Patent Docs

Financial Times to "the Patent Troll Narrative" -- Much Ado About Nothing

By Kevin E. Noonan --

Yesterday, the Financial Times (London) published an article by Rana Foroohar entitled "Big Tech vs. Big Pharma: the battle over US patent protection."  If the article can be encapsulated in a word, that word would be "debunked" for what the article calls the "patent troll narrative" that patent trolls are impeding innovation and costing U.S. jobs to go down and consumer costs to go up.  As has been said in other contexts, "it ain't necessarily so" and, in fact, it isn't so at all.

The article starts with a testimonial from Sherry Knowles, former Chief Patent Counsel at GlaxoSmithKline and a breast cancer survivor, who acknowledges that the drug that "saved her life" -- Adriamycin -- would not have been able to be developed had it been discovered under the unfriendly conditions patentees face today.  She recites an inconvenient truth sometimes ignored by policymakers unduly swayed by the desired outcome of cheaper drug prices:  "[i]f companies can't defend their intellectual property, they won't invest.  It's that simple."

While noting that Big Pharma is unlikely to garner much sympathy, the article properly notes that voices that have been raised against current trends in the USPTO, Congress, and the courts (particularly the Supreme Court) include start-up biotech companies, semiconductor and electronics firms, universities, and other innovators, precisely the sources of both innovation and job growth.

The article discusses the reasons for the complaints -- changes in patent laws including the America Invents Act and Supreme Court decisions like Mayo Collaborative Services v. Prometheus Laboratories and Alice Corp. v. CLS Bank and some of the negative consequences of these trends.  For example, the article shows that the U.S. (which spends 2.79% of gross domestic product on research and development, a total of $518,077,890,000 in 2015 according to the World Bank) has gone from 1st to 10th in patent protection according to Chamber of Commerce, and is now tied with Hungary (which spends 1.38% of its GDP on R&D, a total of $1,715,933,400).  As a consequence, the article says that some companies are encouraged to engage in "efficient infringement" defined in the article as companies that "simply copy or take the IP they want, then settle with aggrieved parties out of court for less than the full value of the IP."

The reason for the change:  "the patent troll narrative," which the author says had reached a "fever pitch" by the time President Obama was inaugurated.  This narrative was a large part of the impetus to change U.S. patent law that culminated in the America Invents Act.  But even after passage of the AIA and institution of inter partes and covered business method reviews (which were intended to solve the problem of improvidently granted patents more cheaply and efficiently than through litigation), the article states that some high tech companies wanted even more patent-unfriendly "reform."  According to David Kappos, former Director of the U.S. Patent and Trademark Office as quoted in the article, "[u]ltimately the read agenda sunk in.  This second round of drastic cutbacks to the patent system was a commercial ploy designed not to stop abuse but to cut supply chain costs by devaluing others' innovation."

In 2013, according to the article, the White House issued a report that 2/3rds of patent litigation was provoked by patent trolls.  This number was disputed by the nonpartisan Governmental Accounting Office (GAO), which estimated the number at about 20%.

The article quotes Randall Rader and Paul Michel, both former Chief Judge of the Court of Appeals for the Federal Circuit, as being against how the USPTO has administered the inter partes review process.  On the other hand Mark Chandler, General Counsel at Cisco, is quoted as saying that the problem is patents that should not have been granted, which "put[] a deadweight burden on the economy by blocking innovation by others and unnecessarily driving up prices to consumers."  But Gary Lauder, a venture capitalist from Silicon Valley, says that the patent system America needs is one where established companies pay innovator companies for their innovations rather than being able to expropriate them.  "We need to protect the larger start-up ecosystem, which is where the majority of jobs are created," he says.

Also cited in the article is a recent study from the National Bureau of Economic Research which found that having a patent increases the likelihood of acquiring venture capital by 53%, of start-up job growth by 36% and start-up sales by 51%.  And a paper by Stanford economist Stephen Haber is cited for finding that the patent troll narrative is inconsistent with the actual behavior of patentees and accused infringers.

The article closes with a view to what may happen next, which includes a bill by Senator Christopher Coons (D-DE) intended to shore up the U.S. patent system in the face of global competition particularly from China.  The article notes that there may be some acquiescence to changing the patent system to accommodate the needs of biotech and pharma with the different needs of the high technology sector, perhaps with different rules for each.

The most cogent commentary in the article regards statistics generated by Lex Machina regarding the effect of trolls on the patent system:  "There has been an abundance of data that both advocates and critics of the current patent system spin in all sorts of ways to make their case," according to the article.  The USPTO estimate that 2/3rds of patent cases involved trolls did not take into account changes in how patent cases could be brought so that this number was somewhat artificially exaggerated.  And the contemporaneous GAO study expressly refuted this number with an estimate of 20%.

Using "the best way to compare" patent lawsuit numbers pre- and post-AIA (using individual defendants as the metric), Lex Machina found that the number of patent lawsuits in fact didn't change with the change in the law, and that the brief spike in 2011 (which was the basis of much of the troll narrative) was accounted for by the law change occasioned by passage of the AIA.  These data are illustrated by Lex Machina's graph, reproduced below:

In short, the article concludes, "[t]rolls have been overblown as a patent issue."  But the consequences of this inaccurate narrative persist.

The paper's conservative bona fides are established on its website:

First published in 1888 as a four-page newspaper, the Financial Times' initial readership was the financial community of the City of London.  The Financial Times soon established itself as the sober but reliable "stockbroker's Bible", with its only rival being the slightly older and more daring Financial News.  In 1893, the FT turned salmon pink -- a masterstroke that made it immediately distinguishable from its competitor.  From their initial rivalry, the two papers merged in 1945 to form a single six-page newspaper.  The Financial Times brought with it a higher circulation, while the Financial News provided enormous editorial talent.

Insofar as many of our elected leaders profess to be conservatives, perhaps it would behoove them to listen to an authentic conservative voice on these matters.

Alternative Facts on Patent-Eligibility from the Electronic Frontier Foundation

By Michael Borella --

The textbook policy rationale for the existence of a patent system is a quid-pro-quo -- a tradeoff in which an inventor is granted a time-limited property right over his or her invention in return for disclosing it to the public.  Such disclosure is expected to, over time, spur further innovation, and bolster research and development.  But empirical measurements of the impact of the patent system on innovation and the economy have been difficult to come by.  Patents are just one factor influencing ongoing scientific and engineering advances, and their impact is perhaps impossible to determine in an aggregate sense.

Heidi L. Williams of the National Bureau of Economic Research reviewed the available evidence of how patents on existing technologies might affect follow-on innovation and research investment.  Her conclusion is that more evidence is needed:  "[G]iven the limitations of the existing literature we still have essentially no credible empirical evidence on the seemingly simple question of whether stronger patent rights -- either longer patent terms or broader patent rights -- encourage research investments into developing new technologies."

Nonetheless, in a recent article, Vera Ranieri of the Electronic Frontier Foundation (EFF) has used this essentially neutral position to argue in favor of recent changes to U.S. patent law that arbitrarily and subjectively limit patentable subject matter.  In doing so, Ms. Ranieri falls back on a number tired tropes and misconceptions about the workings of U.S. patent law, and fails to consider the damage done by these changes to the certainty function of the patent system.

The Alice Decision

In 2014, the Supreme Court handed down a highly controversial decision in Alice Corp. v. CLS Bank Int'l.  In a nutshell, the Court ruled that patent claims should be analyzed to determine whether they are too "abstract," and if they are, these claims should be further analyzed to determine whether they incorporate "significantly more" than an abstraction.  In doing so, the Court went well beyond the plain language that Congress set forth in 35 U.S.C. § 101, the section of the patent statute that defines subject-matter eligibility.  Furthermore, the Court purposely declined to define what it meant by "abstract" and "significantly more," essentially leaving it up to the Federal Circuit, the district courts, and the USPTO to provide meaning for these ambiguous terms.

While not explicitly stating it, in Alice the Court effectively targeted software and business method inventions (and certain types of life science inventions, such as diagnostic methods) for an additional level of scrutiny.  In fact, the EFF's own amicus brief in Alice encouraged the Court to use the case to "reign in overbroad software patents."  Whether or not this argument ultimately swayed the Justices to rule as they did, the effect of Alice is clear -- over 15,000 patent claims have been invalidated under § 101 since this decision came down, the vast majority of these in the software and business method space.  Additionally, some software and most business method claims are now harder to obtain from the USPTO, with rejection rates of over 90% in some business method art units.

In many cases, courts have invalidated patents under § 101 without undertaking claim construction.  Let that sink in for a while -- courts are throwing out patents as allegedly being abstract without determining the actual scope of the claimed invention.

The Alice Decision Has Not Been, and Cannot Be, Applied Consistently or Objectively

The problem with Alice is not just that it limits the scope of patentable subject matter, but that it does so in an arbitrary and subjective fashion.  Courts and the USPTO have struggled mightily with making sense of the decision.  Judge Wu of the United States District Court for the Central District of California criticized Alice for setting forth an "I know it when I see it" test.[1]  Judge Pfaelzer, a colleague of Judge Wu, wrote that the Supreme Court's patent-eligibility cases "often confuse more than they clarify [and] appear to contradict each other on important issues."[2]  Former Chief Judge of the Federal Circuit Paul Michel stated that Alice "create[d] a standard that is too vague, too subjective, too unpredictable and impossible to administer in a coherent consistent way in the patent office or in the district courts or even in the federal circuit."

While the Federal Circuit has attempted to provide a consistent line of post-Alice case law, this has resulted in some very thin bacon slicing.  For instance, in 2014 a panel in Ultramercial v. Hulu found a complex and narrow web-based transaction to be unpatentably abstract, while another panel in DDR v. Hotels.com found a web server that combines the look and feel of two different web sites meeting the requirements of § 101.  Last year, in Synopsys v. Mentor Graphics, an invention automating circuit design procedures was found to be abstract because these procedures had been performed manually by humans.  But in McRO v. Bandai Namco Games America, an invention automating lip-synchronization in animated characters was found not abstract even though the automated procedure could be performed by humans.

While one could argue that there are at least tenuous distinctions between the claimed inventions that were found eligible and ineligible in these four cases, the recent Recognicorp v. Nintendo case clearly illustrates the Federal Circuit's inability to apply Alice consistently.  In the decision, the panel characterized a 154-word claim as nothing more than "encoding and decoding image data," despite the panels in Enfish v. Microsoft and McRo explicitly forbidding such claim over-simplification.

At the USPTO, despite the administrators' admirable efforts to provide clear examination guidelines with respect to Alice, it is notoriously well known amongst practitioners that different art units and different examiners will apply the Alice test in radically different ways.  Further, it is common for an applicant to receive an Alice rejection that is purely conclusory in nature -- the examiner essentially saying "Your claims are abstract, no patent for you!" without any rationale or reasoning to support the rejection.  While the latter type of rejection can be rebutted, it imposes additional and unnecessary costs on the applicant to go through extra cycles of Office actions or appeals.

Ultimately, the problem does not lie with the Federal Circuit or the USPTO.  The Alice test is inherently subjective, requiring one to look at a claim and imagine analogous "well-known, routine, and conventional" activities.  In doing so, examiners and judges often ignore key claim elements, resulting in a 10,000-foot view of the claim being analyzed, rather than the actual claimed invention.

Due to this subjectivity, reasonable minds can differ regarding whether a claim is abstract and whether it contains something more.  There is no way for thousands of examiners and hundreds of federal judges to reach the same conclusion on a consistent basis.

The Lack of Evidence Found in the Williams Paper Cuts Both Ways

For sake of argument, let's assume that Ms. Williams's analysis is correct, and that there is little or no evidence identified yet that establishes innovation is spurred on by a strong patent system.[3]  Ms. Ranieri interprets this result as an invitation to slam the door on software patents, arguing that there is no need to change the law to fix problems introduced by Alice.

But the same argument could be used to establish that there was no need for the Supreme Court to change the law in Alice either.  If the impact of patent system strength on innovation was unclear, the Court should not have instituted such a dramatic change.  Besides, Congress is better equipped than the Court to derive policy from such studies.  If anything, the dramatic growth of technology company profitability and market capitalization from the mid-1990s to the Alice decision in 2014 suggests that a strong patent system is not inconsistent with innovation and technological investment in the software market.

Ms. Ranieri also states that the Williams paper establishes that there is no evidence that the Alice decision has "done any harm to the innovation economy or innovation generally."  But the paper does not address Alice at all, and most of its cited research was conducted prior to the 2014 date of Alice.  Given the lengthy, multi-year time scales of patent lawsuits, patent prosecution, and research and development, the three years between then and now is way too short a time period to draw such broad conclusions.

