Patent Docs

GMO Notification and Labeling Bill Introduced in the House

May 8, 2014

By Donald Zuhn —

Last month, Rep. Mike Pompeo (R-KS) introduced a bill in the House to amend the Food, Drug, and Cosmetic Act with respect to the commercialization of food produced from, containing, or consisting of a bioengineered organism. The bill (H.R. 4432), entitled the "Safe and Accurate Food Labeling Act of 2014," would require developers of bioengineered organisms (defined in the legislation as plants "contain[ing] genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques," wherein "the modification could not otherwise be obtained using conventional breeding techniques") to take several steps before the bioengineered organism is "introduced or delivered for introduction into interstate commerce for a food use or application." Among the required steps would be to provide a "premarket biotechnology notification" to the U.S. Food and Drug Administration or have the food containing the bioengineered organism evaluated under the FDA's voluntary consultation process.

Under the bill's premarket biotechnology notification scheme, the developer of a bioengineered organism would have to provide notification to the FDA at least 210 days before the bioengineered organism is first introduced or delivered for introduction into interstate commerce for a food use or application. Such notification would need to contain, inter alia, the basis for the developer's determination that the food containing the bioengineered organism is "as safe for use by humans or animals, as applicable, as one or more comparable marketed foods that are not produced from, do not contain, or do not consist of such bioengineered organism." Within 30 days of receipt of the notification, the FDA would have to inform the developer that the notification was complete or deficient, and if the notification was complete, the FDA would have to provide a substantive response with 180 days of informing the developer that the notification was complete.

With respect to labeling requirements under the bill, if the FDA "determines that there is a material difference between a food produced from, containing, or consisting of a bioengineered organism and its comparable marketed food and that disclosure of such difference is necessary to protect health and safety or to prevent the label or labeling of such food from being false or misleading," the FDA may "specify labeling that would adequately inform consumers of such material difference." The legislation indicates, however, that "[t]he use of bioengineering does not, by itself, constitute a material difference." The bill would also prohibit any State from establishing any requirement for the labeling of food that was developed or contains an ingredient that was developed using bioengineering.

Following introduction of the bill in the House, the legislation was referred to the Subcommittee on Health.
Guest Post: Patent Reform — Lessons from Capitalism’s Founding Father

May 6, 2014

By Gautham Bodepudi* —

There are those very vocal about proposing legislative amendments to the patent statutes, in an attempt to curb litigation abuse and thereby promote innovation.

The latest round of proposed amendments would allow the government to create a class protected from corporate veil piercing — holding investors and those outside of a protected class with interest in patent assets personally liable, where their infringement accusations in litigation fail to meet the "objectively reasonable" test. But protected from veil piercing would be inventors, law firms, universities, and companies with a track record of commercial activity.

The thinking here: threatening personal liability against investors will disincentivize those outside of the protected class from purchasing patents and filing lawsuits that may fail to meet the objectively-reasonable test. This in turn will reduce frivolous lawsuits, thereby reducing wasteful litigation and promoting innovation.

Seems simple enough, but will it work? Will the creation of a protected class of patent holders reduce the potential for litigation abuse and thereby promote innovation?

Unfortunately no — the protected-class approach will not only (1) fall short of reducing the potential for litigation abuse, but will also (2) threaten the capitalistic underpinnings of our Patent Clause, so much so Adam Smith, respectfully referred to as capitalism's "Founding Father," would turn in his grave.

(1) Why will the proposed protected-class legislation fall short of reducing the potential for litigation?

The proposed legislative amendments will not reduce litigation — they will simply shift the class of entities asserting patent lawsuits. Instead of traditional patent financers, patent monetization knowledge will shift to those in the protected class and to those that are well funded enough to move into a protected class.

As an example, well-funded patent financers will continue to operate by purchasing low-value operating companies and having them hold patent assets to litigate. By owning an operating company, even well-funded "trolls" can fall within a protected class.

Hence, the latest proposed legislative amendments will not eliminate litigation or its potential for abuse — they will only serve to shift the class of entities asserting patent lawsuits to those within the protected class.

(2) Perhaps most importantly, the proposed legislative amendments will be wholly and absolutely detrimental to America's innovation market.

Why?

To understand this, we must understand how capitalistic economies promote innovation — Adam Smith clearly laid out the framework in the well-known An Inquiry into the Nature and Cause of the Wealth of Nations.

Put simply, division of labor produces the greatest improvement of society's productive powers, including innovation. See Wealth of Nations, Book 1, Chapter 1, "Of the Division of Labor," I.1.1 ("The greatest improvement in the productive powers of labour, and the greater part of the skill, dexterity, and judgment with which it is any where directed, or applied, seem to have been the effects of the division of labour.") (emphasis added).

