Patent Baristas

Scott Shane, Ph.D., Professor of Economics at Case Western Reserve University, wrote up a detailed report on why the changes in the way damages are calculated in patent infringement lawsuits being asked for in various patent reform bills is wrong-headed.

As reformers have proposed to change the method of calculating damages from a common-law methodology which equally considers a variety of factors to a statutory methodology putting “apportionment,” above all else, Shane feels that such an apportionment-centric system of damages will likely have several adverse effects, including the following:

1. Reduction in U.S. patent value of between $34.4 billion and $85.3 billion.
2. Reduction in value of U.S. public companies of between $38.4 billion and $225.4 billion.
3. Reduction in R&D of between $33.9 billion and $66 billion per year.
4. Between 51,000 and 298,000 U.S. manufacturing jobs put at risk.
5. Industries employing fewer people favored over those employing more people.

Why would an apportionment-centric system of patent damages reduce the value of patented technology?  Patents are a negative right; they give the patent holder the right to exclude others from practicing that invention.  To do this, the patent holder must be willing to enforce his/her patent by bringing legal action to either seek an injunction or collect damages in the event of infringement.  Because injunctive relief is increasingly difficult to obtain following the U.S. Supreme Court’s decision in eBay vs. MercExchange (2006), the value of a patent is best determined as a function of the amount of damages one can collect if one wins an infringement lawsuit.  Reducing the amount of damages reduces the value of patents, and reducing the value of patents reduces the value of patented technology.

Meanwhile, IBM has tried to see if it can get a patent on everything on earth after it became the first company to ever obtain more than 4,000 in a single year — more than Microsoft and Intel combined (from IFI Patent Intelligence).  IBM picked up 4,186 U.S. patents in 2008, while Microsoft and Intel received 2,030 and 1,776, respectively.  Samsung was in second place with 3,515 patents issued.

The report was prepared for the Manufacturing Alliance on Patent Policy, an ad hoc coalition created to share information with policy makers concerning the effect of patent policy on American manufacturing (including advanced metals, aerospace, automotive technology, chemicals, electronics, information technology, nanotechnology and others).

You can see the whole report here.

Peter Zura’s 271 Patent Blog has a review of patents issued in 2008.  More info at: “IFI Patent Intelligence Analysis of 2008’s Top US Patent Recipients Suggests America May Be Losing Dominance.”

Two new blogs are on the scene for keeping pace with biotechnology.

OnBioVC

OnBioVC, a new blog by veteran blogger Adam Rubenstein, is listed as “Your Source for BioScience Venture Capital Data.”  Headquartered in Boulder, Colorado, OnBioVC provides timely coverage and comprehensive analysis of global bioscience venture capital investment activity.

Although heavy on the financial nitty-gritty of biotech deals, OnBioVC wants to be the premiere destination for timely coverage and comprehensive trend analysis of global bioscience venture capital investment activity.

OnBioVC provides a free and easy way to search databases where information queries may be indexed by therapeutic, diagnostic and medical device company, technology, indication, financing round, close date and geographic region. In addition to the web-based resource, regularly published OnBioVC Trend Analysis studies provide cumulative analytical color by month and quarter.

icademic.org

icademic.org provides detailed lists of links for searches in the field of Biotechnology and Chemistry.  Here, you can connect with universities, book & journal publishers, latest news & research announcements, and commercial companies dealing with Biotechnology and Chemistry.  It’s a good stop for looking through what’s listed for all those who are interested in  Biotechnology and Chemistry.

Pages for specific fields carry categories e.g., News, Journals & Books, Sites in Biotechnology, Employment, Research & Development and Events. You may find this information helpful and easy to access.

Early stage valuation of drug development is complicated and often considered unnecessary given that standard valuation methods can lead to negative numbers.  Most early stage investors use the method known as “making it up” to value really early stage inventions.

