Patent Docs: September 2015

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September 30, 2015

Guest Post -- The Biggest Side-effect of Making Medicine

How to Manage Intellectual Property and Patent Law

By Ralf Boscheck* --

International intellectual property regulations are doing serious damage to the pharmaceutical industry and, by extension, to the health of people around the world. The core of the problem: growing global concern about how to ensure affordable access to medicine without damaging the initiatives that sustain pharmaceutical research. Attempts to address the issues have resulted in significant disagreement between developed and emerging economies about just how much protection should be available to companies that develop new drugs.

Members of the World Intellectual Property Organization, which celebrated its 40th anniversary this year, are trying to resolve their differences on how -- and even whether -- emerging market countries should move to a framework that offers greater IP protection, but the results to date are not promising. "Access to medicine" advocates propose measures based on national income levels; branded drug producers want a time-based transition schedule; others argue that patent protection should be linked with the UN's Human Development Index, which is a relative scale with frequently-changing outcomes and policy incomes.

The case for strong patent protection

Developed countries, particularly the United States, usually try to commit emerging economies to more stringent intellectual property right rules in exchange for bilateral concessions in other areas of trade. These arrangements typically involve an extension of patent terms and data exclusivity as well as limits to parallel trade and accelerated marketing approval for generic producers.

Strengthening intellectual property rights, they argue, incentivizes research on diseases that are specific to developing countries and promotes technology transfer through the localization of R&D and production investments. This then contributes to improving typically inadequate health service infrastructures.

The counterargument: cost and accessibility

For many observers in emerging economies, however, strict protections on IP translate into higher prices for life-saving drugs, delayed generic competition, and weakened local production. As a result, countries like India have taken the lead in employing patentability criteria that may set new standards for emerging and possibly emerging markets alike.

In 2005 India amended its patent law in line with the international agreement on trade-related aspects of intellectual property rights (TRIPS). However, it also inserted a provision preventing the patentability of substances including salts, esters, and metabolites, and other derivatives and combinations of previously known compound. It also banned the patenting of new uses of existing compounds.

This provision has since been used to deny drugs such as Sutent, Pegasys, Tarceva and Glivec the same patent protection available to them elsewhere.

Attempts to challenge the law as not being TRIPS-compliant failed, with India's supreme court ruling that the provision was, among other things, intended to ensure that the country's citizens had easy access to life-saving drugs and to prevent "evergreening" of patents.

However, research published last year casts doubt on just how effective this approach is, at least regarding the first part: a review of 184 drugs between 2000 and 2009 concluded that only 60 percent of the products in US markets were available to Indian patients by 2010. Half of the drugs had a launch lag of more than five years, while a quarter lagged by more than nine.

The "evergreening" debate

"Evergreening" is a series of techniques used by pharmaceutical firms to continue protecting their drugs after the initial patent expires in order to maximize their return on R&D investments. That is, they prevent or limit the manufacture of generic drugs for longer.

The specific approaches used are numerous, but include continued differentiation of branding, dosing, formulation or mode of action; patenting active compounds or co-specialized delivery systems; and seeking to expand a compound's market through approvals for new indications.

Critics of evergreening strategies argue that this means that patients miss out on the benefits of cheaper generic drugs. However, they also usually neglect the existence of regulatory and market responses that limit the risk of abusive patenting.

For instance, patentability typically requires an invention to be novel, non-obvious and useful in the sense of capable of industrial application. The coloring and scoring of a drug may appear on the surface to be purely aesthetic, but if it can be shown to improve patient compliance, and therefore efficacy, that is novel and not obvious, and must therefore be patentable. In short, properly designed and implemented patent systems already deal with some of the often claimed evergreening concerns.

Reverse payments

Both the US and EU systems allow companies to legally challenge patents and potentially speed up generic substitution. In Europe, generic companies have nine months to revoke a patent through a process administered by the European Patent Office. In the US, the Hatch-Waxman Act offers producers of bioequivalent generics that certify not to be infringing any valid patent surrounding the original compound an abbreviated new drug application.

When this happens the patent holder has a choice: contest the application, with all the costs and uncertainty this involves; ignore it, and plan on losing up to 80 percent of its total sales within a year; or pay the generic manufacturer not to get involved for a defined period.

This last approach, known as a reverse payment or "pay for delay," can mean that a big pharmaceutical company that has already spent hundreds of millions of dollars developing a drugs can find itself paying out millions more to another company to hold on to its own IP in what could be characterised as a form commercial blackmail. Or, looked at the other way, big companies are using their financial heft to prevent competition that could lead to cheaper drugs for patients. However, if a settlement allows entry before any litigation would be terminated and patent expires -- whichever comes first -- the apparently anti-competitive agreement may actually improve consumer welfare.

For more than 15 years, pay-for-delay deals have extended the life of contested pharmaceutical patents, and given the indeterminate impact on consumer welfare, the U.S. Supreme Court has been unwilling to take a definitive position either way. Just as in other areas of dispute between intellectual property rights and antitrust law, settlement deals present a substantial conceptual challenge to be translated into efficient regulatory standards. Such difficulty, however, does not justify a call for additional actions against evergreening of pharma patents or the use of any regulatory short-cuts.

Conclusion

Escalating healthcare expenditures and the need to ensure access to affordable medicine in both emerging and emerged economies are fueling calls for containing evergreening practices around the world. But such practices are the necessary outcome of a system that responds to market incentives and is already sufficiently controlled by established patentability standards and policies to determine patent term extension. Even reverse payment arrangements may ultimately deliver consumer net benefits. They present a challenge for efficient rule writing and a reminder of the need for better and coordinated policy analysis.

* Ralf Boscheck is the Lundin Family Professor of Economics and Business Policy at IMD. He is program director of IMD's MBA program. With more than 20 years of teaching in a number of IMD's executive programs, Prof. Boscheck believes in using intensive and direct interaction to develop technical competencies, self-awareness and moral judgment.

For additional information regarding this topic, see Prof. Boscheck's paper "Intellectual Property Rights and the Ever-greening of Pharmaceuticals."

Posted at 11:59 PM in Miscellaneous | Permalink | Comments (0)

September 29, 2015

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: JYANT Technologies, Inc.

By Kevin E. Noonan --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"). Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention. On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc. Over the past few weeks, Patent Docs has been examining these amicus briefs. Today, we review the brief submitted by JYANT Technologies, Inc.

In the brief's Statement of Interest, the amicus states that it is from Marietta, Georgia and is "an early-stage biotechnology/pharmaceutical development company" with an emphasis on companion diagnostics. Specifically, its technologies "provide ground-breaking solutions to diagnosis and treat cancers and inflammatory diseases through the use of anti-chemokine and anti-chemokine receptor antibodies." Patent protection, it says, "is critical to ensure the resources needed for its continued research and development" and the panel decision "threatens to wreak havoc on patent law."

JYANT argues that the panel decision is wrong but acknowledges that the "Supreme Court's efforts have fallen short of clear guidance for distinguishing between a patent-ineligible 'law of nature, natural phenomenon, and abstract idea' and an eligible 'new and useful process, machine, manufacture, or composition of matter.'" Nevertheless, JYANT contends that the panel decision "fundamentally misreads" the Court's precedent, from Funk Brothers Seed Co. v. Kalo Co., 333 U.S. 127 (1948), through Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). Further, the brief asserts that the panel ignored why patent law exists in the first place: to promote progress. In this context, "progress" is in the field of diagnostic tests, and the brief argues that progress in developing a particular diagnostic test does not preempt future research for developing other tests, but rather "it encourages the dissemination of ideas and enables others to invent improved or alternative diagnostic methods" (albeit ignoring the panel's disregard for the preemption issue). Nevertheless, the brief argues that obviousness, rather than patent eligibility, is the proper patent requirement that should be applied to the question. JYANT concludes the summary of its argument by noting that should the panel decision stand, it "threatens to abolish wide swaths of existing and future intellectual property" including "[a]lmost every diagnostic test, whether medical, chemical, or agricultural, relies on some natural phenomenon" because these tests "frequently apply known tools, such as reagents or procedures, to solve a specific problem." The panel's reasoning would render all such inventions ineligible without regard to whether they are novel and non-obvious (which, it must be said, is precisely the point of this attack on the patent system).