This division-of-labor principle is reflected in our innovation industry — some specialize at inventing and creating patented discoveries, others are better suited at financing, others yet are inclined towards manufacturing, and yet others are more skilled at marketing and distribution.

To maximize the power of the division-of-labor principle to our innovation industry, Smith explained that we need to do two things: (1) increase the innovation market size and (2) maximize exchangeability in the innovation market.

(1) Regarding the market size, this sets the upper bound of the division-of-labor principle. The larger the market, the greater potential for the division-of-labor principle to take foothold in the market place. See Wealth of Nations, Book I, Chapter III, "That the Division of Labour is Limited by the Extent of the Market," I.3.1 ("As it is the power of exchanging that gives occasion to the division of labour, so the extent of this division must always be limited by the extent of that power, or, in other words, by the extent of the market. When the market is very small, no person can have any encouragement to dedicate himself entirely to one employment, . . .") (emphasis added).

(2) Regarding exchangeability, Smith explained that the power of exchange is the driving force behind the division-of-labor principle — one man's surplus is exchanged for another's surplus. See Wealth of Nations, Book I, Chapter III, "That the Division of Labour is Limited by the Extent of the Market," I.3.1 ("As it is the power of exchanging that gives occasion to the division of labour . . . .").

And this power of exchange is the catalyst behind commercial growth and activity in any capitalistic society, including one that aims to promote innovation. See Wealth of Nations, Book I, Chapter IV, "Of the Origin and Use of Money," I.4.1. ("Every man thus lives by exchanging, or becomes in some measure a merchant, and the society itself grows to be what is properly a commercial society.").

So we can learn two things from Adam Smith. To promote innovation we must, one, increase the market size for innovation — we need more people specializing as inventors, financiers, manufacturers, distributors, and marketing specialists. And two, we need to maximize exchangeability — not only maximize exchangeability of the above skill sets, but also maximize exchangeability of patent assets — the asset class of innovation.

By maximizing the market and increasing exchangeability in the innovation market, Adam Smith instructs that this will promote the division-of-labor principle, which will in-and-of-itself propel innovation.

So if that's the goal, then why is the proposed protected-class legislation so contrary to these tenants of capitalism?

How is it so contrary?

1. By limiting the innovation market to just those that fit within a protected class, this reduces the overall market for innovation. Notably, those outside the protected class will be removed from the innovation market.

And who are those outside the protected class? Patent financiers — investors, fund raisers, brokers, valuators, monetization specialists.

Alarmingly, the protected-class legislation is attempting to remove this specialization — patent financing — from the innovation market.

But if we strip patent financing from the innovation market, then the successful inventors will be the ones blessed with financial means or an innate ability to fund raise. The successful start-up companies will be the ones with a bankroll or that can raise money on a competitive edge other than their IP. The successful law firms will be the ones that have monetization expertise and a large war chest to fund multi-front enforcement campaigns.

Removing the patent-financing specialization from the innovation market will force others in the protected class to adopt this specialization, on top of their native specialization.

But this contravenes the division-of-labor principle. If we want to promote innovation, we want more specializations, we want more people specializing in each segment, and we want them exchanging knowledge and expertise. We don't want to artificially strip specializations from the market, but this is exactly what the protected-class legislation is attempting to achieve.

As such, the protected-class legislation contravenes the division-of-labor principle and will hurt our innovation market — we don't want this.

2. The proposed protected-class legislation will artificially and significantly reduce the alienability, or exchangeability, of patent assets.

Unlike currency, gold, or real estate, a patent's value will be determined by those wielding it, rather than the intrinsic worth of the patented discovery itself. Why would we possibly want to limit patent exchangeability in such a manner?

Because the protected-class legislation artificially removes specializations from the market to the detriment of the division-of-labor principle, and reduces alienability of patent assets, it is entirely contrary to the tenants of capitalism and will therefore fail to promote innovation in our capitalistic economy.

Put simply, the proposed legislative amendments of forming a protected class will not promote innovation — it will be detrimental and damaging to it.

So, what's the solution?

Instead of trying to regulate litigation abuse through legislation aimed at attacking one group (patent financiers), why not let the courts regulate it? Aren't judges in the best position to determine if litigation abuse exists in a given case, and aren't they equipped with the authority to regulate it?

But isn't that how we got into our present state to begin with, by solely relying on the court system?

Perhaps, but perhaps that's why we're also seeing the Supreme Court make a strong statement of its intent to curb litigation abuse in Octane Fitness. In it, they lowered the bar and gave district courts more discretion to award attorney fees and award sanctions where it sees fit.

As represented by Octane Fitness, we are seeing the courts take an activist role to curb litigation abuse.

Instead of proposing short-sighted legislation that is entirely contrary to the capitalistic underpinnings of our economy and future, why not let the courts do their job?

