Patent Docs

Impax and Medicis Settle Solodyn® Litigation

December 3, 2008

By Sherri Oslick —

Earlier this week, Impax Laboratories, Inc. and Medicis Pharmaceutical Corp. announced that they have entered a Joint Development Agreement and a Settlement and License Agreement that brings to an end their pending lawsuit over Impax's plans to manufacture a generic version of Medics' Solodyn® (minocycline hydrochloride extended release tablets, used to treat acne). Under the terms of the Agreements, IMPAX has a license to market generic Solodyn® no later than November 2011, and may be required to pay Medicis a royalty based on those sales. Additionally, the parties have agreed to collaborate on the development of five dermatology products, including an advanced-form of Solodyn®.

As previously reported in Court Report, Impax sued Medicis for declaratory judgment of invalidity and non-infringement of U.S. Patent No. 5,908,838 ("Method for the Treatment of Acne," issued June 1, 1999) on January 15, 2008 in the Northern District of California. Medicis' Motion to Dismiss was granted in April, 2008 on the grounds that Impax failed to show an immediate controversy sufficient to sustain the case under the Declaratory Judgement Act. IMPAX appealed to the CAFC; the settlement agreement resolves the pending appeal.

For additional information regarding the settlement, please see:

* Impax's press release
* Medicis' press release
USPTO to Appeal Wyeth v. Dudas

December 2, 2008

By Donald Zuhn —

Last Friday, U.S. Patent and Trademark Office Director Jon Dudas filed a Notice of Appeal in the District Court for the District of Columbia appealing the Court's September 30th decision in Wyeth v. Dudas to the United States Court of Appeals for the District of Columbia Circuit. Director Dudas challenges District Judge James Robertson's grant of summary judgment to plaintiffs Wyeth and Elan Pharma International Ltd. and denial of summary judgment to Director Dudas.

As we reported in October, the Wyeth decision could have a significant impact on the manner in which Patent Term Adjustment (PTA) determinations are made. In particular, the Wyeth Court determined that the U.S. Patent and Trademark Office had misconstrued 35 U.S.C. § 154(b)(2)(A), and as a result, had denied Wyeth a portion of patent term to which it was entitled under U.S. Patent Law.

At issue in the case was the interplay, under § 154(b)(2)(A), between the patent term guarantee provision of § 154(b)(1)(A) that provides a one-day extension of patent term for every day that the issuance of a patent is delayed by the failure of the USPTO to comply with various enumerated statutory deadlines ("A delay") and the patent term guarantee provision of § 154(b)(1)(B) that provides a one-day term extension for every day greater than three years after the filing date that it takes for the patent to issue ("B delay"). According to the Patent Office's interpretation of § 154(b)(2)(A), the start of the B delay period is an application's filing date rather than the date occurring three years after the application's filing date, and as a result, any A delay occurring during the first three years of prosecution would overlap with any B delay the application might accumulate. Thus, under the USPTO's procedure for determining PTA, "the applicant gets credit for 'A delay' or for 'B delay,' whichever is larger, but never A + B." The Wyeth Court determined, however, that the proper formula for determining PTA is:

A delay plus B delay less A delay that overlaps with B delay less applicant's delay

In November, we reported that two patentees had followed in Wyeth's footsteps by filing complaints in the District Court for the District of Columbia against Director Jon Dudas for similar PTA "miscalculations." On September 5th, San Francisco-based Napo Pharmaceuticals, Inc. filed a complaint asserting that the correct PTA for U.S. Patent No. 7,341,744 (issued March 11, 2008) is 1007 days rather than the 453-day period calculated by the Patent Office. On November 7th, Ironwood Pharmaceuticals, Inc. of Cambridge, MA filed a complaint asserting that the correct PTA for U.S. Patent No. 7,371,727 (issued May 13, 2008) is 702 days rather than the 411-day period determined by the Office. Both complaints question the Office's interpretation that the B delay period begins on the date of an application's filing.

We thank the Patent Docs reader who brought the Director's Notice of Appeal to our attention.