Ms. Ranieri Mischaracterizes the Efforts to Overturn Alice

Throughout her article, Ms. Ranieri makes misleading statements about efforts to overturn Alice.  Particularly, she focuses on proposals by the Intellectual Property Owners Association and the American Intellectual Property Law Association to rewrite § 101.  A comparison of their efforts indicates that they would replace the Alice test with an analysis of whether the claimed invention as a whole (i) exists in nature independently of human activity, or (ii) solely in the human mind.  Such a test would certainly result in fewer patents being invalidated under § 101, but would also go a long way toward clarifying the law.

Unlike Ms. Ranieri's contentions, this would not "return us to a world where 'do it on a computer' ideas are eligible for a patent."  That world never existed.  If a claimed invention's sole difference from prior art is to perform a known series of steps on a computer, the invention is probably obvious and can be invalidated on those grounds.  In fact, the claims in Alice and many other so-called "overly broad" patents could be invalidated under the patent statute's existing novelty, non-obviousness, and written description provisions.  Ms. Ranieri's further statement that the proposed changes to § 101 would mean that "anything is patentable" aside from the aforementioned exceptions ignores the fact that eligible subject matter is just one requirement of many for a patent to be granted.

Furthermore, Ms. Ranieri asserts that "the recent reform proposals seem like little more than a bid by lawyers to create work for themselves."  If anything, the opposite will likely be the case.  The uncertainty surrounding Alice has been a boon for § 101 focused practice, opening more patent prosecution and litigation opportunities.  While some applicants are filing fewer patents as a result of Alice, many are filing more -- attempting to protect multiple narrow inventions rather than one or two broader ones.  There are more appeals in the USPTO, as well as more covered business method review proceedings as well.

When there is a gray area in the law, lawyers are needed more than ever to help their clients navigate the ambiguities.  If the Intellectual Property Owners Association and the American Intellectual Property Law Association succeed in their efforts, the patent law will be less ambiguous and there will be far fewer billable hours spent determining whether or not a claim is abstract.  Even though such a change might have a negative impact on their bottom lines, many patent attorneys would welcome the change because the patent system is broken as long as Alice stands.

Conclusion

Opposition to the Alice test is not based on it making patents easier to invalidate, but that it does so in an unworkable and intellectually dishonest fashion.  This has resulted in applicants with limited financial resources being unable to pursue patent protection for legitimate technical inventions.  If such a trend is widespread and continuing, small U.S. companies will be reluctant to innovate in certain market segments because of the risk of their U.S.-based or foreign competitors getting a free ride to copying or cloning a product or service.

This is the area that merits academic study -- has Alice actually harmed innovation?  As noted above, it may be a while before we can make that determination.  But if it is the case, that would be just one more reason of many for discarding the test.

[1] Eclipse IP v. McKinley Equipment (C.D. Cal. 2014).

[2] Cal. Inst. of Tech. v. Hughes Commc’ns Inc. (C.D. Cal. 2014).

[3] As far as we know, the paper has not yet been subject to thorough peer review, and therefore its conclusions should be viewed as preliminary at best.

Addressing Increased Drug Costs -- A Proposal

By Kevin E. Noonan --

The New York Times in a recent video (see "'Could You Patent the Sun?'") has returned to its theme against patenting, particularly with regard to patents for life-saving drugs.  This time the paper invokes the meme of Jonas Salk and his response to a question during an interview by Edward R. Murrow that patenting his polio vaccine would be like "patenting the sun."  He certainly said that, and he certainly meant it, and the sentiment has a visceral appeal that echoes the success of the ACLU's anti-gene patenting campaign.  But a closer look at the circumstances in which Dr. Salk could make this statement, and the realities facing drug development today, points out again how dangerous facile pronouncements made in the media (social or conventional) can inhibit rational debate by masking the real differences (and associated challenges) between those times and our own.

As set forth in Jane S. Smith's 1990 book "Patenting the Sun: Polio and the Salk Vaccine," Dr. Salk operated under conditions that gave him the luxury of not having to worry about patents.  One was the famous "March of Dimes" campaign of the National Foundation for Infantile Paralysis, which was created specifically to address polio by President Roosevelt (himself a polio sufferer) in 1938.  The disease, virtually unheard of before the turn of the last century, created a popular panic wherein tens of thousands of children were incapacitated annually, and the grassroots efforts of the March of Dimes generated more than $200 million for research and patient care.  Salk's work (as well as that of Albert Sabin on what would become the preferred form of the vaccine) was funded by March of Dimes money, circumstances very different from how science is funded today.

Other differences involve the regulatory environment and the costs such regulations impose on drug development.  Of course, these regulations are also responsible for protecting (albeit sometimes imperfectly) the American public from ineffective or dangerous drugs, and so the societal costs need to be balanced with increased barriers to new vaccines and other drugs.  But as Ms. Smith sets out, Dr. Salk was able to test early prototypes of his vaccine on children in a nearby institution caring for mental retardation, and the force of the fear regarding polio was such that the propriety of this testing was not questioned.  Moreover, Salk did his work prior to the thalidomide tragedy that led to changes in FDA laws and regulations that greatly increased the stringency (and thus the cost) of obtaining approval.  While a great deal of the cost of drug development can be laid at the feet of other aspects of this endeavor (the cumulative costs of many failed drugs for each successful one, for example), much of the increased costs of bringing new drugs to market since Dr. Salk's day has to do with this increased (but societally desirable) regulatory burden.

But even in view of these realities, the basis for an increasing amount of political pressure on drug companies is higher drug costs, particularly (and ironically) for biologic drugs which have significant advantages in addressing otherwise intractable diseases and which can have a specificity unknown for conventional drugs.  It is easy but incorrect to attribute these costs to patents, but it is equally unavailing to ignore the political power of the many memes relating to failures in American capitalism that permit these seeming cost imbalances to arise.

If the future appears to contain even more expensive drugs and a political backlash against them, then a clear-eyed assessment of that future can provide at least three alternatives.  The first is that the drugs will exist but that their availability will be stratified, between those who will be able to afford them on their own (either out-of-pocket or through so-called "Cadillac" health insurance plans) or through government-sponsored programs for select groups (veterans, for example) and those (perhaps the majority of Americans) who will not.  The second is that these drugs will not be developed in the U.S., due to changes in patent or regulatory law that provide disincentives to development (such as further erosion of patent eligibility by the Supreme Court or a reduction in market exclusivity for biologic drugs as sought after by the Obama Administration).  Neither of these alternatives is palatable, socially or politically.

A third course that may have the ability to address the growing problem of unsustainable increases in drug pricing would be some sort of cost control (presumably by the Federal government, analogous to systems in place in Europe and elsewhere), but to be practical there would need to be an economic incentive for the biotech and pharmaceutical industry to acquiesce.  One quid pro quo in this calculus would be a reversal in the current regime that the FDA imposes user fees on applicants for regulatory approval, and instead to have the government pay the costs of its regulatory requirements.  There is precedent in the negotiations leading to passage of the "Obamacare" healthcare overhaul to have government and the pharmaceutical industry come to an agreement over new ways to reduce healthcare costs.  Such a tradeoff could reduce a significant proportion of the costs of new drug development and thus eliminate the economic pressure for legitimate recompense that is likely not economically sustainable (see, e.g., Picchi, "The cost of Biogen's new drug: $750,000 per patient").  And it might also attenuate the FDA's requirements for approval, wherein the agency as a Federal bureaucracy might have incentives to balance its mandate to ensure safety and efficacy of approved drugs with the realities of drug development, to make both more realistic.

But it is clear that something must be done, if only to ensure that our ability to produce more effective drugs does not founder on soundbite-driven, simplistic solutions to the problems of providing efficient incentives for doing so.

Pigs Fly, Hell Has Frozen Over, and the New York Times Supports Small Inventor and University Patenting

By Kevin E. Noonan --

Admittedly, only on its Op-Ed page.  But last Saturday Joe Nocera wrote a remarkably sane and reasoned column, entitled "The Patent Troll Smokescreen," pointing out that "big companies with large lobbying budgets" are using the patent troll meme to change patent law in their favor (but in ways that will not increase innovation, benefit the country or "promote progress" for anything other than their bottom lines).

The column was prompted by the paradox that for some, like the Electronic Frontier Foundation, anyone who is a non-practicing entity (or NPE) and asserts a patent is a patent troll.  Mr. Nocera clearly understands the received wisdom about patent trolls:  they are NPEs that "use [their patents] not to further innovation or manufacture a product but to conduct a kind of legal extortion racket," based on patents that are "sometimes absurdly vague."  He cites as an example the Lemelson bar code patents (which of course were never accused of being vague but this is journalism so, close enough).  Patent trolls, Mr. Nocera writes, are "sand in the engine of commerce."

But it is clear that Mr. Nocera has been taken aback by the rhetoric that patent trolls should include universities because "[w]henever the university's scientists come up with innovations -- which they rarely intend to use to manufacture a product -- WARF [who licenses patents from the University of Wisconsin] applies for a patent and then seeks to license it, just as trolls do."  Naively, he then states that "of course, nobody thinks a university is a patent troll" based on his (correct) understanding that "[u]niversities are supposed to come up with new ideas, not manufacture new products.  That's what companies do."  And he further understands that even anti-troll champions like Hastings College of Law Professor Robin Feldman recognizes the social utility of encouraging universities to license their patented technology, because it will "encourage the commercialization of new products."

The social utility could be hampered, Mr. Nocera realizes, if the bills in Congress aimed at curtailing the type of "trolling" he disparages ends up "having huge negative consequences for legitimate inventors."  Or if "a series of Supreme Court rulings make matters worse, putting onerous burdens on inventors while making it easier for big companies to steal unlicensed innovations."  (The latter has, of course, already happened; see "The ACLU, Working for the Man").

According to Mr. Nocera, those decisions and the AIA have created a situation where "big companies can now largely ignore legitimate patent holders."  And the companies doing it "don't call it stealing"; instead, they call it "efficient infringing" according to Robert Taylor, a patent lawyer for the National Venture Capital Association.  The result:  the big company expropriates patented technology and then has "top-notch" patent lawyers working for it to invalidate any patent asserted against it.  And "[b]ecause the courts have largely robbed small inventors of their ability to seek an injunction [] the worst that can happen is that the infringer will have to pay some money.  Which, for a rich company like, say, Apple, [is] no big deal," according to Mr. Nocera.  In Apple's case, the piece states that Apple has a policy, expressly stated on its website, that "the company can lay claim to any unsolicited [note, not unpatented] idea."  He then describes the lawsuit between Wisconsin and Apple and the $234 million judgment the WARF obtained against Apple for patent infringement.  But he mentions that this doesn't make Wisconsin whole, due to lost opportunity costs, stating that WARF didn't have the chance to license the technology exclusively to an Apple competitor, and in addition had to risk infringement litigation to obtain any recovery at all.

The piece ends with a reminder that bills remain pending in both the House and Senate that "will [] effectively tilt the playing field even further toward big companies with large lobbying budgets" and states:

For the sake of real innovation, and in the name of the small inventor, who holds a special place in America's mythology, the pendulum needs to start swinging in the other direction.

Perhaps a measure of sanity will return to the patent law debate, if the Times Op-Ed editors saw fit to publish Mr. Nocera's column.  Patentees would do well to send a copy to their Senators and Representatives in Congress, and perhaps take the opportunity to engage legislators in a discussion of these issues.

Because we can be sure that those "large lobbying budgets" are not going unspent by companies engaging in "efficient infringement."

Top Stories of 2014: #10 to #7

By Donald Zuhn --

After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories.  For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants.  On New Year's Eve, we counted down stories #18 to #15, and on New Year's Day, we covered stories #14 to #11.  Today, we count down stories #10 to #7 as we work our way towards the top three stories of 2014.  As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT).  Details regarding the webinar can be found here.

10.  While FDA Accepts First Biosimilar Application, Some Biosimilar Applicants Try to Bypass BPCIA

In July, Sandoz announced that the U.S. Food and Drug Administration had accepted its application to market a version of the protein filgrastim.  The reference product is Amgen's NEUPOGEN®.  Sandoz markets a biosimilar filgrastim outside the U.S. under the brand name ZARZIO®.  Interestingly, in October, Amgen announced the results of a Phase III clinical trial of its own biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab (sold by AbbVie as Humira®).  Amgen and Sandoz were both involved in a BPCIA dispute that was resolved by the Federal Circuit in December.  In what some perceived as an attempt to sidestep the requirements of the BPCIA, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor.  In Sandoz v. Amgen, the Federal Circuit affirmed the District Court's dismissal of Sandoz's suit because "Sandoz did not allege an injury of sufficient immediacy and reality to create subject matter jurisdiction."  In other biosimilar developments, the FDA issued a "Guidance for Industry" in August entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act."  The Guidance provides some grounds for determining the term of market exclusivity under the BPCIA (12 years; Sec. 351(k)(7), codified at 42 U.S.C. 55 262(k)).

