Patent Baristas

Korea is a first-to-file or absolute novelty country, which does not allow an invention to be made available to the public (anywhere in the world) before filing an application for the invention.  Specifically, Article 29(1) of the Korean Patent Act provides that the novelty of an invention is destroyed where:

• the invention was publicly known or publicly worked in Korea or a foreign country prior to the filing date of the patent application therefor; or
• the invention was described in a publication distributed in Korea or a foreign country or was made publicly available through the telecommunication lines, as prescribed by the

In most cases, for an invention to qualify as being publicly known, the public must be able to comprehend the invention through the acts conveying the knowledge upon the public. Thus, a public test of the invention conducted by the inventor or assignee would not qualify as being publicly known if the inventive features were concealed from the public.

Safe Harbor Requirements

Article 30, Paragraph 1 of the Korean Patent Act provides a safe harbor provision allowing an applicant to maintain the novelty of their invention if the patent application is filed within six months of the date that the novelty was destroyed, per Article 29(1), and if the circumstances of the events satisfy any of the following:

1. when a person with the right to obtain a patent causes the invention to fall under either subparagraph of Article 29(1) [except for a laid-open publication or patent registration publication in or outside of Korea under a treaty or law]; or
2. when, against the intention of a person with the right to obtain a patent, the invention falls under either subparagraph of Article 29(1).

The current Korean Patent Act (effective March 3, 2006) now allows applicants to take advantage of the safe harbor regardless of the type of novelty-destroying events.

Procedure for Invoking the Safe Harbor Provision

A prospective applicant who wishes to take advantage of the safe harbor provision must submit a written statement to the Korean Intellectual Property Office (KIPO) Commissioner, stating his or her intention to do so. This statement must be submitted contemporaneously with the filing of a patent application prior to the expiration of the six-month grace period. The prospective applicant must also submit a document to the KIPO Commissioner proving the relevant facts, within thirty-days of filing the patent application.

For applications entering the Korean national phase based on a PCT application, the statement and proving document need to be submitted to the KIPO commissioner within thirty-days of filing the request for examination in Korea, or within thirty-days after the deadline for entering the Korean national phase (thirty-one-months from the earliest filing date in a Paris Convention country), whichever is earlier (Article 201(4)). It should also be noted that the PCT application (request) must indicate that novelty destroying events occurred in order to preserve the right to claim the safe harbor provision after entering the Korean national phase.

The Free Trade Agreement (FTA) currently pending between the U.S. and Korea requires Korea to extend the grace period to one year if the FTA is ratified by both countries.

(via Kim & Chang, Seoul, Korea)

The USPTO has issued “Interim Examination Instructions For Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101” to be used by patent examiners during examination. These instructions supersede previous guidance on subject matter eligibility.

These instructions  must be “really” important given the extraordinarily “high” number of “unnecessary” quotation marks.  Maybe the USPTO could benefit from subscribing to the “Blog” of “Unnecessary” Quotation Marks.

INTERIM EXAMINATION INSTRUCTIONS FOR EVALUATING SUBJECT MATTER ELIGIBILITY UNDER 35 U.S.C. § 101

To pass the threshold eligibility inquiries of § 101 for patent protection, a claimed invention must be directed to statutory subject matter and must be useful. Thus, under § 101 two separate patent eligibility considerations are raised: (1) subject matter and (2) utility.

Subject Matter Eligibility

The following two step analysis is used for determining subject matter eligibility:

1. Step 1: Is the claim directed to one of the four patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
2. Step 2: Does the claim wholly embrace a judicially recognized exception, which includes abstract ideas, mental processes or substantially all practical uses (pre-emption) of a law of nature or a natural phenomenon, or is it a particular practical application of a judicial exception?

Processes (methods)

A process claim, to be statutory under § 101, must pass the machine-or-transformation test (M-or-T test) – at least until the Supreme Court reverses this test.

In accordance with the M-or-T test, the claimed process must:

1. be tied to a particular machine or apparatus (machine implemented); or
2. particularly transform a particular article to a different state or thing.

A method claim that does not require machine implementation or does not cause a transformation will fail the test and should be rejected under § 101:

However, the mere presence of a machine tie or transformation is not sufficient to pass the test. When a machine tie or transformation has been identified, it must be further determined that the tie is to a particular machine or the particular transformation is of a particular article.