The brief enunciates two specific arguments in support of these general themes. The first is that the panel ignored the purpose of the patent clause entirely and "contravened" precedent (which is a little harsh in view of the softness of that precedent). Specifically, the brief argues that the panel ignored the context in which the Mayo decision was reached and that this led to error in how that precedent was applied. Simply put, the brief finds no mandate in the Mayo decision, properly applied, for invalidating diagnostic methods merely because they incorporate known techniques. In making this argument, the brief characterized the Court's Myriad decision (as other amici have done) to stand for patent ineligibility of isolated genomic DNA but patent eligibility for methods "implementing" such genetic knowledge. This argument focuses (as have others' arguments) on Section III of the Myriad opinion, wherein Justice Thomas and a unanimous Court cited with approval Federal Circuit Judge Bryson's "apt observation" that Myriad had alternatives to claiming genomic DNA, because ""[a]s the first party with knowledge of the [gene] sequences, Myriad was in an excellent position to claim applications of that knowledge." Diehr contains similar reasoning, according to JYANT, focusing on the known character of each of the steps but the "patent-eligible improvement of using a particular algorithm together with known steps to achieve an improved result." This is precisely the situation here, according to the brief: the use of "known tools ["blood fractionation, PCR, and detection"] in a novel manner based on a unique scientific insight."

The brief further supports this argument in a creative way, by noting that the Court in Funk Brothers v. Kalo affirmed earlier precedent (Cameron Septic Tank Co. v. Village of Saratoga Springs, 159 F. 453 (2d Cir. 1908)) supporting the argument that claims should considered as a whole:

Claim 1 in Cameron Septic Tank covered a "process of purifying sewage, which consists in subjecting the sewage under exclusion of air, of light and of agitation to the action of anaerobic bacteria until the whole mass of solid organic matter contained therein becomes liquefied, and then subjecting the liquid effluent to air and light." The Second Circuit explained that neither the individual steps nor the anaerobic bacteria used in the process were new [internal citations omitted].

What the Cameron Court recognized, and the Supreme Court in Funk Bros. affirmed, according to the brief, was the "particular implementation of old steps to achieve a new result" as the "innovative feature" of the invention. By necessity (and aided by the Second Circuit's rejection in Cameron of the defendant's argument that the claims were patent ineligible for being a "process of nature"), the brief argues that the Funk Bros. Court's approval of the precedent means the Court "necessarily agreed that conventional tools, employed in a novel combination configured to utilize a natural phenomenon, can be patent-eligible."

With regard to this argument the brief also asserts that Sequenom's claims "do not present the preemption risk of which the Supreme Court has frequently warned" because the claims are sufficiently limited with regard to the methods steps recited therein that the "law of nature" (the existence of paternally derived cffDNA in maternal blood) could be detected using other, unclaimed methods. The "ultimate utility" of the invention is to use a blood test to "determine characteristics of the fetus, such as gender, Rh type, and certain genetic abnormalities." The brief distinguishes Sequenom's methods from Myriad's claims to genomic DNA because in the Myriad case this patenting "might have tied up the basic informational building blocks of the human genome" (honesty would require "might" to be emphasized).

Finally in this section, the brief identifies as a "further flaw" by the panel substituting the eligibility question for obviousness; obviousness has the advantage of "provid[ing] an analytical framework with which a court can objectively determine whether a claimed diagnostic test is a significant enough advance so as to warrant patent protection," citing Graham v. John Deere Co., 383 U.S. 1, 17 (1966). Obliquely, this section of the brief illustrates the negative consequences of this substitution by reminding the Court that "patent protection creates the necessary incentive to develop and disseminate groundbreaking diagnostic technologies" and that the proper distinction between Section 101 and 103 is that "the obviousness inquiry ensures the proper balance of patent protection to provide the necessary incentive for continued innovation."

In the brief's second argument, JYANT argues that the panel decision also "threatens to undermine patent protection for a wide variety of inventions, including diagnostic tests" and "decimate the very legal protection that incentivizes the development of so many useful tools that improve the human condition." What follows is an explication of how patenting has fostered "the development of medical diagnostic tests of all types" and thereby "improv[ed] the standard of care in the vast majority of medical decisions." Because "[a]ll of these tests, at their base, are specific applications relying on some natural phenomenon," the brief argues that the panel decision would make companies "less inclined to invest in research for diagnostic tests." And this section of the brief contends that, using the panel's reasoning, even the polymerase chain reaction itself would not have been patent eligible (noting the Nobel Prize-winning nature of PCR, albeit forgetting how little weight courts are giving inventions of this quality).

JYANT Technologies was represented on the brief by Matthew J. Dowd, Robert A. Gutkin, and Sushila Channana of Andrews Kurth LLP.

For additional information regarding this topic, please see:

Posted at 10:51 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (0)

September 28, 2015

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: NYIPLA

By Donald Zuhn --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"). Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013, and that the panel's decision poses a threat to patent protection in multiple fields of invention. On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc. Over the past few weeks, Patent Docs has been examining these amicus briefs. Today, we review the brief submitted by the New York Intellectual Property Law Association (NYIPLA).

In its brief, the NYIPLA is described as "a professional association of approximately 1,300 attorneys whose interests and practices lie in the area of patent, trademark, copyright, trade secret and other intellectual property law." The NYIPLA notes that a "primary concern" of the association "is that the law applicable to intellectual property be developed in a way that enhances the ability of the clients of its members to conduct their businesses with reasonable certainty concerning the predictability of whether certain patent claims covering inventions developed by them are patent eligible."

The NYIPLA brief focuses primarily on "the role of preemption in the patent eligibility analysis mandated by Mayo and Alice," noting that:

The Supreme Court has long recognized that the proper test for determining patent eligibility is whether the claimed subject matter falls within one of the four statutory classes of subject matter and does not preempt what this Court has called a "fundamental principle" (i.e., abstract idea, natural phenomena or law of nature). See Diamond v. Diehr, 450 U.S. 175, 185 (1981) (citing Parker v. Flook, 437 U.S. 584 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)) [emphasis in brief].

Arguing that "[n]either Mayo nor Alice changed this," the NYIPLA contends that neither case "authorize[d] a court to ignore the ultimate question, i.e., does the claim preempt a fundamental principle instead of merely claim a practical application of such a principle."

In the latter part of the brief, the NYIPLA sets forth its argument that the two-part framework of Mayo and Alice does not moot preemption. Pointing out that "Sequenom offered evidence that there are other uses of cffDNA other than those claimed in the '540 patent," the brief suggests that "thus, preemption did not exist." Noting that the Ariosa panel concluded that "[w]here a patent's claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot" (emphasis in brief), the amicus submits that the Ariosa panel's conclusion "is clear error and needs to be corrected."

The brief also argues that the Ariosa panel "erroneously applied the Mayo framework in a mechanical manner . . . , ignoring the goal of the inquiry -- to determine if the claim includes enough 'something more' to avoid preempting the fundamental principle in question," and contends that "[t]his type of rigid analysis of prior Supreme Court patent-eligibility frameworks was rejected in Bilski v. Kappos, 561 U.S. 593 (2010) and is likewise incorrect here." According to the brief, "[t]he failure to consider preemption has resulted in courts and the PTO over-using §101 in a gatekeeper or threshold fashion for which it was never intended to be used, either as enacted by Congress or as interpreted by the Supreme Court." The amicus contends that the Ariosa panel's failure to consider preemption when applying the framework of Mayo constituted legal error, and therefore concludes that the full Court should grant rehearing to correct that error en banc.

For additional information regarding this topic, please see:

Posted at 11:59 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (0)

September 27, 2015

Guest Post -- On Ariosa and Natural Products

By Leslie Fischer* --

Recently, I had the privilege of speaking at the annual meeting of the American Society of Pharmacognosy in Colorado. Members of this scientific association are dedicated to identifying and isolating natural products from various sources, and finding use for these isolated compositions as medicines, cosmetics, food additives, etc. I don't imagine this group would normally be particularly excited to hear a patent attorney speak for an hour, but these are troubled times for natural products, and these folks were, indeed, troubled. Unfortunately, by the end of the evening, no one was feeling more positive about the patent eligibility of natural products in the United States. I don't relish going back next year with the news that the patent eligibility of claims reciting natural products has gotten even worse, which it has -- thanks to Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015).

In subject matter eligibility (SME) cases, "natural products" traditionally fall within the judicial exception (JE) to 35 U.S.C. §101 referred to as a "natural phenomenon," the other two JEs being "abstract ideas" and "laws of nature." When we look to historical and modern court decisions addressing the eligibility of natural products, we find that product claims have been at issue, e.g., American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1 (1931) (claims to oranges), Parke‐Davis & Co. v. H. K. Mulford Co., 189 F. 95, 103 (S.D.N.Y. 1911) (claims to adrenalin), Diamond v. Chakrabarty, 447 U.S. 303 (1980) (claims to genetically-modified bacteria), Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013) (claims to DNA), In Re Roslin, 750 F.3d 1333 (Fed. Cir. 2014) (claims to cloned sheep). The SME analysis used for product claims is quite different than the SME analysis used for process claims, and this makes sense -- natural products are tangible and concrete things, whereas abstract ideas and laws of nature are intangible concepts. For product claims reciting natural products, courts have asked (in one way or another) whether the composition or manufacture has some meaningful difference from its naturally‐occurring counterpart, whereas for process claims reciting abstract ideas or laws of nature, courts have asked (in one way or another) whether the idea or law recited therein is applied in a meaningful way. Ariosa is the first case that I am aware of in which an application test is used to analyze the SME of a process claim simply because it recites a natural product.

