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November 5 / All Articles, Patent

Bowman v Monsanto Replicates Problems for the Future

Bowman v Monsanto Replicates Problems for the Future

By Hannah Marie Farhan and Jonathan Hu

On May 13, 2013, the Supreme Court decided Bowman v Monsanto 9-0 in favor of Monsanto. Monsanto had sued an Indiana Farmer, Vernon Bowman, for infringing its patents on “Roundup Ready” soybean seeds. Bowman argued patent exhaustion in defense. Justice Kagan, writing for the Court, held that patent exhaustion does not allow an authorized purchaser to replicate patented seeds without permission from the patent holder.

Abstract Idea:

The legal doctrine of patent exhaustion provides that patentees lose their patent protection after the initial authorized sale of their patented product. Quanta Computer, Inc. v. LG Electronics, Inc., 553 U. S. 617, 625. The subsequent owner can thus use or sell the item as he or she pleases without the threat of patent infringement for him/her or secondary purchasers. The Court had previously held, however, that patent exhaustion does not enable an authorized purchaser to reconstruct the patented product. Otherwise, patent holders would only profit from the first few sales of their products. The issue in Bowman v. Monsanto was whether the “natural use” of the seed protected the grower under the doctrine of patent exhaustion.

Case Argument:

Bowman acknowledged that the exhaustion doctrine does not grant the right to “make a new product.” He attempted to differentiate genetically modified seeds within this principal by arguing that seeds control their own natural replication and that this natural process should be recognized within patent exhaustion. The Supreme Court rejected this argument first by pointing out that the seeds Bowman bought were specifically licensed for consumption and not reproduction. The Court also highlighted Bowman’s actions of planting and watering the seeds, thus enabling reproduction. Therefore, the Court concluded that Bowman was in control of the reproduction, finding the “‘blame-the-bean’ defense tough to credit.”

Potential Takeaways and Impacts:

The Supreme Court’s ruling explicitly limited its decision to this specific situation. It recognized possible future cases with potentially unexpected technology and, therefore, distinct needs. Nevertheless, for farmers, the immediate result is a continued spike in prices for both farmers and consumers. Soybeans, cotton, and corn seed prices have shot up between 259 and 516 percent over the past fifteen years. Eamon Murphy, Bowman v. Monsanto: The Price We All Pay for Roundup Ready Seeds, Daily Finance (May 21, 2013, 11:30 AM) http://www.dailyfinance.com/on/monsanto-gmo-roundup-ready-seeds-patents-food-prices/. Genetically modified soybeans are currently three times the price of normal soybeans.  Nina Totenberg, For Supreme Court, Monsanto’s Win Was More About Patents Than Seeds, NPR’s All Things Considered, (May 13, 2013, 6:16 PM) http://www.npr.org/blogs/thesalt/2013/05/14/ 183729491/Supreme-Court-Sides-With-Monsanto-In-Seed-Patent-Case. Additionally, the long term issue has been an increase in the use of Roundup and a resulting prevalence of super-weeds.

This highlights an interesting point: Monsanto creates both the increasingly used, and basically necessary, herbicide (Roundup) and the herbicide resistant seed in question from this case. Accordingly, even if Monsanto could not directly profit at all off its genetically modified seed, it could still profit from the seed’s creation because of the cycle of increased dependency upon Monsanto’s herbicide that the seed is used with. Therefore, the Court could have agreed with Bowman without eliminating Monsanto’s incentive for innovation.

Ultimately, the takeaway question is when, not if, the Supreme Court will balance its protection of innovators with its protection of consumers over replicating technology? With recognized limits like patent exhaustion, the Supreme Court will eventually draw the line on protecting the patents and profits of naturally reproducing products.

April 23 / All Articles, Copyright, Featured, Patent, Trade Secret

Intellectual Property Indemnity Clauses

The practices associated with intellectual property indemnity can be traced in part to Article 2 of the Uniform Commercial Code. At the dawn of the computer age, practitioners searched for legal models that they could use for transactions in intangible rights and products such as computer software. Although computer software did not fit easily into the “sale of goods” paradigm, analogies to the familiar rules governing sales of goods were inevitable.

