Patent Baristas

In September 2009, we reported on an Australian Patent Office (APO) decision relating to an application for an extension of patent term for a trans-dermal patch.  The application for an extension of patent term was denied by the APO on the basis that the claim was not directed to a “pharmaceutical substance” as is required by Section 70(2)(a).  Our report on the APO decision denying the application for an extension of patent term can be found at the below link.  As you can see, we found the APO’s decision uncontroversial, given that the claim was limited by reference to a “backing layer”.  LTS Lohmann Therapie Systeme AG and Schwartz Pharma Ltd and Commissioner of Patents [2010] AAT 809.

The patentee appealed the APO decision to the Administrative Appeals Tribunal (AAT).  The AAT has now handed down a decision confirming the APO’s denial of the application for an extension of patent term.  The AAT appeal decision can be found here:  LTS Lohmann Therapie Systeme AG and Schwarz Pharma Ltd and Commissioner of Patents [2010] AATA 809 (22 October 2010).

Whilst we find the AAT’s confirmation of the original APO denial uncontroversial, we are concerned by the AAT’s reasoning and particularly by the AAT’s comments at paragraph 32 where the AAT is critical of an unrelated APO decision (the Organon decision) in which the APO granted an extension of term for a patent directed to a steroid-impregnated, polymeric implant.  In the Organon decision, the APO formed the view that the proper approach to deciding whether a claim is directed to a “pharmaceutical substance” (and hence eligible for an extension of term) is to look at the level of integration between the formulation and the associated delivery device.

At paragraph 32 of the appeal decision, the AAT suggests that the proper approach is to narrowly construe the phrase “pharmaceutical substance” to mean “the active ingredient(s)”.  If the AAT’s approach is correct, then an extension of term will only be available for patents which have claims directed to novel & inventive active(s).  The presence in the claim of any non-active will disqualify the patent from an extension of term.

It is our view that the AAT has seriously erred in construing “pharmaceutical substance” in this extremely narrow way.  Our view for a broader construction is supported by the fact that “pharmaceutical substance” is defined in Schedule 1 of the statute as meaning “a substance (including a mixture or compound of substances) for therapeutic use…”.

We now wait to see how the APO will deal with the next application for an extension of term where the claim is limited by reference to some non-active constituent.

Today’s post is by Guest Barista Bill Bennett of Pizzeys.

We’ve been quite busy these days and so I wanted to pass along that my firm is currently looking to hire an IP attorney.

The Position:

Patent Associate with at least 3 years of experience.  Applicants should have a degree in Mechanical Engineering, excellent academic credentials, writing and communication skills and be capable of independent and creative work.

The Place:

Frost Brown Todd LLC, one of the 150 largest law firms in the United States with a top rated Midwest intellectual property practice, seeks a Patent Prosecution Associate with at least 3 years of experience.   Initially the candidate will be located in our Cincinnati office with the possibility to relocate to one of our other offices after meeting training requirements.

The Rest:

To learn more about us and the communities we serve, we invite you to visit our home page at www.frostbrowntodd.com.  Send resume, law school and undergraduate transcripts and writing samples to Karen Laymance, Frost Brown Todd LLC, 2200 PNC Center, 201 East Fifth Street, Cincinnati, Ohio 45202 or by email to klaymance@fbtlaw.com.  Frost Brown Todd LLC is an equal opportunity employer.

I know I preach that over-consumerism is a bad thing (see: simplify | the benefits of minimalism) but we’re back again this year with a list of the best gifts for patent geeks and entrepreneurs.  Here are some ideas to stimulate discussion.  So, sit back over a cup o’ joe and take some time to look around to see what gifts you might like:

Apple iPad  Tablet (16GB, Wifi) – You knew this would hit the No. 1 spot, right?  I can’t tell you how much I wish I had one every time I trudge through the airport carrying my laptop (plus charger and accessories).  This is the ultimate geek accessory.  Just don’t forget the Apple iPad Case.

BCBGeneration Charlie Messenger – For the road warrior, nothing makes things go better than having a descent travel bag.  For a wheeled alternative, try:  High Sierra Carry-On Wheeled Backpack with Removable Day Pack (Black).

Rolex Oyster Precision Submariner Chronometer Stainless Steel Watch – For the best in anti-simple living. If you have to be pretentious, go big or go home.  Or, just get a fake like everyone else with the Replica Rolex Submariner (Note:  “Box only be sold with the watches, we do not sell box solely.”)