The process claims at issue in Ariosa relate to methods of detecting fetal DNA in maternal plasma, and, in some claims (e.g., claim 21 and 25), using that detected fetal DNA to provide a diagnosis. The Federal Circuit explains in the decision that the claimed processes begin and end with a natural phenomenon, and then nonchalantly concludes that the process claims are directed to naturally-occurring phenomenon (also called a "naturally‐occurring thing" by the panel). The panel is fairly clear that the alleged ending natural phenomenon is paternally‐inherited fetal DNA derived from maternal plasma (given the moniker "cell free fetal DNA" or "cffDNA" in the decision). But the panel is less clear as to what, exactly, is the beginning natural phenomenon, at one point identifying it as the existence of cffDNA in maternal blood ("It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon.") but in other passages suggesting that cffDNA itself is both the beginning and ending natural phenomenon ("Thus, the claims at issue, as informed by the specification, are generally directed to detecting the presence of a naturally occurring thing or a natural phenomenon, cffDNA in maternal plasma or serum. As we noted above, the claimed method begins and ends with a naturally occurring phenomenon.").

Having identified a natural phenomenon (or two)? in Sequenom's method claims, the panel was faced with a significant decision -- what relevant precedent to apply? cffDNA is, after all, a natural product, but historical and modern SME decisions related to natural products (e.g., American Fruit, Chakrabarty, Myriad, Roslin) analyze product claims, not process claims. And, historical and modern SME court decisions that analyze process claims (e.g., Parker v. Flook, 437 U.S. 584 (1978), Diamond v. Diehr, 450 U.S. 175 (1981), Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. __, 132 S. Ct. 1289 (2012), Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S.__, 134 S. Ct. 2347 (2014)) deal with very different JEs, i.e., abstract ideas and laws of nature. Each of these lines of cases is readily distinguishable. Undaunted, the Ariosa panel creates an entirely new rule of law, ostensibly derived from Mayo, but sounding rather like Flook. The Ariosa SME test may be broadly stated as follows: for process claims that encompass a natural product, the process steps themselves must be new and useful. While this SME test closely resembles Flook in that the process steps themselves must be inventive, it has a significant difference -- Flook's inventive application test has never been triggered by anything other than intangible JEs, i.e., abstract ideas and laws of nature. In contrast, Sequenom's claims recite only a tangible natural product.

Why is this extension of Flook problematic? First, the Flook (and Mayo) application‐based tests were designed to ensure that an intangible JE is meaningfully applied. Yet, many of Sequenom's claims, e.g., claim 1 and 24, are directed to methods of detecting, i.e., finding a substance, not using it. Hence, an application‐based test makes little sense for such claims. Second, the Ariosa panel has gone where no panel has gone before. In all three Federal Circuit Myriad decisions (Ass'n for Molecular Pathology v. USPTO, 653 F.3d 1329 (Fed. Cir. 2011), Ass'n for Molecular Pathology v. Myriad, 689 F.3d 1303 (Fed. Cir. 2012), University of Utah Res. v. Ambry Genetics Corp., 774 F.3d 755 (Fed. Cir. 2014)), the court addressed both product and process claims. For the product claims, which contained the "natural product" DNA, the precedents relied upon by the panels were product cases (i.e., Chakrabarty, Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948), American Fruit, Parke‐Davis, In re Marden, 47 F.2d 958 (CCPA 1931), Myriad, and Roslin). For the process claims, which also contained the "natural product" DNA, the precedents relied upon by the panels were process cases (i.e., Bilski v. Kappos, 561 U.S. 593 (2010), Diehr, Flook, Mayo, and Gottschalk v. Benson, 409 U.S. 63 (1972)). The SME analyses of process claims in the Federal Circuit Myriad decisions were not triggered by the presence of the "natural product" DNA in the claims, but rather by the presence of an abstract idea (i.e., the act of "comparing"). Only Ariosa takes the position that process claims encompassing a natural product trigger a SME analysis. In the SME matrix shown below (click on matrix to enlarge), Ariosa creates a new law, and makes a new space.

Rather than creating a new law for claims reciting natural products, the Ariosa panel could have looked to guidance from several Supreme Court decisions. In Mayo, Justice Breyer noted that a new way of using an old drug is an application of a law (read: patent eligible). But, in fairness, using fetal DNA for diagnostic purposes is not a new use of this substance, even though Sequenom's fetal DNA is clearly derived from a new source. Better is Judge Thomas's tantalizing Myriad passage that the claims in front of the court did not involve new applications of knowledge about the BRCA1 and BRCA2 genes, intimating, of course, that these types of claims are eligible for patenting. If the beginning "natural phenomenon" identified by the Ariosa court is the presence of fetal DNA in maternal serum, then surely an application of that knowledge is to assay maternal plasma for fetal DNA and use that information to provide a diagnosis (see, e.g., Sequenom's claim 21). The whereabouts of a molecule is not a concrete and tangible thing, but rather an observation, i.e., an intangible concept, far more like a law of nature (and in fact, is probably better described as a law of nature), and thus a JE amenable to an application-type SME test. Had the Ariosa panel clearly articulated the intangible nature of the JE it identified in the claims, then tangible natural products would be left out of this murky modern SME case (of course, one has to wonder about the soundness of any system in which the sheer existence of a substance in a particular location is a JE rendering suspect the eligibility of a claim).

Instead of taking advantage of Justice Thomas's offer, the Ariosa court created a chimera, i.e., a Flook-derived application‐based SME test applied to process claims reciting a natural product. Practitioners should be deeply concerned about how future panels (and the U.S. Patent Office) will apply this new animal. In the USPTO's December 2014 Guidance, process claims reciting only natural products, and no other JE, are not subjected to SME analysis, except in cases where a process claim is no different in substance from a product claim, e.g., "A method comprising providing a pomelo fruit." But, is this out of sync with Ariosa? In fact, claims many thought were safe following Mayo, e.g., a method of treatment (with or without a diagnostic aspect) using a natural product, may now fall prey to significant SME scrutiny. Imagine the claim: "A method of treating Disease D by administering Compound C to a patient having Biomarker B." Under a broad reading of Ariosa, the claim "encompasses" a natural product (Biomarker B). Using Ariosa's newly-minted Flook chimera, we ignore Biomarker B and ask whether the remaining aspects of the claim are unconventional or inventive. Assuming Compound C is old, Disease D is old, and methods for administering Compound C are old, what unconventional aspect remains? Why, the natural law that patients having Disease D and Biomarker B respond better to Compound C! But, natural laws are also ignorable JEs, and if we ignore that JE too, nothing remains in the claim that is "inventive." Imagine an even simpler claim: "A method of treating Disease D by administering Compound C to a patient." If Compound C is a natural product, then under a broad reading of Ariosa, the claim "encompasses" a natural product. Using the Flook chimera, we ignore Compound C and ask whether the remaining aspects of the claim are unconventional or inventive. Assuming Disease D is old and methods for administering Compound C are old, what unconventional aspect remains? Why, the natural law that patients with Disease D respond to Compound C! And if we ignore that JE, all that remains in the claim are old, well-known elements.

Why stop there? Let us take it a step further, extending Ariosa to product claims. After all, our courts seem dedicated to shoehorning all claim categories and all JEs into the same SME framework. Imagine an inventor is the first to discover that trypsin is absorbed by the ileum and can be administered orally to patients if enterically coated. The claimed enterically-coated trypsin molecule, analyzed under a broad extension of Ariosa, might not fare very well. Using the Flook chimera test, we ignore trypsin (a natural product) and ask whether the remaining claim elements are unconventional. Since enteric coating is conventional, the only unconventional aspect remaining in the claim is the natural law that trypsin can be absorbed by the ileum. Once we ignore that JE, the claim is empty of anything out of the ordinary. Far-fetched? These are essentially the facts of Armour Pharm. Co. v. Richardson Merrell, Inc., 396 F.2d 70 (3d Cir. 1968). In that case, the 3rd Circuit identified a natural law hidden within a product claim to enterically-coated trypsin (i.e., the natural law that the ileum absorbs trypsin). Citing Funk Bros., the 3rd Circuit pretended that the natural law was known in the prior art, and once done, the solution, i.e., enterically coating trypsin, was entirely conventional. While our §101 jurisprudence has, thankfully, gravitated away from these Funk-based shenanigans, Ariosa threatens to move us back to exactly that point for natural products.