For additional information regarding this and other related topics, please see:
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008
Claim Construction at the Federal Circuit: A District Court Judge’s View

December 2, 2008

Medegen MMS, Inc. v. ICU Medical, Inc. (Fed. Cir. 2008)

By Kevin E. Noonan —

The Federal Circuit recently had the opportunity to appreciate firsthand the frustrations of district court judges with its review of claim construction under Markman v. Westview Instruments, Inc. This teaching came in a dissenting opinion from the Honorable Vaughn R. Walker, Chief Judge, U.S. District Court for the Northern District of California, sitting by designation in Medegen MMS, Inc. v. ICU Medical, Inc. decided November 20, 2008.

The case involves "needle-free valve[s] for intravenous (I.V.) therapy used to administer fluids to a medical patient." The claimed devices are used to connect a syringe to a catheter, without suffering from "retrograde flow." The opinion characterizes retrograde flow as being "the reverse flow of fluid out of the patient's body and back into the catheter tubing, the connector, and the syringe, caused by the negative pressure suction that occurs as the syringe is withdrawn from the connector." Such retrograde flow can result in blood fouling the catheter, with clotted blood necessitating flushing or replacement of the catheter. Positive pressure produced using a plug counteracts the negative pressure that produces retrograde flow.

After a Markman hearing construing several claim terms, including "plug," ICU filed and the District Court granted a motion for summary judgment of non-infringement. The basis for this judgment was that the ICU product embodied a rigid, inflexible plug, while the District Court's construction of plug required a flexible, elastomeric plug.

According to the majority opinion, written by Judge Dyk and joined by Judge Rader, this construction of the term "plug" was error. The opinion characterized the construction as "relying heavily" on the fact that the specification consistently described the plug as having an elastomeric character, and that the specification "nowhere describe[d] a non-elastomeric or rigid plug." The CAFC agreed with Medegen, that the term "plug" should be given "its ordinary meaning" as "a moveable member between an open and closed position." The bases of the Court's opinion included that the term "plug" was claimed "broadly"; that the term was "not expressly limited by the language of the claims"; that there was "no contention that the ordinary meaning of the term 'plug' does not include a rigid plug or that it has a special meaning in the medical field that requires elastomericity"; and that there was no "clear disclaimer of non-elastomeric plugs in the specification."

The opinion expressly disagreed with ICU's contention that the skilled worker "would read the specification as limited to elastomeric plugs," and characterized elastomeric plugs as being "merely an example" of how to practice the invention. The Court reached its determination even though the Detailed Description section of the patent disclosed elastomeric or "rubber" plugs twenty-one times (and never discussed non-elastomeric or rigid plugs). This disclosure merely reflects "preferred embodiments," and limiting the claims to preferred embodiments is improper. According to the opinion, ICU's construction "relies on a single embodiment theory," a construction "specifically rejected" in Phillips v. AWH Corp. In view of this disagreement on the proper construction of the term "plug," the Federal Circuit vacated and remanded to the District Court for trial using this more expansive construction of plug.

Judge Walker (at left) dissented. He asserted that the issues before the CAFC presented "a conundrum often faced by district courts when construing" claim terms. He cited the "twin axioms" of claim construction that produced the conundrum: "[o]n the one hand, claims 'must be read in view of the specification'," citing Markman, while "[o]n the other hand, it is improper to read a limitation from the specification into the claims," citing Arlington Indus. Inc. v. Bridgeport Fittings, Inc. The problem with these axioms, according to Judge Walker, is that "the axioms themselves seldom provide an answer, but instead merely frame the question to be resolved." Here, Judge Walker contended that the majority based its decision to overrule the District Court's construction on the second axiom without properly assessing the term by taking both axioms into consideration. While recognizing the sound policy reasons for a patent drafter to be required to include "all claim limitations in the claims of a patent," he also admonished that "patents must be read as well as written." Citing Phillips, this analysis must be performed with due consideration of a term's "ordinary and customary meaning" informed by the "context of the entire patent, including the specification." The majority's construction gave too little weight to the specification, in Judge Walker's view, in favor of "broad dictionary definitions."