Giuseppe Zanotti Women’s Open-Toe Pumps – Lawyers should dress well.  Actually, dressing well is an important function of a lawyer.  Many faux pas are forgiven the well-dressed lawyer.  Clients appreciate it and dressing well can be done simply without too much expense.  Made in Italy, these Giuseppe Zanotti sophisticated pumps adds a sleek heel and professional polish to suits and pencil skirts.  For the more practical patent attorney, you can always go with the Kenneth Cole New York Penny Loafer.

iRobot 560 Roomba Vacuuming Robot – What lawyer wouldn’t like some obedient servant that slaves away for pennies and never complains?  For the compulsive cleaner in your life, the Roomba vacuum makes its way around furniture, cleans up the place and finds its way back to its charging base. The Roomba may not be the best cleaner but it can make a best friend for a lonely lawyer.  For those that would rather drink coffee than clean: Jura-Capresso Impressa F9 Fully Automatic Coffee and Espresso Center.

Western Digital My Book Essential 2 TB Desktop External Hard Drive – Today, lawyers rely heavily on computers to help accomplish almost every task.  Do you have a disaster recovery plan? Practices and procedures for backup, storage, disaster recovery, and restoration are crucial to your law practice. Get a drive and then put backup procedures in place – don’t wait to “break glass in case of emergency”.  For a more portable option:  Toshiba 500 GB USB 2.0 Portable Hard Drive.

The Daily Show with Jon Stewart Presents Earth (The Book): A Visitor’s Guide to the Human Race – This may not be for everyone but after a long day of dry intellectual property issues, a bit of irreverence feels good.  For the other end of the political spectrum, try Decision Points by George W. Bush.

UGG Australia Women’s Bailey Button Triplet Boots – While I admit I don’t understand the appeal, my daughter swears these are great.  You may want to stay more conservative with some Pelle Moda Women’s Nemo Two Piece Pumps.

Canon VIXIA HF S200 Full HD Flash Memory Camcorder – Patent geeks love gadgets and especially gadgets with killer specs.  Fortunately, this one has great specs but a price that has come down to real world usage.  Want cheaper?  Go with the Flip UltraHD Video Camera.

KitchenAid Artisan Series Mixer – For some reason, I love kitchen gadgets.  This one is a good addition for any chef.  Check prices often because it seems to change hourly but it can be picked up at a good price if you work at it.  If you want smaller, go with the Microplane 40020 Grater/Zester.

Well, that’s the list.  It’s a good place to start and applies equally well to lawyers, inventors and business folks alike.   While I think any of the above gifts would be fine for assistants, too, the consensus seems to be that AmEx cards are best.  Please suggest your own preferences and gift ideas in the comments.

Also, check out last year’s list here.

The University of Baltimore School of Law’s Intellectual Property Law Journal seeks articles for its Spring 2011 symposium issue.  The symposium’s theme is: “The Incentive to Invent: Intellectual Property Protection and the U.S. Biotechnology and Pharmaceutical Industries.”

The symposium seeks to explore issues and trends related to the role which intellectual property plays in the U.S. biotechnology and pharmaceutical industries.  The theme raises many questions, including:

• How has intellectual property affected the development and creation of  biotechnology and pharmaceuticals?
• How is intellectual property protection of the biotechnology and pharmaceutical industries unique?
• Do the biotechnology and pharmaceutical industries require intellectual property protection to survive?
• Is intellectual property protection of pharmaceuticals and biotechnology beneficial for society and consumers at large?

The symposium will attempt to address these and other questions from the perspective of legal academics and practitioners.  The symposium is to be scheduled in mid-March 2011 at the University of Baltimore School of Law.

Submission Guidelines

If interested in speaking at the symposium or publishing an article, please submit an abstract, topic proposal, or draft manuscript by January 10, 2011 to Marie-Therese Goff at marie-therese.goff@ubalt.edu.  Practitioners need not follow a strictly academic format but should address the symposium theme.  Please submit your resume and full contact information including your email address, telephone phone number, and mailing address with your submission.  All working drafts of papers will be due no later than February 10, 2011.

The Intellectual Property Law Journal anticipates publishing three papers in its Spring 2011 symposium issue.  The Intellectual Property Law Journal typically publishes pieces ranging from 20 to 50 pages in length and containing thorough footnote citations.  Authors of accepted submissions are invited to speak at the symposium.

Please note that a limited amount of money may be available to presenters for travel expenses.