Lurking in the lower reaches of Article 2 of the UCC, one finds an implied warranty of non-infringement in Section 2-312(2):

Unless otherwise agreed, a seller that is a merchant regularly dealing in goods of the kind warrants that the goods shall be delivered free of the rightful claim of any third person by way of infringement or the like but a buyer that furnishes specifications to the seller must hold the seller harmless against any such claim that arises out of compliance with the specifications.

In the context of a sale of goods at the time Article 2 was drafted, a non-infringement warranty made good economic sense. The only form of intellectual property likely to be of concern to the purchaser of goods was patent protection. In the mid-twentieth century, when Article 2 of the UCC was adopted, patents were the disfavored stepchildren of the federal courts. A high percentage of patents were held to be invalid, and the damages accorded to those found to be valid were often limited to a modest royalty. Furthermore, patent rights are—as a rule—exhausted upon the first sale of a product and far fewer patents were being issued. Additionally, products were less complex, typically falling into only a single engineering domain, with correspondingly fewer points of intersection with issued patents. For all these reasons, the risk that the ultimate purchaser of a product would be sued for patent infringement was very remote, and even if the purchaser were sued, the damages would be only a tiny fraction of the purchase price—the average and median for all products was between five and seven percent.

In this context, a product manufacturer could provide an implied warranty of non-infringement with very little risk beyond whatever modest risk of infringement the manufacturer had already incurred by manufacturing the product itself. Product purchasers did not typically insist on an indemnity beyond the implied warranty , perhaps because the risk was perceived as too remote to be worth worrying about. The exhaustion doctrine would—in many cases—cause the claim to be made against the manufacturer rather than the user. Therefore, they would assume—probably quite rightly—that the manufacturer would “stand behind its product” and obtain the required license if an infringement claim were actually made.

With this background, and without giving the matter too much additional thought, it did not seem unreasonable for the lawyers representing software and other technology providers to provide a warranty of non-infringement governing their clients’ products as well. Such a warranty was certainly consistent with established practice as embodied in UCC Article 2. It therefore would have met the expectations of the marketplace. Furthermore, the risk of infringement liability seemed manageable. At that time, virtually no one believed that computer software would be patentable, and absolutely no one imagined that business methods would be patentable. The risks of trade secret or copyright infringement liability are more uniquely within the control of the software provider since each of them requires an element of intent or a near equivalent. By adopting appropriate internal controls and standards, sometimes even including a “clean room,” a software provider ought to be able to minimize its infringement risk.

As licensors, software providers had an additional consideration of the desire to control litigation concerning rights in the product. At that time, protection for computer software was in a state of flux. Copyright in computer software expanded in the years following the Copyright Act of 1976, but doubt persisted as to the extent of its protection. For instance, in following decades, the courts were faced difficult questions regarding whether copyright protected operating systems that communicate only with machines and whether it protected the “look and feel” of the user interface generated by the software. These were considered weighty issues going to the heart of the value represented by computer software. Accordingly, the software providers did not want to risk having them decided in litigation against their licensees, whose interest in broad protection would likely be less than the interest of the software providers.

In response to this concern, software providers migrated the infringement issue from the warranty clauses of software license agreements to indemnity provisions. As quid pro quo for indemnity, the licensor obtained prompt notice of the claim and full authority to defend or settle the case on behalf of the licensee. To mitigate their risk, most software licensors further provided that their obligation—and the licensee’s sole remedy—was to (a) obtain for the licensee the right to use the licensed product; (b) modify the product to make it non-infringing; or—failing (a) or (b)—(c) to terminate the license and refund a pro-rated portion of the purchase price depending on how much of the license term had been exhausted at the date of termination.