* Mr. Bodepudi serves as a Managing Member for IP EDGE, which specializes in uncovering hidden value in IP assets and monetizing or acquiring such assets at a price point that maximizes value. Mr. Bodepudi negotiates and executes monetization strategies, directs marketing and lead-generation efforts, and provides client-service delivery.
Guest Post: The U.S. Government Continues to Have “Serious Concerns” with Canada’s Heightened Patent Utility Requirements

May 5, 2014

By Canadian Patent Utility Coalition* —

While the United States and Canada share a border, common values and a strong commitment to international trade and security issues, many are surprised to learn that protection of intellectual property (IP) is a source of significant friction in our relationship. Indeed, in its 2014 annual "Special 301" report released last week on IP practices overseas, the Office of the United States Trade Representative (USTR) again placed Canada on its "Watch List" for inadequate IP protection and enforcement. In making this determination, USTR highlighted in particular that Canada's application of heightened patent utility requirements is "leading to uncertainty for patent holders and applicants and undermining incentives for investment in the pharmaceutical sector". In comments filed with USTR leading up to the issuance of its 301 report, a number of organizations — including the U.S. Chamber of Commerce's Global IP Center (GIPC), Intellectual Property Owners Association (IPO), and the Canadian Patent Utility Coalition (CPUC) — detailed the negative impact of Canada's heightened and improper patent utility standard on U.S. jobs, innovation and competitiveness. USTR's Special 301 process shines a spotlight on the degree to which the Canadian utility standard is contrary to internationally accepted norms and its own trade obligations.

The Issue

It is common for patents involving innovative medicines to be litigated. Competitors often argue that a patent should not have been granted because the invention was obvious or was not really new. However, it is extremely rare for patents to be challenged for lack of usefulness or utility. This is because patents are typically challenged by those who wish to revoke the patent and market the product themselves. If an invention is not useful, it makes little business sense to bear the costs of challenging the patent. Conversely, if the product is actually in production and being used by customers, it should be difficult to demonstrate that the invention is not useful and never should have been patented.

Unfortunately, a pattern has developed in Canada whereby patents for innovative medicines are being challenged on the grounds that the inventions are not useful. Ironically, these challenges have come from companies seeking to have the patents revoked so that they can copy and market these medicines themselves. As a result, Canada has revoked valuable patents for nearly 20 useful medicines over the past nine years because the patents fail to satisfy Canada's unique patent standards. As noted by USTR, under this standard, courts are invalidating patents held by U.S. pharmaceutical companies on the basis of inutility, "even though such products have been in the market and benefiting patients for years".

Background: International and U.S. Patent Standards

Robust intellectual property protections are vital to the biopharmaceutical sector; adequate and effective patent protection, in particular, is what drives innovators to undertake enormous risks by investing in the research, development, and delivery of innovative new therapeutics to patients globally. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and North American Free Trade Agreement (NAFTA) require patents to be granted for inventions relating to all fields of technology that are new, result from an inventive step, and are "capable of industrial application." "Capable of industrial application" is synonymous with "useful" and is often referred to as the "utility" standard. Thus, TRIPS and NAFTA require signatories to provide patent protection to useful inventions that meet the other requirements for patentability.

The utility standard is by no means intended to be a burdensome requirement. It is designed simply to ensure that patents are not granted for inoperable, fanciful, or purely aesthetic inventions. For example, in applying the patent utility test, the United States Patent and Trademark Office and U.S. courts require simply that an invention's claimed utility be specific and practical. The patent utility test applied in the U.S. is very similar to the tests applied in the European Union and Japan, among most other industrialized nations. When a patent is challenged for a lack of utility under Section 101 of the Patent Act, U.S. courts focus on actual utility and will consider evidence developed and submitted after the filing of the patent application in evaluating an invention's utility. Specific utility can be shown where a pharmaceutical or biotechnology patent discloses a specific disease against which the claimed compounds are useful.

Importantly, U.S. courts have made it abundantly clear that the human testing necessary for U.S. Food and Drug Administration (FDA) approval is not a prerequisite for finding usefulness for a therapeutic under the patent laws. The FDA's focus on human testing to demonstrate the safety and efficacy of a therapeutic before it is sold on the market is distinct from the Patent Act's patentability requirements. At the same time, USPTO and the U.S. courts accept evidence of FDA approval of human clinical trials as creating a strong presumption that the utility standard has been met. The U.S. approach is consistent with the practices of most if not all other WTO members. Canada's approach is the exception, and is inconsistent with international standards.

Canada's Patent Utility Standard: An Insolvable Riddle for Patentees

Canada's utility test has three elements which taken together present a riddle that is impossible to solve.