In contrast, the "very able district court . . . looked first to the patent" in performing its construction of the term "plug," basing its decision on the "repeated" description of the plug as having "elastomeric, pivoting and buckling limitations" that the District Court included in its construction. Moreover, the claimed invention would not work using a rigid, non-elastomeric plug, and for this reason alone, Judge Walker contended that the District Court's construction of the term was more consistent with an elastomeric plug being "an essential element" of the invention. In addition to the intrinsic evidence, the District Court also relied on extrinsic evidence from expert witnesses, including evidence that Medegen's expert could not explain how a rigid plug would be operable in the claimed invention.

Judge Walker raises the essential paradox of the Federal Circuit's practice under Cybor Corp. v. FAS Technologies, Inc. of giving no deference to claim construction by district courts: "[a]s a jurist more accustomed to working on the front lines of patent litigation than reviewing decisions from above, it is my experience that claim construction — determining how one of ordinary skill in the art would understand the patent at the time of invention — often requires making fact-like determinations not well suited to appellate review." The "uniformity and predictability" desired by the CAFC as a general, guiding principle is not always best served in the individual determinations necessary to construe claim terms. In this he cites with approval Judge Lourie's point in Phillips, that while there is (and perhaps cannot be) formal deference by the CAFC to a district court's claim construction, it is better policy for the Federal Circuit to affirm "in the absence of a strong conviction of error." Despite the fact that current academic research suggests that Federal Circuit affirmance rates of district court claim construction has "improved" to from 60-70%, these broad statistics do not inform how each Federal Circuit panel addresses, and resolves, specific claim construction issues in any particular case. And so long as a majority of the Federal Circuit judges continue to resist en banc reconsideration of Cybor, and the Supreme Court appears singularly disinterested in the issue, the inconsistencies resulting from the Federal Circuit's "no deference" standard of review will continue to produce the type of results decried by Judge Walker in Medegen.

Medegen MMS, Inc. v. ICU Medical, Inc. (Fed. Cir. 2008)
Panel: Circuit Judges Rader and Dyk and Chief District Judge Walker
Opinion by Circuit Judge Dyk
USPTO News: USPTO e-Commerce Update

December 2, 2008

By Christopher P. Singer —

The U.S. Patent and Trademark Office sent out an e-Commerce e-Alert on December 2, 2008 that included information regarding its recent announcements about the Priority Document Exchange (PDX) Program with the Korean Intellectual Property Office (KIPO); preventing Digital Certificates from expiring; and using the EFS-Web with Adobe 9.0

PDX with Korean Intellectual Property Office (KIPO)

On October 14, 2008, the USPTO announced that KIPO was added as a participant in the Priority Document Exchange (PDX) program, which allows for the exchange of priority documents electronically at no cost to the applicant. Patent Docs previously reported on the Office's initial announcement. In its e-Commerce e-Alert, the Office reminds applicants interested in participating in this program that the proper forms (PTO/SB/01 or PTO/SB/39) that permit release of priority documents can be found on the Office's website. More information about the program can be found here, and specific questions regarding the PDX program can be sent by e-mail to PDX@uspto.gov.

Digital Certificate Maintainence

As previously reported by Patent Docs, digital certificates can expire if registered practitioners fail to maintain them. As the Office reminds practitioners, steps can be taken to prevent digital certificates from expiring, including:

1. Within 120 days of receipt, applicants must use the authorization code and reference number received from the Electronic Business Center (EBC) to create and download a digital certificate. After 120 days, the authorization code and reference number will expire and require replacement.

2. Immediately after downloading a digital certificate, applicants should go to https://sas.uspto.gov/ptosas/ to create digital certificate self-recovery codes. These codes, which allow applicants to immediately recover a certificate should any problem occur, should be saved in a secure location. Applicants are reminded that without self-recovery codes, certificates can only be recovered with the help EBC, and that the process will take several business days.