Clauses along these lines became a de facto standard in the software industry and persisted for many years. They were hardly perfect from the standpoint of licensees. Option (c) could be very detrimental in the case of software that was critical to a business, Even if comparable non-infringing software were available, the end user would be in the position of having to find, implement, and migrate all data or customizations to the new system. This could be expensive, risky and time-consuming. If no comparable non-infringing software were available and the patentee refused to offer a license on commercially reasonably terms, a business that relied on the software could be crippled. Even option (b) could be problematic if the required modifications degraded functionality or compatibility. As a result, licensees with sufficient bargaining power would nibble at the edges of such indemnity clauses, sometimes allowing full refunds and often providing that (b) could only be exercised if functionality were not compromised. Nonetheless, the basic pattern—limited indemnity in exchange for control over litigation—became well-fixed in many practitioners’ minds.

As so often happens in the law, the basic practices that emerged in one field—the software industry—migrated to other industries as well. Intellectual property indemnification clauses were inserted into virtually any agreement in which the parties foresaw a risk of intellectual property infringement.

October 24 / All Articles, Featured, Patent

Do Business Method Patents Encourage Innovation?

Although the United States Patent and Trademark Office (“PTO”) had issued business method patents (“BMPs”) prior to 1999, the decisions of the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) in State Street Bank & Trust Co. v. Signature Financial Group, Inc. in 1998 and AT&T Corp. v. Excel Communications, Inc. in 1999 led to a significant increase in the number of BMP applications filed with and granted by the PTO. Although grants of such patents have considerably stabilized in recent years, many policy issues raised by financial, electronic commerce and software companies in response to the State Street Bank and AT&T Corp. decisions regarding the patentability of business methods remain unanswered. Several legal and economic scholars, as well as the press, have examined this issue and have raised concerns about the quantity, quality and patentability of BMPs. There is some consensus in their point of views.

Many of these scholarly works provide fairly detailed and systematic studies of individual cases and their implications. Comparatively, there is little literature on the effect of BMPs on innovation, which is grounded in a more comprehensive theoretical perspective and empirical approach. This paper endeavors to fill this gap by reviewing the extant literature on patents in general and attempting to draw inferences about the implications of this literature for BMPs. The paper primarily focuses on the role of patents in driving innovation and the effect of poor patent quality on innovation.

The remainder of the paper is divided into seven sections. Section I briefly outlines the history and economic rationale of the patent system. Section II discusses the history of BMPs in the United States. Section III sheds light on the provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement regarding BMPs. Section IV briefly illustrates how different Member States of the World Trade Organization (“WTO”) have used the TRIPS agreement’s flexibility regarding BMPs in their national laws. Section V presents theoretical and empirical evidence about the general relationship between patent system and innovations, with analysis to understand the probable impact of BMPs on innovation. Section VI briefly presents the issues concerning BMPs and their consequences. Section VII presents a summary of the policy recommendations made by various scholars who have followed BMP’s evolution to becoming acceptable subject matter. The paper concludes with a brief discussion about some key policy recommendations for improving BMPs.

Rajnish Kumar Rai & Srinath Jagannathan

June 11 / All Articles, Patent

Dosage Patenting in Personalized Medicine

Inventions for dosage regimens often arise after the pharmaceutical product has been dosed in patients and more information is known about the in vivo and pharmacokinetic properties of the medical agent. However, securing patent protection for this type of invention has been difficult because dosage inventions are considered to be simple medical methods whose protection is believed to limit doctors’ choices in clinical practice. Moreover, novel dosage inventions are also considered to involve a process that does not enjoy the same scope of patent protection as new chemical entities despite their superior therapeutic potential. This article examines the nature of dosage inventions under an increasingly personalized clinical setting and argues that traditional patent jurisprudence might not apply to such inventions in personalized medicine. Therefore, more liberal approaches are needed to foster inventions in this field of technology.

 

*Jerry I-H Hsiao, PhD & Wei-Lin Wang, JSD

September 22 / All Articles, Patent

Patent Litigation: What About Qualification Standards for Court Appointed Experts?