• First, the court or CIPO subjectively construes the "promise of the patent" from the patent specification, sometimes going beyond a mere statement of use and also beyond that which is specifically claimed in the patent application. There is no similar concept under U.S. law or practice. For example, "promises" have been construed as treatment of disease over the long term for conditions deemed chronic. There is no way to know in advance how the "promise" might be construed by the Court or Canada's Intellectual Property Office (CIPO).

• Second, the court or CIPO, using a heightened evidentiary standard of proof, determines whether utility is demonstrated by reference to the promise of the patent. As in the first test, there is no way a patentee can know in advance whether enough proof has been provided. For example, even completed human clinical trials have been found inadequate to demonstrate utility in Canada where the courts have questioned the size or duration of the trials. This stands in sharp contrast to U.S. practice, as noted above, where data from human clinical trials (even those trials conducted after filing of the patent application) create a presumption of usefulness.

• Third, if utility is not demonstrated, the court or CIPO determines whether, at the time of the filing, there was a "sound prediction of utility." In Canada, evidence of utility generated after the filing date is not considered and only evidence contained within the application may be used as proof of utility. This last prong creates heightened disclosure requirements inconsistent with U.S. practice, which does not require evidence of utility to be found within the specification as of the filing date.

The Consequences of Canada's Application of its Outlier Patent Utility Standard

Since the "promise" of the patent is construed by the court years after the filing date, the promise doctrine leads to great uncertainty among innovators as it is now unclear how much information is required at the time of filing to meet these new, onerous requirements. Moreover, this judicially-created utility doctrine applies a shifting standard that places applicants and patentees in an untenable "Catch-22" predicament: To be patentable, useful inventions must also be novel and inventive over all prior art available at the patent filing date. If an applicant aims to meet Canada's enhanced test for proof of utility, which may include carrying out long-term clinical trials prior to filing a patent application, the applicant would have to delay patent filings in Canada and other countries such as the United States. Such delays would increase the risk of patent refusal and patent invalidity in numerous countries on the basis of prior art published during the long-term clinical trials.

Canada's approach to utility is also inconsistent with the patent laws of similarly-situated economies and impedes ongoing efforts to achieve patent harmonization internationally. The Canadian approach is strikingly out of step with the first-to-file rule of the America Invents Act, which encourages early filing. It also compromises the ability of innovators to file patents in Canada using an international application under the Patent Cooperation Treaty (PCT), which has less onerous disclosure obligations. Moreover, the results in Canadian cases contradict those in the United States and Europe: pharmaceutical patents found to lack utility by Canadian courts have been upheld as having utility in U.S. and European proceedings, if utility is challenged at all.

Moreover, Canada's promise doctrine, in practice, has discriminated against a particular area of technology — the biopharmaceutical sector. Since 2005, all patent revocations based on utility in Canada have involved pharmaceutical patents.[1] Given the disproportionate impact of the promise doctrine on the biopharmaceutical sector, Canada is failing to meet its international obligation to apply patent standards in a non-discriminatory manner across different technologies. The graphic below illustrates the disproportionate impact on drug patents.

Conclusion

The heightened test applied by Canada is substantially different from the test required under TRIPS and NAFTA. Parties to these trade agreements cannot redefine core terms like "useful" and "capable of industrial application" without fundamentally changing the essence of the agreements. Canada's substantial redefinition of "usefulness" has severely undermined patent protection for innovators.

* The Canadian Patent Utility Coalition (CPUC) represents 19 innovative companies who are extremely concerned about Canada's heightened and improper patent utility standards which are causing significant economic harm and uncertainty to innovative companies. To learn more about CPUC and its views, please refer to the group's Special 301 Written Submission (footnote 1 of the submission provides a list of the member companies).

[1] In only one case outside the pharmaceutical sector have any challenged claims been found to lack utility; a distinct claim under the same patent was upheld as useful, such that the patent remained valid. See Bell Helicopter Textron Canada Limitée v. Eurocopter, 2013 FCA 219.
Court Report

May 4, 2014

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Cephalon Inc. v. Uman Pharma Inc.
1:14-cv-00568; filed April 30, 2014 in the District Court of Delaware

Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) and 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013) following a Paragraph IV certification as part of Uman's filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma). View the complaint here.

Celgene Corp. et al. v. Fresenius Kabi USA LLC
1:14-cv-00571; filed April 30, 2014 in the District Court of Delaware

• Plaintiffs: Celgene Corp.; Astellas Pharma Inc.
• Defendant: Fresenius Kabi USA LLC

Infringement of U.S. Patent Nos. 7,608,280 ("Method of Producing FR901228," issued October 27, 2009) and 7,611,724 (same title, issued November 3, 2009) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Celgene's Istodax® (romidepsin for injection, used to treatment of peripheral and cutaneous T-cell lymphoma). View the complaint here.

