• Last week, Patent Docs posted an article by Kevin Noonan (see "Once Again, The New Yorker Gets It Wrong on Patents") regarding "The Permission Problem," an article by James Surowiecki that appears in the August 11th edition of The New Yorker.  Over the weekend, Mr. Surowiecki and Dr. Noonan engaged in an interesting and spirited dialog regarding each of their articles in the Comments section following Dr. Noonan’s piece.  For Patent Docs readers who may have missed their online conversation, we are reprinting it:

    Surowiecki_james_3
    Mr. Surowiecki:

    Actually, Heller opens his book with precisely this kind of example:  a drug company that has decided not to develop a promising Alzheimer’s drug because of the patent thicket that surrounds it.

    On the broader point, I’m not "blindly accepting" Heller’s argument.  I’m familiar with the anti-anticommons literature.  I just find it unconvincing, particularly the work based on surveys.

    I’m also mystified by the idea that the U.S. drug industry is "flourish[ing]."  On the contrary, as you well know, despite the massive amounts of money put into R&D, the number of NMEs approved annually has been dramatically lower in the 2000s (with the exception of a spike in 2004) than it was in the 1990s.  And this decline follows, of course, the biggest explosion in patenting in the industry’s history.  Now, it may be that a few years from now we’ll all be reaping the benefits of the patent explosion in the form of powerful and efficacious new drugs.  But to say the empirical record of the past decade demonstrates that more patenting leads to more innovation is absurd.

    What I find most curious is the idea that it’s those who are skeptical about the value of expanding the reach (and length) of patents who are accused of "hysteria."  On the contrary, what’s hysterical is the insistence that any limitations on intellectual-property rights will lead to disaster (thus EG in this thread saying that the anticommons folks are going to "doom this country’s remaining competitive advantage, namely innovation.")  There is no theoretical or historical evidence that would suggest this is true — as Lerner’s work shows, the connection between stronger patent protection and innovation is tenuous at best.  And there’s no good reason to believe that with the expansion of patent rights in recent decades we’ve struck the right balance between giving incentives to innovators (the only justifiable reason for patents or copyright) on the one hand and allowing the free movement of ideas on the other.

    Noonan_kevin
    Dr. Noonan:

    I am aware of Professor Heller’s anecdote to begin his book, and I am skeptical — as someone who performs freedom to operate searches for drug companies, I can think of many ways to avoid the kind of problem he maintains exists.  As I mentioned elsewhere in the thread, with the exception of gene chips, the kind of patent thicket that occurs in IT does not occur in biotech/pharma, and with the Merck v. Integra decision the liability for using such chips to develop new drugs is tenuous at best.

    The anti-commons idea, especially as Professor Heller developed it with Professor Eisenberg, has been debunked by empirical studies showing that patenting has had negligible effects on research.  It was a plausible idea for anyone who had no experience with high-level science; believe me, before patenting became commonplace in the biological sciences, research results and materials were jealously guarded between lab groups.  And the ultimate benefit to society of the research, disclosure, is a goal also served by the patent system.

    As for the state of the pharma industry, my point was about the changes in the robustness from about 1980, when European drug companies and products predominated, until recent times, when it has been U.S. companies that have dominated.  This was discussed in the earlier post referenced in the piece, based on a Washington Post article last year.  I agree that things don’t look so rosy for pharma worldwide at the moment, but every industry has ups and downs, and the Post authors looked over a sufficiently long time frame that the trend became clear.

    It is also untrue that there has been any "expansion" of patent rights in recent times.  Indeed, these rights have been diminished, first by changes in the way patent term is calculated, and second by the expansion of what amounts to inequitable conduct and Supreme Court decisions such as eBay that have reduced the certainty that patent holders have in the patent right.  The "hysteria" I reference is that kind of hyperbole — as if patents were some new government boondoggle that is threatening our economic well being.  The exact opposite is the case.  Your reference to Lerner’s work is telling, since it has also been refuted by others who are not academic economists with a careerist ax to grind.

    Finally, you didn’t address the point — patents are by definition extremely limited in time, and have definite expiration dates which have consequences for the patentee, their competitors and society.  One of the reasons that those who understand this feature of patents strongly react to the anti-patent crowd is that they generally propose long-term changes in patent law, which I believe are not in our best economic interests, to solve short term problems.  Patents are not the problem — being unwilling to license them is the problem.  If the license is too expensive, all a competitor need do is wait a short time (a time getting shorter every minute) and the patents will simply expire.

    So, no, Mr. Surowiecki, if Congress hadn’t stepped in to solve the airplane patent problem in the second decade of the 20th Century, we wouldn’t still be flying blimps.  And if you understood the ephemeral nature of patents you wouldn’t have written that we would.

    Surowiecki_james_4
    Mr. Surowiecki:

    As the recent history of copyright shows, IP rights aren’t "by definition" limited, at least not by any reasonable definition of "limited."  If Congress decided patents should last well over a century, it could.  And by your logic, it seems like that would create an innovator’s paradise.  Part of the point of the anticommons argument is to ensure that we don’t see the kind of creep in patent length that we’ve seen in copyright.