How do we halt this devolution in our §101 jurisprudence?

First, our justices need to clearly identify the exact JE identified in each particular case, and into which category that JE falls (law of nature, abstract idea, or natural phenomenon). Should the JE be a "natural phenomenon", then further distinction is needed between concrete natural products and intangible observations. It is an important distinction whether the JE in Ariosa is the sheer existence of fetal DNA in maternal plasma (intangible law of nature or observation), or whether it is fetal DNA itself (tangible composition of matter), because U.S. courts address the SME of tangible versus intangible JEs differently.

Second, to select the proper SME test based on the proper precedent, a court must also be cognizant of the category of claim under scrutiny, i.e., product vs. process claims. If the JE identified in Sequenom's claims is the sheer existence of fetal DNA in maternal plasma, then the Ariosa court has identified an intangible JE, and, for process claims reciting an intangible JE, an application-based analysis could be appropriate. However, if the JE identified in Sequenom's claims is fetal DNA itself, the Ariosa court has identified a tangible molecule, and because the claims are process claims, no SME analysis is required (excepting a process claim that is no different in substance from a product claim). Cognizance and clarity as to both the type of JE and the particular claim category before a court is critical, as it allows selection and application of the correct legal precedent.

Third, and finally, we must resist the sirens' song to use the same SME test for every claim. In lieu of a single standard for analyzing the eligibility of all claims, our courts have set forth various different ways to satisfy §101. While the two-step framework of Mayo provides a guiding principle, the second step of Mayo, i.e., "what else is there in the claims before us?" does not dictate a process claim‐derived application‐based test for each and every claim. Alice, in fact, tells us that step two of the Mayo analysis is simply the search for an "inventive concept," i.e., an element or combination of elements amounting to significantly more than a claim to the JE itself. Mayo step two encompasses all the many ways the §101 inquiry has been historically satisfied, some precedent being applicable to product claims, some to process claims, some for tangible products, and some for intangible laws and ideas. But, there has never been one test that rules them all. And the more we try to fit everything into one neat little box, the more our §101 jurisprudence devolves, the more confused the Patent Office, practitioners and the public become, and the less likely it is that your valuable invention involving a natural product will see the light of day.

• Dr. Leslie Fischer, Ph.D., J.D., is an Adjunct Professor of Law at Seton Hall University

Posted at 11:59 PM in Patentable Subject Matter | Permalink | Comments (4)

September 26, 2015

IPLAC Seminar on PCT filings and National & Regional Phase Entries

The Intellectual Property Law Association of Chicago (IPLAC) Paralegal Committee and International Patents Committee will be offering a seminar on "Foreign Patent Filings and PCT National & Regional Phase Entries" on October 15, 2015 from 8:30 to 9:30 am (Central) at The Standard Club in Chicago, IL. Mark W. Croll, Senior Advisor, Valipat S.A. will provide an update about and tips for PCT filings and National & Regional Phase Entries. The registration fee for the program is $10 for IPLAC members and $25 for non-members. Those interested in registering for event can do so by here.

Posted at 11:06 PM in Conferences & CLE's | Permalink | Comments (0)

Webinar on Hedge Fund IPR Challenges to Pharma Patents

Strafford will be offering a webinar/teleconference entitled "Hedge Fund IPR Challenges to Pharma Patents: Latest Developments and Strategies to Strengthen Patents -- Lessons From PTAB Denial of Acorda Therapeutics IPR, Celgene's Sanctions Motion, and More" on October 12, 2015 from 1:00 to 2:30 pm (EDT). Rekha Bansal, Sr. Director of IP, Principia Biopharma; Thomas L. Irving, Dr. Amanda K. Murphy, Ph.D., and Barbara R. Rudolph, Ph.D. of Finnegan Henderson Farabow Garrett & Dunner will provide patent counsel with guidance on the recent inter partes review (IPR) challenges by hedge funds to pharmaceutical patents, examining the patents that are being attacked and the grounds for attack, discuss the lessons learned from these challenges, and will offer strategies for strengthening patents to withstand attack. The webinar will review the following questions:

• What types of pharma patents are being challenged by hedge funds in IPR?
• What grounds are being asserted?
• What can be learned from the PTAB's Aug. 24, 2015, decision declining to institute two hedge fund IPRs?
• What message is the PTAB sending by choosing not to take a position on whether a third party’s filing status is determinative of a petition’s ability to be taken up?
• What can the pharma patent owner do to strengthen their patents to enhance the chance of survival in IPR, irrespective of the identity of the petitioner?

The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those interested in registering for the webinar, can do so here.

Posted at 11:05 PM in Conferences & CLE's | Permalink | Comments (0)

PLI Patent Litigation 2015

Practising Law Institute (PLI) will be holding five live sessions of its Patent Litigation 2015 seminar this fall in Chicago (October 8-9) and New York (November 16-17). In addition, Groupcasts will be held in Pittsburgh, New Brunswick, NJ, Mechanicsburg, PA, Philadelphia, Columbus, OH, and Cleveland on November 16-17. Each session of the Patent Litigation 2015 seminar will offer presentations on the following topics:

• Recent Developments in Patent Law and Their Effects on Patent Litigation
• Recent Supreme Court Decisions in Patent Cases -- How Helpful Have They Been?
• The Patentability of Business Methods: The Search for a Clear Rule Goes On (And On)
• Parallel Patent Office Proceedings
• Strategy and Tactics in Patent Litigation -- The Factors That Need to be Considered That You Can't Find in the Statutes, Cases or Rules
• Joint Defense and Indemnification -- Getting Along with Others
• Infringement Based on Acts of Multiple Parties
• Remedies (Including Injunctions)
• NPEs -- The Special Issues Arising From Disputes with NPEs
• Patent Litigation -- Views from the Bench Part 1
• Patent Litigation -- Views from the Bench Part 2
• Ethics Issues in Patent Litigation

A schedule for the Patent Litigation 2015 seminar can be found at here.

The registration fee for the conference is $1,795. Those interested in registering for the conference can do so at the PLI website.

Posted at 11:04 PM in Conferences & CLE's | Permalink | Comments (0)

September 24, 2015

PTAB Finds Two Sets of Claims to Be Not Abstract

By Michael Borella --

As the fallout from the Supreme Court's Alice Corp. v. CLS Bank Int'l case makes its way through the federal courts and the U.S. Patent and Trademark Office (USPTO), applicants and patentees continue to struggle with the implications of the decision. Alice provided a two-part test for patent-eligibility under 35 U.S.C. § 101, requiring that one first determine whether the claim at issue is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then one must further determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to something more than the judicial exclusion. Notably, generic computer implementation of an otherwise abstract process does not qualify as "something more."

Notoriously unclear and difficult to apply in practice, when employed by courts, the Alice test has resulted in the vast majority of claims under review being found patent-ineligible under § 101. Similar statistics are the case for the Patent Trial and Appeal Board (PTAB), the body that handles appeals within the USPTO. As a result, any court or PTAB decision finding that claims meet the requirements of Alice are useful clues for applicants and patentees. For instance, drawing analogies between one's claims that those that a judicial body has found patent-eligible can be persuasive to patent examiners in the USPTO, as well as to other judicial bodies.

Recently, the PTAB twice reversed examiners' rejections of claims under § 101. While both opinions were short, and thus do not provide extensive reasoning, they do offer examples of the type of claim language and subject matter that can be viewed favorably by the PTAB. Notably, in both cases, the PTAB found that the claims were not abstract.

In Ex Parte Cyriac J. Wegman III, 2015 WL 5578687 (P.T.A.B. Sep. 18, 2015), U.S. Patent Application No. 12/765,954 had been rejected by the examiner on the grounds of patent-ineligibility, lack of novelty, and obviousness. A representative claim recites:

1. A method for providing an empirical model of a defined space comprising steps of:
    a. defining the desired space;
    b. describing at least a portion of the defined space with multiple correlated dimensions;
    c. reducing the dimensionality of the described portion;
    d. combining the described portion with the remaining portion of the defined space;
    e. creating a hypothetical model of the defined space; and
    f. calculating coefficients for the hypothetical model according to an analysis of real and/or or virtual objects.

The examiner viewed the claim as being directed to the abstract idea of "providing an empirical model in which a hypothetical model is created and coefficients are calculated for the model." The applicant argued that the claim was more specific than the examiner's characterization, in that it "requires the description of a portion of a defined space using multiple correlated dimensions: the described portion of the space is then altered in terms of the dimensionality of the description of the space." The applicant further stated that "nothing in these steps may be considered necessary, routine, or conventional."