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

• "Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y. 2014)," December 11, 2014
• "Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)," December 9, 2014
• "Amgen Poised to Enter Biosimilars Market," October 8, 2014
• "FDA Releases Another Prospective Guidance," August 13, 2014
• "Finally, A Biosimilar Application Has Been Accepted By The FDA ," July 28, 2014
• "FDA Releases Draft Guidance on Biosimilars," May 14, 2014
• "Indiana Governor Signs Biosimilar Substitution Bill," April 10, 2014

9.  Congress and Tech Sector Wage Battle Against Patent Trolls

Despite having passed patent reform legislation -- the Leahy-Smith America Invents Act -- in September 2011, many in the patent community expected Congress to pass another piece of patent reform legislation in 2014 -- this time addressing patent litigation and the problem of so-called patent trolls.  However, after taking up and tabling legislation in March and April, Senator Patrick Leahy (D-VT), Chairman of the Senate Committee on the Judiciary, announced that he was taking the Patent Transparency and Improvements Act of 2013 (S. 1720) off the Committee's agenda because of a lack of "sufficient support behind any comprehensive deal."  Meanwhile, the tech sector continued to lobby for patent litigation reform.  Congress may take up patent reform again this year.

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

• "More Misinformation Regarding the Patent System and Non-Practicing Entities," December 18, 2014
• "Patent Litigation Reform -- Will the Outcome of the Mid-Term Elections Matter, and Is Reform Still Necessary?" October 30, 2014
• "Teva v. Sandoz -- Is Deferential Review a Boon for Patent Trolls?" October 14, 2014
• "House Tries One More Time: Targeting Rogue and Opaque Letters Act of 2014 ("TROL Act")," July 17, 2014
• "Patent Reform Legislation Off The Table -- For Now," May 21, 2014
• "Senate Judiciary Committee Tables Patent Reform, Again," April 3, 2014
• "Stopping Bad Legislation -- The Innovation Alliance Speaks Out," April 2, 2014
• "Stopping Bad Patents -- Senator Schumer Takes on the "Patent Trolls"," April 1, 2014
• "New York Times Op-Ed Argues Law Takes Misguided Approach to Software Patents," March 30, 2014
• "Senate Judiciary Committee Takes Up, Then Tables, Patent Reform," March 27, 2014
• "A Rebuttal to The Economist's "Stalking Trolls"," March 13, 2014
• "Senate Legislation Update -- The Commerce Committee Gets in the Act," March 5, 2014

8.  Courts and PTAB Deal with Fallout of Alice Corp. v. CLS Bank

In June, the Supreme Court issued its opinion Alice Corp. v. CLS Bank International, affirming the Federal Circuit's per curiam opinion in CLS Bank International v. Alice Corp. (stay tuned for more on that decision as we move closer to the top three stories of 2014).  However, the impact of the Supreme Court's Alice Corp. opinion on Federal Circuit and Patent Trial and Appeal Board decisions made it to #8 on the list.  Patent Docs covered nine such decisions during the second half of 2014, and in only one case (DDR Holdings, LLC) did the Federal Circuit conclude that computer-implemented claims survive a § 101 challenge.  Readers can look for more discussion of this top story, as well as the Supreme Court's Alice Corp. decision, during our live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015.

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

• "DDR Holdings, LLC v. Hotels.com, L.P. (Fed. Cir. 2014)," December 8, 2014
• "Ultramercial Inc. v. Hulu LLC (Fed. Cir. 2014)," November 16, 2014
• "Ultramercial Inc. v. Hulu LLC -- Party Briefs," November 6, 2014
• "Cambridge Assoc., LLC v. Capital Dynamics (PTAB 2014); PNC Bank v. Secure Axcess, LLC (PTAB 2014)," October 16, 2014
• "U.S. Bancorp v. Solutran, Inc. (PTAB 2014)," September 10, 2014
• "Planet Bingo, LLC v. VKGS LLC (Fed. Cir. 2014)," August 27, 2014
• "I/P Engine, Inc. v. AOL Inc. (Fed. Cir. 2014)," August 18, 2014
• "Stewart Title Guaranty Co. v. Segin Software, LLC (PTAB 2014)," July 23, 2014
• "Digitech Image Technologies, LLC v. Electronics For Imaging, Inc. (Fed. Cir. 2014)," July 14, 2014
• "Cyberfone Systems, LLC v. CNN Interactive Group, Inc. (Fed. Cir. 2014)," March 3, 2014
• "SmartGene, Inc. v. Advanced Biological Laboratories, SA (Fed. Cir. 2014)," January 29, 2014

7.  Supreme Court Addresses Fee Shifting Determinations in Exceptional Cases

In April, the Supreme Court issued opinions in Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc.  The issue in both cases centered on the attorney fee-shifting provision of 35 U.S.C. § 285.  In Octane Fitness, a mostly unanimous court held that "an 'exceptional' case is simply one that stands out from others with respect to the substantive strength of a party's litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated," the Court leaving the determination of whether a case is "exceptional" to the discretion of the District Court judge.  In Highmark, the Supreme Court determined that "an appellate court should apply an abuse-of-discretion standard in reviewing all aspects of a district court's §285 determination," even though "questions of law may in some cases be relevant to the §285 inquiry."  The Supreme Court's decisions make it easier for a trial court to shift fees to the non-prevailing party if it believes that the litigation was brought or conducted in an abusive manner, and also make it more difficult for an appellate court to overturn such a determination.

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

• ""Standing Out" -- A Closer Look at the "Exceptional Case" Standard Articulated in Octane Fitness," April 29, 2014
• "Patent Trolls Beware -- Supreme Court Issues Decisions in Octane Fitness and Highmark," April 29, 2014
• "Oral Arguments in the Supreme Court Octane Fitness, LLC v. ICON Health & Fitness, Inc. Case," February 27, 2014
• "Supreme Court to Hear Oral Arguments in Attorney Fee Shifting Cases," February 25, 2014
• "Supreme Court Preview -- Highmark Inc. v. Allcare Health Mgmt. Sys., Inc.," February 19, 2014
• "Supreme Court Preview -- Octane Fitness, LLC v. ICON Health & Fitness, Inc.," February 13, 2014

More Misinformation Regarding the Patent System and Non-Practicing Entities

By Michael Borella and Andrew Williams --

The press has been all too eager to decry the so-called "broken" U.S. patent system and the alleged "scourge" of non-practicing entities (NPEs).  However, few if any articles attempt to provide an even-handed analysis of these issues.  Recently, Jon Potter and Julie Samuels published a piece in Roll Call, urging Congress to pass comprehensive patent reform legislation to clamp down on NPEs, while James Bessen, in The Atlantic, lauded the Supreme Court's recent Alice Corp. v. CLS Bank Int'l decision for already having a deleterious impact on business method patents.  Samuels was formerly of the Electronic Frontier Foundation (EFF), a group with an anti-patent agenda.

The need for patent reform has arguably diminished.  Three decisions handed down by the Supreme Court last year, Alice, Octane Fitness, LLC v. Icon Health & Fitness, Inc., and Nautilus, Inc. v. Biosig Instruments, Inc., each addressed one of the alleged weakness in the patent system that so-called trolls are thought to exploit.  These cases have been credited for the drop in patent litigation seen since the end of the Court's last term.  Moreover, the Patent Trial and Appeals Board ("PTAB") has been accused of becoming a patent "death squad" because of the large number of inventions that it has recently found to be unpatentable.

These articles, therefore, appear to be desperate attempts to flame the anti-patent fervor that existed last year.  As we have come to expect, both articles present only one side of the story, and do not consider the negative consequences that further anti-NPE legislation could bring about, and that the Alice decision has already produced.  Further, the authors make unsupported assertions, draw questionable conclusions, and exhibit a profoundly flawed understanding of patent law.

For example, as with similar articles, the Potter and Samuels's article starts from the presupposition that "our patent system is out of balance," citing the Alice decision for support.  The unsuspecting reader will assume that this is a forgone conclusion.  Nevertheless, it is through their explanation of how this decision and proposed legislation are meant to "solve" the supposed crisis, the authors reveal a lack of understanding of the historical and philosophical basis of the patent system.

To that point, the authors equate "trolls" with NPEs (non-practicing entities).  The term NPE, however, encompasses all entities that do not manufacture products, including most universities, research institutions, and individual inventors.  Interestingly, Ms. Samuels's previous organization, the EFF, accused universities of fueling the patent troll problem.  Patent asserting organizations have been acknowledged by most, including the White House, to serve an important role as mediator between such NPEs and operating companies often necessary to commercialize inventions.  In fact, the United States' patent system purposefully encourages such actions by making patent property rights freely assignable and eschewing a "working" requirement.  This philosophy goes back to the framers of the Constitution, and allows the patent system to be accessible to everyone, not just those with abundant resources.

Potter and Samuels go on to assert, without citing any support, that NPEs "grievously injure innovators, bankrupt small companies, and waste judicial resources."  Yet, the current functioning patent system is essential to the business models of these same innovators and small companies.  Without patents, the innovations of a small software company can be easily reverse engineered and copied by larger players with more market clout, or foreign companies with lower overheads.  Trademarks, copyrights, and trade secrets do little to help in these situations.

In addition, the authors fail to consider the fact that these "innovators" and "small companies" (or any defendant in a patent litigation case for that matter), might actually infringe a valid patent.  If so, should they be allowed to freeload off the labor of others without penalty just because the patent at issue encompasses a business method or software, or happens to be owned by an NPE?

Bessen states that a recent the Government Accountability Office ("GAO") report "attributed 89 percent of the increase in patent litigation [in the 2007-2011 time frame] to software patents."  This report, however, conflated actual software patents and business method patents, collectively referring to both as "software patents."  In fact, the GAO found that "operating companies brought most of the patent infringement lawsuits from 2007 to 2011."  Additionally, the report indicated that the number of defendants in software and business method patent litigation increased 89 percent, but the number of lawsuits increased more modestly.  According to the report, the increase in the number of patent lawsuits in 2011 "was most likely influenced by the anticipation of changes in the 2011 Leahy-Smith America Invents Act (AIA), which made several significant changes to the U.S. patent system, including limiting the number of defendants in a lawsuit, causing some plaintiffs that would have previously filed a single lawsuit with multiple defendants to break the lawsuit into multiple lawsuits."

Of course, even if there was an increase in software patent litigation, it would have likely been a reflection of the increased importance of software in our everyday lives.  The 2007-2011 time frame tracks the rise of the smartphone and always-on computing, dramatic growth in social media, and a multimedia streaming revolution led by Netflix and YouTube, among other factors.  Like it or not, software is now an integral part of our personal and professional lives, as we carry our laptops, tablets, phones, e-readers, and digital fitness trackers with us whether we are going to work or on vacation.  An increase in the number of software patents granted, as well as an increase in software patent litigation, is a natural consequence of the ubiquity of software.

Certainly, no one is denying that there are bad actors that abuse the litigation system both with regard to intellectual property rights and otherwise.  However, elevating this minority of cases to be representative of the norm is not a reason to dispense with the entire system.  In fact, Bessen's methodologies for assessing the cost of so-called patent trolls have been called into question.  See, e.g., Schwartz & Kesan, Analyzing the Role of Non-Practicing Entities in the Patent System, Cornell Law Review, Vol. 99:2, pp. 425-56 (2014).  As a result, the implications that can be drawn from the data with regard to the impact of NPEs on the system are dubious at best.

With respect to the Alice decision, both sets of authors ignore the damage that this case has already caused to the patent system.  Under Alice, when determining whether a patent claim meets the statutory requirements for patent-eligibility, one must determine whether the claim is directed to a patent-ineligible law of nature, natural phenomenon, or abstract idea.  If so, then one determines whether any additional claim elements transform the claim into a patent-eligible application that amounts to significantly more than the ineligible concept itself.