3. Active digital certificates are automatically renewed for indefinite access. This renewal occurs automatically while you are using your certificate. Therefore, it is important to use your certificate regularly, at least every 90 days.

4. If you have copied your digital certificate on multiple computers, be sure to document the locations of each copy. After automatic renewal, only the copy in use at that time of renewal will be valid; all other copies must be updated separately. If you experience problems with your certificate, try the following steps before contacting the EBC: review the modification dates of all certificate copies; determine the most current copy; and then simply replace all outdated copies with the most recent certificate.

Adobe 9.0 and EFS-Web

Practitioners who submit filings via the EFS-Web can use the latest version of Adobe® Reader®, version 9.0, to complete EFS-Web fillable PDF forms. Using the fillable PDF forms provides auto-loading of data directly into USPTO databases. Certain forms for "e-Petitions" including the SB66 Petition to Accept Unintentionally Delayed Payment of Maintenance Fee in an Expired Patent (37 CFR 1.378(c)) and SB130 Petition to Make Special based on Age provide real-time automatic processing. These forms are still compatible with previous versions of Adobe® Reader® including versions 7.0.8, 7.0.9, 8.1.1, and 8.1.2.

Additional Reminder

The biotechnology, chemical, and pharmaceuticals (BCP) technology groups at the U.S. Patent and Trademark Office are holding their quarterly customer partnership meeting on Wednesday, December 3rd. The agenda can be viewed here, and can be viewed over the web at https://uspto.connectsolutions.com/bcp120308/.
European Commission Releases Preliminary Report on Competition in Pharmaceutical Sector

December 1, 2008

By Donald Zuhn —

Last Friday, the European Commission published a 426-page preliminary report regarding its competition inquiry into the European pharmaceutical sector. The Commission commenced the sector inquiry last January to examine why fewer new medicines were being brought to market in Europe and why generic entry seemed to be delayed in some cases (the report notes that while 40 new medicines were introduced annually between 1995 and 1999, only 27 were introduced annually between 2000 and 2007). The Commission, which announced the publication of its preliminary report at a public meeting in Brussels on Friday, has created a dedicated webpage providing additional information regarding the sector inquiry into pharmaceuticals competition.

In its press release announcing the release of the preliminary report, the Commission offered its initial finding that "there is evidence that originator companies have engaged in practices with the objective of delaying or blocking market entry of competing medicines" and that as a result, "competition in this industry does not work as well as it should." The Commission reached this conclusion by examining a sample of 219 medicines facing a loss of exclusivity between 2000 and 2007, determining that but for delaying and blocking strategies employed by originator companies (i.e., innovator or brand companies that develop and sell new medicines), European consumers would have saved an additional € 3 billion ($3.79 billion) over this period. The Commission concluded that the originators' strategies resulted in a delay of generic market entry of between four and seven months.

Among the blocking and delaying strategies outlined in the report are:

• The filing of "patent clusters" — a large number of patent applications covering a single medicine — by originator companies. In one case, the Commission noted that 1,300 applications had been filed on a single medicine.

• The initiation of patent litigations by originators against generic companies. The Commission noted that nearly 700 litigations had been filed against generics, with such litigations lasting an average of three years. The Commission also noted that generics were ultimately successful in 60% of such litigations.

• Settlement agreements between originators and generics. The Commission noted that more
than 200 such agreements had been reached in the EU, and that 10% of these agreements were "reverse payment settlements" which provide for payments from originators to generics, thereby limiting market entry for generic medicines. The Commission also noted that such payments amounted to more than € 200 million ($252 million).

• Intervention by originators in national procedures for approving generic medicines. The Commission concluded that such intervention led to an average delay of four months for market entry of generics.

In conducting the sector inquiry, the Commission sent out requests for information to 43 originator companies and 27 generic companies, engaged in a dialogue with industry associations at the European level, and consulted with representatives of consumer and patients associations, insurance companies, doctors, pharmacies, wholesalers, hospitals, parallel traders, patent offices, and competition authorities. Interestingly, the report states that the two biggest stakeholders — the originator and generic companies — were in agreement regarding the need to create a single Community Patent and a unified and specialized patent judiciary in Europe.