More than that, a large problem is that a company or university performing services early on will often perceive the value of its contribution as far greater than the value provided by any other participant in the development of that pharmaceutical active — and far greater that actually provided.  For example, universities often want a high royalty rate in a license agreement even though the drug in development is still early preclinical. This perceived “value” is usually offered without any regard to the commercial reality that a viable product cannot support more than a certain royalty and that several other technologies may have to be licensed to provide a successful pathway to market.

“Valuation in Life Sciences: A Practical Guide” by Boris Bogdan and Ralph Villiger provides a very thorough case guide for the theory and practice of the valuation of life science products.  It is geared towards both pharmaceutical/biotech investors and business professionals dealing with drug and medical device development.  Set out in 334 pages, this book can move your practices away from making educated guesses.

This book provides a thorough explanation of the theory of valuation, including discounted cash-flow and real options.  It then shows how to value projects, patents, licenses, and companies using examples of business deals and licensing. It includes valuation tools in life sciences as well as practical examples for business development executives to understand ROV and its applications in life science.

The best part of this book is how complete it is in coverage.  It guides the reader through the risks and costs of lead development, preclinical testing, Phase I, II and II testing and approval.  It also provides guidance of licensing valuation and portfolio management.

Whether you are a biotechnology company business development executive and university technology transfer officer, you can benefit by having knowledge on your side.  While it is true that value is in the eye of the beholder, at the end of a negotiation and the signing of a contract, the licensor and licensee must realize that the goal is to receive a fair value for the services rendered and to ensure that the pharmaceutical can be successfully commercialized.

“Valuation in Life Sciences: A Practical Guide” by Boris Bogdan and Ralph Villiger is available form Amazon.

See more on licensing and valuation here: What’s A Reasonable Royalty Rate?

In a search for the best of 2008 in the legal blogospshere, Blawg Review, is looking for which of the year’s 51 host presentations should be named the Blawg Review of the Year 2008.  We hosted Blawg Review #161 on Patent Baristas, the Memorial Day Edition of Blawg Review.

There were many presentations this past year that are worthy of consideration for this special recognition. Among all of our favorites, we are nominating for Blawg Review of the Year 2008 the following hosts:

Blawg Review #145 at What About Clients?

Blawg Review #147 at Rush on Business

Blawg Review #173 at the Chicago IP Litigation Law Blog

Blawg Review #179 at the Securing Innovation blog

Blawg Review #189 at Infamy or Praise

Blawg Review#191 at Likelihood of Confusion

There are the ones that especially moved us.  We encourage everyone to check out all the presentations of Blawg Review, including many by intellectual property law bloggers, and nominate your favorites for Blawg Review of the Year 2008.

Last month, Abbott Laboratories was sued by Bayer AG’s HealthCare unit alleging that drugmaker Abbott Laboratories’ best-selling drug, the arthritis drug Humira, infringes on a Bayer patent.  (Bayer HealthCare LLC v. Abbott Laboratories, 08cv507, U.S. District Court for the Eastern District of Texas).  Bayer claims that Humira®, a recombinant human IgG1 monoclonal antibody specific for human TNF used to treat severe types of arthritis and other immune disorders, infringes on US Pat. No. 5,654,407, issued August 5, 1997.

Bayer’s lawsuit was filed six years after Humira was approved for sale in the U.S. in the District Court for the Eastern District of Texas, a venue considered to be very favorable for patent-holders. The lawsuit seeks triple damages for past and future patent infringement, attorney fees and other relief, but does not seek an injunction against sales of Humira.  Bayer does not sell any products of its own that compete with Humira.

One issue that may come into play here is the Doctrine of Laches, an equitable defense that arises from a delay in taking action. Laches defenses have been successful in cases in which a patent owner knows about an infringement and then delays many years before bringing suit. Laches typically bars the recovery of any past damages but allows for the recovery of damages arising after the filing of the lawsuit.  Once the laches defense has been raised, the plaintiff may still offer evidence that the delay either was reasonable or not prejudicial to the defendant.