    Your contention that we haven’t seen an expansion in patent rights in "recent decades" (which is what I wrote) is simply mystifying.  Strictures against universities (particularly public universities) patenting have been abolished.  Living-organism, business-method, and software patents have all become generally accepted by the court and ubiquitous.  Things have gotten a little better in the last couple of years — thanks to a widespread sense that our veneration of IP rights has gone way too far — but the arc of the last 25 years is clear, and it bends firmly in the direction of more patents, not fewer.

    Finally, on the supposed impact of Josh Lerner’s "careerism" on his research findings.  Let’s be serious.  The people producing much of the research and the studies you cite so favorably — like BIO — have a huge financial stake in keeping their own IP rights as strong as possible.  Other researchers receive funding from the drug industry.  You yourself, meanwhile, are apparently a patent attorney, which I assume means that in a world with many fewer patents you would have less work.  The financial incentives that are influencing your side of the argument, in other words, are huge, and I think most people would say that they might very well have a material impact on your arguments and your findings.  Lerner, by contrast, is an academic who can look at whatever he wants to look at, who reaps no obvious financial (or career, for that matter) benefit from reaching one conclusion or another.  (You can bet that if he’d found that patents had a massively positive impact on innovation that he’d have been feted by industries across America.)  The notion that his research is somehow less valid than the work you cite because of some supposed ax he has to grind (when all the obvious grinding axes are on your side) is preposterous.

    Noonan_kevin_2
    Dr. Noonan:

    As to the "expansion" of patent rights, it isn’t the rights that have expanded, it is the scope of what can be patented.  Part of that has to do with new technologies that didn’t exist decades ago, like biotech.  If you want to write an article about copyright, you won’t hear from me — as important as culture may be it doesn’t hold a candle to policy decisions that will influence development of life-saving drugs.  And while I question the wisdom of business method patents (and software patents for that matter, since copyright protection on top of patenting seems like a "double dip"), my objections to the statements in your article were focused on biotech and pharma patenting, where the stakes are, in my opinion, too high for the kind of sloppy arguments the anti-commons folks like to trot out.

    As for university patenting, would you prefer that U.S. taxpayer funded technology be freely exported abroad as it was prior to Bayh-Dole, or that the producers of the research supporting the technology have the opportunity to license that technology and become more self-supporting (look at the data on licensing revenues for universities if you think it is insignificant)?

    And remember, the whole "anti-commons" argument was based on how patenting would purportedly inhibit academic research, not commercial drug development.  The "creep" I see is in the arguments that anti-commons is somehow necessary to analyze commercial competition; trust me, these competitors don’t need anti-commons crusaders protecting them from each other.  The negative effects on academic biotech research anticipated by Heller and Eisenberg just didn’t happen.

    You are correct that Congress could, within constitutional boundaries, expand the length of patent term, but I wouldn’t be in favor of it and it wouldn’t be good for innovation.  It would, in fact, create the fictional patent hell of your article, since then blimps might be our only option.  I think limited patent term is fine, because it satisfies the balance between the public benefit of disclosure and the fire of interest patenting brings to innovation.

    Finally, I am a patent attorney.  I find it funny when people immediately point to my "vested interest" in the patent system, which is always presumed to be purely financial.  Don’t fret:  unless Congress totally abolishes patent law, there will always be work for me to do, and the more Congress and the Patent Office and the Supreme Court monkeys with the rules, the more work there will be, and the more valuable my services will become.  So if money were the object, I would welcome the kinds of misinformed arguments made by Lemley and Lerner and Mauer and you, because it would mean more work for me.

    But enough about me.  Your defense of Josh Lerner is surprisingly naive, in view of the competition academics rightly feel to publish work deemed to be important and significant.  Frankly, had Mr. Lerner "found" that patents were a good thing, he would have started to work on something else, because that has been the prevailing belief.  Academics don’t get invited to testify before Congress and get interviewed on NPR because they verify beliefs; the point is to challenge them.  So while my interests appear clear to you, don’t be too sure that you understand Mr. Lerner’s.  Maybe you should look into who is funding his research, and how many of the anti-patent people are funded by think tanks and interest groups funded by Cisco, Microsoft, Intel and the other members of the IT community who want restricted patent rights to improve their corporate bottom lines and support the latest "gee-whiz" gadget.  That might be a quite a story.

    Editor’s Note:  Mr. Surowiecki’s and Dr. Noonan’s comments were edited to correct minor typographical and grammatical errors.  In addition, portions of the comments that were not relevant to the discussion of their articles were deleted.  However, the original comments can be found in their entirety at the end of Dr. Noonan’s article.

  •     By Sherri Oslick

    Gavel_7
    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.


    Sepracor Inc. et al. v. Barr Pharmaceuticals, Inc. et al.

    3:08-cv-03920; filed August 4, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent No. 5,698,558 ("Methods for Treating Allergic Disorders Using Optically Pure (-)Cetirizine," issued December 16, 1997), licensed to UCB, following a Paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of UCB’s XYZAL® (levocetirizine dihydrochloride, used to treat seasonal and perennial allergic rhinitis).  An uncorrupted copy of the complaint could not be obtained.