This two-prong test has been widely criticized for its vagueness and subjectivity.  The Supreme Court refused to define what it meant by the term "abstract idea," leading to consternation among patentees, patent attorneys, and even federal judges.  For instance, Judge Wu of the United States District Court for the Central District of California criticized Alice for setting forth an "I know it when I see it" test.  Judge Pfaelzer, a colleague of Judge Wu, wrote that the Supreme Court's patent-eligibility cases "often confuse more than they clarify [and] appear to contradict each other on important issues."

The Supreme Court also blurred the lines between the assessment of patent-eligibility and other patentability requirements.  The patent law requires that, among other things, claims must be novel and non-obvious, as well as encompassing patent-eligible subject matter.  In 1981, the Supreme Court clarified that each of these inquiries were separate and distinct, and that it was "inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis."  Alice, as well as its 2012 predecessor case Mayo Collaborative Servs. v. Prometheus Labs., Inc., turned this notion around.  Now, when conducting a patentable subject matter review, claims can be analyzed element by element and compared to prior art.

As many commentators have articulated since the Mayo opinion was handed down, determining whether the breadth of a claim is appropriate is better served by conducting the well-understood and more objective and established analyses of novelty and obviousness.  Despite the lack of any suggestion from Congress that patent-eligibility is to be used for these purposes, the Supreme Court, now followed by the Federal Circuit, has made patentable subject matter a perverse weapon for the unsupported rejection and invalidation of claims.

The well-understood obviousness analysis asks whether the differences between the claimed invention and the prior art would have been obvious to one of ordinary skill in the art.  The Alice test, for a claim that incorporates a preexisting algorithm or a longstanding practice, inquires if the claim adds "significantly more" to that algorithm or practice.  The substantive difference between the two is that the obviousness test is grounded using prior art as a reference point for what is known, while the Alice test is not.  This eliminates much of the objectivity from the Alice analysis, putting thousands of patents in a state of legal uncertainty.  The "validity" of such patents may depend on which judge or panel conducts the test.

Bessen goes as far as to suggest that while the Alice decision is limiting the number of granted business method patents, it hasn't gone far enough to similarly limit software patents.  But why should we view patents in such sweeping terms, with the connotation that business method and software patents are inherently bad?  Patents are either valid or invalid, regardless of the technology claimed therein.

Furthermore, the implication that software should not warrant patent protection unfairly singles out one of the greatest drivers of the U.S. economy over the last forty years.  A major aspect of innovation is to make products and services faster, cheaper, and better.  The patent system is intended to incentivize individuals and organizations to publicly disclose such inventions, and as a result receive a limited exclusive-use property right thereover.  Despite contentions of the deleterious impact of a "broken" patent system on the software industry, the computer and information industry as a whole continues to grow, as evidenced by recent record-breaking stock values, billion-dollar acquisitions, and successful initial public offerings. A broad exclusion of computer-implemented inventions is illogical and disregards the fundamental tradeoff on which the system is based.

Graphic of troll (above) by JNL was modified (cropped) from a graphic available at the Wikipedia Commons, pursuant to the Free Art License.  Any use of the modified graphic is subject to the same license.

Dr. Cook-Deegan Brings the Medical Community Up to Date on the Myriad Case

By Kevin E. Noonan --

In an article in The Cancer Letter entitled "Robert Cook-Deegan's Viewers' Guide To the Super Bowl of Gene Patent Cases," Professor Robert Cook-Deegan (at right) of the Institute for Genome Sciences & Policy and Sanford School of Public Policy, Duke University provides his colleagues in the medical arts with an update on the progress of the Myriad case, specifically the several pending district court actions, now consolidated before Judge Robert Shelby in the District of Utah.  Continuing the pervasive presence of kitsch in everything Myriad (recall Judge Moore's disdain for Acting Solicitor General Katyal's "magic microscope on these grounds), Dr. Cook-Deegan analogizes patent litigation to a "blood sport," complete with analogies between hemorrhage and spilled ink/lost profits.  Dr. Cook-Deegan's focus is on Judge Shelby's recent denial of Myriad's preliminary injunction motion, as well as providing broad hints to the court and defendants regarding other legal avenues for attacking Myriad's patents.  Dr. Cook-Deegan is not a thoughtless partisan in this debate (indeed, he provided an insightful basis for invalidating Myriad's probe-and-primer claims based on traditional patent law concerns with novelty; see "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims"), but he has certainly taken a side.

The article starts with Judge Shelby's 106-page ruling; as with most articles on the Judge's decision its length is apparently a relevant supernumerary for the correctness of the Court's conclusion (brevity being the soul of wit but clearly not a hallmark of judicial acumen).  Dr. Cook-Deegan correctly points out that the Court understood that Myriad might in fact suffer irreparable harm to its BRCA gene testing franchise but that this likelihood was trumped by the Court's determination that Myriad was unlikely to prevail on its patent infringement claims.  Dr. Cook-Deegan characterizes the Court's assessment as being that "the claims to DNA molecules -- mainly to DNA primers used to amplify the DNA in its tests -- are in trouble; and the claims to methods are in very deep trouble."  He cites the Myriad franchise in BRCA gene testing as having generated $2.8 billion in revenues since 1996, and asserts that Myriad's "monopoly" on testing (it always a tell for a writer's opinion on patents to describe them as a monopoly) ended in June 2013 with the Supreme Court's decision in AMP v. Myriad Genetics.

Dr. Cook-Deegan (much like Judge Shelby in his opinion, one of the reasons it is 106 pages long) then follows with a synopsis of the Supreme Court's decision in the Myriad case, recognizing that Justice Thomas's opinion, while more straightforward than most of the Court's pronouncements on patent law did not produce "a map locating [the] Rubicon" between patent ineligible and patent eligible forms of DNA.  (This characterization is somewhat unfair to the Court's opinion; it seems clear that the Court decided that merely being synthetic in nature was not enough, but that the DNA sequence itself could not occur in nature.)  The article sets forth what has transpired since the Supreme Court's decision, specifically Myriad's activity in suing anyone offering a BRCA gene test and there being several potential or actual Myriad targets filing declaratory judgment actions against Myriad for invalidity based on the Supreme Court's decision.  This list includes Ambry Genetics, Gene-by-Gene, Ltd. (this defendant has since settled with Myriad); Quest Diagnostics; GeneDx; InVitae; Counsyl Genetics; and LabCorp.

Dr. Cook-Deegan notes that these lawsuits generally involve Myriad's assertion of several of the hundreds of claims remaining after the ACLU's suit against 7 claims of 15 patents.  The article questions why Myriad would sue in view of its track record before the Federal Circuit (as to some of its method claims) and the Supreme Court, and of course mentions Myriad's profits as a motive (recall that patents are intended to garner money damages upon infringement), and that the $10 million that Myriad purportedly "set aside" for patent litigation represents "one week's profits" from a purported $520 million in revenues (not profits) Myriad made "in its most recent fiscal year."  In fairness to Myriad, Dr. Cook-Deegan also acknowledges that the company thinks it will win, particularly because these lawsuits are more traditional patent infringement actions and very different from the "court of public opinion" that the ACLU manipulated so expertly in the AMP case.  But he also correctly notes that Judge Shelby's ruling on Myriad's preliminary injunction motion has changed the odds against Myriad, returning to the sports theme by drawing an analogy with the Denver Broncos recent unsuccessful experience in the Meadowlands relating to meeting a strong offense with a strong defense.  This section of the article ends by noting that up until now the issue has been one of patent eligibility, and there may be other grounds for attacking Myriad's claims that may be raised in the pending lawsuits.

At this point the article veers more closely to advocacy, with Dr. Cook-Deegan making a case for invalidating Myriad's claims to the BRCA2 gene (and any that depend, logically or legally, on Myriad's claim to having invented the isolated form of this gene) based in Section 102(g) of the (1952) Patent Act.  This section can be used to invalidate a claim if the claimed invention was made prior to the patentee's making of the invention by a first inventor who did not "abandon, suppress or conceal" the invention.  This argument involves factual issues from the time during which several laboratories, including those of Mark Skolnick (Myriad's inventor) and Mary-Claire King in Seattle, were trying to identify human genes that were involved with an increased propensity for breast and ovarian cancer.  Dr. Cook-Deegan, citing Kevin Davies's book Breakthrough, concedes that the Skolnick lab "won" the race to isolate the BRCA1 gene.  The situation is different for BRCA2, according to Dr. Cook-Deegan, and he lays out in detail the "case" for third party invention of BRCA2.

According to this article, a British group, led by Michael Stratton, first provided linkage analysis data showing the gene now know as BRCA2 resided on human chromosome 13 in 1994.  As it turned out, Myriad filed its BRCA2 patent application three days before Dr. Stratton announced his team's discovery of BRCA2 in the scientific journal Nature.  In a sentence no doubt intended to illustrate the frenzied nature of the scientific race for BRCA2 (but that also seems to imply Myriad-associated shenanigans), Dr. Cook-Deegan asserts that "[t]he scientific scuttlebutt has long been that Myriad scientists learned of the pending publication and filed just in time.  But was it really in time?"  This quasi-allegation is followed by a timeline of events as follows:

The Stratton group, working with Andrew Futreal of Duke, filed a UK patent application on BRCA2 on November 23, 1995 (UK patent 2,307,477 was published on May 28, 1997).  The Stratton team submitted their BRCA2 paper on December 5.  Stratton's UK patent application was thus filed almost a month before Myriad's US application for BRCA2, and the Myriad/Utah team did not publish on BRCA2 until March 1996, three months after Stratton's team.  The Stratton team also got a US patent (6,045,997).  That patent was allowed to lapse when the first maintenance fee was due, but the US patent and patents in 18 other jurisdictions do establish a presumption of priority from Stratton's UK patent.

The plot spun in the article thickens, Dr. Cook-Deegan stating (correctly) that the U.S. Patent and Trademark Office is precluded from granting patents on the same invention (stated in the article slightly differently, that the Office is "not supposed to grant overlapping claims").  He also notes that the Office did not declare an interference proceeding, the way that priority disputes between separate inventors were resolved under the previous "first to invent" patent regime (that changed with the enactment of the Leahy-Smith America Invents Act).  He then states tantalizingly that "[t]he current litigation could finally bring to light the documents that would establish who knew what when, both who made the discovery and who deserves any patent rights on which mutations and the wild type sequence of BRCA1 and BRCA2."  The reader will be excused if she gets the impression that Dr. Cook-Deegan fervently wishes this eventuality to come to pass (and who he thinks will turn out to be the first inventor).

The article then turns to the question of whether Myriad's primer (and probe) claims satisfy the requirements of 35 U.S.C. § 101.  Much of this section of the article unfortunately relates to the recently issued Guidelines from the U.S. Patent and Trademark Office regarding patent eligibility in view of the Supreme Court's Mayo v. Prometheus and Myriad decisions.  While it is true that Judge Shelby's decision was made in consideration of these Guidelines, they do not have the force of law and represent merely how the Office (for now) is interpreting the Supreme Court's decisions.  They are certainly relevant to how claims in pending applications are being examined; they are of dubious relevance to the legal question of where the Court drew the line with regard to the patent eligibility of DNA primers and probes.

The article then discusses whether Myriad's primer and probe claims satisfy the written description and enablement requirements of Section 112.  The grounds for this challenge are that Myriad uses primers that flank BRCA gene exons and thus fall outside the scope of the claims reciting primers and probes that are fragments of BRCA cDNA (in view of the fact that these primers and probes are not expressly described in the BRCA gene patent specifications).  This argument seems to conflate whether these primers fall within the scope of Myriad's claims (and thus that construing the claims to so include these sequences may render them invalid for lack of descriptive support) and whether the practice of BRCA gene diagnostic testing by others using these non-exonic primers and probes would infringe Myriad's primer claims insofar as they are properly cabined within the confines of exonic sequences.  But Dr. Cook-Deegan is correct when he states that the validity vel non of these claims may depend on how they are ultimately construed by the District Court.

The article also focuses on claim 6 of U.S. Patent No. 5,747,282 which is not directed to DNA amplification methods and that would doubtless "capture" genomic DNA molecules clearly invalidated by the Supreme Court in Myriad.  These are also the types of molecules Dr. Cook-Deegan and colleagues showed to be invalid under 35 U.S.C. § 102, and the article briefly reviews the scientific basis for this conclusion.