Ultimately, the burden of proving laches rests with the defendant, who must prove that there was an unreasonable delay in bringing suit and that this delay prejudiced the defense. However, a rebuttable presumption of laches arises when the patentee waits more than six years from the time when he or she discovered (or reasonably should have discovered) the infringement to file a lawsuit.

The ‘407 patent, set to expire in 2014, very broadly covers human monoclonal antibodies that bind specifically to human tumor necrosis factor alpha. It is doubtful that Bayer suddenly realized that it held the ‘407 patent.  The filing of a lawsuit at this late stage may have been prompted by Humira sales, which increased 50% to $1.2 billion in the third quarter of 2008 after Abbott received regulatory approval to sell the drug for treatment of psoriasis and juvenile rheumatoid arthritis. In October, the company boosted its forecast for full-year sales to $4.4 billion.  See SEC filings.

Humira (adalimumab) is the third TNF inhibitor, after infliximab and etanercept, to be approved in the U.S. and is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It is also used to treat Crohn’s disease after other drugs have been tried without successful treatment of symptoms.  Humira competes with the drug Remicade, made by Johnson & Johnson’s Centocor unit. That company and New York University filed a patent infringement suit against Abbott in April 2007, also in the Eastern District of Texas.

Humira binds to TNFα, preventing it from activating TNF receptors; adalimumab was constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimeric antibody and etanercept is a TNF receptor-IgG fusion protein. TNFα inactivation has proven to be important in downregulating the inflammatory reactions associated with autoimmune diseases.

Tumor necrosis factor (TNF, cachexin or cachectin and formally known as tumor necrosis factor-alpha) is a cytokine involved in systemic inflammation and is a member of a group of cytokines that stimulate the acute phase reaction.  The primary role of TNF is in the regulation of immune cells. TNF is also able to induce apoptotic cell death, to induce inflammation, and to inhibit tumorigenesis and viral replication. Overproduction of TNF have been implicated in a variety of human diseases, as well as cancer.

In one new twist, Abbott Labs has now turned around and sued Bayer AG’s HealthCare unit, claiming that the Bayer patent is invalid, not infringed or unenforceable. The competing lawsuits could set up a dispute over where the case will be heard.  Abbott, in its complaint, said the case should be heard in Boston because some of its research and manufacturing of Humira is done at the company’s Worcester facility.  (Abbott Laboratories v. Bayer Healthcare LLC, 09cv40002, U.S. District Court for the District of Massachusetts).

It could be that Abbott feels that Humira can be distinguished from the claims of the ‘407 patent since its monoclonal antibodies were created using phage display technology resulting in an antibody with human-derived heavy and light chain variable regions and human IgG1:κ constant regions. However, it appears that Humira antibodies are  fully humanized monoclonal antibodies.  So, we could see a detailed battle over the definition of “human”antibodies.

Theoretically, Bayer could go after other producers of anti-TNF-alpha drugs as well such as Enbrel (etanercept), co-marketed by Amgen and Wyeth, and Remicade (infliximab), sold by Schering-Plough and Johnson & Johnson. However, Bayer HealthCare has noted in its complaint that its lawsuit against Abbott is “an exceptional case,” whatever that means.  Although, infliximab is actually a chimeric antibody so it could fall outside of the scope of the “human” claim in the Bayer patent. Likewise, etanercept is not really an antibody but rather a receptor-Fc fusion protein, which also could fall outside of the scope of Bayer’s claims.

Generally, it is possible to make mouse-human hybrid antibodies including chimeric antibodies, where the antibody combines the antigen-binding parts (variable regions) of the mouse antibody with the effector parts (constant regions) of a human antibody, and humanized antibodies, where the antibody combines only the amino acids responsible for making the antigen binding site (the hypervariable regions) of a mouse (or rat) antibody with the rest of a human antibody molecule thus replacing its own hypervariable regions.

However, you can make transgenic mice that have had human antibody gene loci inserted into their bodies so that they produce fully human, not mouse, antibodies against the antigen and can yield cells that can be fused with myeloma cells to manufacture all-human monoclonal antibodies. Unlike some related technologies that create chimeric or partly humanized proteins, the antibodies produced by these mice are 100% human protein.