Applying the first part of the Alice test, the PTAB found that "claim 1 requires performing an analysis of objects, either actual or virtual, and calculating coefficients for the model based upon that analysis," and that "these steps are sufficiently concrete as to set them outside the broad definition of abstract idea as set forth in Alice." Consequently, the PTAB reversed the examiner's § 101 rejection.

In Ex Parte Bruce Gordon Fuller, Brian Alexander Wall, Kevin George Gordon, Mark David Hobbs, and Mohamed Salehmohamed, 2015 WL 3467122 (P.T.A.B. May 28, 2015), U.S. Patent Application No. 11/864,531 had been rejected by the examiner on the grounds of patent-ineligibility and obviousness. A representative claim recites:

1. A method of associating a first variable and an event on a display, the method comprising:
    displaying the first variable relative to a time period on the display, resulting in a graph of the first variable;
    receiving first user input from a graphical indicator device, wherein the first user input comprises an instruction to position an indicator over a portion of a data curve of the graph corresponding to a time period of interest to the user;
    in a processor, determining if the event occurred during the time period of interest; and
    displaying the event on the display nearby the portion of the graph if the event occurred during the time period of interest.

In rebutting the § 101 rejection, the applicant argued that "claim 1 recites physical elements that allow a user to view a graph and an event occurring during a time period of interest on the display if the processor determines that an event occurred" and that "these elements provide sufficient structure to prevent the method steps from being interpreted as too abstract."

Using terse reasoning, the PTAB stated that the applicant's arguments were persuasive and that the examiner did not rebut these arguments in the examiner's answer to the applicant's appeal brief. Thus, the PTAB reversed the examiner in this case as well.

Despite these two applications involving different subject matter, a commonality can be found between their respective claims. Particularly, both claim sets involve or incorporate a physical-world aspect. For instance, Application No. 12/765,954 recites "calculating coefficients for the hypothetical model according to an analysis of real and/or or virtual objects." Likewise, Application No. 11/864,531 requires displaying a graph, receiving user input related to a time period of interest on the graph, and then "displaying the event on the display nearby the portion of the graph if the event occurred during the time period of interest."

While the blessing of the PTAB is in no way a guarantee that a reviewing court will come to the same conclusion, these cases provide applicants with indications of what types of claims and arguments are likely to result in the Alice test being satisfied. Unfortunately for the applicants here, the examiners' rejections of both applications were ultimately upheld on other grounds.

Posted at 11:36 PM in Patent Trial and Appeal Board, Patentable Subject Matter | Permalink | Comments (2)

September 23, 2015

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Novartis AG

By Kevin E. Noonan --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"). Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention. On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc. Over the next few weeks, Patent Docs will examine these amicus briefs. Today, we review the brief submitted by Novartis AG.

In the brief's Statement of Interest, the amicus states that they are "a global healthcare company whose mission is to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life for patients across the world." The company's interest in the panel's decision is that it is "at heart an innovation company, relying primarily on our substantial investment in our own research and development (R&D) -- $9.9 billion in 2014 alone -- to fuel the ingenuity and high-stakes work that it takes to invent, develop and deliver new medicines." Accordingly, the company relies on patenting to protect its investment "in spite of the high costs and risks inherent in biopharmaceutical R&D." And the amicus notes that, for most of the 220 years of the U.S. patent system these protections have been successful in encouraging investment in innovation because patent protection was extended to "anything under the sun made by man [] subject only to limited judicial exceptions." The brief characterizes Section 101 as a "Janus," "with the power to begin entire fields of useful Arts -- or, if the gates are closed, to end them as abruptly." Being a business dependent on patent protection, the company asserts that the "critical role" of Section 101 as a gatekeeper has motivated it to follow the recent Supreme Court decisions "with concern over the certain and uncertain ways that it might impact the direction of our R&D, and have provided comments to the U.S. Patent and Trademark Office regarding the Guidances the Office has promulgated in an attempt to adapt government patent policy to those decisions. The continued viability of the Court's "seminal cases" (including Diamond v. Chakrabarty and Diamond v. Diehr), says this amicus, have provided "reassurance" in the face of the questions raised by these cases about the boundaries of patent eligibility, as has the Court's "repeated admonitions to interpret those holdings narrowly, lest they 'eviscerate patent law'" (citing Mayo).

This reassurance has "slipped away," according to Novartis, with the panel's "erroneous" decision, which "ignores the case 'most directly on point' (Diehr), misinterprets the framework of the principal case on which it relies (Mayo) and dangerously expands the judicial exceptions further than any decision in history" (a passage that most succinctly states the position of most of the amici, Sequenom and most of the biotech patent bar). The brief argues that Section 101 is intended to be a broadly interpreted threshold of "possibly patentable subject matter" (citing Diehr) and not as a door that forecloses what the "stricter" substantive patent law provisions of the statute would allow (saying colorfully that "such a door cannot be correctly construed as a vanishing portal that shrinks in scope with every step of the 'Progress of Science and the useful Arts'").

This is precisely what the panel decision does, however according to the brief, an outcome caused by "a fundamental misreading" of Mayo. And (perhaps even more dangerously) "the decision goes well beyond merely finding that a particular invention that applies 'manmade tools of biotechnology' in a 'revolution[ary]' way is ineligible for patenting": citing Judge Linn's soi-disant concurrence, "the decision threatens to signal to other courts and the USPTO to expand its flawed reasoning to untold numbers of other inventions." The panel decision threatens Novartis's "own inventions related to personalized medicine, biomarkers and point-of-care testing" as well as third party tests that may be of interest to Novartis in future. The consequences are dire indeed: "[i]f these inventions are no longer patent-eligible, the incentives to develop them may well disappear, or move overseas, or push us and others to rely on trade secrets, marking the death of a system in which the "public good fully coincides . . . with the claims of the individuals," citing The Federalist No. 43 (James Madison). And the decision might also bleed over to threaten "methods of treatment, medical therapies [and drug development]," having a "devastating" effect on medicine. Accordingly, this amicus concludes that the panel decision "deserve[s] another look" by the court en banc.

With this explication of the situation as prelude, Novartis makes three arguments in favor of reconsideration (and reversal) of the panel decision. The first of these is that the panel "impermissibly narrow[ed] the eligibility test for method claims by failing to consider the "claims as a whole." According to this brief, the second step in the Mayo/Alice test for patent eligibility not only "does not compel" the panel's result but indeed "leads readily to the opposite" one (emphasis in the brief). This assertion is based on the command from Mayo that the second step mandates that a court "consider whether 'other elements or a combination of elements, sometimes referred to as an "inventive concept"' transform the claim into a patent-eligible application [of a judicial exception]." The error was not in deciding that cffDNA was a natural phenomenon in applying the first step of the test, but instead by "completely excising these natural phenomena from the claim, asking only whether what remained (e.g. PCR) was 'inventive' on its own." PCR could not be considered inventive per se in 1997, but performing PCR on cffDNA from material blood "surely was," according to the brief. This situation is sanctioned (in the good way) by Mayo, being either an inventive "combination of elements" or by considering the claim as a whole. This "second layer of analysis," arose in Diehr and was cited with approval by the Court in Mayo and quoted in the brief as standing for the principle that the Court rejected the "rigid 'additional elements' approach applied by the panel:

[It is argued that] if everything other than the [patent-ineligible concept] is determined to be old in the art, then the claim cannot recite statutory subject matter. The fallacy in this argument is that we did not hold in Flook that the [patent-ineligible concept] could not be considered at all when making the §101 determination. To accept [that] analysis . . . would, if carried to its extreme, make all inventions unpatentable because all inventions can be reduced to underlying principles of nature which, once known, make their implementation obvious.

According to the brief's interpretation of the Court's Mayo decision, this was the "secondary check" on step 2 of its patent eligibility test, applied after the Court had determined that none of the steps recited in the claim by themselves contained an inventive concept. The brief then argues that "in line with Diehr, the Court's secondary analysis indicates that it was searching for an inventive concept in the way that the inventor arranged the known elements in the claim as a whole, including the natural phenomenon." It was the panel's failure to perform this assessment that lead it to error as argued in this brief.