Stakeholders and members of the public have until January 31, 2009 to submit comments
concerning the Commission's preliminary findings, with the Commission
expected to issue a final report sometime in the spring of 2009.
Court Report

November 30, 2008

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.

Eurand, Inc. et al. v. Mylan Pharmaceuticals, Inc. et al.
1:08-cv-00210; filed November 26, 2008 in the Northern District of West Virginia

Eurand, Inc. et al. v. Mylan Pharmaceuticals, Inc. et al.
1:08-cv-00889; filed November 25, 2008 in the District Court of Delaware

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 7,387,793 ("Modified Release Dosage Forms of Skeletal Muscle Relaxants," issued July 17, 2008), licensed to Cephalon, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Cephalon's Amrix® (cyclobenzaprine hydrochloride, used for relief of muscle spasm associated with acute, painful musculoskeletal conditions). View the Delaware complaint here.

CIMA Labs Inc. et al. v. Novel Laboratories Inc.
1:08-cv-00886; filed November 25, 2008 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,024,981 ("Rapidly Dissolving Robust Damage Form," issued February 15, 2000) and 6,221,392 (same title, issued April 24, 2001), licensed to Azur Pharma, following a Paragraph IV certification as part of Novel's filing of an ANDA to manufacture a generic version of Azur's FazaClo® (clozapine, used to treat schizophrenia). View the compliant here.

Eli Lilly and Company v. Lupin Limited et al.
1:08-cv-01596; filed November 24, 2008 in the Southern District of Indiana

Eli Lilly and Company v. Aurobindo Pharma Ltd. et al.
1:08-cv-01595; filed November 24, 2008 in the Southern District of Indiana

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 5,023,269 ("3-Aryloxy-3-Substituted Propanamines," issued June 11, 1991) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Lilly's Cymbalta® (duloxetine hydrochloride, used to treat depression and generalized anxiety disorder and for the management of diabetic peripheral neuropathic pain and fibromyalgia). View the Lupin complaint here.
Conference & CLE Calendar

November 30, 2008

December 1, 2008 – 19th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) (Intellectual Property Owners Association) – Washington, DC

December 2, 2008 – Patent Interferences Rules & Practice (Intellectual Property Owners Association) – Washington, DC

December 3, 2008 – Biotechnology, Chemical, and Pharmaceuticals (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office)

December 3, 3008 – Parallel Patent Reexamination and Litigation 2008: The Latest Developments and Their Impact (Practising Law Institute) – San Francisco, CA

December 8-9, 2008 – Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) – Atlanta, GA

January 3-7, 2009 – 26th Annual National CLE Conference (Law Education Institute) – Vail, CO

January 12-13, 2009 – Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) – San Diego, CA

January 20-21, 2009 – Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle
Strategies*** (Center for Business Intelligence) – Baltimore, MD

January 26-27, 2009 – Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) – London, England

January 27-28, 2009 – ITC Litigation (American Conference Institute)*** – Washington, DC

January 28-29, 2009 – 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) – New York, NY

January 29-30, 2009 – Commercialization of Life Sciences Inventions (Law Seminars International) – Phoenix, AZ

***Patent Docs is a media partner of this conference or CLE
USPTO News: Agenda for Next BCP Meeting

November 26, 2008

The biotechnology, chemical, and pharmaceuticals (BCP) technology
groups at the U.S. Patent and Trademark Office will hold their next quarterly customer partnership meeting on December 3, 2008.