    Bayer Schering Pharma AG et al. v. Sandoz, Inc.

    1:08-cv-01638; filed August 1, 2008 in the District Court of Colorado

    Bayer Schering Pharma AG et al. v. Sandoz, Inc.
    2:08-cv-00995; filed August 1, 2008 in the District Court of Nevada

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. RE37,564 ("Composition for Contraception," issued February 26, 2002) and RE37,838 (same title, issued September 10, 2002) following a Paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of Bayer’s Yaz® (drospirenone & ethinyl estradiol, used for oral contraception).  View the Colorado complaint here.


    Novartis Pharmaceuticals Corp. et al v. Roxane Laboratories, Inc.

    2:08-cv-03853; filed July 31, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent No. 5,246,937 ("Purine Derivatives," issued September 21, 1993) following a Paragraph IV certification as part of Roxane’s filing of an ANDA to manufacture a generic version of Novartis’ Famvir® (famciclovir, used for the treatment of acute herpes zoster (shingles), the treatment or suppression of recurrent genital herpes in immunocompentent patients, the treatment of recurrent herpes labialis (cold sores) in immunocompetent patients, and the treatment of recurrent mucotaneous herpes simplex infections in HIV-infected patients).  View the complaint here.

  • Calendar_6
    August 11-12, 2008 – Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

    August 10-15, 2008 – Advanced Courses (Patent Resources Group) – Washington, DC

    September 11, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – New York, NY

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

    September 15-16, 2008 – Biotech Patents*** (American Conference Institute)

    September 21-23, 2008 – 2008 Annual Meeting (Intellectual Property Owners Association) – San Diego, CA

    September 22-23, 2008 – USPTO Boot Camp: Patent Edition*** (American Conference Institute) – Alexandria, VA

    September 22-23, 2008 – FDA Boot Camp*** (American Conference Institute)

    September 22-23, 2008 – Patent Litigation 2008 (Practising Law Institute) – San Francisco, CA

    September 23-24, 2008 – Biotech Patenting (C5) – London, England

    October 6-7, 2008 – Patent Litigation 2008 (Practising Law Institute) – McLean, VA

    October 7-8, 2008 – Global Patent Litigation*** (American Conference Institute) – New York, NY

    October 15, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – San Francisco, CA

    October 15-16, 2008 – Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) – Philadelphia, PA

    October 15-17, 2008 – Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) – New York, NY

    October 23-24, 2008 – Patent Litigation 2008 (Practising Law Institute) – Chicago, IL

    October 28-29, 2008 – Pharma/Biotech IP Due Diligence*** (C5) – Amsterdam, Netherlands

    November 10-11, 2008 – Patent Litigation 2008 (Practising Law Institute) – Atlanta, GA

    November 17-18, 2008 – Patent Litigation 2008 (Practising Law Institute) – New York, NY

    November 19-20, 2008 – Paragraph IV on Trial*** (American Conference Institute) – New York, NY

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

  • The Center for Business Intelligence (CBI) will be holding its Pharmaceutical Congress on Paragraph IV Disputes on October 15-16 in Philadelphia, PA.  The conference will cover important issues for both brand and generic companies during two days of presentations and panel discussions on litigation strategies, statutory guidelines, current cases, and their landmark decisions.  Topics to be discussed at the conference include:

    • FTC address on pharmaceutical antitrust;
    • In-depth analysis of recent court cases and their implications on brand and generic companies;
    • Effects of KSR on brand and generic litigation strategies;
    • Panel discussion on acceptable settlement strategies for Paragraph IV disputes;
    • Litigating Paragraph IV disputes with multiple ANDA filers;
    • Interpreting forfeiture provisions for better business decisions;
    • Pre-suit preparedness strategies for Paragraph IV disputes;
    • Citizen petitions and their impact on generic entry;
    • Declaratory judgments; and
    • At risk launches.

    Among the presentations and panel discussions that CBI faculty will be providing are:

    • Strategies to optimize patent lifecycle from drafting to maturity;
    • Preparing for Paragraph IV challenges — generic pre-suit strategies;
    • Best practices in e-discovery — overcoming obstacles, controlling costs and maximizing benefits;
    • The KSR decision and ANDA litigation;
    • Lessons from the court — examine the proceedings of a key victory on an important case;
    • Implications of recent developments and trends in litigating Paragraph IV disputes;
    • Citizen petitions and their impact on generic entry;
    • Interpreting forfeiture provisions — an analysis of recent cases to increase preparedness and improve product strategy;
    • The FTC, antitrust law, and settling Paragraph IV litigation; and
    • Acceptable settlement strategies for Paragraph IV disputes.

    An additional pre-conference workshop entitled:  "Litigation Strategies to Proactively Plan for Paragraph IV Disputes" will be offered on October 15, 2008.  The pre-conference workshop will set up a mock Paragraph IV dispute, with a hypothetical patent, from the initial certification through disposition of the suit, addressing all options for both the innovator and generic companies along the way.