Additionally, the particular machine tie or particular transformation must meet two corollaries to pass the test for subject matter eligibility. First, the use of the particular machine or transformation of the particular article must impose a meaningful limit on the claim’s scope. So, a machine tie in only a field-of-use limitation would not be sufficient. Second, the use of the particular machine or the transformation of the particular article must involve more than insignificant “extra-solution” activity. If the machine or transformation is only present in a field-of-use limitation or in a step that is only insignificant “extra-solution” activity, the claim fails the M-or-T test, despite the presence of a machine or a transformation in the claim.

Insignificant “extra-solution” activity means activity that is not central to the purpose of the method invented by the applicant. For example, gathering data to use in the method when all applications of the method would require some form of data gathering would not impose a meaningful limit on the claim.

You can see the whole set of interim guidelines (pdf) here.

Bill Bennett, of Pizzeys in Australia, sent a note detailing how in order to be eligible for an extension of term, the patent in question must claim “one or more pharmaceutical substances per se”, and there must have been a delay of more than 5 years between the date on which the patent was filed and the date of first marketing approval.  See the earlier description of the eligibility requirements for pharmaceutical patent term extension.

Historically, difficulties have arisen where the pharmaceutical substance is claimed in combination with a delivery device, typically a patch or implant. There are a number of office decisions where patents for trans-dermal patches have been found ineligible for an extension on the basis that such a claim is not directed to a “pharmaceutical substance per se”.

In a recent patent office decision (N.V. Organon [2009] APO 8), in which a patent for a steroid-impregnated, polymeric implant was found to be eligible for an extension, the patent office held that the proper approach was to look at the level of integration between the pharmaceutical substance and the associated delivery device in deciding whether the claim should be regarded as being directed to a pharmaceutical substance per se (extension possible) or to a pharmaceutical substance in combination with a separate feature (extension not possible).

Pursuant to the N.V. Organon decision, wherever possible, the claims of a patch patent should not be limited by reference to the backing layer of the patch as this was likely to be held to be a “separate feature” which would make the patent ineligible for extension.

The patent office has now handed down its first patch decision subsequent to the N. V. Organon decision, LTS Lohmann Therapie-Systeme AG and Schwarz Pharma Limted [2009] APO 16. The claims in question included reference to the backing layer. As predicted, the office found the patch patent ineligible for extension.

The patent related to a transdermal therapeutic system (transdermal patch) to deliver the D2 receptor agonist rotigotine), for the purpose of treating Parkinson’s syndrome. Transdermal administration of rotigotine via a patch is known in the art, but the invention lies in the matrix formulation which allows administration of the active, free base form of rotigotine, improved release of the agonist from the patch, and ease of manufacture.

It was found that the claimed pharmaceutical compound comprised three components – a polymer matrix containing rotigotine, an inert backing layer and a protective layer. It was further found that the claimed product as a whole, comprising a protective layer which is to be removed before use, constituted a pharmaceutical substance in combination with a separate integer, and consequently the application does not satisfy the requirements of s 70(2)(a) and the patent cannot be granted an extension of term. Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 and Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77 applied.

In this latest patch case, the patentee erred in claiming the backing layer. The additional claim limitation of “an inert backing layer” appears to have been unnecessary to achieve patentability and had the unintended consequence of making the patent ineligible for extension.

Dinesh Vadhia, CEO of Xyggy Corporation, gave us an early look at a new patent search tool Xyggy Patent, which allows you to search for similar patents using known patents as the query.

The queried patents are selected by patent number or patent title and the results are returned in ranked order according to their relevance to the referenced patent.

“Our paradigm for search is based on the fundamental idea that search should be item-based not just text-based, and that a query based on items provides substantial advantages and additional information as compared to queries involving only keywords.”  ~Xyggy Patent

As an example, we did a search for the Bayer patent for drospirenone (U.S. Pat. No. 6,787,531).  The search box has an auto-complete function so entering “6787531” brings up the patent but entering just the title “Pharmaceutical composition for use as a contraceptive” also brought up the correct patent.

In a comparison, a search of Google Patents brought up the ‘531 patent and just three related patents, ranked according to popularity where Xyggy Patent found 19 pages of patents  and ranked them based upon how similar they are to the Bayer patent.

The search results are presented as titles only but a mouse over brings up a pop-up box with various pertinent details like the title and a portion of the abstract.

The coverage for Xyggy Patent is US patents from 1976 to end-June ’09 and they’ll begin regular updates in September.  It is clearly still in the early stages and mentions expanding to further types of searches including dating services and biotechnology sequences.  Whether those two things should ever come from the same entity we’ll leave for another day.

Disclaimer: No offense meant to Will Smith.