If you have further questions, please contact:

Marie-Therese Goff, Articles Editor
Intellectual Property Law Journal
University of Baltimore School of Law
marie-therese.goff@ubalt.edu

Teva Pharmaceuticals has launched a new online game promotion generic substitution among consumers. The link is below – as you can see, it allows players to replace popular brand-name drugs with their generic equivalents, and it shows how much one would save if they made the switch.

According to Teva PR, they’ve had 17,000 views in just two weeks.  But, I played the game (you know, research) and found that there was really no game to it.  You just clicked on drugs and got comparison pricing for generic substitutions over brand drugs.  I really can’t see my son spending an afternoon playing this game.  Or even 15 seconds.

You would think that with Teva’s last quarterly net sales of $4.3 billion — an increase of 20% over the comparable period in 2009 — they could afford to put together a better game.  Maybe Call of Duty: Modern Generic Drug Warfare.

You can check out the game yourself here:  Switch-n-Save — Teva’s Year Of Affordable Healthcare

*Update:  The link was not working but has now changed to a new address.

The United States Patent and Trademark Office (USPTO) is implementing a pilot program (Extended Missing Parts Pilot Program) in which an applicant can request a twelve-month time period to pay certain fees and to reply to a Notice to File Missing Parts of Nonprovisional Application.

Under the Extended Missing Parts Pilot Program, applicant must file a nonprovisional application within twelve months of the filing date of a provisional application and directly claim the benefit of the provisional application, as well as submit a certification and request to participate in the Extended Missing Parts Pilot Program with the nonprovisional application.

The USPTO cautions all applicants that, in order to claim the benefit of a prior provisional application, the statute requires a nonprovisional application filed under 35 U.S.C. 111(a) to be filed within twelve months after the date on which the corresponding provisional application was filed. See 35 U.S.C. 119(e). It is essential that applicants understand that the Extended Missing Parts Pilot Program cannot and does not change this statutory requirement.

In addition, applicant must not file a nonpublication request. Applicant will be given a twelve-month period to decide whether the nonprovisional application should be completed by paying the search fee, the examination fee, any excess claim fees, and the surcharge ($130.00 for non- small entity or $65.00 for small entity) for the late submission of the search fee and examination fee within that twelve- month period.

The nonprovisional application will be published under the existing eighteen-month publication provisions. Therefore, applicants have to submit the basic filing fee, an executed oath or declaration, and application papers that are in condition for publication, on filing of the application with the request to participate in the pilot. If the basic filing fee, an executed oath declaration, and/ or application papers that are in condition for publication are not submitted with the application and the request to participate in the pilot, applicants will need to submit these items within a two-month (extendable) time period.

The Extended Missing Parts Pilot Program should benefit the USPTO and the public by removing from the USPTO’s workload those nonprovisional applications for which applicants later decide not to pursue examination. Applicants are advised that the extended missing parts period does not affect the twelve-month priority period provided by the Paris Convention for the Protection of Industrial Property. Thus, any foreign filings must still be made within twelve months of the filing date of the provisional application if applicant wishes to rely on the provisional application in the foreign-filed application or if protection is desired in a country requiring filing within twelve months of the earliest application for which rights are left outstanding in order to be entitled to priority.

Requirements:

In order for an applicant to get a twelve- month (non-extendable) time period to pay the search and examination fees and any required excess claims fees under the Extended Missing Parts Pilot Program, the applicant must:

(1) submit a certification and request to participate in the Extended Missing Parts Pilot Program with the nonprovisional application on filing;

(2) the application must be an original nonprovisional utility or plant application filed under 35 U.S.C. 111(a) within the duration of the pilot program;

(3) the nonprovisional application must directly claim the benefit under 35 U.S.C. 119(e) and 37 CFR 1.78 of a prior provisional application filed within the previous twelve months; the specific reference to the provisional application must be in the first sentence(s) of the specification following the title or in an application data sheet under 37 CFR 1.76 (see 37 CFR 1.78(a)(5)); and

(4) applicant must not have filed a nonpublication request.

See the entire notice here.

Deservedly or not, Patent Baristas has been featured on the Guide to Online School’s list of the Top 50 Patent blogs.  For the list, Online Schools hand-picked a list of their favorite patent blogs and outlined the unique reasons why they think they’re great.

The blogs were selected because they demonstrate expertise and thorough knowledge of relevant topics, are updated frequently, and are particularly user-friendly.  According to the Guide:

“[Patent Baristas] blog is one of our favorite five. We love the feeling of a cyber cafe you’ve created.”