A second argument proposed by Novartis is that the panel decision applies Section 101 more restrictively than the other statutory sections, contrary to the "broader patent law." Cited as an example of this conflict is the likelihood that a claim could contain an inventive step (non-obviousness) sufficient to pass muster under Section 103 but lack an inventive concept sufficient to confer patent eligibility. Acknowledging that what the Court meant by the term "inventive concept" (insofar as the term is different from non-obviousness) is still being developed, the brief finds conflict in the language of the statute, specifically that patents shall be granted on eligible subject matter "subject to the conditions and requirements of this title." 35 U.S.C. § 101 (emphasis added). The brief repeats the point that the Supreme Court considers Section 101 to be a threshold test, and that Congress intended the section to be construed broadly ("anything under the sun made by man"). Using language from the panel opinion recognizing that the invention was "a significant human contribution that "combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care," the brief asserts that the opinion satisfies the hypothetical raised earlier that a claim could be simultaneously non-obvious and ineligible, an outcome the brief argues is contrary to the statute and "broader" patent law precedent. Simply put, here the brief argues that a claim cannot be both non-obvious and patent ineligible so long as the criteria for eligibility includes the existence of an inventive concept.

Finally, the brief argues that the panel opinion turns the judicial exceptions into "moving targets" and as a result "creat[es] needless uncertainty [that] undermin[es] the objectives of the patent system." (The basis of this in reality stems from Justice Breyer's reincorporation of inventive concept" into Section 101 sixty years after Giles Rich and P.J. Federico thought they had relegated this requirement to Section 103.) But Novartis has a point when it states that the panel's application of the eligibility test makes what is an exception depend on the "constantly-changing state of the art" and that this is in conflict with how the Court has defined and (until now at least) applied the judicial exceptions. Novartis argues that the exceptions are exceptions because they are "universal constants" that are "outside the reach of human intervention" and hence do not change over time. Logic dictates that "what amounts to a 'natural phenomenon' at a given time cannot become an invention later, nor can a human invention become a 'natural phenomenon' with the passage of time." One illustrative basis for this idea is PCR: the panel determined that amplifying cffDNA using PCR was not "enough" to infuse the claim with an inventive concept because the technique was known in the art. The brief then notes that "implicit in this reasoning is that the use of PCR would be patent-eligible if the technique were new, as it was when Kary Mullis invented (and indeed patented) the process in 1983." While this may make sense under a novelty (Section 102) or obviousness (Section 103) analysis, the brief argues that it not only should not but "logically cannot be" under the judicial exceptions to patent eligibility under Section 101. "If the broad application of PCR to any form of DNA was not an ineligible 'natural phenomenon in 1983 [as presumptively it was not because Mullis was awarded a patent on the method], it cannot have become one 14 years later when applied to a more specific form of DNA in an admittedly 'revolution[ary]' way," the brief concludes.

Novartis was represented on the brief by Corey A. Salsberg.

For additional information regarding this topic, please see:

Posted at 11:59 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (7)

September 22, 2015

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Paul Gilbert Cole

By Kevin E. Noonan --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"). Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention. On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc. Over the next few weeks, Patent Docs will examine these amicus briefs. Today, we review the brief submitted by Paul Gilbert Cole (at right).

In the brief's Statement of Interest, the amicus states that he is "a practising UK and European patent attorney, is a visiting professor in IP Law at Bournemouth University in the UK and has been writing about and teaching patent law for over 35 years." He is "concerned with the integrity of the legal system and the correctness of the consequential guidance that is given to patent examiners in the USPTO" and in his professional opinion "the panel decision's application of § 101 exceeds the scope of the Supreme Court's § 101 jurisprudence and the scope of Article 27 of the TRIPS agreement."

Mr. Cole makes several arguments. First, he contends that the panel decision is contrary to controlling Supreme Court and other precedent, citing a dozen cases ranging from Mayo and Myriad to Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911), and Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156 (4th Cir. 1958). He also argues that it is "based on a legally incomplete and a legally and factually incorrect interpretation of the invention described and claimed in U.S. Patent No. 6,258,540." The brief then sets forth three "precedent-setting questions of exceptional importance":

(1) Should the context in which a claimed method that involves a newly discovered natural phenomenon be disregarded for the second part of the test in Mayo, so that steps that are known but only in different contexts do not count towards eligibility?
(2) How relevant to the natural phenomenon exclusion of § 101 is a new and beneficial result never attained before and evidencing inventive step under § 103?
(3) Is the second part of the Mayo test applied in the breadth of the Panel Opinion incompatible with the obligations of the United States under Article 27 of TRIPS?

The brief then sets forth Mr. Cole's reasons for urging the court to grant Sequenom's en banc petition.

The first reason Mr. Cole asserts is that the decision will "likely" be the basis of further guidance from the U.S. Patent and Trademark Office. This is problematic, according to Mr. Cole, because the Office "has a history of over-broad interpretation of Supreme Court and other decisions, which has created widespread difficulty for patent applicants and hence widespread adverse comment from both individuals and organizations." This tendency should not be encouraged.

Second, Mr. Cole asserts that the District Court and the panel "mischaracterized" the amplified cffDNA as being a natural phenomenon, when instead it should be considered as a manufacture and hence to fall within an expressly recited patent-eligible category of invention according to the statute. (It could be argued that this rationale underlay the Supreme Court's distinction between patent-ineligible genomic DNA and patent-eligible cDNA in its Myriad decision). In addition, Mr. Cole argues that the amplification primers are not natural phenomena, because they do not exist in the bloodstream; he further states that "[t]he fact pattern here diverges materially from that in Myriad where neither wild-type BRCA1 nor the corresponding cDNA were reported as having been isolated as real and tangible molecules" (based on the lack of description of actually isolating a BRCA cDNA clone, which while true doe not answer the Section 112 issue: the entire coding sequence was disclosed and it was within the skill of the ordinarily skilled artisan to make such a cDNA clone from the information disclosed in Myriad's patents). Mr. Cole also argues (citing Learned Hand in Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911)) that the real and tangible oligomer sequences in their amplified form have become for every practical purpose a new thing commercially and analytically (wherein the amplified PCR fragments can be detected visually by ethidium bromide staining, something that the unamplified cffDNA cannot be). The brief also cites Hartranft v. Wiegmann, 121 U.S. 609 (1887), as that case was cited in support of the Court's Diamond v. Chakrabarty decision, wherein "a change of form accompanied by new utility is the hallmark of a manufacture." 447 U.S. 303 (1980). Along these lines, the brief echoes the Chakrabarty decision in stating that "[t]he amplified sequences are the product of human ingenuity being a non-naturally occurring composition of matter having (following the wording in Chakrabarty and Myriad) a distinctive name (amplified maternal plasma sequences), character (short oligomer sequences in high and analyzable concentration) and use (analytical detectability) not possessed by maternal cffDNA," and hence that the sequences themselves met the eligibility test and thus negated the panel's basis for applying the Mayo/Alice test.

In the brief's third basis for urging en banc reconsideration, Mr. Cole argues that the panel found patent ineligibility based on a consideration of the claim limitations individually and ignored the Court's exhortation that "ordered combinations" can recite patent-eligible subject matter. Under a proper application of the law, the brief argues that the "starting point" for the claimed methods was maternal plasma or serum (not cffDNA), and thus the selection of this source "set[s] the claimed method apart from the prior art," citing United States v. Adams, 383 U.S. 39 (1966). Considered as such an ordered combination, the brief maintains that the claims are directed to "a hitherto unavailable test of high sensitivity for a range of medical conditions that can be applied early in pregnancy and avoids the risks to the fetus inherent in amniocentesis and that revolutionized prenatal care," i.e., something that is patent eligible.

Point four of the brief expands on this assessment of Sequenom's claims as reciting "an ordered combination" by applying the rule from Webster Loom Co. v. Higgins, 105 U.S. 580, 591 (1881), that "if a new combination and arrangement of known elements produce a new and beneficial result, never attained before, it is evidence of invention." Here, according to the brief, "the claimed combination of starting material and method steps here produced a new and beneficial test for fetal abnormalities and the like [that] is affirmative evidence of invention" and the panel erred in not considering this.

Finally, Mr. Cole cites the conflict of the panel's decision with U.S. treaty obligations including the TRIPS agreement, citing a comment from the Japan Intellectual Property Association to the effect that "the U.S. was introducing special eligibility criteria contrary to the international trend of intellectual property protection." The brief also cites Article 27.1 of the TRIPS agreement, which the brief asserts is binding on member nations and requires patents to be available "for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application, and that patent rights should be enjoyable without discrimination as to the field of technology." And the brief cites Art. 52(2)(a)-(d) for the provisions that define unpatentable subject matter in Europe that are limited to those satisfying these criteria:

If a new property of a known material or article is found out, that is mere discovery and unpatentable because discovery as such has no technical effect and is therefore not an invention within the meaning of Art. 52(1) EPC. If, however, that property is put to practical use, then this constitutes an invention which may be patentable. To find a previously unrecognised substance occurring in nature is also mere discovery and therefore unpatentable. However, if a substance found in nature can be shown to produce a technical effect, it may be patentable...."