    The agenda for the Pharmaceutical Congress on Paragraph IV Disputes can be found here.  A brochure for this conference can be requested here.

    Header_logo_2
    The registration fee for the conference is $1,995.  Attendees registering on or before August 15, 2008 will receive a $300 discount off the registration fee, and attendees registering a group of three individuals will receive a fourth registration for free.  Those interested in registering for the conference can do so here, by calling 1-800-817-8601, or by e-mail at cbireg@cbinet.com.

    Patent Docs is a media sponsor of CBI’s Pharmaceutical Congress on Paragraph IV Disputes.

  •     By Donald Zuhn and Christopher P. Singer

    Uspto_seal_no_background_2
    In a Notice published in the Federal Register on August 7, 2008 ("Clarification of Patent Regulations Currently in Effect, and Revision in Applicability Date of Provisions Relating to Patent Applications Containing Patentably Indistinct Claims," 73 Fed. Reg. 45999), the U.S. Patent and Trademark Office "clarified" the patent-related regulations that are currently in effect, and identified the applicability date of two provisions of the continuation and claims rules that were enjoined by the Eastern District of Virginia more than four months ago in Tafas v. Dudas.  The provisions relate to applications containing patentably indistinct claims — in particular, Rules 78(f)(1) and 78(f)(2) — and the USPTO indicated in the Notice that the provisions will "apply only to applications filed on or after any new effective date that would be published by the USPTO in the future."  The new applicability date will also only apply if the injunction issued by Judge Cacheris is lifted.

    Before addressing new Rules 78(f)(1) and 78(f)(2), the Notice "clarified" that the continuation and claims rules package had amended a long list of regulations, that these changes were permanently enjoined by the District Court in Tafas v. Dudas, and that the Tafas decision is currently on appeal to the Federal Circuit.

    With respect to Rules 78(f)(1) and 78(f)(2), the Notice states that:

    The USPTO anticipates that it will be some time before the litigation concerning the Claims and Continuations Final Rule is finally resolved.  The USPTO is concerned that some applicants may be taking preparatory action anticipating the new requirements of 37 CFR 1.78(f)(1) and (2), as added by the Claims and Continuations Final Rule, due to the possibility that the injunction by the district court in Tafas will be removed.  The purpose of this notice is to aid applicants who might otherwise feel the need to take such preparatory actions by identifying the applicability date of the provisions of 37 CFR 1.78(f) in the event that the injunction by the district court in Tafas is removed.  Specifically, the changes in 37 CFR 1.78(f)(1) and (f)(2) will only apply to applications filed on or after any new effective date that would be published by the USPTO after the removal of the injunction.

    The USPTO also released a statement about the Notice, in which the Office indicated that the Notice was published to "alert[] the public to a new applicability date of regulatory provisions dealing with related applications in the ‘Claims and Continuations’ Final Rule."  The statement goes on to say that "[a]ware that some applicants may be anticipating a removal of the injunction, the USPTO wishes to notify the public as soon as possible of a change in the applicability date of provisions pertaining to related applications so applicants do not undertake unnecessary preparatory actions to comply with these provisions."

    Last year, as part of a series of articles on the continuation and claims rules, Patent Docs provided an extensive analysis of Rule 78(f) (see "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents").  Because we do not count ourselves among those "anticipating a removal of the injunction," we have chosen for the time being to defer further discussion of Rules 78(f)(1) and 78(f)(2).

  •     By Kevin E. Noonan

    Surowiecki_james
    James Surowiecki is exercising his antipatent animus once again in the August 11th edition of The New Yorker.  Mr. Surowiecki (at right) writes a weekly column called "The Financial Page" in the magazine, and he has shown that he doesn’t like patents several times in his work.  These instances include complaining about business method patents in the July 14, 2003 issue of the magazine (see "Patent Bending"), the Blackberry litigation in the December 26, 2005 issue (see "Blackberry Picking"), and the intellectual property provisions of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) as it applies to patent protection for drugs (see "Exporting I.P.") in the May 10, 2007 issue.  This week, in a piece entitled "The Permission Problem," he addresses (a bit belatedly) the "anticommons" problem as discussed in Michael Heller’s book, "The Gridlock Economy."

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    Mr. Heller (at left), a Professor at Columbia University Law School (he is the Lawrence A. Wein professor of Real Estate Law) argues in his book that patents (and other property rights) can create a "tragedy of the anti-commons."  It is a catchy phrase, first popularized when Professor Heller collaborated with Professor Rebecca Eisenberg (Heller and Eisenberg, 1998, "Can Patents Deter Innovations? The Anticommons in Biomedical Research," Science 280: 698-701) to describe the risk that gene patents purportedly raise for scientific research.  This idea has been thoroughly debunked (see "The ‘Anti-Commons’ Aren’t So Tragic, After All" and "BIO Issues White Paper Examining If The ‘Tragedy of The Anticommons’ Is Relevant to Biotechnology").  Mr. Suriwiecke extends the assertions in Professor Heller’s book, stating as an example of the "tragedy" situations where "[i]n biotechnology, the explosion of patenting over the past twenty five years – particularly efforts to patent things like gene fragments – may be retarding drug development, by making it hard to create a new drug without licensing myriad previous patents."  The wording is comfortably conditional – "may be retarding" – and for good reason:  Mr. Surowiecki would be hard pressed to identify any actual example of this hypothetical situation.  Indeed, the evidence is to the contrary:  the U.S. pharmaceutical industry has flourished during the past 25 years, coming to predominate over European and other foreign drug companies, precisely because the U.S. adapted its patent system to accommodate patenting "things like gene fragments" (see "The Continuing Value of Biotech Patenting").