Patents, trade secrets and confidentiality agreements are mere words on paper to the scientist, engineer or executive intent on deception and theft.

And if you have outsourced your research and development efforts overseas to countries with unenforced intellectual property laws and cultural norms that ignore individual property rights, then the intent to deceive and thieve isn’t even present—in their eyes, your intellectual property may already be their intellectual property.

Rise in IP Theft

Every other week seems to bring out a story of industrial espionage—in aerospace, technology or biopharmaceuticals.  A Kiplinger news story in January of last year noted that cyber-thieves are increasingly working behind the scenes to sell and deliver American and European company secrets to overseas competitors.

In the meantime, there has been a rise in overseas outsourcing from pharmaceutical, medical device and biotechnology companies looking to reduce expenses.  While some of this is in manufacturing, the majority of outsourcing so far has been in research and development, and in clinical trials, providing non-company personnel direct access to a firm’s developing intellectual property.

At the end of 2007, the Department of Commerce’s International Trade Administration released its summary of countries with whom it is struggling to advance US intellectual property protections.  While China may come as no surprise, few executives are aware of the second-class status of their intellectual property in India, Israel, the Philippines, Thailand and Mexico.

While these reports set the stage on the international scene, what is also on the rise is trade secret theft inside a company.  Recent lawsuits involving former executives of medical device firm Kinetic Concepts, aerospace giant Boeing and tech firms Quantum3D and SAP should give you pause for thought.

Joel Brenner, national counterintelligence executive in the Office of the Director of US National Intelligence, discussed a great shift toward increasing espionage reliance on private sector employees during a recent speech.  His main point:  employees of US and European companies can make quick cash by selling electronically-stored documents to overseas organizations simply through a few email clicks and web-based payments.

In my November 2008 webinar, Preventing Intellectual Property Theft by Contractors and Partners, I gave attendees current estimated marketplace value of different components of confidential information – from private contact information all the way through prototype blueprints and promising new drug or biologic formulations.

Gone are the days of dark street corners and cash-laden briefcases; today, IP theft occurs with the click of an email and an online bank deposit—it’s far safer, far faster and far more difficult to detect.

So what to do?

Decide What to Protect

One of the first items I ask my clients for is a list of the types of information they consider critical to business operations.  After more than 16 years, not a single client has shown me even a simple list typed on a single sheet of paper.  If you do not know what you need to keep safe, how do you expect to protect it?

The first step is to identify the information you need to protect.  Consider prioritizing your efforts on truly proprietary information such as unique processes, formulations, home-grown software, customer details, and so on.

The simplest way is to ask your colleagues, “What do we have that gives us a competitive advantage  (or will allow us to have a competitive advantage, in the case of new products) that no one outside of our company knows about?”  I also encourage you to ask your outside counsel and patent attorneys; they will also be able to give you specific insights, especially if you have not put all of the details in your patent applications.

When you’ve identified this information, it is time to explore where that information exists.  Sadly, you may be in for a surprise.

Segregate Standard Operating Procedure (SOP) Information

In an ideal world, no one individual would be able to put together the puzzle pieces of your intellectual property by themselves.  Unfortunately, in their zeal to detail out procedures, companies inadvertently place step-by-step instructions to recreating intellectual property in their standard operating procedures (SOPs). In my consulting engagements, I have seen this most often in SOPs that tackle formulations, mixing, assembly (for medical devices), and even in-process or post-assembly quality testing.

Conduct a review of your SOPs that relate in some way to your intellectual property.  Look for any detailed Step 1, Step 2, etc. processes that would give a knowledgeable person enough to duplicate your product … or get 90% there. Revise your SOPs to eliminate any trade secret-revealing step-by-step details, making sure to still capture the process and its regulatory and quality requirements.  This is a fine line to walk, but a necessary one.

If you are using a contract manufacturer (CMO)—especially for new product pilot production or clinicals—this review (and revisions to SOPs) is absolutely essential. You may also want to take this review one step further and look at the CMO’s internal SOPs related to production of your product.  Their SOPs may very well spell out your IP in step-by-step fashion.