Abstract–“The descriptions in patents are not addressed to the public generally, to lawyers or to judges, but, as [35 U.S.C.] section 112 states, to those skilled in the art to which the invention pertains ***.” [1] This leads to a tenet of patent law, that the meaning of patents and claim terms must be construed by a person of ordinary skill in the relevant art (“POSA”). However, federal district court docket statistics show that for tasks such as claim construction, the “experts” hired by courts to aid the courts themselves may, in fact, not meet the POSA standard In contrast, to perform the very same tasks, the testifying experts hired by the party litigants are now required to be POSAs. This article argues that logic dictates that there should be consistency in the requirement of skills for both court-appointed experts and party-employed experts when they perform the same tasks.

 

I. Introduction

 

Do you understand an invention regarding DC to AC power converter circuits used to drive cold cathode fluorescent lamps? [2] Would you understand the patent claims, the long run-on sentences defining the invention? [3] Well, sometimes courts may not either. However, when complex patents surface in litigation, there are many types of experts to help a court construe the words and decide whether patent claims are valid and whether they have been infringed. There are both experts hired by the parties (“party experts”) and experts hired by the courts themselves (“court experts”) whose roles are finely delineated. [4] For example, among party experts, there are trial-preparation experts, consulting technical experts, and Fed. R. Ev (“FRE”) 702 experts whose goals are to champion the particular party that hired them. [5] Among court experts, there are (special) masters, (technical) advisors, and FRE 706 court-appointed experts whose goals are to aid the judge who hired them. A problem is that, with regards to court appointed experts, practitioners continue to be concerned about the confidential nature of their influence on the ultimate decision of the court can obscure a possible lack of neutrality or relevant expertise of the purported expert. [6] The problem is exacerbated in patent cases because an invention may be complex and obscure so that there is often little choice but to use experts to elucidate the technology. [7] Accordingly, it is highly unlikely that courts will stop appointing experts; even the U.S. Supreme Court has occasionally utilized this practice that is allowed by statute and common law. [8] Thus, restraining the frequency of using experts is not a viable solution. But, setting threshold standards on the appointment requirements of the court experts is a reasonable compromise solution towards improving the quality of the influence that the experts do have. Presently, however, there is a lack of standards in the qualification of court experts in patent law. Therefore, this article proposes that courts implement a defined set of standards for court experts, specifically requiring them to be POSAs for matters that require a POSA point of view. This proposed solution is consistent with the traditional tenets of patent law, and it is now within practical reach due to recent case law. Setting qualification standards helps ensure that parties do not needlessly pay for court experts whose influence may be based on an inaccurate knowledge of the technology and which may lead to inaccurate analyses and decisions. Beyond patent law, the same concepts may be extended to other areas of law that also rely heavily on experts, such as products liability or criminal law. [9]

 

Setting qualification standards is compelling because of the frequent use of experts. Experts are so prevalent in patent litigation that even appellate judges in the U.S. Court of Appeals for the Federal Circuit (“CAFC”) lamented: “Evidentiary conflicts with respect to technology and science arise in a variety of cases; and the conflicting testimony of expert witnesses is ubiquitous.” [10] Given the likelihood of conflicting testimony and of complex inventions, court experts are necessary. But, it is important that their use be consistent with the traditional tenets of patent law, which includes a person-of-ordinary-skill-in-the-art standard (“POSA”) for patent claim construction, invalidity, and infringement determination. This POSA standard should also set restrictions on the qualification of all experts, whether they are party or court experts.

 

The CAFC recently set standards for someone to qualify as a FRE 702 party expert. In Sundance v. DeMonte, the CAFC held that a patent attorney who did not practice or have formal training in the technology was improperly permitted to testify as a FRE 702 party expert regarding invalidity and infringement. [11] The expert testimony was rejected because the attorney was not deemed a POSA. [12] Thus, Sundance seemingly heightened the standard to be a POSA. The CAFC also decided that party experts must be POSAs if they provide opinions on claim construction and other matters which traditionally have required a POSA point of view. [13] Given Sundance, rationally, it would be incongruous if court experts are not also as least as qualified as party experts. Presently, however, party experts must qualify at least as POSAs, but court experts need not do so, [14] which seems contrary if they are opining about the same issues. The incongruity is all the more a concern considering that court experts may have to distinguish between opposing technical viewpoints and play a decisive role in the outcome of a case. [15]

 

With this context, this article addresses the qualification standards of court experts. Section II provides an overview of court experts and relevant case law. In Section II-C, court docket statistics illuminate the present practice regarding the experts. Section III discusses the criteria to be a POSA. Section IV describes how Sundance and SEB v. Montgomery Ward [16] require higher standards for FRE 702 experts and also seemingly change the traditional POSA criteria. Section V considers the implications for court experts….

