Patent Docs

USPTO News Briefs

By Donald Zuhn --

USPTO to Hold Roundtable on Recordation of Real-Part-in-Interest Information

Last month, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 70385) indicating that the Office will be holding a roundtable from 8:30 am to 12:00 pm (EDT) on January 11, 2013 to obtain public input regarding changes to the Office's rules of practice for collecting and providing patent and application ownership information and making such information publicly available.  The roundtable will be held in the Madison Auditorium on the USPTO campus (600 Dulany Street, Alexandria, Virginia 22314).

Those wishing to participate in the roundtable must submit requests by Friday, December 21, 2012.  Requests can be submitted by e-mail to [email protected], and should include the name of the person wishing to participate, the person's contact information (telephone number and e-mail address), and the organizations that the person represents.  The notice indicates that the roundtable will be webcast, and that information regarding accessing the webcast will be made available prior to the roundtable.

The Office is also seeking written comments on the issue.  Written comments, which must be submitted by January 25, 2013, can be sent by e-mail to [email protected] or [email protected], or by regular mail to:  Saurabh Vishnubhakat, Expert Advisor, Office of Chief Economist, United States Patent and Trademark Office, Mail Stop External Affairs, P.O. Box 1450, Alexandria, VA 22313–1450.

The Office is seeking comment regarding whether the definition of real-party-in-interest (RPI) information should be broad (RPIs would correspond to those entities having the legal right to enforce the patent and would likely require the disclosure of exclusive licensees) or limited (RPIs restricted to legal title holders and "ultimate parent entities"), and the timing of and mechanism for collecting such information.

USPTO Requests Comments on Grace Period Study

Last week, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 73452) inviting the public and other Federal agencies to submit comments regarding the Office's grace period study.  The notice states that:

The United States' grace period, which permits exceptions to absolute novelty, figures centrally in the international discourse on patent law harmonization.  The grace period allows individuals to improve upon their ideas by sharing them with the research and business communities without jeopardizing their intellectual property interests.  Many European countries, however, lack adequate grace periods.  The consequences of this are not fully understood.  Few studies in the past ten years have dealt with the grace period, and none of them have quantified the effects of premature disclosure on researchers’ failure to apply for or receive patents.

To examine this issue, the Office will be conducting a study "to estimate the commercial opportunities lost as a result of the lack of grace periods."  As part of the study, the Office will survey scientific researchers affiliated with certain European universities who have published journal articles disclosing potentially patentable materials during a five-year period.

Written comments regarding the collection of information with respect to the grace period study, which must be submitted by February 8, 2013, can be sent by e-mail to [email protected] (those submitting comments by e-mail should include "0651–00xx Grace Period Study comment" in the subject line of the message); by regular mail to:  Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450; or using the Federal Rulemaking Portal.  Additional information, including the specific topics for which the Office has invited comment, can be found in the Federal Register notice.

USPTO Seeks Comments on Patent Small Claims Proceedings

On Tuesday, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 74830) seeking comments as to whether a small claims proceeding for patent enforcement should be developed.  The Office is particularly interested in obtaining comments regarding whether there is a need and desire for this type of proceeding, the circumstances for which such proceedings would be needed, and the features such proceedings should have.  The Office is also interested in collecting comments regarding the characteristics of such proceedings, including subject matter jurisdiction, venue, case management, appellate review, available remedies, and conformity with the U.S. constitutional framework.  The Office's notice provides a list of additional topics and questions for which the Office is seeking comments.

Written comments regarding patent small claims proceedings, which must be submitted by March 18, 2013, can be sent by e-mail to [email protected], or by regular mail to:  Mail Stop OPEA, P.O. Box 1450, Alexandria, VA 22313–1450, ATTN: Elizabeth Shaw.