Amarin Pharma, Inc. et al. v. Dr. Reddy's Laboratories, Inc. et al.
3:14-cv-02760; filed April 30, 2014 in the District Court of New Jersey

• Plaintiffs: Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendants: Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.

Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc.
1:14-cv-00901; filed April 25, 2014 in the Northern District of Ohio

• Plaintiffs: Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendant: Roxane Laboratories, Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,293,728 ("Methods of Treating Hypertriglyceridemia," issued October 23, 2012), 8,318,715 (same title, issued November 27, 2012), 8,357,677 (same title, issued January 22, 2013), 8,367,652 (same title, issued February 5, 2013), 8,377,920 (same title, issued February 19, 2013), 8,399,446 (same title, issued March 19, 2013), 8,415,335 (same title, issued April 9, 2013), 8,426,399 (same title, issued April 23, 2013), 8,431,560 (same title, issued April 30, 2013), 8,440,650 (same title, issued May 14, 2013), 8,501,225 ("Stable Pharmaceutical Composition and Methods of Using Same," issued August 6, 2013), 8,518,929 ("Methods of Treating Hypertriglyceridemia," issued August 27, 2013), 8,524,698 (same title, issued September 3, 2013), 8,546,372 (same title, issued October 1, 2013), 8,551,521 ("Stable Pharmaceutical Composition and Methods of Using Same," issued October 8, 2013), and 8,617,594 (same title, issued December 31, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Amarin's Vascepa® (icosapent ethyl, used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia). View the Dr. Reddy's complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Amneal Pharmaceuticals, LLC et al.
3:14-cv-02700; filed April 28, 2014 in the District Court of New Jersey

• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Amneal Pharmaceuticals, LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. India Private Ltd.

Infringement of U.S. Patent No. 8,642,600 ("Method of Treating Autism," issued February 4, 2014) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder, schizophrenia, and austistic disorder, and as an adjunctive treatment of major depressive disorder). View the complaint here.

Medicines Company v. Exela Pharma Sciences, LLC et al.
5:14-cv-00058; filed April 25, 2014 in the Western District of North Carolina

• Plaintiff: Medicines Company
• Defendants: Exela Pharma Sciences, LLC; Exela Pharmsci, Inc.; Exela Holdings, Inc.

Infringement of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued September 1, 2009) and 7,598,343 (same title, issued October 6, 2009) following a Paragraph IV certification as part of Exela's filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty). View the complaint here.

Dow Pharmaceutical Sciences, Inc. et al. v. Actavis, Inc. et al.
2:14-cv-02661; filed April 25, 2014 in the District Court of New Jersey

• Plaintiffs: Dow Pharmaceutical Sciences, Inc.; Valeant Pharmaceuticals North America LLC
• Defendants: Actavis, Inc.; Watson Laboratories, Inc.; Andrx Corp.; Watson Pharma, Inc.

Infringement of U.S. Patent No. 8,663,699 ("Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent," issued March 4, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Dow's Acanya® (clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%, used to treat acne). View the complaint here.

AbbVie Inc. et al. v. Hetero USA Inc. et al.
1:14-cv-00543; filed April 24, 2014 in the District Court of Delaware

• Plaintiffs: AbbVie Inc.; Abbvie Deutschland GmbH & Co. KG
• Defendants: Hetero USA Inc.; Hetero Labs Ltd.; Hetero Labs Ltd.; Hetero USA Inc.

Infringement of U.S. Patent Nos. 8,470,347 ("Self-Emulsifying Active Substance Formulation and Use of This Formulation," issued June 25, 2013) and 8,399,015 ("Solid Pharmaceutical Dosage Form," issued March 19, 2013) following a Paragraph IV certification as part of Hetero's amendment of its ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection). View the complaint here.
Conference & CLE Calendar

May 4, 2014

May 6, 2014 – GW Law Symposium on Intellectual Property (George Washington University Law School, Mayer Brown, and Pillsbury) – George Washington University Law School

May 13-15, 2014 – Fundamentals of Patent Prosecution 2014: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – Chicago, IL

May 14-15, 2014 – EU Pharmaceutical Law Forum*** (Informa Life Sciences) – Brussels, Belgium

May 15, 2014 – "Patent Subject Matter Eligibility: Navigating the New 'Myriad' Guidelines — Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework" (Strafford) – 1:00 to 2:30 pm (EDT)

May 22, 2014 – "Patent Infringement: Structuring Opinions of Counsel: Leveraging Opinion Letters to Reduce the Risks of Liability and Enhanced Damages" (Strafford) – 1:00 to 2:30 pm (EDT)