Dr. Cook-Deegan further attempts to implicate the government's rights in the BRCA genes (stemming from National Institute of Health support for the basic genetic research underlying discovery of the BRCA genes).  It is worth noting that the "march-in rights" he cites as part of the Bayh-Dole Act have been available for the entirety of the time Myriad has held and threatened to assert its BRCA gene patents, and that the government has never used these march-in rights under any circumstances (although, famously, the government threatened to do so regarding the availability of the antibiotic Cipro in the wake of the anthrax scare after the terrorist attacks on September 11, 2001).  And it is further worth noting that the government has not acted even in the face of calls by Senators to do so after Myriad filed its lawsuits against BRCA genetic diagnostic test providers in the wake of the Supreme Court's decision invalidating some (but not all) of its claims.  Here, Dr. Cook-Deegan invokes not only Bayh-Dole but the Stevenson-Wydler Act (relating to rights in inventions made in government laboratories), as well as assorted misfeasances by Myriad having to do with reporting and other requirements with regard to whether the government can and should act.  And in this regard Dr. Cook-Deegan cites the knowledge (and possible testimony) of Dr. Andrew Futreal, who the article describes as:

[A] pivotal figure in understanding the discovery process in court proceedings.  He was a coauthor and co-inventor on the Myriad/Utah team that first characterized BRCA1 when he was at NIEHS, and then coauthor and coinventor on the Stratton papers and patents that first reported BRCA2.  . . .  He is thus the only person who was coauthor and coinventor for the first papers and patents for both BRCA1 and BRCA2.

In view of these assertions, it is surprising that the article doesn't supply defendants' counsel with Dr. Futreal's address.

Finally, Dr. Cook-Deegan points his readers (and defendants' counsel) to Myriad's litigation against OncorMed in 1997 over U.S. Patent No. 5,654,155, one of the patents Myriad is now asserting but that it attempted to invalidate in the prior litigation.  Dr. Cook-Deegan presents no information about any relevant evidence from this earlier litigation, but speculates that "[t]he 1997 litigation may have left a paper trail that the discovery process will unearth" because "[c]laims in the OncorMed patents were likely to be revoked or considerably weakened in 1997, and they are no more likely to be robust and enforceable now."

Finally, after noting more putative evidence of Myriad's bad behavior (here, with regard to "hoarding" its BRCA gene mutation database as a trade secret, complete with reference to "tart words" from Judge Shelby in dicta from his preliminary injunction decision), Dr. Cook-Deegan confesses that:

The historian in me wants this to go to court so we can learn what happened two decades ago.  Litigation is very costly, however, and the trial and appeals process is protracted, saps management attention, and poses recurrent decisions about whether and how to proceed further.  Moreover, litigation is a very expensive and not entirely reliable way to document historical events.  No one predicted a safety on the first play from scrimmage in the Super Bowl; any number of outcomes can still emerge from the litigation over BRCA1 and BRCA2.  The business models that emerge, however, are likely to entail more competition than Myriad's unitary genetic testing service that prevailed 1996-2013.

Perhaps.

New York Times Op-Ed Argues Law Takes Misguided Approach to Software Patents

By Michael Borella --

On March 28, Professor Robin Feldman of the University of California Hastings College of Law wrote an op-ed piece in the New York Times entitled "Slowing the Patent Trolls".  Unfortunately, like so many articles of its ilk, Professor Feldman's offering uses misleading hypotheticals and unsupported assertions to allege that the mere existence of software patents is allowing the so-called trolls to harm our economy.

Ostensibly written in anticipation of Monday's Alice v. CLS Bank oral arguments scheduled to be heard by the Supreme Court, Professor Feldman writes that the case "offers the court an opportunity to resolve two decades of economically harmful confusion over how the law grants patent protection to computer software."  Professor Feldman, however, seems to be focused not on the specific facts that lead to the Court's review of Alice's patents, but instead on her erroneous belief that software patents are, by their very nature, too broad.

She immediately starts off on the wrong foot by stating that "[s]ince the mid-1990s the software patent system has operated by its own rules . . . compared with patents for other innovations, those for software are granted using a very broad and lax standard of invention."  This is untrue, even as an opinion.  There certainly are specific rules regarding computer-implemented inventions, particularly with regard to subject-matter eligibility (see, e.g., the USPTO's post-Bilski and post-Mayo examination guidelines).  Additionally, several well-known Federal Circuit cases have resulted in the requirement that, for inventions that operate on a general-purpose computer claimed in means-plus-function format, the specification must provide an algorithm that performs the claimed functions (see, e.g., M.P.E.P. 2181(II)(B) for an overview of the case law).

If anything, computer-implemented inventions are held to a higher standard than most other types of inventions due to these additional requirements.  Rather than acknowledging that the computing arts have been singled out in this fashion, Professor Feldman contends that "[o]rdinarily, the law requires inventors to explain not just the result of an invention, but also how the invention actually works.  If you invent a car that drives on water, you have to explain exactly how you get it to stay afloat.  Not so for software: the mere idea of a floating car is enough."

This statement is a misrepresentation of the law.  If Professor Feldman can cite to an issued patent that claims software for a flying car but does not disclosed how the invention works, I will happily join her in condemning that specific patent for being vague and overly broad.  But even if such a patent comes to light, Professor Feldman's statement is yet another example of the hyperbole that is drowning out reason in an otherwise important debate.

Surely, not all patent applications that claim software should be allowed.  Some claims will be anticipated, obvious, or vague.  But this analysis is currently carried out on a case-by-case basis by USPTO examiners who apply the guidelines cited above, as well as a comparison of the claims to prior art.  Professor Feldman's flying car hypothetical would simply not pass muster under the existing examination standards.

Professor Feldman provides another hypothetical about a "software program to assess the riskiness of a driver for car-insurance purposes . . . based on how much the person texts while driving, combined with other risk indicators."  She adds that "[u]nder the current software patenting paradigm, providing the description above without much more could be enough to merit protection."  As discussed above, this notion is unsupported by the facts.

Regardless, she proposes that if one were to "specify the particular inputs used -- texting frequency, credit score, hobbies, driving history -- along with the weights and multipliers and software approach used to produce the risk score" the resulting invention would be patent-eligible.  Maybe.  The problem with approaching the topic of patentable subject matter at such a high level of abstraction is that patentability decisions are made based on the specific language of the claims when read in light of the invention as disclosed in the specification.  Hypotheticals may be useful thought exercises, but patent eligibility decisions must be made based on facts and the law.

Now turning briefly to her patent troll contentions -- Professor Feldman fails to acknowledge that the United States' patent system purposefully encourages the existence of non-practicing entities by making patent property rights freely assignable and eschewing a "working" requirement.  This is thought to help make the patent system accessible to those without abundant resources.  Indeed, public universities, such as the one that employs Professor Feldman, are permitted to acquire and hold patents related to the inventions fostered by research conducted under their auspices.  Further, as we have pointed out recently, calculations of the supposed harm due to such non-practicing entities are questionable at best.

The issues of patent-eligible subject matter and patent "trolls" are neither simple nor black-and-white.  There is a need for a rich, informed public discourse regarding both.  But this discourse is not aided by drawing questionable conclusions from an incomplete view of patent law.

A Rebuttal to The Economist's "Stalking Trolls"

By Michael Borella and Andrew Williams --

On March 8th, The Economist published an article deriding both so-called "patent trolls" and "software patents" as being impediments to innovation in the United States.  Unfortunately, as we have seen all too often when the mainstream media discusses the patent system, the article contains unsupported assertions, draws questionable conclusions, and displays a profoundly flawed understanding of patent law.  Such commentary is particularly troublesome in this case because of the wide circulation of this periodical.

At the outset, the article contains a proclamation that the United States' patent system is "dysfunctional," suggesting this fact is a forgone conclusion to the uninformed reader.  Nevertheless, in explaining how the reported developments are meant to "solve" this supposed crisis, the author reveals his unfamiliarity with the philosophical basis of the patent system in this country.  For example, the article equates non-practicing entities ("NPE") with "trolls."  The term "NPE," however, encompasses all entities that do not manufacture products, including most universities, research institutions, and individual inventors.  Even the reviled "patent assertion entities" have been acknowledged by most to serve an important role as mediator between such NPEs and operating companies often necessary to commercialize inventions.  In fact, the United States' system purposefully encourages such actions by making patent property rights freely assignable and eschewing a "working" requirement.  This is thought to help make the system accessible to everyone, not just those with abundant resources.

Certainly, no one is denying that there are actors that abuse the litigation system in this country, both with regard to intellectual property rights and otherwise.  However, elevating this minority of cases to be representative of the norm is simply unproductive.  So is the dissemination of questionable statistics.  For example, the article states as fact that patent "trolls" cost U.S. companies $29 billion in 2011.  It is presumed that the author is referring to the research of James Bessen and Michael J. Meurer, which has come under recent scrutiny because of the particular methodology used.  See, e.g., Schwartz & Kesan, Analyzing the Role of Non-Practicing Entities in the Patent System, Cornell Law Review, Vol. 99:2, pp. 425-56 (2014).  As a result, the implications that can be drawn from the data with regard to the impact of "trolls" on the system are questionable at best.

Moreover, the article's description of the patentability requirements in the United States also betrays the author's lack of understanding of the topic.  With regard to patentable subject matter, the article uses "boiling water to make tea" as an example of a "common idea" which certainly must be a law of nature, natural phenomenon, or abstract idea.  However, not only is this example not apropos, but it actually supports the counterpoint.  Heating water itself might occur in nature, but the application of that "natural" process to "make tea" does not.  And, even though people were certainly brewing tea before the United States' patent system was formed, does this mean Keurig was undeserving of a patent to its K-cups, which were essentially a new way to make tea?

Even worse, to support the allegation that the United States is issuing non-novel and obvious patents, the article mentions a single patent directed to "upgrading computer software over the internet."  Noticeably missing, however, was the patent number, title, inventor(s), and date of filing, without which it is impossible to determine just what would qualify as prior art.  The article appears to be referencing U.S Patent No. 5,771,354, which was the subject of a This American Life episode in 2013 ("When Patents Attack . . . Part Two!").  If so, contrary to the suggestion in the article, the invention claimed in that patent dated back to the early 1990s, and was ultimately found to be invalid by a jury not because the invention was being practiced in the prior art, but because the correct inventors were not listed on the patent.

Nonetheless, the reference to the "computer software upgrade" patent is yet another example of how the media mistakenly characterizes a patented invention in a few short words, rather than by the patent's allowed claims.  While gospel to patent attorneys, the well-established principle that "the claims define the invention" gets little attention elsewhere.  Instead, it is easy for a commentator to read the patent's title, abstract, part of its summary, or a few of its drawings, and then provide an over-simplified synopsis of what the patent allegedly covers.  Such an interpretation is not in accordance with U.S. patent law, where special court hearings are used during litigation for the sole purpose of defining the scope of asserted claims.  Simply put, one cannot determine what a patent actually protects by attempting to determine the "gist" of the invention from the specification -- a careful evaluation of the claims is required.

This type of fundamentally flawed analysis is often directed to software and business method patents.  Never mind that neither type of patent is actually defined by the author, or that many patents purportedly directed to either of these technologies explicitly claim computer hardware or other types of physical devices carrying out, or being impacted by, the steps of a method claim.  Perhaps software in particular is an easy target for such bullying, because it is less tangible than say, a cotton gin or a light bulb, and often operates invisibly.

However, the implication that software is too abstract to warrant patent protection unfairly singles out one of the greatest drivers of the U.S. economy over the last forty years.  A major aspect of innovation is to make products and services faster, cheaper, and better.  The patent system is intended to incentivize individuals and organizations to publicly disclose such inventions, and as a result receive a limited property right thereover.  Despite contentions of the deleterious impact of a "broken" patent system on the software industry, the computer and information industry as a whole continues to grow, as evidenced by recent record-breaking stock values, billion-dollar acquisitions, and successful initial public offerings.  A broad exclusion of computer-implemented inventions is illogical and disregards the fundamental tradeoff on which the system is based.  A ban on software patents would make as much sense as, for example, barring any invention that uses plastic from being patented.

To the extent that criticism of the patent system might be warranted, the notion that software and business methods should be unpatentable per se is gross overreaction.  In addition to having to meet the patent-eligibility bar for subject matter, a claimed invention must also be novel, non-obvious, and described in such a way that it can be practiced by one of ordinary skill in the art.  The inventions of Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank have only been analyzed for validity under the subject matter rubric.  In these cases, the Supreme Court has applied (or in the case of CLS Bank, is being asked to apply) the blunt knife of subject matter eligibility rather than the more incisive tools of novelty and obviousness.

As noted by the Court in 1980's Diamond v. Diehr, "[t]he 'novelty' of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within [patentable subject matter]."  This understanding was in accordance with that of Judge Giles Rich, coauthor of the 1952 Patent Statute, who wrote "[a]chieving the ultimate goal of a patent [requires] having the separate keys to open in succession the three doors of [patentable subject matter, novelty, and non-obviousness]."