 

 

Dolly Wu*

September 22 / All Articles, Patent

Proveris v. Innovasystems: Redefining a Patented Invention under § 271(E)(1): An Examination of the Federal Circuit’s Narrowing of the § 271(e)(1) “Safe Harbor” Exemption

The Food and Drug Administration’s (“FDA”) regulation of drugs and medical devices impacts the everyday lives of Americans in both noticeable and inconspicuous ways. [1] For example, a recall of contaminated food or adulterated pharmaceuticals illustrates how the FDA noticeably affects impacts our everyday lives. [2] Additionally, unobservable consequences springing from the overlap between FDA regulations and patent law also affects the lives of Americans by stimulating market competition and providing incentives for medical research and development. [3]

 

Attempting to promote continued innovation in medical science, while at the same time provide the public with “more low cost generic drugs,” the U.S. Government amended both FDA regulations and patent laws through the Price-Competition and Patent Term Restoration Act (“the Act”). [4] The Act, commonly known as the Hatch-Waxman Act, consists of two sections, Title I and Title II, which function in tandem “affect[ing the] introduction procedures and patent requirements for certain kinds of generic new drugs.” [5] Title I of the Act provides for a new route of FDA regulatory approval for generic drugs (also known as “generics”), the Abbreviated New Drug Application (“ANDA”). [6] Congress’s intent behind the ANDA process was to allow generic drug manufacturers to get generics on the market sooner and at lower costs. [7] Title II of the Act made several amendments to the U.S. patent laws regarding how they apply to federally regulated products. [8]

 

The “safe harbor” provision of 35 U.S.C. § 271(e)(1) is a patent law amendment created by Title II of the Act. [9] Utilized in conjunction with the ANDA provision in Title I, Congress believed § 271(e)(1) would aid generics in obtaining market approval “between 18 months and 2 years earlier.” [10] Under § 271(e)(1), the otherwise infringing use of a “patented invention” is immunized from liability if the infringing use is “reasonably related” to the development of data for FDA approval. [11] Although § 271(e)(1) appears to lend itself to a fairly straightforward interpretation, its scope has been the source of much judicial and commentator debate over the last two decades. [12]       Since the enactment of § 27(e)(1), the Supreme Court has weighed in on its scope only twice. [13] In both cases the Court held the plain language and legislative intent behind the Act indicated that § 271(e)(1) was supposed to immunize a broad scope of inventions and actions, related to FDA approval, from patent infringement. [14] Despite the Court’s broad holdings in both cases, the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”) recently narrowed the scope of § 271(e)(1) with its holding in Proveris Scientific Corp. v. Innovasystems, Incorporated. [15] The Federal Circuit employed a narrow test, termed the “perfect product fit” analysis, for determining what constitutes a “patented invention” under § 271(e)(1). [16] Under Proveris’ perfect product fit analysis, in order for infringement of a patented invention to be immunized by § 271(e)(1), the “patented invention” must be eligible for a 35 U.S.C. § 156(e)(1) patent term extension. [17]

 

While Proveris may appear to comport with sound patent policy, the reasoning of the Federal Circuit fails to properly consider Congress’s overall purpose for the Act. Additionally, Proveris’ new interpretation of “patented invention” flatly contradicts the meaning previously assigned to the statutory phrase by the Supreme Court in Eli Lilly & Company v. Medtronic, Incorporated. [18] Further, the Federal Circuit misinterprets Lilly’s discussion of statutory symmetry (between § 271(e)(1) and § 156), through which the Court intended to broaden the § 271(e)(1) term “drugs,” not narrow the phrase “patented invention.” [19]