The two most important questions for a firm are: “How does the firm make money?” and “How can the firm’s intellectual property help the firm make money?”
~ The Business of Intellectual Property

Intellectual property practices may be borne of law and precedents but the real domain of IP is business.  Woe Unto You, Lawyers! who do not understand the fundamentals of business practices.

In “The Business of Intellectual Property” (Oxford University Press, USA), Chris Arena and Ed Carreras detail the growing importance of intellectual property assets from both legal and business perspectives, and offer strategic advice on how to manage IP assets for competitive advantage, profitability and return on investment.

Focusing on the interplay of law and business, The Business of Intellectual Property combines statutory frameworks, case law, business and legal principles of accounting and valuation, and various case studies of successful companies, to give readers practical advice needed to integrate these processes into their own company’s operations.

Gleaning knowledge from businesses as diverse as twin pop frozen novelties to mp3 music files, the authors guide the reader through the application of various intellectual property rights to real life-and-death competitive struggles in business.  The various cases studies show that almost any business can gain through better extraction of value out of their IP assets.

This book is not just a text stating the obvious that IP makes money.  While the overarching goal of a business is to make money, that goal is only achievable through individuals and The Business of Intellectual Property discusses what motivations support the goal of innovation within the business to gain a competitive advantage.

While not a light read, there is plenty of value available for the reader.

About the Authors

Christopher M. Arena is a partner in Woodcock Washburn LLP, a national intellectual property firm with offices in Atlanta, Philadelphia, and Seattle. He is the former Chief Intellectual Property Counsel at Cingular Wireless.

Eduardo M. Carreras is of counsel with the Atlanta office of Woodcock Washburn LLP. He is the former Chief Intellectual Property Counsel of the Coca-Cola Company.

“The Business of Intellectual Property” by Chris Arena and Ed Carreras (412 pages; Oxford University Press, USA)  is available through Amazon.

SCOTUScast is presenting a podcast debate between Professor Michael Risch (WVU) and Professor Joshua Sarnoff (American) on the In re Bilski case.  They each filed competing amicus briefs before the en banc panel last year, and so are ideal opponents.

This 30-minute podcast, part of a podcast series called SCOTUSCast run by the Federalist Society, is a summary of the case and all of the issues that will be raised in argument.  The podcast is available for download at iTunes (via the SCOTUSCast podcast series), or at the Federalist Society’s website.

Bilski v. Doll – Cert Granted SCOTUScast – MP3
Running Time: 00:31:25

In the In re Bilski case, a patent application for a method of hedging risks in commodities trading was rejected by the examiner and review board. The patent examiner rejected the application on the grounds that the invention is not implemented on a specific apparatus, and only manipulates an abstract idea which cannot be used in the technological arts. Bilski appealed to the Board of Patent Appeals and Interferences, which also rejected the application, but on the grounds that the applicants’ claims did not involve any patent-eligible transformation because there was no transformation of physical subject matter from one state to another, and non-physical financial risks do not qualify for patent-eligible subject matter.

The U.S. Court of Appeals for the Federal Circuit upheld the rejections of the Board, holding that the issue at hand is whether the method is patentable, and referred to previous Court decisions that determined that patent-eligible processes do not include abstract ideas.  The Supreme Court has taken up the case to determine whether a “process” must be attached to a particular machine or apparatus or transform a particular object into a different state or object to be patentable and if the “machine-or-transformation” test for patent eligibility contradicts Congressional intent that patents protect “method[s] of doing business.”  Joshua Sarnoff and Michael Risch will discuss this case, moderated by Adam Mossoff.

Featuring:

• Michael Risch, Associate Professor of Law, West Virginia University School of Law
• Joshua Sarnoff Professor of the Practice of Law, American University’s Washington College of Law
• Moderator: Adam Mossoff Associate Professor, George Mason University School of Law

Questions Presented:

Whether the Federal Circuit erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing (“machine-or-transformation” test), to be eligible for patenting under 35 U.S.C. § 101, despite this Court’s precedent declining to limit the broad statutory grant of patent eligibility for “any” new and useful process beyond excluding patents for “laws of nature, physical phenomena, and abstract ideas.”

Whether the Federal Circuit’s “machine-or-transformation” test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.”  35 U.S.C. § 273.

The Supreme Court has not considered what is patentable subject matter since 1981. This case now raises fundamental questions of what can be patented? Are patents only for manufacturing processes that are tied to a particular machine or produce some physical transformation? Or do patents also embrace modern business processes that do not depend on a particular machine or device?  We’ll find out.