    To be fair, Mr. Surowiecki recognizes that "[p]roperty rights (including patents) are essential to economic growth, providing incentives to innovate and invest."  But in blindly accepting Heller’s arguments, and defining "science" as a "common resource" (when it is technology, not science, that is the subject of patent protection), he misses (and misstates) the benefits of protecting innovation using private property rights.

    New_yorker
    One of the most inapposite comparisons he makes, and one without any factual basis, is the hypothetical drug company that has to "strike bargains with thirty or forty other companies" in order to develop a new drug.  This, to Mr. Surowiecki is analogous to the situation with airplane manufacturers at the beginning of the 20th Century.  The difference, of course, is that the latter is historical fact, while the former is contemporary fiction.  The historical fact:  it was almost impossible to build an airplane in the U.S. just prior to World War I, due to patents on the various components needed to make an airplane, because "dozens" of companies held patents.  With the onset of the war, Congress provided the solution:  a patent pool that put the separately-held patents under control of a new entity that obtained licenses from the patentees.  But then Mr. Surowiecki shows the limitations of his analysis (or his understanding):  "Had Congress not stepped in," he states, "we might still be flying around in blimps."  Evocative, but wrong.

    What Mr. Surowiecki misses is the effects of patent term on the value of patent rights.  Patents are limited in time:  the right to exclude expires within 20 years of the earliest filing date of a patent application under current law.  Like everything with an expiration date, the value of patent rights decreases during the course of its term.  This happens for at least two reasons.  First, the closer it comes to the end of patent term, the less disadvantageous it becomes for a competitor to merely wait until the patent expires, and the more likely it becomes that the competitor frustrated by the patentee’s rights will do just that.  From the patentee’s perspective, the effect of patent term is that the value of any licenses a patentee can grant diminishes as the patent approaches its expiration date.  These realities in fact promote licensing under circumstances (such as university inventors) where the patent owner does not have the ability to bring a drug to market.  The only time patent rights will "frustrate" a competitor, at least in the biotechnology and pharmaceutical arts, is when not innovation but copying is prevented (which is precisely what patents are intended to do).  This is the reality of how patent rights impact innovation, and Mr. Surowiecki is entitled to not agree with it.  But it would be better if he presented more accurately the facts behind the influences, good and bad, of patents on innovation and new drug development.

  •     By Kevin E. Noonan

    Evaluatepharma
    EvaluatePharma, a London-based company providing forecasting and industry analysis to the biotech and pharma sector, released a report today predicting the big pharma landscape in 2014, based on industry trends, current and prospective drug pipelines, acquisitions and partnering and the predicted "patent cliff" that will occur as blockbuster drugs come "off-patent" and are subject to generic competition.  And the picture looks bleak for U.S. innovator pharmaceutical companies.

    As published today on The Wall Street Journal’s Health blog, EvaluatePharma predicts the following changes in pharma company rankings based on prescription and over-the-counter sales between 2007 and 2014:

    Table_1

    For comparison, the ranking of the top 10 companies based on actual data for prescription and OTC sales for 2006 is:

    Table_2

    According to the company’s website, forecasts are based on "SEC filings, annual and quarterly reports, presentations to analysts and investors, company press releases, supplemented with information from additional sources, notably the FDA and US PTO websites as a source of patent information."  Its database is purportedly updated monthly, and contains information on over 900 biotech and pharma companies.  In addition to its forecasts, the company sponsors industry conferences in the U.S. and abroad.

    There are a large number of assumptions built into these projections, but they reinforce the apprehension felt by many about the health of the U.S. innovator pharmaceutical industry.  These projections must be kept in mind when policymakers address again, as they certainly will, the need for patent "reform" pressed with such urgency by the IT industry in its efforts to rid itself of the patent thicket that its business model fosters.  Congress and the new administration must recognize that as important as the IT industry is to the U.S. economy, increasing the expense or time to market of the next electronic gadget is ultimately less important than fostering an environment conducive to developing the next generation of drugs that will reduce morbidity and mortality in an aging population.  Recent history has shown that such policy decisions can have large effects on the pharmaceutical industry:  the hesitancy with which Europe and Japan accepted patentability of biotech inventions over the last twenty years led to a decline in pharmaceutical innovation that inverted the relative prosperity of U.S. and foreign innovator drug companies (see "The Continuing Value of Biotech Patenting").  The resulting  burst of innovation by U.S. drug companies is now approaching the end of its life cycle.  It would be tragic if current concerns of the commercial few endangered the capacity for native U.S. innovator drug companies to create the next generation of blockbuster drugs.