 

By reducing the scope of “patented inventions” within § 271(e)(1) to only inventions comporting with the “perfect product fit” analysis, Proveris has drastically altered the function of § 271(e)(1) and potentially impairs the ability of generic manufactures to fully utilize the ANDA process created in Title I of the Act. [20] Adherence to Proveris’ “perfect product fit” rule risks establishing loopholes that potentially allows patent holders of pioneer drugs and medical devices to delay generic manufacturers from bringing less expensive generics to the market. [21]

 

This Note critiques the Federal Circuit’s recent narrowing of § 271(e)(1) in Proveris. Part I provides a historical overview of FDA regulations on drugs and medical devices, the promulgation of the Act, and judicial interpretations of § 271(e)(1). Part II furnishes an in-depth review of the Federal Circuit’s holding in Proveris, and discusses the reasons cited as supporting the court’s narrowing of § 271(e)(1). Part III analyzes the Federal Circuit’s “perfect product fit” test, found to control the scope of § 271(e)(1), and discusses how the “perfect product fit” test contradicts the judicial precedent cited by the court as supporting its holding. Part IV illustrates how Proveris operates contrary to Congress’s intention for the Act, and suggests a “sliding scale” analysis for Federal courts when faced with a § 271(e)(1) defense….

 

Duane C. Marks*

July 19 / All Articles, Patent

The Biologics Price Competition and Innovation Act: Innovation Must Come Before Price Competition

Unlike traditional pharmaceutical drugs, which are small molecule compounds synthesized by chemists, biologics are typically large molecules that are produced in living things. [1] [2] Breakthroughs in the life sciences over the last two decades have led to new biologically derived treatments for debilitating diseases including autoimmune diseases, metabolic disorders, degenerative diseases, blood disorders, and cancer. [3] Several new biological treatments for diseases presently untreatable by other means are currently under development. [4] Despite these advances, new biologics come at a substantial cost for developers, consumers, and health care payers and providers. For developers, internal research, development, and production costs often exceeds a billion dollars per product brought to market. [5] For consumers, the purchase price of any given biologic treatment can be up to several thousand dollars per year. [6] For example, the cost per year per patient for Avastin®, a biologic used to treat colon cancer, is $100,000, and the cost for Cerezyme®, which is used to treat the metabolic disorder Gaucher Disease, is over $300,000. [7] On average, across treatments, the cost of medicinal biologics per patient is over $16,000 per year. [8]

 

For health care payers, the cost of biotech products is rising dramatically. According to IMS Health Inc., a provider of business intelligence for biotech and pharmaceutical companies, expenditures on biologics in the United States was over $40.3 billion dollars in 2006, which marks an increase of 20% from 2005. [9] Public and private insurance companies have declared that a continued increase is not sustainable without cuts to health care coverage. [10] Biologic medicines are of little benefit if they are too expensive for patients to afford.

 

Although Congress has made efforts to make biologics more affordable for the consumer market, such legislation must be carefully balanced to maintain incentives for innovators as they develop new therapeutic regimens. [11] [12] Without adequate incentives for biotechnology companies to discover new market-viable biologic medicine, there would be a dearth of breakthrough products available to patients. The majority of new biologics are discovered by small to medium-sized innovative biotechnology companies. [13] Research and development of biologics is an extraordinarily high risk endeavor requiring a great deal of up-front capital investment, [14] and returns are often not realized for several years due to the length of time required for the product to be developed and go through the stringent regulatory approval process of the Food and Drug Administration (“FDA”). [15]

 

In an effort to reduce the costs of medicine for patients, Congress must be especially careful not to impair the ability of the biotechnology industry to thrive by substantially diminishing profitability. Currently, the biotechnology industry is “still relatively nascent” and is largely fueled by venture capital investment. [16] Of the approximately 1400 biotechnology companies operating in the United States today, only twenty are profitable. [17] Many of these companies are small, with revenues of under a million dollars per year, and do not even have a product on the market yet. [18] Leaders in the biotechnology industry have expressed concern over the ability to secure investments in the wake of new biologics legislation:

 

Biotechnology researchers must have some certainty that they can protect their investment in the development of new breakthrough therapies for a sufficient period of time in order to secure necessary financial resources. If … legislation were to fail to provide adequate protections, it could jeopardize the ability of biotechnology researchers to continue to innovate. [19]

In June 2007, a bipartisan bill sponsored by Edward Kennedy (D- Mass.), and co-sponsored by Hillary Clinton (D- N.Y.), Orrin Hatch (R- Utah), Mike Enzi (R-Wyo.), and Charles Schumer (D- N.Y.), titled the Biologics Price Competition and Innovation Act of 2007 (“BPCIA”), was introduced to and unanimously passed by the Senate Committee on Health, Education, Labor, and Pensions. [20] The BPCIA seeks to balance patients’ needs for affordable biologic medicine with the needs for innovation in the biotechnology industry to continue to develop new therapeutics. [21]

 

This Note will discuss key provisions of the BPCIA and will analyze the likely impact of its passage on innovation in the biotechnology industry and patient access to lower cost biologic medicine. Part I will provide a brief background on biologics and the complexity of their manufacture. Part II will describe the regulation of small molecule drugs under the Food Drug and Cosmetic Act (“FDCA”) [22] and the regulation of biologics under the Public Health Services Act (“PHSA”). In addition, the Hatch-Waxman amendments to the FDCA that allow for abbreviated new drug applications (e.g., generics) will be discussed. [23] Part III will explain why legislative action is necessary for a viable path forward to abbreviated FDA approval of biologics. Part IV will describe key provisions of the BPCIA that lay the framework for regulation of follow-on biologics. Finally, in Part V, this Note will analyze the impact that enactment of the BPCIA might have on innovation in the biotechnology industry and patient access to lower cost biologic medicine….

 

Robert N. Sahr*

July 5 / All Articles, Patent

Rounding Up Plant Patents & Other Growing Patent Concerns a Comment on Monsanto v. Schmeiser

On the heels of their ubiquitous and controversial decision in Harvard College v. Canada (Commissioner of Patents) (the so-called ‘Harvard Mouse’ case), [1] the Canadian Courts were soon asked to re-consider the issues surrounding the patentability of biotechnological inventions in Monsanto v. Schmeiser. [2] Unlike Harvard Mouse, this matter was an infringement action. At the Trial Division, the crux of the action lay with Schmeiser’s alleged failure to obtain a license Monsanto’s patented [3] “Roundup Ready Canola” (a canola seed tolerant of glyphosate herbicides including Monsanto’s own “Roundup”). [4]

 

“The infringement alleged is by the defendants using, reproducing and creating genes, cells and canola seeds and plants containing genes and cells claimed in the plaintiffs’ patent, and by selling the canola seed they harvested, all without the consent or licence of the plaintiffs.” [5]…

 

 

Emir A. C. Mohammed

January 21 / All Articles, Computing, Patent

Can An Internet Reference Be A “Printed Publication”?

Much of the information to the public is provided by the Internet today. The Internet has also become increasingly popular among researchers who now turn to it for articles, journals, and online databases. [2] Therefore, the question of whether an Internet reference is a “printed publication” is critical for today’s inventors, patent attorneys, and judges. [3] It is important for inventors and patent attorneys because they decide whether to pursue a patent based on the existing prior art. [4] It is likewise important for judges because judges may be asked to resolve a dispute where the party challenging a patent’s validity offers an Internet reference as the potentially invalidating prior art. [5]

This Article argues that an Internet reference is a “printed publication” within the terms of Section 102 if it is accessible to the public and credible. This Article begins with a brief review of the “printed publication” requirement of Section 102. Next, it discusses two different theories that emerged interpreting the “printed publication” bar to patentability, focusing, in particular, on the impact of technological advancement on judicial interpretations of § 102. The Article then explores existing commentary on the matter and argues that while the commentaries address many crucial aspects of the statutory bar, they may nevertheless be insufficient in defining whether an Internet reference is a “printed publication.” The article continues by recommending that a “printed publication” requires both public accessibility and credibility. Accessibility should be dependent on the author’s or inventor’s intent to share his work with the public. Moreover, the Federal Rules of Evidence may be used to ensure the integrity of a reference. Lastly, the article analyzes the unanswered question in MercExchange v. eBay of whether a newsgroup posting is a “printed publication” within the terms of §102. [6] The article concludes that the newsgroup posting in MercExchange was not a “printed publication” because it was not publicly accessible; however, newsgroup postings could be “printed publications” if certain other requirements are met. [7]…