The schedule of topics for discussion include (all times Eastern):

Morning Session

• Greetings and Overvie (9:00 – 9:15 AM): John LeGuyader, George Elliot, and Remy Yucel, Directors, Technology Center 1600

• TC1600 Chemical Non-Statutory Double Patenting Examples (9:15 – 10:00 AM): Daniel Sullivan SPE, Art Unit 1621

• Personalized Medicine (10:00 – 10:45 AM): Kathleen Bragdon, QAS, TC 1600

• Break (10:45 – 11:00 AM)

• Restriction Burden and Petition Data (11:00 AM – 12:00 PM): Julie Burke, QAS, TC 1600

• Lunch (12:00 – 1:15 PM)

Afternoon Session

• Overview of New Rules before the Board of Patent Appeals and Interferences (1:15 – 2:00 PM): Michael Fleming, Chief Administrative Patent Judge, BPAI

• Searching in Applications Containing Bio-Sequences (2:00 – 2:45 PM): Ram Shukla, SPE, Art Unit 1634

• Break (2:45 – 3:00 PM)

• TC Training – How to Read Case Law (3:00 – 4:00 PM): Janet Gongola, Associate Solicitor Office of the Solicitor

• Closing Remarks/Discussion (4:00 – 4:15 PM): John LeGuyader, George Elliot, and Remy Yucel, Directors, Technology Center 1600

The BCP meeting can be attended in person at Madison Auditorium (600 Dulany Street, Alexandria, VA), or it can be viewed over the the internet at: https://uspto.connectsolutions.com/bcp120308/.
Medco Predicts Follow-on Biologics Regulatory Pathway by 2011

November 25, 2008

By Donald Zuhn —

Last Friday, Medco Health Solutions, Inc. added its name to the list of companies seeking a follow-on biologics (FOB) regulatory pathway (see Reuters report). The endorsement was not entirely surprising given Medco's vested interest — the company, based in Franklin Lakes, NJ, is the nation's largest mail order pharmacy and a leading pharmacy benefit manager (PBM). According to Medco's website, it manages prescription drug benefit programs for about one-third of the companies on the Fortune 500 list, and counts among its clients BlueCross/Blue Shield plans, managed care organizations, insurance carriers, third-party benefit plan administrators, employers, state and local government agencies, and union-sponsored benefit plans. Medco also claims to provide PBM services for approximately one in five Americans.

In backing the establishment of an FOB pathway, Medco believes that more than $34 billion worth of biogeneric drugs could become available in the United States between 2013-2017 if Congress were to establish such a pathway. The company's calculations are based on the establishment of an FOB pathway by 2011 with a subsequent two-year interval for follow-on biologics to become available after innovator patent rights expire. Medco listed Johnson & Johnson's Remicade, Amgen's Aranesp, and Genentech's Avastin as among the big-selling biologics that would become available in the 2013-2017 time period.

Medco believes that the issue of establishing an FOB regulatory pathway will likely take on a "new urgency" now that the Democrats have gained tighter control of the House and Senate. While this may be debatable given the country's current economic crisis, there is no doubt that an FOB regulatory pathway would be a boon to Medco. The company acknowledged as much, noting that it already profits from the availability of lower-cost generic drugs, and telling investors that biogenerics would be "one of [Medco's] possible growth drivers." Chief Financial Officer Rich Rubino added that biogenerics represented a "very powerful opportunity" for Medco and its clients.

In a report in the Wall Street Journal's Health Blog earlier this month, Medco CEO Dave Snow was quoted as saying that "the odds of the Democrats’ version [of an FOB bill] going through relatively quickly are really high." Snow told the WSJ Health Blog that 16% of all biotech drugs dispensed by Medco are already off patent, and that an additional $10 billion worth of biologic drugs would see their patent protection expire by 2010.

For additional information regarding this and other related topics, please see:

• "Former House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is Sufficient," November 20, 2008
• "A Second Look at President-elect Obama's Technology Platform," November 4, 2008
• "Follow-on Biologics in the News," September 23, 2008
• "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation," September 18, 2008
• "Congressional Fact-finding on Follow-on Biologics," August 13, 2008
• "CBO Releases Report on Senate Follow-on Biologics Bill; BIO Calls for Congress to Pass Biologics Bill in 2008," July 1, 2008
• "Follow-on Biologic Drugs and Patent Law: A Potential Disconnect?" March 25, 2008
• "New Follow-on Biologics Bill Introduced in the House," March 18, 2008
• "Dr. Robert Shapiro Discusses Follow-on Biologics Report," February 19, 2008
• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation – Part II," February 14, 2008
• "Biologics Legislation Faces Unresolved Issues," December 28, 2007
• "Senate Committee Passes Biologics Legislation" July 5, 2007
Pinkos Appointment Provokes Allegations – Updated