  •     By Christopher P. Singer

    No_fax
    In a Notice published in the Federal Register (73 Fed. Reg. 45662) on August 6, 2008, the U.S. Patent and Trademark Office proposes new rules that severely limit the types of papers that can be submitted to the Office by facsimile.  Essentially, the USPTO proposes to amend the rules relating to facsimile correspondence to exclude any document that could be submitted using the EFS-Web.  Thus, this rule would no longer permit facsimile-based filings of (for example) amendments, information disclosure statements, petitions, requests for continued examination, papers in ex parte or inter partes reexamination proceedings, design patent CPAs, refund requests, papers submitted to the US Receiving Office, papers relating to pre-appeal or appeal before the Board of Patent Appeals and Interferences (BPAI), and status inquiries.  A list of the various documents that can be submitted to the USPTO using EFS-Web is detailed in the Legal Framework for EFS-Web.  While facsimile based transmissions would still be acceptable for documents that are not properly submitted by EFS-Web (examples include: Certified Copies submitted under § 1.4(f); correspondence in an application under a secrecy order; correspondence regarding Registration to Practice under § 1.4(e); protests; public use hearings; papers filed in contested cases before the BPAI; third party papers; and maintenance fees under § 1.366), if the rule change is enacted, any "improper" submission sent by facsimile (which is "properly" submitted by EFS-Web) would be treated as an unofficial communication, and not entered into the official file record.

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    The USPTO provides several justifications for the proposed rule change, including an increased time and paper burden that facsimile transmissions require, delays caused by mis-routing of facsimile correspondence through use of the incorrect facsimile number, and the poor reproducibility of documents received by facsimile.

    The Notice also describes a proposed rule change that would increase the minimum mandatory font size.  This proposed change:  (1) specifies that fonts must be of a size where capital letters are no smaller than 0.28 cm (0.11 inch) high (essentially 12 point Times New Roman); (2) establishes that the requirement applies to prosecution-based papers; (3) clarifies that the requirement does not apply to preprinted information on PTO-based papers and forms or U.S. Patents printed in double-column format; and (4) clarifies that papers submitted electronically are part of the official application/reexamination file, and must be readily legible.  The USPTO justifies this new requirement on the basis that because OCR technology is used to recognize text in documents submitted using EFS-Web, the use of unreasonably small fonts in documents yields recognized documents that contain many OCR-related errors.

    The Office is accepting written comments to these proposed changes, which must be received on or before October 6, 2008.  While comments can be submitted by regular mail (Mail Stop Comments-Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450) the USPTO encourages that comments be submitted electronically to:  AC27.comments@uspto.gov, or by using the Federal eRulemaking Portal Website.  Individuals who wish to obtain further information regarding this notice are directed to contact Mr. Hiram H. Bernstein, Senior Legal Advisor (517.272.7707) or Mr. Raul Tamayo, Legal Advisor, (571.272.7728).

  •     By Donald Zuhn

    Pubpat
    Last week, the Public Patent Foundation (PUBPAT) announced that a coalition of consumer advocacy and public interest groups had filed an amici brief in the Tafas v. Dudas appeal.  The brief, which was signed by PUBPAT Executive Director Dan Ravicher (below left), was filed on behalf of PUBPAT, AARP, the Computer & Communications Industry Association (CCIA), Consumer Watchdog, Essential Action, Initiative for Medicines, Access & Knowledge (I-MAK), Prescription Access Litigation (PAL), Public Knowledge (PK), Research on Innovation (ROI), and the Software Freedom Law Center (SFLC).

    Ravicher
    The public interest groups wasted few of the brief’s 30 pages explaining the perceived flaws in Judge Cacheris’ opinion, electing instead to repeat the mantra that the continuation and claims rules were good because they "would significantly advance both the general public interest and the specific aspects of the public interest that [the amici] each separately exist to represent."  According to the brief, these specific aspects include facilitating the entry of generic drugs to the marketplace (AARP), fighting embryonic stem cell patents that allegedly impede research efforts (Consumer Watchdog), challenging illegal prescription drug price inflation by pharmaceutical manufacturers (PAL), and advancing the development and free distribution of Free and Open Source Software (SFLC).

    Lemley_mark_3
    Outside of a few generalized statements about "curtail[ing] abusive behavior by exploitative patent applicants" and improving patent quality, the brief provides little explanation as to how the continuation and claims rules would allow the amici to achieve their specific objectives.  With respect to curtailing abusive behavior, the amici argue that the continuation and claims rules "do not restrict any of the rights of patent applicants under the law," but rather, "strike a fair and reasonable balance between preserving the rights of patent applicants to obtain all of the patent protection they deserve and ensuring that those patent applicants who want to game the system for undue advantage are thwarted in such attempts."  The amici then trot out Lemley (at right) and Moore’s "Ending Abuse of Patent Continuations" to establish that an "endless stream of continuation applications" results in a "wearing down" of examiners, which in turn leads to the issuance of undeserved broad patents.