 

Joanna Toke [1]

January 1 / All Articles, Patent

Utility Models and Their Comparison with Patents and Implications For The US Intellectual Property Law System

Abstract–European Patent Office (EPO) practice, guided by the European Patent Convention (EPC) is in many aspects very similar to Europe’s national patent practice, such as the German patent law. In this article, the US practitioner is briefly reminded of some of the considerable differences between US Patent and Trademark Office (USPTO) patent prosecution practice and its European counterparts, primarily the EPO. The utility model is highlighted and discussed using the patent laws of Germany as a case study for comparison. Additionally, this paper examines the potential benefits of utility model protection in the US, as well as what changes would be required in order to minimize any negative impact of the introduction of such a new intellectual property (IP) right to the existing US legal system.

 

Introduction

 

USPTO and EPO patent prosecution practices differ in several respects. For example, a patent application to the EPO goes through a centralized application and prosecution phase, and, if granted by the EPO, this patent has the same effect as a national patent granted by all contracting states. Therefore a European patent (EP) is subject not only to the national law of the individual member states but also to the provisions of the EPC. During centralized prosecution at the EPO, patent claims are generally amended more easily than in the US, and without significant negative consequence. Finally, one of the more notable differences is that an EP application may be subject also to a centralized inter-parties opposition process at the EPO in which it may be granted in either its original or amended form or revoked.

 

Another important difference is that the USPTO has a “first to invent” system whereas the EPO is a “first to file” system. Thus, the earliest applicant may obtain an EP even if the invention was first invented or conceived of by another party. Also, an inventor has the right to be named on an EP application, but–in contrast to the US–the inventor on an EP application has the right to decline being named as an inventor on the patent application. In addition, and most importantly, incorrect naming of the inventor will not jeopardize the validity of the EP.

 

Also in contrast to US patent law, EP applications are required to have “absolute novelty.” For the purposes of the EP application, if the invention was known, described in a printed publication, or publicly used anywhere prior to the priority date of the EP application, novelty of the invention is destroyed. Thus the concept of a grace period is not known in Europe, generally, with the exception of a six-month grace period in extremely rare cases related to certain exhibitions or instances of evident abuse. Novelty of an EP application is destroyed also if the invention has been described in another EP application with an earlier priority date–even if it was not published before the priority date of the application under examination. However, even where such “special” prior art does carry an earlier priority date, it cannot be used for evaluating non-obviousness (inventive step) in the prosecution of an EP application.

 

The hurdle to demonstrate inventive step is often higher in EP practice. EPO examiners have never been under an obligation to demonstrate a prima facie case, for example, and they are able to base their arguments on what is generally known to one skilled in the art more than their US counterparts. Another key difference is that it is expected that inventive step in EPO practice will be argued on the basis of the “problem solution approach”, which consists of determining (1) the closest prior art, (2) the technical problem which the claimed invention addresses and solves in light of the closest prior art (the objective technical problem), and (3) examining whether the claimed solution to the objective technical problem is obvious to the skilled person in view of the state of the art in general. [i]

 

Furthermore, there is no requirement to specifically disclose a “best mode” in an EP application; an enabling mode is sufficient. Also, applicants for an EP are not under any requirement to disclose known prior art or evidence relevant to the patentability of an application to the EPO together with the application or later during its prosecution.

 

It is worth noting, finally, that European prosecution history estoppel has been a matter for national law rather than one for the EPO. With fairly limited exceptions, prosecution history estoppel does not exist in the member states of the EPO.

 

Dr. Hans-Peter Brack [a1]