with only minor changes (according to StemCells) or with "numerous substantial changes" (according to Neuralstem).

On May 6th, Neuralstem announced that it had filed a motion to reopen the 2006 lawsuit, which had been stayed pending the outcome of the reexamination proceedings.  Neuralstem CEO Richard Garr contended that "the recent actions of the U.S. Patent Office now entitle [Neuralstem] to summary judgment in the case," and that "[c]ompletely contrary to the public statements made by StemCells, Inc., the Patent Office actions have destroyed the basis for the infringement suit filed by StemCells, Inc."  In a May 12th press release, Neuralstem reiterated its position "that actions of the Patent Office have destroyed the basis for [StemCells'] infringement assertions against [Neuralstem]."

In response to Neuralstem's May 7th press release, StemCells issued its own statement, announcing that it had filed suit against Neuralstem in the Northern District of California with claims for patent infringement, libel, and unfair competition.  In its statement, StemCells contended that "Neuralstem’s repeated false statements and public accusations over the past year, culminating in its allegations on the procurement of the ‘505 patent this month, together with its continued and willful infringement of StemCells’ intellectual property, necessitated the Company’s California action."  In response to Neuralstem's assertion that StemCells was unwilling to reopen the 2006 (implying that the reexamination result had been less than favorable for StemCells), StemCells President and CEO Martin McGlynn stated that "[o]nce the reexaminations of all [four] patents have been fully settled, we will move to reopen the Maryland litigation and have our day in court."  For now, it appears that the battle between the two companies is far from over.

For additional information about this and other related topics, please see:
• "Neuralstem Announces Grant of European Patent for Neural Stem Cells," April 30, 2008
• "StemCells Announces Issuance of Human Neural Stem Cell Patent," April 24, 2008
• "StemCells' Patents Survive Reexam -- StemCells and Neuralstem Differ on Extent of Changes," April 22, 2008

Lunch with Commissioner Doll

    By Kevin E. Noonan --

John Doll, Commissioner for Patents of the U.S. Patent and Trademark Office, gave a luncheon seminar today concerning the state of the USPTO, hosted by the Boston office of Kirkpatrick & Lockhart Preston Gates Ellis LLP.  As we've said before, Commissioner Doll (at right) is the happy face of the U.S. Patent and Trademark Office:  smiling, self-deprecating, and charming while he espouses the Patent Office mantra that the Office is willing to do everything possible to improve the patenting process in the United States.  Today's offering was no different.

The Commissioner touted a number of programs and policies in the Office intended to address the twin goals of reducing the backlog of unexamined applications and improving the quality of granted patents.  The first initiative Commissioner Doll mentioned was the accelerated examination (AE) program, which he considers an unqualified success.  The statistics he cited bear him out:  110 patents have been granted under the program, and the goal of filing to final disposition (abandonment, grant, or exit from the program for appeal or further prosecution) within a year has "never" been missed.  One unnamed patent was particularly speedy:  allowed within 17 days of filing and granted 58 days thereafter (75 days filing to grant).  Use of the program is accelerating, with 200 applications filed requesting AE in the past month.  Commissioner Doll confessed that his intuition about what would be the most important component of the program - the Examination Support Document, in which the results and detailed analysis of an applicant-performed search are submitted to the Office - was wrong; both applicants/practitioners and Examiners report that it is the interview that makes the greatest difference.

This result has led to a second program initiative, the "interview before first action" program (see "PTO Announces New Program to Reduce Pendency and Improve Patent Quality").  After the Examiner has performed a search, participants can have an interview to discuss the art.  Thereafter, the expectation is that the Examiner will be able to mail an allowance or a first action on the merits, which will be (presumably) the parts of the interview where the examiner and applicant could not reach agreement.  Such interviews have been available for many years.  (For many law firms, one of the purported advantages of a Washington, D.C. office in the old, cooperative days of the Patent Office was the ability to walk down the street and meet with an examiner to discuss an application prior to first action.  This practice was discouraged over the past few years, since it resulted in many instances with a first action allowance and a patent having essentially no prosecution file history.)  The pilot program is limited for now to the computer database arts; the Commissioner referred the curious to the PTO website for more information (alternatively, the curious could refer to the Patent Docs post on this pilot program).

The Commissioner announced a major initiative to bring the Office into compliance with its responsibilities under the Patent Cooperation Treaty, specifically with regard to its status as an International Searching Authority.  The Office currently complies with the time limits for providing a Chapter I search about 4% of the time.  There are currently 17,000 PCT applications unacted upon (i.e., no search has been performed).  The goal is to have these applications searched by the end of the calendar year, and to bring the Office into 80-90% compliance as soon as possible.  While admirable, the way this is being done may be problematic:  the Office has outsourced searching to two professional search firms for the 17,000 "backlogged" PCT applications, and intends to outsource 100% of PCT searching.  While not controversial in and of itself, it seems that these searchers will also be responsible for determining (and denoting on International Search Reports) whether a reference is novelty-destroying (an "X" reference) or precludes inventive step (a "Y" reference) according to the provisions of PCT Article 33.  This raises the question of whether these searchers are competent to make these determinations, and whether the Office has abandoned its responsibility to provide a proper PCT search.  Ironically, the Commissioner also stated that he thought such searches should be "fee neutral" to the Office - raising the possibility that applicants would be charged additional fees under the PCT for searches that may not be PCT-compliant.