    The brief also labels the practice of submitting claims that read on a competitor’s product in a later filed continuation application as a "perverse manipulation of the patent system" that "defeats the public notice function of patent claims."  As for the assertion that the continuation and claims rules do not restrict the rights of patent applicants, the amici contend that applicants denied an additional continuation (after using up their two continuations as a matter of right) are not left without a remedy, but can elect to pursue an appeal to the Board, and if that doesn’t work, take their appeal to the Federal courts.  For the amici, the costs of such appeals must be small when compared with the opportunity to eliminate a yet to be quantified amount of "abusive procedural gamesmanship" committed by a yet to be determined percentage of patent applicants.

    Not surprisingly, the amici take the position that "any claims desired and deserved by a patent applicant can and should be included in the original application, an amendment to it, or any of the continuation applications allowed under the Final Rules as a matter of right without justification."  As luck would have it, the continuation and claims rules would have provided precisely the number of continuation applications that an applicant would have needed to secure all of the claims it "desired or deserved."

    The brief treats unlimited claiming as it does the right to file unlimited continuations, arguing that "some applicants purposefully attempt to overwhelm the USPTO examiner by submitting dozens, if not hundreds, of claims in their application with the hope that the examiner will simply not have sufficient time to fully analyze and review each one."  Alluding to the creation of Examination Support Documents (ESDs) under the continuation and claims rules, the amici argue that applicants "who seek more than a reasonable number of claims [should] provide some assistance to the USPTO in reviewing that application."  Notwithstanding the ESD requirement, the amici argue that the continuation and claims rules "do not in any way preclude applicants from applying for as many claims as they would like, nor do they take away any right granted to patent applicants under the Patent Act."

    The brief concludes by taking up the second of its generalized statements, i.e., that the continuation and claims rules would improve patent quality.  The amici argue that "there have been several patents that were used to preclude competition in markets worth billions of dollars that were later proven to be undeserved," and that "this phenomenon repeatedly occurs is the pharmaceutical industry."  As evidence of this "phenomenon," the brief points to the invalidations of the paclitaxel patent in Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001), and the fluoxetine hydrochloride patent in Eli Lilly & Co. v. Barr Labs., 251 F.3d 955 (Fed. Cir. 2001).  However, if it only takes one or two invalidations to establish that the patent system is in desperate need of repair and that the continuation and claims rules present a reasonable solution, then opponents of these rules will have a difficult time convincing the amici that the continuation and claims rules went too far and would have caused far too much damage to the public interest.

    For information regarding this topic, please see:

    • "USPTO Files Opening Brief in Tafas v. Dudas Appeal," July 22, 2008
    • "Save the Date — Initial Scheduling of the Tafas/GSK v. Dudas Appeal," May 21, 2008
    • "USPTO to Appeal Tafas/GSK v. Dudas," May 7, 2008
    • "No April Fool’s Joke — Tafas and GSK Win on Summary Judgment," April 1, 2008
    • "Judge Cacheris Takes GSK Case under Advisement," February 8, 2008
    • "GSK Summary Judgment Hearing Set for Friday Morning," February 7, 2008
    • "New Briefing Deadline Set In PTO Rules Case," December 18, 2007
    • "Court Sets Summary Judgment Schedule in New Rules Case," December 3, 2007
    • "No Discovery in New Rules Case," November 27, 2007
    • "Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)," October 31, 2007
    • "USPTO Late to Its Own Party," October 31, 2007
    • "GSK Secures Injunction," October 31, 2007 (includes links to Court’s Order and Opinion)
    • "GSK TRO/Preliminary Injunction Hearing," October 29, 2007
    • "GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules," October 24, 2007
    • "Hooray! – (Finally) the Big Dogs Have Joined the Hunt," October 11, 2007
    • "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
    • "Inventor Sues PTO to Prevent New Continuation and Claims Rules from Taking Effect," August 30, 2007

  • Cover
    Patent Docs
    provides two reviews for the price of one as Kevin Noonan and Donald Zuhn each discuss the second edition of Martin Voet’s book "The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management."

        By Kevin Noonan

    Martin A. Voet, Senior Vice President and Chief Intellectual Property Counsel at Allergan, Inc., has published the second addition of his helpful primer, "The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management" (Brown Walker Press: Boca Raton, FL; 183 pp., $28.95).  And primer it is:  Mr. Voet gives the reader a comprehensive, up-to-date tour of the issues facing innovator drug companies in the current patent and regulatory climate.

    The subtitle presages the structure of how Mr. Voet sets out the topics in the book.  The first three chapters are about patents (Overview of Patents; Patent Enforcement and Infringement; and Pharmaceutical, Biological and Medical Device Patents).  Next come the chapters on regulation (Overview of FDA; Drug Product Exclusivity; and Hatch Waxman Act).  The book wraps up with chapters entitled Putting it All Together: Product Life Cycle Management and Conclusions and Final Thoughts.