November 24, 2008

By Kevin E. Noonan —

Maybe Hal Wegner (at right) is surprised by the continuing shenanigans of the current Patent Office administration. Maybe he is genuinely offended by their many actions and appointments made with seemingly little or no heed of the legal requirements for holding positions of authority in the Office. Or maybe he has finally just had enough.

But in a series of e-mails sent to members of his extensive mailing list, Mr. Wegner, the dean of U.S. patent commentators, uncharacteristically excoriated the appointment of Stephen M. Pinkos (at left) to a position on the Patent Public Advisory Committee (P-PAC). He begins his commentary by noting that "[h]eretofore, the principle concern with the Pinkos P-PAC appointment" was that he might be in a position to "whitewash" his own performance as Under Deputy Secretary for Intellectual Property and Deputy Director of the Office from 2004-2007. This, of course, would be bad enough. But now it seems that Mr. Pinkos, like Margaret Peterlin before him, may lack the statutory requirements for holding the position.

These requirements include someone "chosen so as to represent the interests of diverse [patent] users of the United States Patent and Trademark Office" under 35 U.S.C. § 5(b)(1) or qualified to "represent . . . applicants located in the United States" under 35 U.S.C. § 5(b)(2) or with "substantial background and achievement in finance, management, labor relations, science, technology, and office automation" under 35 U.S.C. § 5(b)(3).

Mr. Pinkos has been a lobbyist since leaving the Patent Office, according to the website of his company, PCT Government Relations LLC. Although he is a graduate of the DePaul University School of Law, he is not licensed to practice law (according to Martindale-Hubbell) nor is there any record that he has passed the registration examination to practice before the Patent Office. The website for the International Intellectual Property Institute (where Mr. Pinkos is a member of the Board of Advisors) reports that he is a member of the Virginia bar.

Mr. Pinkos' experience is as a Capitol Hill staffer, specifically as counsel for the House Judiciary Committee. His appointment as Under Secretary and, presumably his current post, is reportedly nothing more than a political reward for his efforts in support of House Republicans' benighted and ultimately futile attempt to remove President Clinton from office through impeachment.

The motivation for placing Mr. Pinkos on the P-PAC, according to Mr. Wegner, is part of an effort to "whitewash" the incompetence of the current management. This impression is reinforced by the 2007 P-PAC Annual Report, which is a glowing encomium to the Office's success in promoting patent "quality." Also praised in the report are efforts to coerce applicants to make statements on the relevance of cited references, shifting the burden of examination from examiners to applicants, placing patent applicants at risk for charges of inequitable conduct, and producing an ethical conflict of interest between patent practitioners and their clients.

It is one thing when Greg Aharonian, known to be occasionally intemperate in his criticism of Patent Office officials, makes similar charges. It is another thing entirely when someone with the experience and gravitas of Mr. Wegner is compelled to come to the same conclusions. And it is a testament to how thoroughly current Patent Office management has poisoned the relationship between the Office, applicants, and their representatives, that Mr. Pinkos' appointment has produced this reaction. If we (and the Office) are lucky, things will begin to change with the commencement of the new administration. It cannot come too soon.

UPDATE: Lest anyone think Patent Docs doesn't
appreciate Greg Aharonian's tireless efforts in combating Patent Office shenanigans, we
refer you to our post on his (ultimately unsuccessful) attempt to have judicial
review of the Peterlin appointment (see "Margaret Peterlin Gets to Keep
Her Job"). Greg was one of the first members of the
patent community to recognize the qualitatively different approach of the
current administration, particularly its penchant for doing whatever it wants
with little regard for the procedural or statutory requirements. And whatever you think about his methods or
his rhetoric, in these times "occasional intemperance" in defense of
the U.S. patent system is no vice.

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