Scattershot Storage

In a forthcoming article for BioProcess International, I point out that a 2002 University of California-Berkeley’s School of Information study calculated an interesting ratio:  for every piece of information available in front of you, there are an estimated ten pieces of directly related information (rough drafts, notes, raw data, copies, various iterations, etc.) stored elsewhere.

Think about this in the context of a blueprint of a new product yet to be launched.  Do you know where in your company – or in your development partner’s company – all the various iterations of that blueprint are stored?  What about those left accidentally lying about?  If I were to tell you the number of times over the past three years I’ve found some of my clients’ confidential documents lying in open, shared areas near copiers and printers either in their company or in the facility of a contract partner, you would have a good idea of how many intellectual property theft assessments I’ve conducted.

I recommend to my clients that they work with their legal counsel, records management groups, information technology (IT/ICT) teams, and development project personnel to put together a matrix of their stored intellectual property to ensure they’ve accounted for it all – and have published policies and contractual terms and conditions that govern its control.  This can be a lengthy process, but if you know exactly what to do and how to do it, then it can be easy.  In workshops and consulting engagements, I caution that while perfection is ideal, a capture rate in the 90th percentile is usually “good enough.”

Communicate to Personnel

If your personnel – particularly those that deal with outside vendors and suppliers – do not know that particular information is confidential, they may not know not to share it (or at least to ask permission before sharing it).

This does not mean you spell out the particulars of your trade secrets or intellectual property, but rather you note that (in the case of a drug, for instance) the formulation is considered highly confidential and will only be shared with certain individuals.  I recommend you also clarify that information supporting the creation and testing of the product “may be confidential as well” and provide a point of contact (such as your patent counsel) to seek further clarification.   While stating that something “may be confidential as well” is not akin to marking it “confidential” or “trade secret,” I’ve found that this ambiguity ironically can give people pause and serve as another check on critical knowledge leakage.

Work with your computer department to ensure that access to the information is restricted and monitored.  In the stories I tell in my workshops, I make it clear that simply restricting access is like expecting a locked door to prevent burglaries.  Some level of monitoring is necessary to deter a would-be thief, stop them in the act, or catch them afterward.  While there are many tactics to take advantage of French philosopher Michel Foucault’s Panoptikon theory when it comes to preventing intellectual property theft, one of the first is informing all personnel that the company has monitoring in place, just as a burglar alarm company places a “protected by” sign out in front of a building.

Final Thoughts

Deciding what to protect, finding it, communicating its importance to personnel, and then ensuring your SOPs are not inadvertently providing step-by-step trade secrets recipes are only a few of the tactics to master when it comes to saving your intellectual property.

Fundamental to all of this is recognizing that the greatest threat is not without, but within.  Ignoring the realities of internal risks ignores reality:  employees do not work for you for their lifetime; contractors come and go; and outsourced partners grow stale.  In the end, money is always more tempting than any corporate mission statement.

Are you ready?

About the Author

John Avellanet is the founder of the regulatory intelligence, quality systems and intellectual property protection advisory program for executives and business owners, SmarterCompliance.  He is the author of more than 30 articles on intellectual property theft and modern quality systems, a contributing author to the book Best Practices in Biotechnology Business Development, a syndicated columnist, and a frequent speaker on preventing intellectual property theft and cost-effective life sciences regulatory compliance in research and development environs.

He can be directly reached through his independent advisory firm, Cerulean Associates LLC, on the web.

Today’s post is by Guest Barista John Avellanet, Managing Director and Principal of Cerulean Associates LLC.  Adapted, in part, from the SmarterComplianceâ„¢ newsletter  2(2):  pp. 1,4-5 (February 2008).

James Greenwood, President & CEO of the Biotechnology Industry Organization (BIO), wrote an open letter to President-Elect Obama for his ideas on reform for the U.S. Patent and Trademark Office. With more than 1.2 million patent applications pending before its more than 6,000 examiners, there is a sense that something needs to give.