    The book is intended to be comprehensive but not exhaustive, and accordingly, the essentials of each topic are highlighted without the kind of in-depth coverage that would have doubled (at least) the length of the book and decreased its easy accessibility.  Mr. Voet is thorough, however, and a reader knowledgeable in the topics is left with few quibbles regarding what he has included and what he has left to others (preferably, as he notes in his Disclaimer, a legal professional; the book is not intended to be a substitute for formal legal advice) to explain.

    One big advantage of the second edition is that it brings many topics up-to-date in view of the changes (occasioned principally by court cases) that have occurred in these topics since the 2004 first edition.  Thus, Mr. Voet discusses the Supreme Court’s KSR Int’l Co. v. Teleflex Inc. decision, as well as how the Federal Circuit has adapted to it (including a mention of the contrasting decisions in its Lexapro® and Altace® cases).  He discusses the difficulties for innovator pharmaceutical companies caused by the Supreme Court’s eBay Inc. v. MercExchange, L.L.C. decision, particularly with regard to the uncertainties created for investors when the ability to keep a competitor off the market cannot be counted upon.  In re Seagate is mentioned in his discussion of patent litigation and the changes in risk assessment as a result of this decision.  He includes Medimmune, Inc. v. Genentech, Inc. and Merck KGaA v. Integra Lifesciences  I, Ltd. as cases affecting (at different decision points) how generic companies may behave with regard to ANDA activities, particularly noting that the Medimmune case should permit a generic company to sue an innovator who does not file suit with 45 days of receiving statutory notice of an ANDA filing; using the Supreme Court’s logic, the generic company should not have to launch "at risk" in order to ask a District Court to find invalid the innovator’s Orange Book listed patent(s).

    In addition to the situation in the U.S., Mr. Voet touches on the patent and regulatory situation abroad, specifically in Europe, Japan and Canada.  While less detailed than his treatment of U.S. law and regulation, the book provides a succinct comparison among the different countries, noting areas where the consequences for innovators are better, or worse, than they are in this country.

    The second edition of "The Generic Challenge" is much like the first:  an easy, enjoyable read that touches all the high points and is comprehensive enough to alert the reader to the issues in drug product life cycle management.  It should prove useful for executives and in-house counsel, as well as the interested general reader who would like an appreciation of the issues facing new drug development that goes beyond the inadequate treatment found in the popular press.

        By Donald Zuhn

    Martin A. Voet, the Senior Vice President and Chief Intellectual Property Counsel at Allergan, Inc., recently provided Patent Docs with a copy of the second edition of his book "The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management."  It is a book that any patent attorney or regulatory attorney should consider adding to his or her library.  Despite dealing with two topics that could (and do) fill multi-volume treatises, Mr. Voet provides a thorough yet light and interesting discussion of both patent law and regulatory law.

    The 183-page book is divided into eight chapters.  The first three chapters (Overview of Patents; Patent Enforcement and Infringement; and Pharmaceutical, Biological and Medical Device Patents) relate to patents, the fourth and fifth chapters (Overview of FDA and Drug Product Exclusivity) address regulatory matters, the sixth chapter (Hatch Waxman Act) presents what Mr. Voet describes as the "final piece of the puzzle," the seventh chapter (Putting It All Together: Product Life-Cycle Management) synthesizes the first six chapters, and the final chapter (Conclusions and Final Thoughts) provides some closing thoughts.

    Mr. Voet offers that "The Generic Challenge" might be helpful to the regulatory lawyer or patent lawyer "who wishes he or she had a better understanding of the interaction of patent law with regulatory law so that they can better see the bigger picture and help achieve the goal of successful pharmaceutical product life-cycle management."  As a patent attorney, I found the chapters on regulatory matters to be quite informative, and believe that regulatory lawyers would find the patent chapters to be equally informative.  Mr. Voet suggests that patent and regulatory attorneys might want to save time by skipping the chapters in their own specialty, but the book is such an easy read that there is really no need to skip anything.  For example, the first three chapters provide as thorough and up-to-date an overview of patent law as I imagine one can get less than 100 pages, and I suspect that regulatory attorneys would say the same about chapters four through six.

    In the introduction to his book, Mr. Voet states that "[i]f the generic industry is not kept in check, the balance between the goals of low-priced currently available drugs and innovative, life-saving and life-enhancing future drugs will not be maintained, and while we may have cheap, old drugs, we will have no new, innovative drugs."  Coming as it does from the Chief IP Counsel for a brand pharmaceutical company, this is perhaps not a surprising sentiment.  However, Mr. Voet understands the importance of both innovator and generic drug companies, and in the last chapter of his book, he advocates for a system in which innovative pharmaceutical companies are encouraged to innovate, generic drug companies are allowed to offer low-cost medicines to people who need them, and the law is crafted "to maintain the delicate balance between fostering new innovative drugs and providing good quality, inexpensive generic drugs."  Mr. Voet recognizes — and addresses in his book — the reality that the U.S. pharmaceutical industry will soon have to deal with a follow-on biologics regulatory pathway, and as Congress begins to debate the issues of exclusivity and bioequivalence, members of the Senate and House would be wise to keep the above goal in mind.