The brief closes by accusing the panel decision as being "an internationally discordant, not harmonious, result, contrary to the eligibility requirements of TRIPS Article 27," and notes that the European counterpart was challenged on inventive step not eligibility grounds (and was found to satisfy the EPC requirements).

For additional information regarding this topic, please see:

Posted at 11:59 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (4)

September 21, 2015

R+L Carriers, Inc. v. Qualcomm, Inc. (Fed. Cir. 2015)

Be Wary of Claim Amendments During Reexamination

By Joseph Herndon --

Traditional patent law holds that a patentee of a patent that survives reexamination is only entitled to infringement damages for the time period between the date of issuance of the original claims and the date of issuance of the reexamined claims if the original and the reexamined claims are "substantially identical." If, on the other hand, a substantive change has been made to the original claims during reexamination, the patentee is entitled to infringement damages only for the time period following issuance of the reexamination certificate. This notion is referred to as intervening rights, which protect the public's reliance on the scope of an issued patent. Intervening rights are granted to anyone who relied on the original scope of the issued patent and had already begun to make, use, or sell a given invention that is now newly infringing under the amended patent.

In this recent Federal Circuit decision, R+L Carriers, Inc. ("R+L") sued Qualcomm, Inc. ("Qualcomm") asserting infringement of U.S. Patent No. 6,401,078 ("the '078 patent"). This is the second time R+L has brought the case to the Federal Circuit (in a prior appeal, on June 7, 2012, the Federal Circuit held that R+L's induced infringement claims survived Qualcomm's motion to dismiss, In re Bill of Lading Transmission & Processing Sys. Patent Litig., 681 F.3d 1323, 1346–47 (Fed. Cir. 2012), and the case was remanded against Qualcomm for further proceedings).

While the case was pending, R+L filed for ex parte reexamination of the '078 patent based on prior art identified by a third party. This strategy can be helpful if R+L believed the prior art to be troublesome and likely to invalidate the patent. Thus, R+L put the patent back into examination likely to modify the claims to be in a stronger position to survive an invalidity challenge, or to "whitewash" the patent over newly found art. Although the patent survived reexamination, R+L added language to all of the claims at issue. Accordingly, this case turns on whether the original claims and the amended reexamined claims are "substantially identical" so as to avoid intervening rights to be granted to Qualcomm.

The Bill of Lading Patent

R+L obtained the '078 patent, that generally relates to an improved method of consolidating freight into trailers to optimize delivery efficiencies for the loads in each trailer. According to the '078 patent, prior art shipping practices would evaluate the contents of each incoming trailer by reviewing bills of lading for the packages when they arrived at a central terminal. The patent explains that the freight on each trailer was then consolidated with freight going in the same direction and hauled away from the central terminal. The patent explains that the purpose of consolidation was to deliver all of the freight on time, while using the fewest number of trailers to do so. Although load planning software at the time could help perform this task more efficiently, the patent asserts that the prior art software could not account for unscheduled freight that was not entered into the computer.

To solve this alleged deficiency in the prior art, the '078 patent discloses a system for transmitting the contents of a trailer to the central terminal so that load planning can occur while the trailer is en route. The system contemplates the scanning of bills of lading, transmitting those documents once scanned, and receiving the data where it can be extracted for load planning and billing purposes. The patent describes two methods for extracting the load planning information from the transmission and preparing loading manifests therefrom: (1) a computerized system automatically interpreting the data; and (2) a data entry clerk manually reviewing the information. The U.S. Patent and Trademark Office (USPTO) initially issued the patent on June 4, 2002, containing only one independent claim (original claim 1).

During reexamination, in a first office action, the USPTO rejected original claim 1 as being anticipated by a key prior art reference. To overcome the USPTO's rejection, R+L amended original claim 1 as follows (deletions shown in brackets; additions shown by underlining):

1. A method for transferring shipping documentation data for a package from a transporting vehicle to a remote processing center comprising the steps of:
    placing a package on the transporting vehicle;
    using a portable document scanner to scan an image of the documentation data for the package, said image including shipping details of the package;
    providing a portable image processor capable of wirelessly transferring the image from the transporting vehicle;
    wirelessly sending the image to a remote processing center;
    receiving the image at said remote processing center; and
    prior to the package being removed from the transporting vehicle, utilizing said documentation data at said remote processing center to prepare [[a]] an advance loading manifest document for another transporting vehicle which includes said package for further transport of the package on another transporting vehicle.

The USPTO then allowed the amended claim 1 and issued the reexamination certificate, and stated that the key prior art reference only discussed loading a "manifest for the current shipping vehicle and not an advance loading manifest document for another transporting vehicle."

Were Substantive Changes Made to Claims During Reexamination?

To determine whether substantive changes have been made, and thus intervening rights exist, the Federal Circuit considers "whether the scope of the [original and amended] claims are identical, not merely whether different words are used."

The two conflicting arguments presented by Qualcomm and R+L focused on why the amendments were presented during reexamination. The Federal Circuit, though, stated that under the statute and prior case law, it is irrelevant why an amended claim is narrowed during reexamination, or even whether the patentee intended to narrow the claim in a particular way. The important aspect to note, according to the Federal Circuit, is whether the scope of the amended claim is not "substantially identical" to the scope of the original claim -- based on a normal claim construction analysis. When the scope is different, intervening rights apply.

The fact that the reason for the amendment during reexamination might not have been for the purpose of narrowing the claim in a particular way does not matter. In determining whether an amended claim is narrower, the Federal Circuit stated that the analysis includes determining whether there is any product or process that would infringe the original claim, but not infringe the amended claim. The purpose of the amendment is irrelevant to this inquiry.

The Federal Circuit ultimately agreed with the District Court's thorough claim construction analysis of original claim 1 and its conclusion that the term "loading manifest" is broad enough to encompass both manual and computer generated documentation. The question then is whether amended claim 1 covers a different scope.

The Federal Circuit noted that R+L only made amendments to original claim 1 after the USPTO rejected original claim 1 over various pieces of prior art. The term "advance" was added during reexamination in amended claim 1 to get around the key prior art, which, among other things, disclosed manual entry of the loading manifest.

To determine that amended claim 1 resulted in a narrowed claim scope, the Federal Circuit placed reliance on reasons for allowance given by the examiner during reexamination. Namely, the examiner expressly stated he was allowing amended claim 1 because "the manifest discussed by [the prior art] is a manifest for the current shipping vehicle and not an advance loading manifest document for another transporting vehicle." In other words, the examiner's focus in allowing the claims was not on whether a computer produced the loading manifest, but on the additional limitation that the advance loading manifest be "for another transporting vehicle." Although the amendment may not have limited amended claim 1 to computer-produced loading manifests, the examiner's commentary reveals a method that would be covered by original claim 1 but not amended claim 1: the process of preparing a loading manifest "for the current shipping vehicle." Thus, claim 1 was narrowed during reexamination, and is not substantially identical to original claim 1.

The Federal Circuit noted that even if the word "advance" was only added to "provide clarity," as R+L argues, R+L clearly understood that it was limiting the scope of its claims in another way to get around the prior art. This is almost always necessarily the case when presenting amendments during prosecution, and also follows the Festo presumption that amendments made during prosecution are for presumed to be for reasons of patentability. R+L was unable to overcome this presumption.

Since amended claim 1 is not "substantially identical" to original claim 1, R+L is not entitled to infringement damages prior to issuance of the reexamination certificate. At this time in the litigation there was no dispute that Qualcomm ceased its allegedly infringing activity. As a result, there can be no damages against Qualcomm, and the infringement claims were dismissed by the Federal Circuit.

R+L Carriers, Inc. v. Qualcomm, Inc. (Fed. Cir. 2015)
Panel: Circuit Judges Newman, O'Malley, and Wallach
Opinion by Circuit Judge O'Malley

Posted at 11:59 PM in Damages, Federal Circuit | Permalink | Comments (3)

September 20, 2015

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Bioindustry Association

By Kevin E. Noonan --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"). Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention. On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc. Over the next few weeks, Patent Docs will examine these amicus briefs. Today, we review the brief submitted by the Bioindustry Association.

In the brief's Statement of Interest, the amicus states that it is a "United Kingdom trade association of over 300 member organizations working in research and development ("R&D") and manufacturing in the bioscience sector." The association's members "include emerging and established biotechnology companies, pharmaceutical companies, academic research and philanthropic organizations," which are "responsible for over ninety per cent of biotechnology-based medicines currently in clinical development in the UK; they are at the forefront of innovative scientific developments targeting areas of unmet medical need." The amicus asserts that the issues in this case are of "great importance" because "[t]he majority of BIA's members are small and medium size enterprises" and thus "the ability to raise R&D funding or attract larger companies to collaborate heavily depends on the strength of their intellectual property, primarily patents." Without patent protection, the ability of BIA members to bring to life new and improved treatments" is "severely hinder[ed] and, in many cases, [is] impossible." Unique to the amicus briefs that have been filed, this brief makes the point that the U.S. represents 47% of the biotech market globally and that about 50% of U.S. biotech applications are filed by foreign companies (putatively to inform the Court of why a foreign trade association is concerned with the panel's interpretation of U.S. law).