Commissioner Doll next addressed the issue of examiner hiring efforts.  The Office has hired 1,200 new examiners each year for the past few years and will be doing so for the next few years, and these efforts will have swollen the examiner ranks to about 6,000 at the end of FY2008; this number is expected to reach 8,000 by the end of FY2010.  Since attrition has been a problem (in the "two steps forward, one step back" sense) with the examiner corps, the Commissioner was happy to say that overall attrition rates are at 8.5%, a number he compared favorably both with Federal government employees overall (11.2%) and employees at high-tech industries.  It also seems that the likelihood of becoming a Patent Office "lifer" goes up dramatically after these first three years; while the attrition rate for "new" examiners (those with less than 3 years on the job) was 15.5%, the attrition rate for years 4 through 30 is only 4%.  To increase the likelihood that examiners stay long enough for these statistics to apply, the Office has instituted a number of financial and lifestyle incentives.  Retention bonuses are the most naked form of gentle coercion (he did not specify the amount of these bonuses); in addition, the Office has instituted overtime and quality bonuses (the latter subject to negotiation with POPA).  There are also programs for "flat goal" work, where the examiner can commit to a certain production level (with, presumably, adjustments in salary for performance below the standard requirements); the Office will pay bonuses of up to $20,000 plus 3% of their base pay for those examiners exceeding the goal.  On the lifestyle side, the Office has a "hoteling" program, where examiners can work remotely.  An impediment to greater use of this program is the requirement (under Federal law) that employees must "report to their station" once a month.  The Commissioner mentioned a bill pending in Congress (S. 1000) that would loosen that requirement.  Finally in this regard, giving laptops to examiners having GS9 seniority or greater has almost doubled the amount of overtime these examiners work.  All of these initiatives are directed, according to Commissioner Doll, to effecting a reduction in the backlog.  Interestingly, another aspect of the Office's focus on the backlog is that the Office is targeting its examiner hiring to those art units most in need of backlog reduction.

A program that the Commissioner ascribes to Director Jon Dudas (who is "aggressively pursuing it") is a "worksharing" program, that is an offshoot of the Patent Prosecution Highway programs currently in place with the Japanese Patent Office and other offices, and soon to be established with the EPO.  The Commissioner drew a distinction between the programs, however, saying that the PPH program was "applicant-initiated" while the proposed worksharing program would be Office-initiated.  Under the PPH, an applicant having an examination in one office can have the results transmitted to a second PPH office, to expedite prosecution in the second office based on (successful) prosecution in the first office.  The worksharing program would also permit examination results to be transmitted between offices, although it can be expected that the offices will not have the applicant's incentive to transmit only positive prosecution results.  Commissioner Doll was particularly hopeful about the economies of scale that could be achieved by having available to the U.S. Office results of a Japanese Patent Office search of Japanese patents and applications (which are rarely a major part of the prior art considered during U.S. prosecution), and envisioned a "common" prior art database that could be used by all offices.  An amusing aspect of this program is the establishment of a PTO "Facebook" so examiners at the different offices can "get to know one another."  The worksharing idea will be further discussed in a meeting between the "Big 5" offices (the USPTO, EPO, JPO, Korean Patent Office and Chinese Patent Office) chaired by Deputy Director of the USPTO Margaret Peterlin, to be followed by a Director level meeting in several months.  Importantly, at least as currently proposed there are no "full faith and credit" provisions for one office to another.

The last part of Commissioner Doll's prepared remarks was a brief encomium to the EFS-Web electronic filing system, which has increased users from 2% to 70% over the past two years.  Calling those not using the program "technology dinosaurs," he offered to do whatever it takes to help those to get with the program.

Commissioner Doll's comments during the Q&A session were not particularly remarkable, except insofar as he stated that the now-enjoined new continuation and claims rules were never viewed as a "silver bullet" for solving the backlog problem.  He reported that the rate of increase in the backlog had slowed (to about 40,000 applications for FY2008), and suggested that the Office had not "given up" on the other pending rules packages (Markush, IDSs, biological deposits) that have been subject to public comment.  He strongly supported provisions of pending legislation that would give the Office fee-setting authority, and hinted that if they got it they would use it to establish disincentives to current continuation practice.  He repeated the Office policy that the "best" application was one where the applicant presented the "best" claims upon initial filing and came to an ultimate resolution in that case, and said the best way for that to happen would be if the Office could impose the Applicant Quality Statement obligation contained in S. 1145.  Using his "crystal ball," he predicted that the growth rate of new filings would be about 5% in FY2008 and at the same level over the next few years.  He characterized this as "healthy," saying that the variances in application filing rates of the last 20 years average about 6.5%, with some years being as high as 25% and others close to zero.  He opined that the Supreme Court's KSR decision might influence filing rates, and defended how the examining corps was applying PTO guidelines on implementing the KSR decision.  He also asserted that the Office had trained "every" examiner on the new guidelines.

With regard to patent reform legislation, Commissioner Doll said Deputy Director Peterlin and USPTO General Counsel John Toupin (at right) were on the Hill "almost daily" working for the legislation, and said the AQS provision was on his "wish list" as the single change that would improve patent quality.  He cautioned against "dumping" too much irrelevant material on the Office in the guise of an IDS, and used two examples.  One was the prosecution history of related applications, where merely filing the entire file history was disfavored.  Also a Patent Office no-no would be filing "boxes and boxes" of material from litigation (seemingly unaware that generating boxes and boxes of material is what happens in patent litigation).  He was similarly unconcerned about the risks of inequitable conduct allegations even for practitioners diligently attempting to comply with Rule 56, and backed Harry Moatz's interpretation of 37 C.F.R. § 10.19 that a practitioner is required to review every page of every reference submitted to the Office.