Notably, the backlog of applications may be leading to aggressive production goals for USPTO examiners, which decreases staff retention (the USPTO hires two examiners for every one that stays on the job long enough to learn how to search and examine patent applications in 20 hours or less).  Aggressive production goals also are driving the rate of application rejections to historically-high levels.

To this end, BIO has submitted its ideas for consideration by the incoming Administration, including the following:

Reassessment of examiner compensation, retention, and production goals and incentives

The USPTO’s production system in its current form was established in 1976 and has not been fundamentally changed since. Production goals and time per application could be adjusted to account more for the relative complexity of the technology area, and examiners could receive credit proportionate to the relative amount of work required for different applications. In addition, production metrics could be reassessed so as to reduce examiner incentives to trigger requests for continued examination or excessive divisional applications, instead providing greater reward for initial patentability determinations.

PTO branch offices and other measures to facilitate hiring and access to talent

To facilitate hiring and retention of qualified engineers and scientists, the USPTO could consider establishing branch offices in various parts of the country. The existing telework program could be combined with a system of regional branch offices to ensure that examiner staff would have adequate supervision and “face-time” with colleagues and supervisors without burdensome travel requirements. The USPTO could explore whether the costs of regional branch offices could be mitigated by using existing space in federal facilities across the country.  We think Cincinnati, Ohio, would be a great location and there is precedent for such a move:  after the War of 1812, many considered relocating the the entire U.S. capital to Cincinnati (inland to a growing metropolis).

Pre-first action interviews and issuance of “short form” search reports

In a move that could greatly ease tensions between examiners and applicants, the USPTO could expand programs under which applicants and examiners could meet for an informal pre-examination conference to discuss the application, explain the underlying technology, and agree on ways the application could be improved for more efficient substantive examination. Such a pre-first action interview program could be combined with an abbreviated search report, under which examiners could supply a listing of relevant references with an indication of their likely impact on the patentability of the claims.  Based on such preliminary feedback and discussion, applicants should be given the opportunity to make amendments to their claims before their cases enter substantive examination.  Currently, the predominant “pre-first action, short form response” is a restriction.

Reassessment of current restriction practice in light of the European unity-of-invention concept

Currently, there is little to prevent examiners from restricting an invention down to every patentably distinct embodiment, which would be searched and examined separately in subsequent divisional applications. The USPTO should consider whether more examination efficiency can be gained by adopting the European unity of invention concept, under which examination could be conducted more efficiently on a single application for a group of closely-related inventions that are linked so as to form a single general inventive concept. (Can I get an Hallelujah, Amen?)

To see the complete letter, click here:  ideas-for-reform-of-the-united-states.pdf.

Hal Wegner, former Director of the Intellectual Property Law Program and Professor of Law, George Washington University Law School and now Partner at Foley & Lardner, updated his list of the Top 10 Patent Cases.

We’ll be keeping an eye on these and more in 2009:

(1)  Lucent v. Gateway:   Where indirect infringement is found, can damages be based on the entire market value of the accused products where the allegedly infringing features are neither necessary for use of the products nor the basis for consumer demand and where there is no evidence of any instance of direct infringement?  Patent damages are a key sticking point in the patent reform debates.

(2)  Prometheus  v. Mayo:  What Hal calls “Metabolite déjà vu II,” concerns a patent for a means to measure the level of 6-thioguinine (6-TG) and 6-methylmercaptopurine (6-MMP), which indicates that an adjustment in drug dosage may be required at certain metabolite levels.  The patent includes only two active steps, “administering” the drug and then “determining” metabolite levels.  The claim really just explains the correlation between metabolite levels and therapeutic efficacy and “what the inventors claim to have discovered is that particular concentrations of 6-TG and 6-MMP correlate with therapeutic efficacy and toxicity in patients taking AZA drugs.”