Bonus Materials:

Court of Appeals for the Federal Circuit Opinion (PDF)
Questions Presented (PDF)
Petition for Certiorari (PDF)
Amicus Briefs

Labeled as BioGPS (Global Positioning for Success) the 2009 BioOhio Annual Conference will be held September 30 & October 1 at the Embassy Suites in Dublin/Columbus, OH.

Where in the world are bioscience opportunities?

The 2009 BioOhio Annual Conference is set to answer the question “where in the world are bioscience opportunities?” with topics related to the globalization of bioscience business and research, from conducting foreign clinical trials and exporting your products to the global impact of the Third Frontier Project and the influx of international companies expanding in Ohio.

Our keynote address will be delivered by Battelle President & CEO Jeffrey Wadsworth, who will describe the global success and future ambitions of the world’s largest non-profit independent research and development organization.

The conference also will feature a multitude of topics related to the globalization of bioscience business and research, from conducting foreign clinical trials and exporting strategies to the global impact of the Third Frontier Project and the influx of overseas companies expanding in Ohio. Panelists/presenters will include P&G Health Care’s Kevin Driscoll, U.S. Export Assistance Center Director Roberta Ford, Dr. Michael Knopp of the Wright Center of Innovation in Biomedical Imaging, the Center for Stem Cell & Regenerative Medicine Executive Director Dr. Debra Grega, Proxy Biomedical’s Peter Gingras, and more.

View full agenda here.

BioOhio reserved a block of discounted suites ($149/night) at the Embassy Suites Columbus/Dublin for conference registrants until Sept. 9. For reservations, call 1-800-EMBASSY or 614-790-9000.

OK, I admit it. I judge a book by it’s cover. There, I said it. I’m not proud of it but I’m very visually oriented and there is something about a beautifully designed cover of a book that makes me want to open and read the pages inside.  So it was when I received my copy of “Intellectual Property in Government Contracts: Protecting and Enforcing IP at the State and Federal Level” by James G McEwen, David S Bloch and Richard M Gray (Oxford University Press, USA).

I immediately glanced over the (Army?) green cover. Like the subject of the book, the cover evokes an image of government-issued surplus. Inside the covers, however, you’ll find a step-by-step guide to the protection of IP in government contacts and the various ways to enforce IP rights in the event the government violates them

Federal government contracts can be a trough/source of business for private companies, particularly for companies engaged in developing new technology and products. This does not apply to just the $787 billion being doled out in the current economic stimulus bill (a/k/a the American Recovery and Reinvestment Act). The federal government spends over $100 billion each year on contracts, grants, and other agreements with private companies to develop new products and processes.

This brings up important questions relating to intellectual property since the Bayh-Dole Act (35 U.S.C. Sects. 200-212) allows contractors to retain title to intellectual property developed under federally- funded projects in order to bring the technology to the commercial marketplace. Under the Act, a contractor is now permitted to retain title to patented or patentable subject inventions subject to reporting and other requirements in 35 U.S.C. Sect. 202 within a specific time period to identify and protect patent rights. Failure to do so could result in a contractor losing title to such intellectual property.

The government is typically granted a non-exclusive, nontransferable, irrevocable, paid-up license to practice (or have practiced) the invention, for or on behalf of the U.S. Government. Infringement mostly occurs from other contractors doing business with the government. A contractor’s only recourse in the event of unauthorized use of its patent, whether by the government or another contractor in the performance of its own government contract, is a lawsuit against the government, not against the contractor, and only for money damages, not injunctive relief.

Books related to government contracting usually focus only on contracting with the U.S. government. Here, Intellectual Property in Government Contracts provides a comprehensive survey of U.S. federal intellectual property procurement laws in the first four chapters but then provides a detailed analysis of state procurement rules over a whopping 372 pages. This book is a valuable resource for anyone dealing with U.S. federal and state procurement systems providing strategies for handling government misuse of private-sector IP rights.

About the Authors

• James McEwen, a partner of Stein McEwen LLP, has prepared and prosecuted patent applications in computer hardware and software, control systems, mechanical and optical devices, semiconductor manufacturing, batteries, and display device technologies.
• David S. Bloch is a partner with the law firm of Winston & Strawn, LLP., at their San Francisco office.
• Richard M. Gray is Associate General Counsel (Acquisition & Logistics), Department of Defense Office of General Counsel.

You can purchase “Intellectual Property in Government Contracts: Protecting and Enforcing IP at the State and Federal Level,” by James G McEwen, David S Bloch and Richard M Gray (Oxford University Press, USA), at Amazon.