There was one note of disingenuousness in Commissioner Doll's responses.  He was asked whether a Quality Review official could overrule an examiner.  He said the quality reviewer merely provided a recommendation, because the statute gives primary examiners the authority to decide whether to allow a case, and a Supervisory Examiner (SPE) or even the Commissioner did not have the power to overrule them.  This could be the basis for an important practice tip, except that in the next breath he said that where there was a genuine disagreement with a primary examiner, the examiner could either withdraw the notice of allowability or the SPE would transfer the case.  Even though he said this occurs very rarely (twice in his 33 years, and he was decent enough to admit that in one case the applicant appealed and the Board sided with the applicant), it is perhaps an illustration of his limitations as Commissioner that he obviously didn't see how he had enunciated a distinction without a difference (i.e., that supervisory personnel exercise de facto veto power over the primary examiners).

Not surprisingly (but a little disappointingly), Commissioner Doll is not a big fan of blogs.  While he later backed off his original characterization of bloggers as people without enough to do, in fairness the question was asked with regard to websites that "rate" examiners.  Although understandable in thinking that it was more likely to contain brickbats than kudos, he has obviously not read one lately; there are a surprising number of bouquets among the criticisms, perhaps reflecting real differences between different examiners (which is something you'd think he would want to know).

Commissioner Doll said he valued the kind of face-to-face discussions like today's meeting to discuss how to improve the patenting system.  While that is certainly true, his ardor cannot hide the fact that the actions of the Patent Office over the past few years suggests to many that no one is listening to the patenting community.

An Analysis of the New Written Description Training Materials – Antisense

    By Christopher P. Singer --

Last month, the U.S. Patent and Trademark Office announced that it had updated the training materials to be used by examiners in the examination of patent applications for compliance with the written description requirement of 35 U.S.C. § 112, first paragraph.  The revised training materials supersede and replace the previous set of training materials issued by the Patent Office in 1999.  The new training materials provide seventeen examples, of which fourteen are specifically related to biotech inventions.  In particular, the biotech-specific examples address expressed sequence tags (ESTs) (example 4), a partial protein structure (example 5), DNA hybridization (example 6), allelic variants (example 7), bioinformatics (example 8), protein variants (example 9), a product claimed by its function (example 10), a polynucleotide or polypeptide sequence sharing percent identity with another sequence (example 11), antisense oligonucleotides (example 12), antibodies to a single protein (example 13), antibodies to a genus of proteins (example 14), a genus with widely varying species (example 15), a process claim where novelty resides in the process steps (example 16), and methods of using compounds claimed by functional limitations, methods of identifying compounds, and compounds identified by such methods (example 17). Continuing our review, Patent Docs provides an overview of the example covering aspects of antisense oligonucleotides.

Example 12 – Antisense Oligonucleotides

Example 12 relates to claims directed to an antisense oligonucleotide complementary to an mRNA that encodes a "newly discovered growth factor" (NDG).  This Example is essentially identical to the guidance in the former written description guidelines (presented therein as Example 15).  The exemplary claim in the new training materials recites:

Claim 1:  An antisense oligonucleotide complementary to all or a portion of a messenger RNA having SEQ ID NO: 1 and encoding NDG, wherein said antisense oligonucleotide inhibits the production of NDG.

The hypothetical specification provides the mRNA sequence encoding NDG as SEQ ID NO: 1 and states that the invention includes antisense oligonucleotides that inhibit NDG production.  While no sequences of such antisense oligonucleotide are provided in the specification, it does describe several art-recognized screening methods for identifying target mRNA sequences for candidate antisense molecules (e.g., gene walking, randomized oligo libraries, and DNA arrays).  The specification also describes the use of chemically modified nucleotides that reduce the amount or rate of degradation by nucleases.  While the specification fails to provide any explicit example of an antisense oligonucleotide to SEQ ID NO: 1, the training materials reason that one of skill would understand that complementary sequences that approach the full length of an mRNA (such as SEQ ID NO: 1) are more likely to have antisense activity as compared to smaller sequence fragments.  Therefore, one of skill would acknowledge that the specification does provide one species of the claimed genus, that being the full-length complement to SEQ ID NO: 1.  Moreover, the structure of all possible antisense oligonucleotides falling within the scope of the claim are bound and limited by the full-length complement to SEQ ID NO: 1.  Given the art-recognized correlations between antisense function and structure of the target mRNA (e.g., as provided by certain computer mRNA modeling software packages), certain fragments having antisense activity can be identified and screened to confirm or assess inhibitory activity.  Thus, when the high level of skill and knowledge in the art relating to antisense technology is combined with the disclosure of an mRNA sequence (SEQ ID NO: 1), there exists sufficient written description support for the full scope of claim 1.