The Court's recent Mayo decision has been roundly criticized for combining considerations of novelty and obviousness into the patent-eligibility inquiry in a way that requires determining the "gist" of the invention.  Consequently, Mayo runs counter to the statute, the Court's own precedent, and well-established practices of claim interpretation.  And yet, Mayo may be the standard under which CLS Bank is decided.  The problem lies not in the topic of these patents, but in the inherent subjectivity of the Mayo analysis.  The fractured, six-opinion Federal Circuit ruling in CLS Bank demonstrates that ten federal judges, who are experts in patent law, could not agree how Mayo should be applied.

Surely, not all patent applications that claim software or business methods should be allowed.  Some will be too broad, obvious, or vague.  But this analysis is best carried out on a case-by-case basis by well-educated USPTO examiners who apply workable and reasonably objective standards.

The article ends with yet another oft-asserted falsehood -- that copyright would be a "perfectly adequate means of protecting and rewarding software developers for their ingenuity."  Copyright does not protect inventions -- it protects expressions of ideas.  In the case of software, this would be the source or object code itself.  If software innovators were required to rely on the weak protection that copyright provides, the computer industry would become rife with clean-room copyists who misappropriate the ideas behind innovative software by developing cloned applications.  And the so-called "trolls" are supposed to be a drain on the economy?

Top Stories of 2013: #7 to #10

By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories.  For 2013, we identified fourteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  Yesterday, we counted down stories #14 to #11, and today we count down stories #10 to #7 as we work our way towards the top three stories of 2013.  As with our other lists (2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT).  Details regarding the webinar can be found here.

10.  Myriad Asserts Patents Against Diagnostics Companies

Less than one month after the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., holding that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, Myriad filed suit against Ambry Genetics, Corp. for infringement of ten patents relating to genetic diagnostic testing.  Ambry Genetics had been one of the first companies to announce that it would provide genetic diagnostic testing for the BRCA 1 and BRCA 2 genes following the Supreme Court's decision.  Since Myriad filed suit against Ambry, it has followed with suits against Gene-by-Gene, Quest, GeneDx, Invitae, and LabCorp.  The accused infringers have not sat idly by, with both Quest and Invitae filing declaratory judgment actions against Myriad (Counsyl has also filed a declaratory judgment action against Myriad).  Myriad has also expanded its suit against certain defendants to encompass claims directed to colon cancer predictive genetic diagnostic testing.  The lawsuits show that Myriad is serious about protecting its intellectual property, including more than its BRCA tests, and may have decided it has much more to lose than the company's patents scheduled to expire over the next few years.  Sixteen years of patent exclusivity have certainly provided Myriad with the motivation and the economic means to protect its franchise, but this story will have to wait until at least 2014 for an ending.

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

• " Invitae Files Motion to Dismiss for Lack of Personal Jurisdiction in Myriad Genetics v. Invitae Corp.," December 11, 2013
• " Myriad Genetics Sues LabCorp over BRCA Gene Testing," December 4, 2013
• " Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back," November 27, 2013
• "Where Do We Stand?" October 31, 2013
• "Defendants' Oppose Myriad's Motions to Dismiss Antitrust Counterclaims," October 28, 2013
• "Myriad Genetics Files Amended Complaint Relating to Colon Cancer Genetic Diagnostic Testing," October 23, 2013
• "Myriad Genetics Sues Quest for Patent Infringement," October 22, 2013
• "Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents," October 21, 2013
• "Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics," October 13, 2013
• "Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics," October 10, 2013
• "Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies," October 9, 2013
• "Defendants' Response to Myriad's Preliminary Injunction Motions," September 19, 2013
• "Myriad Moves to Dismiss Ambry's Antitrust Counterclaims on Noerr-Pennington Doctrine," August 28, 2013
• "Amici Submit Brief in Support of Ambry Genetics and Gene by Gene," August 27, 2013
• "Ambry Responds to Myriad Lawsuit," August 7, 2013
• "Why Does Myriad Think It Can Win BRCA Gene Lawsuits?" July 30, 2013
• "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes," July 10, 2013
• "Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes," July 9, 2013

9.  District Court Finds Prenatal Diagnostic Method Not Patent Eligible; Alternatives to Method Not "Commercially Viable"

On October 30, Judge Susan Illston of the Northern District of California granted summary judgment to declaratory judgment plaintiff Ariosa Diagnostics Inc. in Ariosa Diagnostics v. Sequenom.  In a case on remand from the federal Circuit, and involving claims directed to non-invasive prenatal diagnosis of sex determination, blood typing, other genetic disorders, and detection of pre-eclampsia, using a simple blood test that reduces or eliminates the need for amniocentesis and chorionic villus sampling (which incur risks to both mother and child), the District Court determined that the asserted claims were not drawn to patent eligible subject matter because paternally inherited cffDNA is a natural phenomenon and the asserted claims merely add well-understood, routine, conventional activity in the field to that natural phenomenon.  With respect to the issue of preemption, the District Court noted that "[b]ecause generally one must be able to find a natural phenomenon to use it and apply it, claims covering the only commercially viable way of detecting that phenomenon do carry a substantial risk of preempting all practical uses of it."  The District Court therefore agreed with Ariosa's argument that the alternative methods for detecting cffDNA that Sequenom presented were not practical and commercially viable.  Life sciences patent practitioners will be following this case closely in 2014.

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

• " Patent Eligible Subject Matter in the District Courts: Ariosa Genetics v. Sequenom (N.D. Cal. 2013)," November 5, 2013

8.  Media and Congress Combat Patent Trolls

Only months after the final provisions of the Leahy-Smith America Invents Act were implemented, Congress deemed it necessary to propose further reforms to U.S. patent law.  The outcries last year stemmed from the apparent proliferation of "Patent Trolls," also known by the less derogatory term Patent Assertion Entities (or PAEs), and their alleged penchant of engaging in abusive patent litigation.  The mainstream media, as exemplified by National Public radio (NPR), focused on the Patent Troll problem, and Congress, perhaps swayed by the media's focus, started introducing a number of bills intended to remedy the problem.  The bill at the forefront of the discussion has been H.R. 3309, which was introduced by Rep. Bob Goodlatte (R-VA), and which the House passed in early December.  The Senate is now working on its own bills to curb PAE abuse, and given the speed with which the House passed H.R. 3309, there is a possibility that legislation may be presented to the President sometime in 2014.

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

• "Senate Judiciary Committee Holds Hearing on 'Protecting Small Businesses and Promoting Innovation by Limiting Patent Troll Abuse'," December 23, 2013
• "Reaction to the Passage of the Innovation Act (H.R. 3309)," December 9, 2013
• "Innovation Act Passed By House -- A Closer Examination," December 5, 2013
• "House Passes H.R. 3309 (Innovation Act)," December 5, 2013
• "'Non-Practicing Lawmakers' -- The Mark-up of H.R. 3309 (Innovation Act)," November 27, 2013
• "The Futility of Petitioning Congress (After the Fix Is In): Stakeholders Tell Judiciary Committee What's Wrong with Goodlatte Bill (H.R. 3309)," November 21, 2013
• "Yet Another 'Patent-Troll' Bill – Senator Leahy Introduces Patent Transparency and Improvements Act," November 20, 2013
• "When NPR Podcasters Hit the Patent System – An Update," November 12, 2013
• "Trolls Better Watch Out This Halloween -- Senator Hatch Introduces Patent Litigation Integrity Act," October 30, 2013
• "House Judiciary Committee Holds Hearing on Innovation Act," October 29, 2013
• "Rep. Goodlatte Introduces 'Innovation Act" to Combat Patent Trolls," October 23, 2013
• "Rep. Goodlatte Introduces Second "Discussion Draft" of Legislation Aimed at Curbing "Abusive Patent Litigation"," September 24, 2013
• "The War on Patent Trolls -- Congress Prepares for Battle," September 18, 2013
• "The GAO Issues a Report on Patent Litigation Trends -- It Turns Out that the Sky Is Not Falling," August 29, 2013
• "In Defense of the Patent System: How the Mainstream Media's Representation of it is "Broken"," July 31, 2013
• "New Patent Litigation Bill Introduced in House," July 16, 2013
• "When NPR Podcasters Hit the Patent System," June 12, 2013
• "Congress Continues Efforts to 'Reform' U.S. Patent Law," June 10, 2013
• "'When the Patent System is Attacked!' -- The White House Task Force on High-Tech Patent Issues," June 4, 2013

7.  EPO Removes Time Limit for Filing Divisional Applications

In August, word started to leak out that the European Patent Office (EPO) would be removing the current two-year time limit for filing divisional applications.  By October, reports indicated that the administrative council of the EPO had voted to amend Rule 36 EPC to remove the controversial 24-month time limit within which European divisional applications may be filed, with the sole criterion set forth in amended Rule 36(1) EPC being that the application to be divided still be pending.  In practice this means that any case that is not granted or finally refused can be divided once the new rule comes into force.  The amended rule is set to come into force on April 1, 2014.  While rules changes are frequently met with trepidation, this rule change will no doubt be welcomed by patent practitioners and applicants prosecuting applications before the EPO.

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

• " News from Abroad: EPO to Rescind Deadline for Filing Divisional Patent Applications," October 17, 2013
• " News from Abroad: EPO Proposal Would Remove Time Limit for Divisional Filing," September 13, 2013

When NPR Podcasters Hit the Patent System – An Update

By Andrew Williams --

In May of this year, the NPR podcast "Planet Money" released an episode entitled "When Patents Hit the Podcast."  At that time, we reported on this podcast, and the misconceptions of the patent system that the show perpetuated (see "When NPR Podcasters Hit the Patent System").  NPR rebroadcast the episode last week, including an update related to the podcasting patent that was featured in that show, owned by Personal Audio LLC ("Personal Audio").  Even though that patent does not deal with the Biotech or Pharmaceutical industry, the criticisms that the show levied against the patent system affect all patents.  Therefore, an update of our story seemed appropriate.

As suggested, the majority of the Podcast was a straight repeat of the earlier show.  One of the updates provided was a description of the recently introduced patent-reform legislation.  The only other update was a report that, as Planet Money host Zoe Chace put it, the Electronic Frontier Foundation ("EFF") recently filed "a complaint" with the Patent Office saying that the podcast patent "should not exist."  The EFF is an organization that describes itself as a "donor-funded nonprofit" that "has championed the public interest in every critical battle affecting digital rights."  The originally aired episode explained that the EFF was seeking to invalidate this patent at the United States Patent Office.  The EFF has now filed a petition for inter partes review of U.S. Patent No. 8,112,504 ("System for Dissmeinating Media Content Representing Episodes in a Serialized Sequence"), the so-called podcasting patent.  Interestingly, the EFF basically crowd-sourced both the cost of filing the petition, and the technological substance found within the petition.  A link can still be found on the EFF website for the "Save Podcasting" donation page, on which it is reported that the original goal of $30,000 was met in under 10 hours.  The website solicited donations at levels from its Silicon/Student Member ($25) to as high as its Super Major Donor ($2,500).  The site reports having received $76,890 to date, although it does not indicate what it will do with the excess money, other than its work to "stop trolls and stupid patents for good."

With regard to the art cited in the petition, the EFF appears to have crowd-sourced this information also.  The EFF website contains a link labeled "Prior Art," which opens an "Ask Patents" webpage requesting help to "bust a patent being asserted against podcasting."  Claim 31, the claim that has been asserted against several podcasters, reads as follows:

13. Apparatus for acquiring and reproducing media files representing episodes in a series of episodes as said episodes become available, said apparatus comprising: a digital memory, a communications port coupled to the Internet for transmitting data requests for data identified by specified URLs, for receiving downloaded data identified by said URLs in response to said requests, and for storing said downloaded data in said digital memory, and a processor coupled to said digital memory and to said communications port for executing one or more utility programs for: performing, from time to time, one of a sequence of update operations, each of said update operations comprising: downloading via the Internet the current version of a compilation file identified by a predetermined known URL, and storing attribute data contained in said current version of said compilation file in said digital memory, said attribute data describing one or more episodes in a series of episodes, said attribute data for each given one of said episodes including one or more episode URLs identifying one or more corresponding media files representing said given one of said episodes, accepting a selection of a particular episode described by attribute data stored in said digital memory by the operator of said apparatus, downloading and storing the particular media file identified by an episode URL included in the attribute data for said particular episode if said particular media file is not already stored in said digital memory, and reproducing said particular media file in a form perceptible to said operator.