June 4, 2014 – "Patent Due Diligence Post-AIA: Avoiding Dangers of Inadequate Investigation — Evaluating Validity of Key Patents, Identifying Enforceability Issues, Addressing New Considerations Under the AIA" (Strafford) – 1:00 to 2:30 pm (EDT)

June 4-6, 2014 – Biosimilars*** (American Conference Institute) – New York, NY

June 9-10, 2014 – Hatch-Waxman Boot Camp*** (American Conference Institute) – Chicago, IL

June 10, 2014 – "'Standing Out' — The Supreme Court's Redefined Standard for Fee Shifting in Patent Litigation, and How It Might Impact 'Patent Troll' Litigation" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

June 11-13, 2014 – Fundamentals of Patent Prosecution 2014: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

July 9-11, 2014 – Fundamentals of Patent Prosecution 2014: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

***Patent Docs is a media partner of this conference or CLE
Webinar on Supreme Court Octane Fitness and Highmark Decisions

May 2, 2014

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "'Standing Out' — The Supreme Court's Redefined Standard for Fee Shifting in Patent Litigation, and How It Might Impact 'Patent Troll' Litigation" on June 10, 2014 from 10:00 am to 11:15 am (CT). Patent Docs contributor and MBHB attorney Dr. Andrew W. Williams and MBHB attorney Erin R. Woelker will cover the potential implications of the Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc. decisions on fee-shifting in patent litigation, especially in cases involving these "patent trolls." The webinar will address the following topics:

• An overview of the fee shifting statute § 285 and how it has been applied in federal court;
• A review of the Octane and Highmark cases and an analysis of the new standard for obtaining attorney fees;
• A discussion of how the broadened "exceptional case" test may be applied by courts going forward, including a review of the fee-shifting provision under the Copyright Act; and
• A discussion of the implications of these decisions on "patent troll" litigations, and the impact they might have on the legislation aimed at curbing abusive litigation currently pending in Congress.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.
Hatch-Waxman Boot Camp

May 2, 2014

American Conference Institute (ACI) will be holding the next session of its Hatch-Waxman Boot Camp conference on June 9-10, 2014 in Chicago, IL. ACI faculty will help attendees:

• Understand the interplay of between the PTO and FDA in the patenting of drugs and biologics;
• Learn about the essentials of the FDA approval process and its link to biopharmaceutical patents;
• Develop an in-depth and practical knowledge of Hatch-Waxman protocols;
• Navigate the intricacies of patent term adjustment and patent term extension; and
• Comprehend how the BPCIA biosimilars pathway for large molecules will compare to the Hatch-Waxman schematic for small molecule.

In particular, ACI's faculty will offer presentations on the following topics:

• Key agencies overview: Understanding the jurisdiction and interplay of the FDA and PTO in the patenting of drugs and biologics;
• Exploring the link between the FDA approval process and the patenting of drugs and biologics;
• IP overview for drugs and biologics: Hatch-Waxman, BPCIA, trade dress, and more;
• ANDA litigation 101: Paragraph IV disputes primer;
• Orange Book listings, de–listings, and related challenges;
• Bioequivalence and the "same active ingredient" vis-a-vis patentability;
• An in-depth look at 180-day exclusivity;
• Comprehending the intricacies of non-patent/regulatory exclusivity;
• Assessing patent protections afforded under the safe harbor; and
• Examining pharmaceutical patent extensions: Patent Term Adjustment and Patent Term Restoration.

A post-conference interactive biosimilars strategy session, entitled "Biosimilars 101: Interpreting the Law, Appreciating the Science, Anticipating Regulations and Preparing for Litigation," will be offered from 9:00 am to 12:00 pm on June 11, 2014.

The agenda for the Hatch-Waxman Boot Camp conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,295 (conference alone) or $2,895 (conference and workshop). Those registering by May 9, 2014 will receive a $300 discount. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Hatch-Waxman Boot Camp conference.
Webinar on Patent Due Diligence Post-AIA

May 2, 2014

Strafford will be offering a webinar/teleconference entitled "Patent Due Diligence Post-AIA: Avoiding Dangers of Inadequate Investigation — Evaluating Validity of Key Patents, Identifying Enforceability Issues, Addressing New Considerations Under the AIA" on June 4, 2014 from 1:00 to 2:30 pm (EDT). Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner; Donna M. Meuth, Associate General Counsel for Eisai; and Lauren L. Stevens of Global Patent Group will provide guidance to patent counsel regarding the impact of the America Invents Act (AIA) on patent due diligence, and offer best practices for conducting due diligence in light of the AIA. The webinar will review the following questions:

• How do the AIA and recent court decisions affect the due diligence process?
• Is an application correctly filed in the name of the applicant or should it be filed in the name of the inventors because it is under the old 120/119(e)?
• What changes should patent counsel make in the due diligence process as a result of the AIA?