For additional information on this topic, please see:

• "Antibodies to a Single Protein & Antibodies to a Genus of Proteins," May 12, 2008
• "ESTs & Partial Protein Structures," May 8, 2008
• "DNA Hybridization & Percent Identity," May 6, 2008

An Analysis of the New Written Description Training Materials – Antibodies to a Single Protein & Antibodies to a Genus of Proteins

    By Christopher P. Singer --

Last month, the U.S. Patent and Trademark Office announced that it had updated the training materials to be used by examiners in the examination of patent applications for compliance with the written description requirement of 35 U.S.C. § 112, first paragraph.  The revised training materials supersede and replace the previous set of training materials issued by the Patent Office in 1999.  The new training materials provide seventeen examples, of which fourteen are specifically related to biotech inventions.  In particular, the biotech-specific examples address expressed sequence tags (ESTs) (example 4), a partial protein structure (example 5), DNA hybridization (example 6), allelic variants (example 7), bioinformatics (example 8), protein variants (example 9), a product claimed by its function (example 10), a polynucleotide or polypeptide sequence sharing percent identity with another sequence (example 11), antisense oligonucleotides (example 12), antibodies to a single protein (example 13), antibodies to a genus of proteins (example 14), a genus with widely varying species (example 15), a process claim where novelty resides in the process steps (example 16), and methods of using compounds claimed by functional limitations, methods of identifying compounds, and compounds identified by such methods (example 17).  Patent Docs continues the discussion of these examples, reviewing Examples 13 and 14 drawn to antibody technology.

Example 13 – Antibody to a Single Protein

Example 13 provides guidance for a single exemplary claim directed to an isolated antibody that binds to an isolated and structurally characterized antigen.  This Example is essentially identical to the prior guidance in the former written description guidelines (presented therein as Example 16).  Nevertheless, the single claim presented in the new training materials recites:

Claim 1:  An isolated antibody capable of binding to antigen X.

The fact pattern of this example states that the specification discloses that "antigen X" was isolated from HIV and is useful for detection of HIV infection.  The specification describes purification of antigen X by gel filtration and discloses its amino acid sequence.  The specification also discloses that antigen X is a 55 kDa monomer, has no disulfide bonds, and has a slightly acidic pI.  While the hypothetical specification discusses antibodies that specifically bind to antigen X and states such antibodies can be used in immunoassays to detect HIV, the specification lacks a working or prophetic example of an antibody that binds to antigen X.  Nevertheless, given the level of skill and knowledge in the art of antibodies at the time the application was filed, production of antibodies against a well-characterized antigen was routine, and therefore the specification satisfies the written description requirement of § 112, first paragraph, with respect to the full scope of claim 1.

While the example fails to provide a specific filing date for the specification, it cites to the 1976 reference of Elvin A. Kabat ("Structural Concepts in Immunology and Immunochemistry," 2nd Ed. (Holt, Rinehart and Winston)) to provide evidence of the knowledge in the art that antibodies can be generated from isolated antigens, that the various isotypes (IgG, IgA, IgM, IgD, and IgE) share certain physical, chemical, and biological properties, and that there is sequence variation in the variable and hypervariable regions of the antibody sequence.  Thus, even though the specification fails to describe (a) any partial physical or chemical properties (e.g., molecular weight, association constant); (b) a partial structure of the claimed antibody by sequence, reference to a deposit, or in the drawings; (c) any functional correlation of antibody structure to binding activity to antigen X; and (d) any method for making an antibody that binds antigen X, the production of such antibodies is so conventional that the amount of disclosure present in this specification is adequate to demonstrate possession of the claimed antibody.

Example 14 – Antibodies to a Genus of Proteins

Example 14 is based on the fact pattern of the 2004 Federal Circuit case, Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), and provides guidance for three exemplary claims directed to antibodies that bind to "Protein X" which was isolated from murine tissue and has been structurally characterized.  This Example is new relative to the prior written description training materials.  The three presented claims in this Example recite:

Claim 1:  A monoclonal antibody that binds Protein X.

Claim 1:  The antibody of claim 1 which binds murine Protein X.

Claim 3:  The antibody of claim 1 which binds human Protein X.

The fact pattern of this example states that the specification describes a monoclonal antibody that specifically binds to Protein X isolated from murine tissue, and protocols for producing anti-Protein X antibodies.  Protein X is disclosed as being located on the surface of certain immune cells and is asserted to be useful for treating immune disorders involving cell signaling.  The specification describes purification of murine Protein X and discloses its amino acid sequence.  The specification does not disclose any physical or chemical property for Protein X from any other species (e.g., no disclosure of molecular weight or cross-reactivity of human Protein X with anti-murine Protein X antibodies, and no sequence information for Protein X from any species other than mouse).  The specification does state that human Protein X is expected to have the same in vivo function as murine Protein X, and that antibodies to human Protein X will be useful for treating immune disorders involving cell-to-cell signaling.

Not surprisingly, the written description requirement for claim 2 above is completely satisfied by the disclosure in the specification, essentially for the same reasons provided in Example 13 (adequate description of the purified antigen satisfies written description for antibodies which bind the purified antigen).

As to claim 3, the lack of any physical or chemical description of an antibody that binds human Protein X, along with the lack of any physical or chemical description of human Protein X leads to the conclusion that written description is not satisfied for this claim.  As detailed in the analysis, the specification and prior art fail to provide any evidence that the disclosed properties of murine Protein X are predictive of the properties of human Protein X.  Further, the disclosure of human Protein X in the specification is purely functional and fails to provide any correlation to physical and chemical properties.  As stated in the materials, "Claim 3 is directed to an unknown that is identified only by reference to another unknown."