This patent claims priority back to October 2, 1996.  The Planet Money hosts noted that Personal Audio originally distributed magazine content via audio tapes.  They joked, therefore, that the patent could be invalidated by any teenager in the 1980s that created a mixed tape.  Clearly, such a tape would not invalidate the above claim (which speaks volumes regarding the patent sophistication of the Planet Money reporters).  The EFF, on the other hand, has an understanding of the patent system, even if they are skeptical of it.  They requested on the webpage "prior art that describes accessing a series of media files organized as episodes, tracks, installments, or the like, through the use of "compilation" data that (a) available to be downloaded by a client device, and (b) updated to describe the media files that are currently available."  To date, they received 107 answers.

The inter partes review petition for the '504 patent references three different prior art "publications" that were alleged to anticipate or render obvious at least claims 31-35 of the patent.  The first piece of prior art included was the "Geek of the Week" Internet talk radio show.  The first two grounds referenced in the petition were (1) the website www.ncsa.uiuc.edu/radio/radio.html, appearing on April 22, 1993, and (2) the April 22, 1993 edition of the SurfPunk Technical Journal.  These "publications" were cited as 35 U.S.C. § 102(b) prior art.  The first of these publications was one of the webpages for the "Geek of the Week" Internet talk radio show.  The SurfPunk Technical Journal publication, on the other hand, republished the "Geek of the Week" webpage as it existed on April 22, 1993.  The petition also included a third ground for invalidity related to the Geek of the Week publications themselves.  In an abundance of caution, the EFF alleged that the Geek of the Week publications collectively contained all of the limitations, and therefore rendered the claims 31-35 obvious.  To help provide some context of these early "podcasts," the Planet Money updated episode contained some of the audio from these early "Geek of the Week" shows.

The second prior art reference was a Canadian Broadcasting Corporation ("CBC") Radio Article, which appeared on January 1, 1996, and which described an Internet radio trial that was available on demand beginning in December 1993.  This article allegedly described the "availability of regularly-updated episodic radio programs on a web page at a predetermined location."  This was cited as 35 U.S.C. § 102(a) prior art.  Finally, the third prior art publication was the "Internet CNN Newsroom," which was a master's thesis submitted to MIT in May 1995, and made available on August 10, 1995.  Apparently the limitation of an "updated" compilation file was missing from the publication, but the EFF alleged that such a file would have been an obvious design choice.

We take no position on the merits of this inter partes review petition, but we will continue to monitor its progress.  As we noted at the time, such a proceeding is a completely legitimate mechanism to address these so-call "bad" patents that people consider to be overbroad.  It would appear that if the EFF's characterization of these prior art publications is correct, even if they do not serve to invalidate the claims, it is a distinct possible that the claims will be narrowed such that Personal Audio will no longer be able to assert them against podcasters.  This is because the cited art appears to be similar to the same activity that gave rise to the demand letters and infringement lawsuits (such as the dissemination of podcasts like Marc Maron's WTF podcast and "The Adam Carolla Show").  Of course, we have not yet heard from Personal Audio, because they have filed no response yet with the Patent Office.  Nevertheless, it would not be surprising if Personal Audio was able to identify some distinction between their claims and these Internet radio shows from years earlier.

In Defense of the Federal Circuit: A Response to Judge Wood

By Edward Reines --

Edward Reines (at right), a partner at Weil, Gotshal & Manges, frequently argues before the Federal Circuit and is chair of the court's Advisory Council.  Prepared remarks for Judge Wood's Sept. 26 talk at the Illinois Institute of Technology Chicago-Kent College of Law can be downloaded here.

The Chief Judge of the U.S. Court of Appeals for the Seventh Circuit, Diane Wood, recently delivered a speech provocatively titled "Is It Time to Abolish the Federal Circuit's Exclusive Jurisdiction in Patent Cases?"  While it is trendy to criticize the patent system, Judge Wood's prominence and her colorful critique have raised eyebrows.  Frequently mentioned as a potential Supreme Court nominee, Judge Wood's far-reaching proposal deserves close consideration -- and honest rebuttal.

The judge's focus on the Federal Circuit is understandable.  Although historically patent law was considered an esoteric backwater, it is now recognized as a dynamic legal field involving fascinating subjects and great financial stakes.  Our world is filled with amazing new inventions that improve the way we work, how we are entertained, and our healthcare.  Patent appeals now attract the finest advocates and garner national media attention.  In many ways, the Federal Circuit's patent docket has become the envy of the system.

Judge Wood did not mince words in advancing her proposal to redistribute patent appeals back to the regional circuits.  In her live remarks, she critiqued the Federal Circuit for a lack of "intellectual ferment," highlighted the frequency of Supreme Court review, and described the court as too "specialist."  She proposed a dual jurisdiction system, allowing appellants to elect between the Federal Circuit and the regional circuits, with the Judicial Panel on Multidistrict Litigation resolving conflicts by lottery.

The meteoric rise of technology, to be sure, has tested the patent system.  The Patent Office's inability to cope with the deluge of applications is well documented.  Patent assertion abuses, especially by so-called trolls, plague the system.  But are Judge Wood's criticisms of the Federal Circuit itself valid?

Judge Wood suggests that having eleven regional circuits join the Federal Circuit in addressing patent law would add intellectual heft and avoid group think.  She theorizes that the Federal Circuit's culture of consistency stifles the freedom the regional circuits would have to make "big mistakes" that might advance patent law.

The Federal Circuit was created in 1982, after studies showed that the regional circuits' handling of patent appeals was dysfunctional.  Renowned Second Circuit Judge Henry Friendly criticized the "mad and undignified" race to the courthouse stemming from regional circuit management of patent appeals.  A study cited by Judge Wood reported that patents in the Eight Circuit suffered an 88.8 percent invalidity rate -- meaning virtually all patents were ruled invalid.  It is doubtful that a return to such a free-for-all would raise the quality of discourse.

In contrast to Judge Wood's concerns about Federal Circuit unanimity, the bar of the court often complains that each judge holds independent views, creating too much panel-to-panel variability.  If those from afar consider a court's jurisprudence too uniform, and those up-close consider it too diverse, the likelihood is that the court has struck about the right balance.

Judge Wood's critique of the Federal Circuit based on the rate of Supreme Court review is in tension with her suggestion that it deserves a worthy counter-weight.  On the big issues, such as whether genetic tests may be patented, the Supreme Court has not been shy about its role.  And although the Supreme Court has historically heard as many as 20 Federal Circuit cases per term, more recently it has only decided a handful per term.  It is capable of addressing any perceived Federal Circuit bias.

The portrayal of the Federal Circuit as too "specialist" overlooks the varied docket of the court, which includes veterans' appeals and trade disputes.  It also underrates the rich diversity and high caliber of the judges on the court.  This includes generalists with backgrounds as respected Supreme Court advocates and high-performing federal trial judges.  Of President Obama's six Federal Circuit appointees, only one is a patent expert, former Patent Office star Ray Chen, who would elevate the performance of any circuit.

Judge Wood's proposal to reintroduce the regional circuits to patent appeals is, respectfully, impractical.  It would give litigants an incentive to race to appeal to obtain their preferred circuit law.  Trial courts would not know if they were governed by Federal Circuit or regional circuit patent law when they made decisions.  Simply put, adding the option of regional circuits to the Federal Circuit would worsen the unacceptable pre-1982 forum shopping.

Finally, the idea of using the MDL panel to select the appeal court by lottery is dubious.  Judge Wood cites existing uses of this scheme.  But it has only been sparsely used in niche areas.  One real-world example provides a cautionary tale:  In an attempt at forum shopping, appeals were filed in 11 different regional circuits including the D.C. Circuit.  The MDL panel selected the Eighth Circuit by lottery.  The Eighth Circuit then transferred the appeal back to the D.C. Circuit.  Given the fast pace of patent litigation, such appellate roulette would be intolerable.

In the end, calls to return patent appeals to the regional circuits cannot survive study of the pre-Federal Circuit mess.  A hybrid system with the Federal Circuit and the regional circuits competing for jurisdiction, while imaginative, would be a big mistake.  The Federal Circuit has presided over a technology boom like no other.  We know from hard-worn experience that the grass is not greener on the other side.

The above article was originally published on October 7, 2013 in The Litigation Daily, and is being reprinted here with the author's permission.

The War on Patent Trolls -- Congress Prepares for Battle

By Andrew Williams --

In case it was not clear that Congress is serious about combatting the perceived problem of "patent trolls," Sen. Patrick Leahy (Vermont) and Sen. Mike Lee (Utah) published an opinion piece this week on the POLITICO.com website, which is now entitled "America's Patent Problem."  Both Senators are members of the Senate Judiciary Committee, chaired by Sen. Leahy (at right), the committee which has jurisdiction over patents, copyrights, and trademarks.  The article started from the premise that there are patent holders that are abusing the system, and that this abuse has resulted in a drag on the economy.  The example of "patent misuse" that the article highlighted is a patent holder that insists that Wi-Fi routers infringe its patents.  Sen. Leahy and Sen. Lee (below) took the position that, even if this patent holder's infringement allegations are legitimate, it should only be allowed to sue the companies that make and sell the routers, not the small businesses that are using these routers.  But, the small business examples to which the authors pointed included "hotels or small coffee shops" -- entities which others have referred to as "end-users" of the technology.  It is hard to believe, though, that these small businesses are using these routers for non-commercial purposes.  Even if the "hotels and coffee shops" don't charge their customers for the use of the Wi-Fi, it is almost certain that they seek to attract customers with the service.  More importantly, a patent holder's rights are not limited to preventing the making and selling of a patented product.  Instead, 35 U.S.C. § 271(a) provides that "whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent" (emphasis added).  Thus, it is unclear what the justification is for excluding such "end-users" in this case, especially when the "end-users" is more likely than not using this technology for commercial purposes.  The Senators did not provide an answer.

To be fair, we are not taking any position on the merits of the case to which this example refers.  Indeed, the Senators themselves did not provide any specifics; for example, no parties or patent numbers are cited.  Instead, Senators Leahy and Lee focused on the fact that certain patent holders are targeting small businesses for the sole reason that the cost of settling can be far less than defending against a lawsuit.  This may be true.  However, it is difficult to distinguish between such alleged tactics and the licensing efforts of "legitimate patent holders."  Instead, the authors concluded (without much explanation) that "this misuse of the patent system" does not belong to "the patent system provided for in our Constitution."

But is this true?  Not if an article that appeared on the Forbes website on Tuesday is to be believed.  Former undersecretary of commerce and director of the U.S Patent and Trademark Office Jon Dudas (at right), and author of the book "Rembrandts in the Attic," David Kline, wrote a piece entitled "Thank the Founding Fathers for the Open Market in Patents."  Contrary to the sentiment expressed by Senators Leahy and Lee, and almost every report in the mainstream press, Mr. Dudas and Mr. Kline (below) explained that the founding fathers not only anticipated non-practicing entities, they encouraged them.  Of course, these are the same founding fathers that provided for a patent system in the Constitution, and helped to draft that first patent act.  The authors pointed out that the young American economy needed a kick-start because, at that time, "the U.S. had a lower standard of living than many South American countries."  The founders looked to the British patent system, but according to Bowdoin College historian Zorina Khan, this system had high fees ("11 times the per capita income of the average citizen") and a working requirement (they had to practice the invention).  The article continued by citing the work of historians Naomi Lamoreaux from Yale and the late Kenneth Sokoloff of UCLA, who explained that the founders wanted to design a system that would "stimulate the inventive genius and entrepreneurial energy of the common man," even if such individuals could not commercialize their own inventions.  They accomplished this by instituting fees much lower than in Britain, not imposing a working requirement, and by expressly allowing the sale and licensing of patent rights.  The article continued to cite the work of professors Lamoreaux and Sokoloff, who explained that new intermediaries (think non-practicing entities) "'lowered the transaction costs and improved the efficiency' of the trade in and commercialization of patented technology."  Mr. Dudas and Mr. Kline concluded that this system, which is currently embodied by universities and industry NPEs, has sparked many new products and businesses over years.