The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those registering by May 9, 2014 will receive a $50 discount. Those interested in registering for the webinar, can do so here.
Rep. Anna Eshoo to Address Congressional Battle for Biotech on BioCentury This Week

May 2, 2014

Rep. Anna Eshoo (D-CA) will appear on BioCentury This Week on Sunday, May 4 to address "The Congressional Battle for Biotech." BioCentury This Week television host Steve Usdin will interview Rep. Eshoo about her life sciences agenda, in which Rep. Eshoo:

• Makes the case for increasing funding for federal health R&D;
• Suggests that Congress create a "safe harbor" for companies that provide compassionate access to experimental drugs;
• Says the FDA needs to do more to make the biosimilars pathway work; and
• Calls for Congress to write "rules of the road" for personalized medicine.

The interview can be viewed on WUSA from 8:30 to 9:00 EST or online at www.biocenturytv.com beginning at 9:00 am EST.
Sherry Knowles “Speaks Truth to Power” on the PTO’s § 101 Guidelines

May 1, 2014

By Kevin E. Noonan —

Last week, Sherry Knowles, former chief patent counsel for GlaxoSmithKline and now principal at Knowles Intellectual Property Strategies, LLC submitted to Managing Intellectual Property magazine a detailed critique of the U.S. Patent and Trademark Office's Guidelines for examination under Section 101 of the Patent Act in view of the Supreme Court's opinions in Mayo v. Prometheus and AMP v. Myriad Genetics. Her detailed (and critical) assessment of the Guidelines was prompted by a spirited defense of those Guidelines by Drew Hirschfield published by MIP in its March 4th issue, which in turn was occasioned by Ms. Knowles' assertion on March 26th at a MIP-sponsored panel session where, among other things, she characterized the Guidelines as "horrifying to the pharmaceutical and biotech industry."

Ms. Knowles raises the issue recognized by many in the patent community upon first inspection of the Guidelines: rather than merely attempting to administer the Court's decisions by limiting them to their facts (a particularly appropriate approach in view of the fact-specific bases for the Court's decisions in each case), she asserts that "these Guidelines appear to expand the Supreme Court analyses, apply the expanded analysis to products and methods that have not yet been litigated, and in doing so arguably de facto expand the law, which currently stands only in the form of judicial exceptions to patentability." These are not prospective or potential problems; Ms. Knowles rightly notes that this expansion of the "natural products" judicial exception is forming the grounds for rejecting U.S. patent applications now, and that the expected consequence (delay in obtaining patent protection and uncertainty about the validity and scope of such protection) could easily "chill[] any ability to attract venture capital and strip[] the value of numerous emerging life science companies."

She also raises the specter of the U.S. being out of step with the rest of the world, noting that many U.S. trade partners and competitors on the world stage (including the countries of Europe, China, Australia, Japan and Russia) grant patent protection for products now outside U.S. patent protection (according to the Guidelines) and that this reality threatens the U.S.'s position as a global biotechnology leader. Insofar as developing countries look to the U.S. to lead, these Guidelines encourage the sort of "anti-innovation" sentiments the U.S. has long opposed (for example, those preventing pharmaceutical patenting that were part of the impetus for the GATT treaty).

Ms. Knowles asks a simple but fundamental question: How did we get here? In her analysis, which reviews the Constitutional approach to patent protection as implemented by U.S. patent law and in particular, the 1952 Act, places at least some of the blame for the current circumstance on Congress, which "has only issued one sentence on what constitutes patentable subject matter in the United States." As a consequence, the "great void" created by this lack of attention has been filled by the Supreme Court, which is "immune from the political process" and lacks the resources needed to appreciate the effects on U.S. innovation its economy of its policy decisions. This institutional lack of competence is illustrated by the Court's decision in Funk Bros. Seed Co. Vs. Kalo Inoculant Co. (333 U.S. 127; 68 S.Ct 440 (1948), which forms the basis for the PTO's interpretation of the Court's recent cases. (Indeed, in a panel discussion at the Spring BIO IPCC meeting last week in Palm Springs, the Office's reliance on Funk Bros. was readily acknowledged by its representative on the panel.) Ms. Knowles notes that the "fatal flaw" in Kalo's patent claim (Claim 4 of U.S. Patent No. 2,200,532) was that it attempted to encompass all combinations of Rhizobium species that could permit growth in each other's presence, a case of "an aspiration which defined the material not by what it is but by what it does." This problem is one governed not by Section 101 of the Patent Act but rather Section 112, first paragraph (now Section 112(a)), for failure to provide an adequate written description of the invention. Rather than rely on this principle (which, while as recited was part of the revisions to the patent laws enacted four years after Funk Bros., but which was already enshrined in prevailing law), the Court relied on its "gut-feel that if one simply tells the public to find a bacteria that works, and use a prior art method to do so, that alone is not patentable." The result was "immeasurable damage []caused by using 101 as the rationale and with expansive, unnecessary and not politically tested verbiage that any mixture of natural materials is not patentable." (As close readers of the opinion have long recognized, Ms. Knowles references Justice Frankfurter's concurring opinion which is much more informative than Justice Douglas's principle opinion on the Court's concern and intended scope of its opinion.) And she puts paid to the misunderstanding of the case (that persists even today on the Court and particularly in the PTO) by citing Judge Giles S. Rich (author of the 1952 Patent Act) on this issue:

The real vice or inadequacy of the judge-made requirement for "invention" was in the truism Mr. Federico [one of the drafters of the 103 statute] restated, "the so-called standard of invention is an unmeasurable quantity having different meanings for different persons." It left every judge practically scott-free to decide this often controlling factor according to his personal philosophy of what inventions should be patented, whether or not he had any competence to do so or any knowledge of the patent system as an operative socioeconomic force. This was too great a freedom because it involved national policy which should be declared by Congress, not by individual judges or even groups of judges on multiple-judge courts.

Per Judge Rich, the test for "invention," as that term was inexactly used for many years by the Court, is embodied in Section 103 and adoption of that section of the patent law evinces Congress's judgment on how best to put into effect the Constitutional purpose of the patent grant.

Fast forward to the present day, and Ms. Knowles assays the current Court's statements in its Mayo and Myriad decisions showing that these principles and appreciation of Congressional intent have been forgotten if ever appreciated at all. She notes that the Court has expressly stated that "mere discovery" does not satisfy the legal standard for invention, which requires the Court to ignore the words of the statute that "Whosoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor," and asks "[d]oes the Supreme Court have the right to pencil out two very important words of a statute? Can the Supreme Court decide to honor only part of a statute and judicially except the rest?" This is not interpreting the law, Ms. Knowles contends; it is changing it (and about that she is completely correct).

The next section of her piece is perhaps the most salient to the policy question raised by the Court and improvidently addressed by the Guidelines. Relying on a 2012 report from the National Institutes of Health, Natural Product Branch, she recites the statistics relating to the number of FDA approvals (a total of 1,355) for new drugs falling into the following categories:

Drug type/source                                Number

Biological (B)                                            203

Natural product (N)                                    55

Natural product (botanical) (NB)               149

Derived from a natural product (ND)          298

Totally synthetic (S)                                  393

Total synthesis/natural product (S*)           176

Vaccine (S)                                                 81

These statistics illustrate the consequences of the Court's and the Office's policymaking; of the 1,355 drugs approved between 1981 and 2010:

• 968 (71%) are outside the scope of the Guidelines

• 636 (47%) are B, N, NB, and V

• 50% of all small molecule drugs are natural products (2000-2010)

• About 75% of antibacterial drugs are natural products or derived from natural products

• Almost 80% of small molecule anticancer drugs were natural products or derivatives

The Report also has specific information on particular drugs among these different catagories.

Ms. Knowles does not state the obvious: these statistics are chilling. It is of particular note that during the 1982-2010 timeframe only 15% of approved drugs were biologics; every study has shown that the percentage of drugs that are biologics has been growing and will be the predominant type of drug developed in the 2011-2030 time period. And these drugs are the among the ones that the PTO would preclude from patenting, based on its over-interpretation of the Court's decisions in Mayo and Myriad.

In closing, Ms. Knowles does not shy away from the implications of her analysis, that what we have here is a breakdown of the separation of powers that is the basis of our Federal government. The Supreme Court is legislating rather than interpreting the law, and Congress seems unable to identify the portions of the patent law that are actually important for innovation, producing the legislative void the Court has taken upon itself to fill. She notes that the Guidelines cite the "judicial exceptions to patent[-eligibility]" eighty-two times, without citing the relevant language of the Patent Act at all. The short term answer may be as simple as having the Office listen to the patenting community and the outrage the Guidelines have created, but that may be a false hope: the Office was tone-deaf enough to promulgate these Guidelines without notice and comment (which, even if not necessary would have alerted the relevant parties to provide whatever counter-arguments they are now raising after the fact). And she is even more hopeful in calling for us all to "encourage our Congressional representatives to open the political process to update the patent statutes, and in doing so, provide the necessary clarity and leadership on patentability in this complex technology space and override the Supreme Court's 'judicial exceptions to patentability.'" The solution may be as simple as the Office rescinding these Guidelines, publishing them for notice and comment, and then working with its relevant stakeholders to find a workable compromise. No matter how this is resolved, we owe it to ourselves if not the public to try to educate our leaders on these important issues.

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