Similarly, the specification fails to provide written description for the full scope of claim 1, because the claim relates generically to many species of monoclonal antibodies that specifically bind to Protein X from any species.  While the specification adequately describes murine Protein X and therefore an antibody that binds murine Protein X, it fails to provide any physical or chemical description of Protein X from any other organism, and fails to describe a method of making an antibody that binds non-murine Protein X without first having the particular non-murine Protein X in hand.  Thus, because claim 1 is generic to antibodies to Protein X from a variety of organisms, and the specification fails to describe anything other than murine Protein X, claim 1 does not satisfy the written description requirement.  The analysis notes, without further clarification, that if any evidence was presented that murine Protein X was representative of the genus of Protein X molecules from other species, it is possible that claim 1 could meet the written description requirement.

For additional information on this topic, please see:

• "ESTs & Partial Protein Structures," May 8, 2008
• "DNA Hybridization & Percent Identity," May 6, 2008

Platypus Genomic DNA Sequence Revealed

    By Kevin E. Noonan --

Ever since it was discovered by European explorers at the end of the 18th Century, the duckbill platypus (Ornithorhynchus anatinus) has been a biological anomaly.  Fur-bearing and lactating like a mammal (although lactation is through the abdominal wall because the animal lacks nipples), the platypus reproduces by egg-laying like a chicken and produces a venom like a reptile.  The platypus is so strange that George Shaw, who named the animal, thought it was a hoax:  he is reported to have said "[i]t was impossible not to entertain some distant doubts as to the genuine nature of the animal."  On Thursday, Nature reported the complete nucleotide sequencing of the platypus genome by an international team headed by scientists from Washington University/St. Louis (see "Top billing for platypus at the end of evolution tree").  Not surprisingly, the platypus' phenotypic peculiarities are reflected in its DNA, but the sequence promises to reveal a great deal more than that about the evolution of chickens, reptiles, and mammals, including man.

The sequencing experiments were performed using genomic DNA from one animal, obtained from the Glenrock Station at new South Wales, Australia (and nicknamed "Glennie").  It was known prior to sequencing that the platypus karyotype has 52 chromosomes, which is reported in Nature to comprise 2.3 billions basepairs of genomic DNA.  These chromosomes are morphologically characterized as comprising a few large chromosomes and several smaller ones, "reminiscent," according to the Nature report, "of reptilian macro- and microchromosomes."  Included in the chromosomal complement are multiple sex chromosomes, including five "X" and five "Y" chromosomes, which have been observed to properly segregate in sperm and egg cells.  In addition, these chromosomes have a certain level of homology to the "Z" sex chromosomes found in birds.

The sequencing efforts identified repetitive elements as well as putative protein-coding sequences.  The study of repetitive elements is informative in at least two ways.  First, the pattern and number of such elements provides a historical record of genetic events (such as retrovirus-mediated retrotransposition) that can be used to relate evolutionary events between different species of different phylogenies.  Second, at least some of these repetitive elements comprise structural or regulatory molecules (such as miRNA) that can be informative about genome structure as well as phylogenetic relationships.

Overall, the authors found fewer of the predicted non-protein coding RNA species than expected from mammalian species (1220 RNA species in the platypus compared with 4421 species in human and 655 in chicken).  On the other hand, the platypus shows amplification of small nucleolar RNA (snoRNA)-encoding sequences (2000 species in platypus compared with 200 in mammals); snoRNA is used in RNA modifications, particularly ribosomal RNA.  Notably missing in platypus genomic DNA are L1-retrotransposons, a feature in common with chickens, and notably present is a novel short interspersed (SINE) element present at about 40,000 copies.  The complexity of these SINE elements suggests a rapid and relatively recent genomic proliferation from an ancestral element.  Interspersed repetitive elements of all types comprise almost one-half of the platypus genome, the most abundant of which are a 5-kb long-interspersed-element (LINE2; about 1.9 million copies) and a "non-autonomous SINE-companion" interspersed repeat (about 2.75 million copies) that has been extinct in the other branches of the amniote phylogenetic line about 60-100 million years ago.  Finally, the mean microsatellite coverage in the platypus genome were estimated to be 2.67 +/- 0.34%, which is significantly lower than all mammalian genomes sequenced to date and most resembles what has been observed in chicken genomic DNA.

Protein-coding DNA was analyzed globally for comparison with mammalian DNA, and specifically to identify genes related to the aspects of platypus phenotype characteristic for features identified with its putative mammalian, avian, and reptilian roots.  Globally, the platypus genome encodes 18,527 protein-coding genes, which is similar to both humans and opossum.  The majority of these genes (15,312 out of 18,596, or 82%) have orthologous sequences in five other species for which comparisons were made (human, mouse, dog, opossum, and chicken).  Instances of simple 1:1 correspondence between platypus genes and orthologous genes in other species were enriched for so-called housekeeping genes, such as those involved in cellular metabolism, gene expression (especially mRNA splicing), and DNA replication.  However, although there was no correlation found in the position of such orthologous genes on the smaller platypus chromosomes and chicken microchromosomes, there was "considerable sequence alignment similarity" between the platypus "X" chromosomes and the chicken Z sex chromosome.  In contrast, there were no orthologous gene alignments observed when platypus sex chromosomes were compared to human X chromosomes.  The authors opine that this implied platypus X chromosomes evolved "directly from a bird-like ancestral reptilian system."