Rounding out the Top 5:

1. Anticipate This!|Patent and Trademark Law Blog

Why We Love It: This blog has the unique ability to hold its readers’ attention by structuring posts in a manner that is captivating, stimulating, and engaging. Some of the posts even analyze the patents behind some of today’s most widely used products.

“In every crisis, there is opportunity” ~Chinese Proverb

With a GDP of more than $8,000 billion, China is poised to become the world’s third-largest pharmaceutical market next year – up from number eight in 2006.  The $24.5 billion pharmaceutical market is expected to swell to $68 billion to $78 billion by 2013, leaving it behind only the United States and Japan.  Multinationals currently hold 30 percent of the market with local drug companies taking 70 percent.

In addition, under the 2006 Science and Technology Plan, China has set a goal of investing 2.5% of its GDP in research and development, a quadrupling of expenditure.  What remains to be seen is how intellectual property rights — and their enforcement — helps or harms these efforts.

Dr. Yahong Li addresses this matter in her new book, Imitation to Innovation in China: The Role of Patents in Biotechnology and Pharmaceutical Industries (New Horizons in Intellectual Property), which outlines the role of patent rights in innovation.

This book not only looks at the innovation capacity and infrastructure of China’s biotechnology and pharmaceutical industries, it also put this in context of the role of the Chinese government in promoting these innovations.  The Chinese government perceives biotech and pharmaceutical industries as strategic sectors and treats them as the top priority in the nation’s current development plan, the 11th Five-Year Plan (2006-2010).  In addition to preferential tax schemes and other favorable policies, the Chinese government has also set very clear targets for these industries. For example:

1. Developing and commercializing 10-15 innovative drugs and vaccines with Chinese-owned IPRs for the treatment of major, acute infective diseases or chronic severe diseases.
2. Marketing five chemical synthetic finished drugs to US or EU countries.
3. Fostering five large-scale pharmaceutical groups with sales revenue of more than five billion yuan ($640 million), promoting 10 pharmaceutical distributors with over three billion yuan ($384 million) sales revenue, and helping five domestic pharmaceutical enterprises evolve into international enterprises.

The Chinese government is a major funding source for R&D in the biotech and pharmaceutical industries. Through various programs, the government has invested $205 million from 1996 to 2000 and $731 million from 2000 to 2005. The figure is expected to reach $8.8 billion in 2010.

After going through case studies of patent lawsuits, the author notes that after 1993, the patent law was amended to allow for the patenting of chemical substances and pharmaceuticals. Since then, China’s biotechnology and pharmaceutical industries have been filing (and obtaining) more patents and fighting more patent infringement battles. This demonstrates the connections between patent law and patent activities. The author then explores “does an increase in patent filings or litigation mean more and higher-level innovations?”

However, the newly amended patent law seems to reverse the trend of the last two rounds of amendments and opts for a more protectionist approach. That is, it gives more attention to the protection of public interests and public health rather than merely increasing protection of patent rights. The author posits that this come from a genuine realization from Chinese scholars and government officials that while the protection of patents can promote innovation, patent protection must be limited to the extent that the balance between patent right holders and public interests can be maintained. The question is, however, how can these two seemingly contradictory objectives be reconciled?

With China’s pharmaceutical market valued at $76–$86 billion (based on 2008–2013 IMS Health estimates), the key question is how much of the market will be supplied domestically and to what extent will the projected 23–26% compounded annual growth rate (2008–2013) for China’s pharmaceutical market be an engine for growth for China’s domestic pharmaceutical companies.

About the Author

Dr Yahong Li is an Associate Professor and Director, LLM Program in Intellectual Property and Information Technology, Faculty of Law, University of Hong Kong.   She is also an author of International and Comparative Intellectual Property: Law, Policy and Practice (LexisNexis, Butterworths 2005).

Imitation to Innovation in China: The Role of Patents in Biotechnology and Pharmaceutical Industries (New Horizons in Intellectual Property) is available through Amazon.

For additional insights in the the market in China, look at Embedded: Intel in China: The Inside Story by Tan Wee Theng.  It is a firsthand account of Intel’s spectacular growth in China from the mid 1990s, which includes interviews with key Chinese officials, a wide range of Intel corporate executives and frontline managers, and expert observers.  It sheds light on the complexities and idiosyncrasies of doing business in China.