(3)  Cardiac Pacemakers v. St. Jude:   A panel decision found that the export of subject matter to be used offshore in a patented process could constitute a “component” within the meaning of 35 USC § 271(f), is in conflict with Microsoft Corp. v. AT&T Corp., 550 U.S. 437 (2007).

(4)  Bilski v. Doll:  A decision that revisits earlier decisions on patent standards in which the Federal Circuit limited patentability to inventions (1) tied to a particular machine or (2) that transform an “article” into a different state or thing. The court also confirmed previous cases holding that fundamental principles of mathematics or science are not patentable.  But, since the claims in Bilski were not tied to particular hardware, the court did not consider the viability of patenting specific functions carried out by a computer. Now, how the phrase “tied to a particular machine” will be applied to software patents.

(5)  Lupin Ltd. v. Abbott Labs: – Deemed Quanta déjà vu, it concerns whether product-by-process claims are infringed by sale of a claimed product produced by a different method.  The Scripps Clinic & Research Foundation v. Genentech case (opinion by Judge Newman) held that it would, while Atlantic Thermoplastics Co., Inc. v. Faytex Corp. (opinion by Judge Rader) held that it did not.

(6)  In re Kubin: – This is significant in two critical areas of biotechnology patent law in (a) it repudiates Deuel, keyed to language taken from the Supreme Court KSR decision as well as the Federal Circuit Kahn opinion that preceded KSR; and (b) it adopts the controversial Enzo line of “written description” biotechnology case law as the position of the PTO Board.  The Board upheld an examiner’s rejection that claims for a polynucleotide coding for a polypeptide 80% identical to a disclosed polypeptide were unpatentable under 35 U.S.C. § 103 for being obvious and under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.  The Board based its obviousness determination on its interpretation of the KSR Int’l Co. v. Teleflex decision that it would have been “obvious to try” to isolate the claimed gene using well-established molecular biological techniques.

(7)  Biomedical Patent Management v. State Of California: – The case looks at (a) whether a state’s waiver of Eleventh Amendment immunity in one action extends to a subsequent action involving the same parties and the same underlying transaction or occurrence and (b) whether a state waives its Eleventh Amendment immunity in patent actions by regularly and voluntarily invoking federal jurisdiction to enforce its own patent rights.  At the district court, Judge Marilyn Hall Patel dismissed the lawsuit but expressed concern over the fact that California could sue for patent infringement on one hand while using sovereign immunity to keep from being sued for patent infringement itself:  “The court is indeed troubled by the University of California’s ability to reap the benefits of a patent system without being exposed to liability for infringement,” she wrote. “Similarly situated private universities enjoy no such advantage.”

(8)  United States v. Eurodif: – Looks at whether the Federal Circuit should have accorded Chevron deference to the Commerce Department’s construction of 19 U.S.C. § 1673. That statute allows the Commerce Department to impose duties on imports of foreign merchandise when that merchandise is “being, or is likely to be, sold in the United States at less than its fair value” – a practice known in the international trade world as dumping – and where the dumping causes or threatens to cause material injury to a U.S. industry.

(9)  Tafas v. Dudas: – concerns the appeal of the claims and continuations rules promulgated by the USPTO which were preliminarily enjoined and ultimately permanently enjoined by the District Court.  One critical piece here is whether Congress provided the USPTO the rule making authority explicitly for the purpose of expediting patent applications.  Judge Rader asked whether the real issue in this case is whether the PTO is entitled to Chevron deference and whether the rules were procedural or substantive.  That is, the rules of statutory construction dictate that “the agency’s interpretation as long as it is based on a permissible construction of the statute’” would control the case.

(10)  Ariad v. Eli Lilly: – This addresses patent validity and enforceability issues where Lilly contends that the asserted claims of US 6,410,516 are invalid for including non-statutory subject matter, for being obtained through inequitable conduct, and are unenforceable due to prosecution laches.  Lilly argues, and of course Ariad disputes, that the claims cover unpatentable naturally-occurring phenomena, that Ariad withheld critical documents from the patent examiner not only to get the patent issued, but to avoid the risk of losing 13 years of patent term.