Turning to specific genes, the authors report results obtained for reproduction and lactation, chemosensory abilities, venom-producing genes, and cellular immunity.  The platypus genome contains four proteins homologous to human zona pellucida proteins, in addition to two genes (ZPAX) homologous to genes in birds, fish, and amphibians.  The platypus contains a single vitellogenin gene (chickens have three vitellogenin genes, while mammals have none), but lack testes-specific protease genes found in mammals.  Platypus milk is similar to mammalian milk, comprising sugars, lipids, and milk proteins with nutritional, anti-microbial, and bioactive functions.  Platypus casein genes, encoding the most abundant milk proteins (as in mammalian milk) are located in a syntenic position (adjacent to tooth enamel matrix protein genes) in platypus and mammalian chromosomes.

The platypus chemoreception system was found to be encoded by large numbers of genes encoding odorant receptors V1R and V2R, although the majority of these genes were genetically-inactivated pseudogenes.  The numbers of these genes were lower than those found in mammals (specific comparisons were made with rat and mouse); the odorant receptor gene complement was found to be about one-half that found in mammals.  However, the number of platypus V1R genes encoding an undisrupted open reading frame was about 50% higher than in mouse, and is the largest number of such genes yet detected in animal genomic DNA.  The genetic expansion of these specific receptors may, the Nature authors speculate, be the result of adaptations for pheromonal communication or detecting water-soluble odorants; this possibility is consistent with the animal's reliance on "smell" when underwater (since their other senses are muted in that environment).

Platypus venom is a complex mixture of at least 19 different peptides, including defensin-like peptides (vDLPs), C-type natriuretic peptide (vCNP) and nerve growth factor (vNGF).  Sequencing revealed that the genes encoding these various peptides appeared to have been produced from duplications of genes having different (i.e., non-venomous) functions.  The authors' analysis supported the conclusion that venom production comprising defensin, C-type natriuretic peptide, and nerve growth factor genes occurred independently in platypus and reptiles.

Finally, the platypus genome was remarkable for encoding at least 214 natural killer receptor genes, compared with human (15 genes), rat (45 genes), or opossum (9 genes) genomic DNA.  The platypus genome shares the feature of gene expansions in the cathelicidin antimicrobial peptide gene family with opossum genomic DNA.

The authors conclude that the homologies and differences between platypus genomic DNA and the sequences of the mammalian and other species observed by their comparisons support the hypothesis that the platypus lineage (the Monotrema) diverged from the rest of the eutherian lineage about 166 million years ago, and that the genetic distance of echidna (Tachyglossus aculeatus) from platypus . . . predicts that the platypus last shared a common ancestor with the other member of the Monotrema, the echidna, about 21 million years ago.

The authors express the hope that continued explication of the results of studies on platypus genomic DNA will contribute to a better understanding of the evolutionary relationship between mammals, including man, and other animals.  What is clear is that the relationships of the genes and other genetic elements found in platypus genomic DNA are consistent with descent with modification from a common ancestor guided by natural selection, and frankly inconsistent with "intelligent design" precepts.

IPO Disagrees with Director Dudas

    By Kevin E. Noonan --

As reported by Patent Docs on April 30th, Jon Dudas (at right), Undersecretary of Commerce and Director of the U.S. Patent and Trademark Office, has a message for the public (and Congress, and the courts and particularly the patent community):  one of the problems that ails the Patent Office is that "[w]e [the Patent Office] are getting more and more unpatentable ideas, worse and worse quality applications."  His "evidence":  falling allowance rates, which he asserts dates from about 2003, when the allowance rate was about 70%, until now when the allowance rate is less than 50%.  This is convenient, because it roughly correlates with the beginnings of the examination backlog that began under his watch and has gotten steadily worse under his leadership.  This even while Congress has (for the past 4 fiscal years) reversed a twenty-year trend of raiding Patent Office receipts to fund other parts of the federal government.  The Patent Office is getting full funding, and hiring thousands of new examiners, and yet it still can't reduce the backlog of pending applications.  The Office's answer, as it has been for several years, is that patent applicants and the patent bar are to blame (see "New Rules, New Threats: More on the Office of Enrollment and Discipline").  The reason used to be a proliferation of continuation applications and RCEs (before Judge Cacheris enjoined the ill-advised "new rules" designed to reduce the backlog by precluding applicants from filing more than two continuations in an application family).  Now the mantra is "quality" (which ranks with the flag, motherhood, and apple pie in the Patent Office pantheon) and the Patent Office cannot "do its job" because of these "poor quality" applications.

On May 6th, the Intellectual Property Owners Association (IPO) joined the ranks of those understanding these Patent Office pronouncements for what they are:  desperate attempts to shift the blame for the application backlog to anyone other than the managers whose incompetence is actually to blame.  In a letter to Mr. Dudas, the IPO stated it was "not aware" of any such quality decline.  The IPO reminds the Director that IPO members file almost 30% of all U.S. patent applications by U.S. citizens, and "take patent quality very seriously."  The IPO also reminds the Director that, as an organization, the topic of patent quality "is a regular subject of discussion within IPO committees and at public conferences attended by our members."