Mr. Dudas and Mr. Kline warned, therefore, that not all non-practicing entities should be lumped together into the designation of "Patent Troll."  Nevertheless, this appears to be exactly what Congress is doing.  Senators Leahy and Lee explained that their committee is working "on a bipartisan basis" to address this so-called Patent Troll problem.  In addition, they are coordinating with the Representative Bob Goodlatte, chairman of the House Judiciary Committee.  The stated goal for this legislation is to "make it harder for bad actors to succeed, while preserving what has made America's patent system great."  Of course, that is easier said than done, and the difficulty is narrowly crafting such legislation to specifically address the perceived problem without also ensnaring all of the so-call "legitimate patent holders," or without introducing unexpected negative consequences for the patent system as a whole.  Some of the suggested legislation includes increasing transparency of patent ownership, protecting the end-users when the manufacturers should be the real defendants, and improving the process for reviewing patents at the Patent Office (although it is unclear why Sen. Leahy did not mention the post-issuance review procedures of the Leahy-Smith America Invents Act in his article).  We have previously reported on some of the proposed legislation, and we will continue monitor and report on the activity of Congress.  It is likely that with so much momentum and apparent public support, there will probably be some sort of bill passed in the next year or so.  We can only hope that in doing so, Congress does not toss out the proverbial baby with the bathwater.

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

• "The GAO Issues a Report on Patent Litigation Trends -- It Turns Out that the Sky Is Not Falling," August 29, 2013
• "New Patent Litigation Bill Introduced in House," July 16, 2013
• "Congress Continues Efforts to "Reform" U.S. Patent Law," June 10, 2013
• ""When the Patent System is Attacked!" -- The White House Task Force on High-Tech Patent Issues," June 4, 2013
• "The More the Merrier: The Journal Joins the Times in Complaining about Patents," April 20, 2011
• "In Defense of Patents (And Even Their "Trolls")," Fenruary 21, 2007

A Reply to the New England Journal of Medicine

Editor's Note:  Yesterday, we reported on a perspective, entitled "Patents, Profits, and the American People -- The Bayh–Dole Act of 1980," that was published in the August 29 issue of the New England Journal of Medicine.  Earlier today, we received an e-mail from Joseph Allen, who noted that he had authored a reply to the NEJM article.  His response was originally published on IPWatchdog, and is being republished here with the permission of IPWatchdog founder Gene Quinn.  Patent Docs thanks Mr. Allen and Mr. Quinn for allowing us to republish Mr. Allen's response.

By Joseph Allen --

In its August 29, 2013 edition, the New England Journal of Medicine saw fit to print two "perspective" pieces attacking the Bayh-Dole Act.  The primary article is by Dr. Howard Markel entitled "Patents, Profits, and the American People -- The Bayh–Dole Act of 1980."  It repeats previously refuted charges that patenting and licensing federally funded inventions harms the public interest.  To give the author due "credit," Dr. Markel does invent some new allegations as well which simply cannot go unanswered.

The Bayh-Dole Act was passed because Congress was rightly concerned that potential benefits from billions of dollars of federally funded research were lying dormant on the shelves of government.  Government funded inventions tend to be very early stage discoveries -- more like ideas than products -- requiring considerable private sector risk and investment to turn them into products that can be used by the public.

Under prior patent polices, government agencies took such inventions away from their creators and offered them non-exclusively for development.  There were no incentives for the inventors to remain engaged in product development.  Not surprisingly, few such inventions were ever commercialized even though billions of dollars were being spent annually on government R&D.  This failure spurred two Senators from opposing sides of the aisle, Birch Bayh of Indiana and Bob Dole of Kansas, to form a remarkable partnership seeking a remedy.

But here's how Dr. Markel characterizes the impetus for Senator Bayh's involvement:

In 1978, a group of constituents representing Purdue University lobbied Bayh to seek ways of reaping profits from government allocations for university-based research, arguing that although the United States spent billions of dollars annually funding more than half of all academic research and owned 28,000 patents, it had little to show for the investment.

Unlike Dr. Markel, I was actually in that meeting.  Ralph Davis, who then ran Purdue's technology transfer office, is no longer with us to defend himself.  Neither Ralph nor anyone else present was looking for "ways of reaping profits from government allocations for university-based research." Quite the contrary, Ralph said that Purdue had made several promising inventions under Dept. of Energy grants which would never benefit U.S. taxpayers unless they were effectively licensed and developed.

This motivation was reflected in Senator Bayh's statement on introducing the bill:

The bill addresses a serious and growing problem: hundreds of valuable medical, energy and other technological discoveries are sitting unused under government control, because the government, which sponsored the research that led to the discoveries, lacks the resources necessary for development and marketing purposes, yet is unwilling to relinquish patent rights that would encourage and stimulate private industry to develop discoveries into products available to the public.

The cost of product development exceeds the funds contributed by the government toward the initial research by a factor of at least 10 to 1.  This, together with the known failure rate for new products, makes the private development process an extremely risky venture, which industry is unwilling to undertake unless sufficient incentives are provided.

The consequences of our inadequate government patent policy have not gone unnoticed.  In the energy area, bureaucratic delays caused by case-by-case review of each patent application are now running behind by almost two years. . . .

But nowhere is the patent situation more disturbing than in biomedical research programs.  Many people have been condemned to needless suffering because of the refusal of agencies to allow universities and small businesses sufficient rights to bring new drugs and medical instrumentation to the marketplace.  The exact magnitude of this situation is unknown, but we are certain that the cases we have uncovered to date are but a small sample of the total damage that has been done and will continue to be done if Congress does not act.

Dear Colleague letter from Senator Birch Bayh on the introduction of Bayh-Dole, Sept. 6, 1978.

Senator Bayh's wife was then suffering from a cancer which would later take her life.  Senator Bayh was very grateful for the help she received from the doctors at the National Institutes of Health.  His determination to enact Bayh-Dole to ensure that new treatments for relieving human suffering were being developed was driven by a passionate concern for patients, not "reaping profits."

Markel repeats the discredited allegation that technology licensing was more successful before Bayh-Dole than claimed by proponents of the law.  This charge used to be widely circulated leading my colleagues Norman Latker and Howard Bremer to look up the actual source materials the critics cited.  Perhaps not surprisingly, they found the critics were misreading the data.  See "The Bayh-Dole Act and Revisionism Redux," pp. 9-10.

Dr. Markel lightly dismisses as "[m]ore difficult to confirm" the meticulous work that Lori Pressman and her team (which included economists at the Department of Commerce) put into a ground breaking study estimating the significant economic impact of university patent licensing on the U.S economy.  Lori documented the methodology behind the study which until now, no one has challenged.  Perhaps Dr. Markel's "difficulty" would be solved if he actually read the paper.  To make it easy, here's the link: "The Economic Contribution of University/Nonprofit Inventions in the United States: 1996-2010."

Adding insult to injury, Markel continues:  "Indeed, the law's many critics question how much it has actually benefited the economy (as opposed to individuals and stakeholders) and the extent of its social costs."

Here's some data that may help Dr. Markel and the other critics:

• Since 1980 more than 9,000 new firms have been created around university inventions, more than 4,000 of which are still in business.  These companies tend to locate in the same state as the university, spurring economic growth.

• 705 new companies were created by university patented inventions in FY 2012 alone, along with 591 new commercial products introduced for consumers to use.  Not a bad performance in an economy otherwise stuck in the doldrums.

• There are now more than 40,000 active licenses and options in place on university inventions, the majority of which are with small businesses.

• No new drugs were commercialized when the government took inventions away from universities before Bayh-Dole.  Since then at least 153 are now on the market fighting the scourge of disease world-wide according to a study published in the New England Journal of Medicine.  See "The Role of Public-Sector Research in the Discovery of Drugs and Vaccines."

A new Forbes magazine analysis calculates that it now costs $5 billion to develop a new drug -- expenses that are borne by the private sector.  If the critics ever get their way and succeed in undermining Bayh-Dole, we could return to the days when we again pull the plug on drugs developed from federally funded research.  One has to wonder where those suffering will then turn for relief.  It's unlikely the critics will be able to offer them much solace.

While not in Dr. Markel's article, publications covering it surmised from his characterization of its legislative history that enactment of Bayh-Dole was "fluke ridden" (University of Michigan Health.org) or a "rocky and somewhat inglorious road to passage by a lame duck Congress" (Tech Transfer News blog).  Such language reflects a fundamental lack of understanding of the legislative process.  Bayh-Dole passed on its merits in the full light of day, not through any legislative sleight of hand.

The bill not only went through all of the steps for passing a new law that you read about in civics class, it was subjected to additional scrutiny not normally required for legislation:  it needed a unanimous vote of approval in the closing days of the Congress.  Bayh-Dole was even attacked by its bureaucratic opponents after enactment who sought to undermine the new law by wrecking the regulations needed for its implementation.  See "The Enactment of Bayh-Dole, An Inside Perspective."

Dr. Markel saves his "best" for last:

It's time for Congress to recalibrate Bayh-Dole.  Profits and patents can be powerful incentives for scientists, businesspeople, and universities, but new and ongoing risks -- including high prices that limit access to lifesaving technologies, reduced sharing of scientific data, marked shifts of focus from basic to applied research, and conflicts of interest for doctors and academic medical centers -- should be mitigated or averted through revisions of the law.  All Americans should be able to share in the bounties of federally funded research.

Oh my, where to begin?  Would Dr. Markel feel better knowing that a survey of academic researchers concluded that "patenting does not seem to limit research activity significantly, particularly among those doing basic research," with only 1% of their random sample of 398 academic respondents reporting a project delay of more than a month due to patents on knowledge inputs necessary for their research, and none reporting abandoning of a research project due to the existence of patents?  See Final Report to the National Academy of Sciences' Committee Intellectual Property Rights in Genomic and Protein-Related Inventions: Patents, Material Transfers and Access to Research Inputs in Biomedical Research (Sept. 20, 2005).

Would he feel better knowing that Bayh-Dole has not shifted the focus of federal R&D from basic to applied research?  See "The Bayh-Dole Act and Revisionism Redux," pp. 11-12.  This is hardly surprising as federal agencies fund research either in pursuit of expanding the frontiers of knowledge or to meet their mission needs.  With industry abandoning basic research, being able to partner with our unparalleled public research institutions is a tremendous competitive advantage for the United States.  Bayh-Dole makes this possible.

Perhaps Dr. Markel will feel better knowing that all Americans can only share in the bounty of federally funded research when embryonic ideas are taken from the lab and turned into new products they can actually use, while creating new jobs and companies where they can work.  The United States is leading the world in this regard -- thanks to the Bayh-Dole Act.

About the Author

Joesph Allen is a 30-year veteran of national efforts to foster public/private sector commercialization partnerships, and author of numerous articles on technology management for national publications.  Mr. Allen served as a Professional Staff Member on the U.S. Senate Judiciary Committee with former Senator Birch Bayh (D-IN), and was instrumental in working behind the scenes to ensure passage of the historic Bayh-Dole Act.  Mr. Allen has served as the Executive Director of Intellectual Property Owners, Inc., a trade association representing major R&D companies, he was involved in the creation of the Court of Appeals for the Federal Circuit, and he also served at the U.S. Department of Commerce as the Director of the Office of Technology Commercialization.  From 1992 until 2004, Mr. Allen was with the National Technology Transfer Center (NTTC), becoming President in 1997.  Clients included NASA, the Department of Defense, EPA, the Department of Veterans Affairs, and the Department of Commerce.  Between 2004 until 2007, Mr. Allen was the Vice President and General Manager of the West Virginia High Technology Consortium Foundation.  In 2008, he founded Allen & Associates to continue to facilitate public/private partnerships between universities, federal laboratories, and industry.

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

• "NEJM Perspective Calls for Recalibration of Bayh-Dole Act," September 10, 2013
• "Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test," July 17, 2013
• "Patent Docs Author Testifies at Genetic Diagnostic Testing Hearing," February 16, 2012
• "AUTM Survey Shows Significant Increases in University Patent Filings and Issuances in FY2010," October 5, 2011
• "USPTO Recognizes 30th Anniversary of Bayh-Dole Act," December 9, 2010
• "University Start-ups and Licensing Activity Held Steady During Recession," October 7, 2010
• "AUTM Survey Shows Drop in Issued Patents," March 9, 2010
• "BIO Comes out Swinging against SACGHS Report," February 4, 2010

• "Patent Haters Take Notice! University Innovation Fuels Robust Economic Activity," IPWatchdog, August 7, 2013
• "Intellectual Dishonesty About Bayh-Dole Consequences," IPWatchdog, May 10, 2013
• "The Good Steward -- Turning Federal R&D into Economic Growth," IPWatchdog, August 2, 2012
• "University Tech Licensing Has Substantial Impact on Economy," IPWatchdog, December 10, 2012
• "AUTM Survey: University Licensing Strong Despite Economy," IPWatchdog, December 17, 2010
• "Statement of Senator Birch Bayh on the 30th Anniversary of the Bayh-Dole Act," IPWatchdog, December 5, 2010