The brief cites stark facts: that the panel decision is at odds with patent eligibility standards throughout the rest of the world and is contrary to (and harms) efforts to harmonize patent law among industrialized nations. The panel's interpretation of U.S. law also disadvantages foreign and multinational companies because inventions not patentable in the U.S. under the unique standards applied by the panel forces these companies to choose between getting patent protection abroad or keeping the technology as a trade secret globally. The brief counsels that "the unintended consequence of the Sequenom decision may be an exodus of investment and businesses from the US market or the life science industry in general."

The brief then sets forth its evidence and arguments regarding how outside the bounds of accepted patent eligibility standards the panel decision is, beginning with the statement that "[t]he Supreme Court could not have intended a general exclusion denying patent protection to meritorious inventions merely because they are based on a discovery of something that occurs in nature." What is "critical," according to this amicus, is "to delineate with clarity when a patent-ineligible discovery becomes sufficiently transformed" to become patent eligible. Too broad an interpretation of Supreme Court precedent leads to the "unfortunate result[]" that "even an acknowledged ground-breaking meritorious invention is denied patent protection merely because it originates from a discovery of a natural phenomenon." The brief then provides a concrete example for comparison: European Patent No. EP 994 963, which is the counterpart of the Sequenom patent at issue in this case (U.S. Patent No. 6,258,540) which was granted having claims almost identical to the one invalidated by the District Court. The brief notes that this patent was opposed in the EPO but survived, and cites decisions of the EPO Board of Appeals affirming the patentability of these claims (which were not challenged in eligibility grounds in Europe). And the brief sets for the EPO Guidelines for comparison:

If a new property of a known material or article is found out, that is mere discovery and unpatentable because discovery as such has no technical effect and is therefore not an invention within the meaning of Art. 52(1). If, however, that property is put to practical use, then this constitutes an invention which may be patentable. For example, the discovery that a particular known material is able to withstand mechanical shock would not be patentable, but a railway sleeper made from that material could well be patentable. To find a previously unrecognized substance occurring in nature is also mere discovery and therefore unpatentable. However, if a substance found in nature can be shown to produce a technical effect, it may be patentable. An example of such a case is that of a substance occurring in nature which is found to have an antibiotic effect.

EPO Guidelines for Examination (emphasis added).

Specifically, the brief identifies the "significantly more" requirement enunciated by Mayo as having "no equivalent in the patent laws of other industrialized countries."

Using these discrepancies as context, the brief then argues that the decision "frustrates" efforts to harmonize patent law globally. More importantly, the brief also asserts that the panel's application of the Supreme Court's Mayo/Alice precedent is also contrary to U.S. treaty obligations (and, of course, contrary to the constitutional basis of Congress's exercise of the patent power). With regard to the treaty aspects, the brief goes back to the Paris Convention of 1883 as the beginning of harmonization efforts, and includes the creation of WIPO (1967), the Patent Cooperation Treaty (1970), and GATT/TRIPS (1995) to illustrate these harmonization efforts, evidenced by the overwhelming majority of countries that have acceded to these treaties. The brief than takes a short detour to argue that the panel decision is also inconsistent with provisions of the Leahy-Smith American Invents Act, insofar as the Act was directed at harmonizing U.S. patent law with the rest of the world and in particular how the AIA did not change § 101 (except for expressly precluding claims to a human organism in superposition to the 13th Amendment). Insofar as the panel decision has effects contrary to this push towards harmonization, the brief argues that "the panel decision threatens the innovativeness and competitiveness of the US economy," something the Supreme Court could not have contended.

Finally, the amicus argues that the traditional alternative to eschewing patent protection, trade secret, is not available to foreign and multinational companies because of the disjunction between U.S. patent eligibility standards the rest of the world. Such companies face the choice of filing only in the U.S. and requesting no publication, and then keeping the invention as a trade secret if unsuccessful, or filing everywhere and having patent protection globally but no protection (patent or trade secret) in the U.S. The result: "a consequence of the panel's decision in Sequenom is the de facto abolition of intellectual property protection in the United States for many foreign and multinational companies who were able to procure patents abroad."

The thrust of the arguments made by this amicus may be more persuasive to Justice Breyer than they will be to the Federal Circuit; the Justice has received a fair amount of press (both good and bad) over his assertions in a recent book (The Court and the World: American Law and the New Global Realities, Knopf, 2015) that the Court should look to the laws of other nations in making its decisions.

This amicus were represented by Konstantin Linnik, Lana Gladstein and Isaac Hubner of Nutter McClennen & Fish.

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: WARF, Marshfield Clinic, and MCIS, Inc.," September 17, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA," September 16, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.," September 15, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine," September 14, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015

Posted at 10:50 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (10)

Conference & CLE Calendar

September 22, 2015 - "The Evolving World of Biosimilars Litigation" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 am to 11:15 am (CT)

September 22, 2015 - "Advanced Conflict Waivers: How to Avoid Unpleasant Surprises" (Intellectual Property Owners Association) - 2:00 to 3:00 pm (ET)

September 23, 2015 - "Pharma Leaders IP Conference" (J A Kemp) - London

September 24, 2015 - "Trade Secrets and Cybersecurity: Protecting Intellectual Property, Mitigating Loss and Navigating Legal Responses" (Strafford) - 1:00 to 2:30 pm (EDT)

September 24, 2015 - "Patent Term Adjustments and Extensions: Leveraging Recent Decisions and USPTO Rule Changes" (Strafford) - 1:00 to 2:30 pm (EDT)

September 24, 2015 - "IP Licensing: Implications & Best Practices in Light of Brulotte [Kimble v. Marvel]" (American Intellectual Property Law Association)

September 24-25, 2015 - Advanced Patent Law Seminar (Chisum Patent Academy) - Washington, DC

September 24-25, 2015 - Seminar on European Patent Law (Grünecker) - Munich, Germany

September 27-29, 2015 - 43rd Annual Meeting (Intellectual Property Owners Association) - Chicago, IL

September 30 to October 1, 2015 - Paragraph IV Disputes master symposium (American Conference Institute) - Chicago, IL

September 30 to October 1, 2015 - FDA Boot Camp (American Conference Institute) - Boston, MA

October 1, 2015 - "USPTO Rule Changes for PTAB Trial Proceedings -- Navigating Changes to New Testimonial Evidence, Rule 11-Like Requirement, Claim Construction Standard, Motions to Amend, and More" (Strafford) - 1:00 to 2:30 pm (EDT)

October 2, 2015 - Developments in Pharmaceutical and Biotech Patent Law 2015 (Practising Law Institute) - New York, NY

October 6, 2015 - "USPTO's Proposed Changes to PTAB Practice: A Primer on the Recently Proposed Amendments to the Rules Governing PTAB Proceedings" (American Intellectual Property Law Association) - 12:30 - 2:15 pm (Eastern)

October 7, 2015 - "Unitary Patent Protection in Europe - An Attunement on the Upcoming New System" (American Intellectual Property Law Association) - 12:30 - 2:00 pm (Eastern)

October 8, 2015 - "Proactive Patent Procurement and Prosecution Strategies: Minimizing the Threat of Post-Grant Challenges -- Insulating Your Patent Portfolio From New Threats" (Strafford) - 1:00 to 2:30 pm (EDT)

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

Posted at 10:31 PM in Conferences & CLE's | Permalink | Comments (0)

September 19, 2015

AIPLA Webinar on Unitary Patent Protection

The American Intellectual Property Law Association (AIPLA) will be offering a webinar on "USPTO's Proposed Changes to PTAB Practice: A Primer on the Recently Proposed Amendments to the Rules Governing PTAB Proceedings" on October 6, 2015 from 12:30 - 2:15 pm (Eastern). Acting Deputy Chief Judge Scott Boalick and Lead Judge Susan Mitchell of the U.S. Patent & Trademark Office, Todd Baker of Oblon McClelland Maier & Neustadt, LLP, and Joseph Palys of Paul Hastings will provide a fulsome discussion of the second package of proposed PTAB rule changes including strategies and practice tips for practitioners as the rules are implemented.

The registration fee for the program is $145 (AIPLA member rate) or $195 (non-member rate). Those interested in registering for the program, can do so here.

Posted at 11:59 PM in Conferences & CLE's | Permalink | Comments (0)

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