The IPO's letter also reminds the Director what the other side of the Patent Office's mouth has been saying for several months:  that the reduction in the allowance rate was not because patent quality has declined, but because patent examination quality has increased (see "USPTO Announces 'Record Breaking' 2007 Performance").  In addition, the letter specifically cites comments at a public conference on March 17, 2008 by the former Chief Administrative Patent Judge of the Board of Appeals and Interferences, that "it was not clear" (presumably to the Office) why patent allowance rates were falling.  However, the artificial "abandonments" recorded with the filing of Requests for Continued Examination ("RCEs") were mentioned by the Judge as a possible reason.  Considering this rationale, it appears reasonable that RCEs may be contributing to the statistic, especially if "patent quality" initiatives were resulting in a decrease in the number of allowances and an increase in the time and number of Office Actions needed to reach agreement with Examiners about the scope of patentable subject matter in an application.

The IPO's letter also points out, accurately, that declining allowance rates today occur in applications filed several years ago, in view of the time it takes for an application to be examined (which, by the Patent Office's own measurements were, on average, 31.9 months in 2007).  And if there is a basis for "declining quality," according to the IPO, it may reside in the greater number of prior art citations applicants make today than they did in the past, in an effort to forestall inequitable conduct allegations when patentees attempt to enforce patent rights.

The IPO closes its letter with a challenge:

Therefore, we request that the USPTO share the data it has to support the proposition that the quality of applications submitted to the office is declining.  If the data does indeed support this position, IPO would be very interested in working with the USPTO to improve application quality, consistent with keeping the responsibility for examining patent applications with the office and not transferring it to patent applicants.  As you are aware, we oppose legislation mandating "Applicant Quality Submissions," but we remain willing to explore voluntary actions that could be taken by patent applicants to reverse any demonstrated decline in the quality of submitted applications.

The challenge is likely to fall on deaf ears, since Mr. Dudas' comments were not intended to address an actual problem.  No, the answer to "bad quality" patents is easy:  don't allow them.  If they are of particularly poor quality, or don't claim a patentable invention, it should be easy to continue to reject them without expense or extensive Patent Office resources.  And these applications, if pursued, will continue to be a boon to patent examiners, who can continue to exploit the antiquated "count" system with these applications and allocate more time to other applications containing patentable subject matter.

Thus, Mr. Dudas' comments are yet another Patent Office straw man raised to deflect attention from the real root of the problem:  mismanagement.  The management problem exacerbated the lack of funding that started the Office down this path at a time of great technological advances in several scientific and industrial fields.  This was coupled with changes in what was considered within the scope of patentable subject matter, and with Patent Office rule changes (like publication) that created strong incentives for applicants to file new, continuing, and divisional applications before these rule changes went into effect in the fall of 2000.  As a consequence of all these factors, the Office (as well as patent offices worldwide) experienced a large increase in the number of applications, an application "bubble," that is the true "cause" of the application backlog.  Instead of pointing fingers, the more productive approach would be to accept the IPO's invitations (and others like it from other groups and organizations in the patent community) to join with the Office in an attempt to solve these problems, rather than merely assessing blame.  Perhaps the next Administration will be able to field a Patent Office team capable of doing so.

For additional information on this topic, please see:

• "New York Times to Innovation: Drop Dead," April 30, 2008

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

StemCells, Inc. et al. v. Neuralstem, Inc. et al.
4:08-cv-02364; filed May 7, 2008 in the Northern District of California

Infringement of U.S. Patent Nos. 7,115,418 ("Methods of Proliferating Undifferentiated Neural Cells," issued October 3, 2006) and 7,361,505 ("Multipotent Neural Stem Cell Compositions," issued April 22, 2008).  View the (amended) complaint here.

Neuralstem, Inc. v. StemCells, Inc. et al.
8:08-cv-01173; filed May 7, 2008 in the District Court of Maryland

Declaratory judgment of non-infringement, unenforceabilty and/or invalidity of U.S. Patent No. 7,361,505 ("Multipotent Neural Stem Cell Compositions," issued April 22, 2008) in conjunction with Neuralstem's use of neural stem cell technology to treat diseases of the central nervous system.  View the complaint here.

Ivax Pharmaceuticals, Inc. v. Astrazeneca AB et al.
3:08-cv-02165; filed April 30, 2008 in the District Court of New Jersey

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 5,690,960 ("Pharmaceutical Formulation of Omeprazole," issued November 25, 1997), 5,900,424 ("Omeprazole Magnesium Salt Form," issued May 4, 1999), 6,147,103 ("Omeprazole Process and Compositions Thereof," issued November 14, 2000), 6,166,213 (same title, issued December 26, 2000), and 6,191,148 (same title, issued February 20, 2001) in conjunction with Ivax's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.

Sanofi-Aventis U.S. LLC et al. v. APP Pharmaceuticals LLC et al.
3:08-cv-02019; filed April 22, 2008 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,338,874 ("Cis oxalato (trans 1-1,2-cyclohexanediamine) PT(II) Having Optically High Purity," issued August 16, 1994), 5,420,319 ("Cis-oxalato(trans-1-1,2-cyclohexanediamine) Pt(II) Complex Having High Optical Purity and Process of Preparing Same," issued May 30, 1995), 5,716,988 ("Pharmaceutically Stable Preparation of Oxaliplatinum," issued February 10, 1998), and 5,290,961 ("Platinum Compound and Process of Preparing Same," issued March 1, 1994), based on APP's filing of a DMF (drug master file) with the FDA for the manufacture of Eloxatin® (oxaliplatin for injection, used to treat colorectal cancer).  View the complaint here.

Conference & CLE Calendar

May 15, 2008 - The Federal Circuit: A National Court of Appeals: Addressing New Challenges (U.S. Court of Appeals for the Federal Circuit) - Washington, DC

May 28, 2008 - Advanced Patent Licensing 2008: What You Need to Know Before Licensing Your Patent (Practising Law Institute) - New York, NY

May 28-30, 2008 - PharmaBiotech IP Summit (Worldwide Business Research) - Philadelphia, PA

June 11, 2008 - Advanced Patent Licensing 2008: What You Need to Know Before Licensing Your Patent (Practising Law Institute) - San Francisco, CA

June 16, 2008 - Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA

June 17-20, 2008 - BIO International Convention (Biotechnology Industry Organization) - San Diego, CA

June 18-20, 2008 - Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

June 23, 2008 - Multilateral Patents (Law Seminars International) - San Francisco, CA

July 1, 2008 - Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY

July 9-11, 2008 - Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

July 16, 2008 - Patent Claim Construction Workshop (Law Seminars International) - Seattle, WA

July 24-25, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

August 11-12, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA

***Patent Docs is a media sponsor of this conference or CLE

LSI Current Issues in Complex IP Licensing Conference

Law Seminars International (LSI) will be holding its fourth annual conference on Current Issues in Complex IP Licensing on September 11-12, 2008 in Philadelphia, PA.  The workshop will provide information on:

• How to get what you want out of the deal;
• Legal update on major recent and pending cases;
• The fallout from the Tafas/GlaxoSmithKline v. Dudas decision;
• Business structures and receiving full value;
• The intersection of antitrust law and IP protection;
• Social networking and user generated content;
• Trademark and copyright transactions and patent law reform;
• University technology transfer;
• Special issues in information technology, outsourcing, and international transactions;
• Dealing with risky partners; and
• Evolving business, IP, and standards strategies.

In particular, LSI's faculty will offer presentations on the following topics:

I.  Current best practices for covering the fundamentals:  Making sure there will be a match between what you want to get out of the deal and what you actually get

• A structured approach to verifying the licensor's IP rights and litigation status;
• Third-party technology and rights in the subject matter;
• Verifying the other party's financial stability;
• Tips for resolving issues that are discovered.

II.  Legal update of major recent and pending cases

• Patent exhaustion or post-sale license restrictions;
• Quanta Computer v. LG Electronics;
• Implied licenses;
• Licensee Waiver of Sovereign Immunity (Baum Research v. University of MA, CAFC)

III.  Update on the fallout from the Tafas/GlaxoSmithKline v. Dudas decision

IV.  The lumbering movement towards patent law reform:  What are the current proposals and their prospects?  How are the elections likely to change the outcome?

• Details of the bill passed by the House;
• What is likely to happen in the Senate;
• Likely impact of the change in administration and political control of the Congress.

V.  The impact of business structures on your licensing strategy

• How your selection of a business entity affects taxes, liability, standing and potential damages from infringement;
• Additional business structure considerations for joint ventures;
• Impacts on a licensee's ability to enforce the patent;
• Remedies.

VI.  Maximizing the bottom line and receiving full value

• Effective auditing procedures:  How to define royalty base;
• Royalty triggering events;
• Parent subsidiary relationships.
• Sub-licensing:  Implications of the shift towards partnering as a primary driver;
• Most commonly negotiated rights;
• Provisions relating to licensor rights and licensee responsibilities, and to ensure sub-licensee compliance;
• Typical financial arrangements.

VII.  New developments at the intersection of antitrust law and intellectual property protection

• What the IP lawyer needs to know about antitrust in the U.S. and around the world;
• Update on patent tying, standards setting and patent pools;
• Settlement of IP litigation;
• Strategies for structuring transactions to avoid antitrust problems.

IX.  Special issues for outsourcing transactions

• Checklist for necessary clauses;
• Terms for ensuring compliance with privacy, information security, and other regulatory requirements;
• Norms for indemnifications, liabilities, and warranties.

X.  Social networking and user generated content

XI.  Current issues and best approaches for trademark and copyright licensing transactions

• Litigation update:  Areas where the cases suggest you may want to update your licensing and protection strategies;
• Current issues arising from the use of trademarks and copyrighted materials on the Internet:  Fair use in advertising;
• Web publishing;
• Data sharing arrangements and consumer privacy;
• Regulatory compliance strategies.

XII.  University technology transfer and licensing

• The necessary and unique approach for licenses of life sciences technologies from universities and research institutions;
• The differences from traditional licenses between commercial entities;
• The impact on the terms of the deal.

XIII.  Special issues in information technology transactions:  Licensing and distributing open source with closed source software

XIV.  Dealing with risky partners

• Avoiding problems arising from licensing with troubled companies:  Update on issues related to the interface between intellectual property law and insolvency law;
• Provisions for licensing agreements to minimize and better control bankruptcy risks.

XV.  Special terms for international transactions involving the export or import of technology

• Update on export control and the Freedom of Information Act;
• Technology transfer licensing competition rules in the EU and Pacific Rim.

XVI.  Evolving business, intellectual property and standards strategies for the information technology industry

The agenda for the Current Issues in Complex IP Licensing conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee is $497.50 for students and new employees, $795 for government employees, or $995 for all other attendees. Those interested in registering for the workshop can do so here, by calling 800-854-8009, or by faxing a registration form to 206-567-5058.