Congressional Misunderstandings (Apparently) Motivate H.R. 6621

By Kevin E. Noonan --

The House passed H.R. 6621 last night, on a vote of 308-89 (the roll call being demanded by Rep. Dana Rohrabacher over a request for a voice vote from the bill's sponsor, Rep. Lamar Smith).  The substance of the substantive provisions of the bill, and their evolution since the bill was introduced, have been discussed in prior posts.  Excerpts from the floor debate on the provisions, specifically Section 1(m) of the bill having to do with "pre-GATT" applications (i.e., applications that were filed prior to the change in U.S. patent law that made the patent term 20 years from earliest priority date rather than 17 years from grant date), are illustrative (and disappointingly so) when it comes to the extent to which at least these two legislators are misinformed about the legislation they pass and it's effects on the patent system.

First, Rep. Rohrabacher (at right):

Mr. Speaker, I rise in strong opposition to H.R. 6621.

The bill being considered is being promoted as a technical corrections piece of legislation, and by and large that's exactly what it is.  But also, there is one provision in this bill that raises significant concerns and needs to be addressed.  I would ask my friend from Michigan perhaps to consider this and perhaps reconsider his position on the bill, because I'm sure he does not know about this.

Our country's patent system has long been one of the strongest in the world.

One of its basic tenets has been the steadfast adherence to the principle of total confidentiality of a patent application until the patent is granted.  Congress has repeatedly stood by that principle even though there have been many powerful forces in this country trying to eliminate that concept, but we've stood by this principle that these applicants should have confidentiality as their application works its way through the patent system.  It prevents the big guys with money and power from attacking and neutralizing the little guys with genius but few resources.

H.R. 6621 threatens to disrupt this longstanding practice and principle by requiring the United States Patent and Trademark Office to submit a report to Congress on certain patent application sections.  This report, as mandated by this bill, will include information about the applications that have been traditionally kept confidential, including the name of the inventor, which has always been confidential to prevent these inventors from attack by very powerful interests who would steal their invention.

While the technical contents of the applications would be most likely not included in the report, this legislation requires the PTO, in their report to Congress, to report the names of the applicants.

 * * *

There is a requirement to report the names [of the inventors], so this bill requires in this report to have the names of the applicants and other identifying information that could be used by powerful outside groups -- yes, read that foreign and multinational corporations -- to make these applicants potential targets even before their patent is granted.

Anonymity could easily be accomplished by a simple change to one section of this bill.  Perhaps the PTO could create a unique identifier for each applicant so that they could easily be tracked but without giving risk that the public would know about this and be able to identify the inventor.

We can make this a good bill.  We just need to take a couple words out of it or one small section out of it, because as the ranking member suggested, it does a lot of good, but it does a lot of harm, much more harm, unless we take this out of the bill.

So I would ask my colleagues to oppose this legislation until it is perfected so we are not going to hurt the little inventors and hurt our country's ability on the technology front by trying to make a few technical corrections to the way the Patent Office does its job.

(emphasis added).

Admirable sentiments, and Rep. Rohrabacher raises many of the issues regarding the consequences of a lack of confidentiality that were raised 14 years ago, when the American Inventors Protection Act of 1999 was passed.  The AIPA mandated publication of U.S. applications 18 months after their priority date, unless the applicant certified that no foreign filings would be made (the rest of the world having been publishing applications at the 18-month date for a generation).  The time for the fight for confidentiality has passed, and while it remains for the "pre-GATT" cases (as well as any pre-AIPA cases that may exist), not only the application but the complete prosecution file history is public in real time, as the result of a decision by the Director when implementing the AIPA.

It may be bad enough that Rep. Rohrabacher is behind the times; Rep. Smith's (at right) understanding of the reasons for the persistence of the pre-GATT cases is worse:

Mr. SMITH of Texas.  . . .  The report on pre-GATT applications refers to applications that were filed prior to the Uruguay Round amendments taking effect in June 1995.  The 103rd Congress intended for a brief transition period as the United States patent system was updated.  Unfortunately, a small number of applicants have engaged in clearly dilatory behavior and continue to maintain pending applications with effective filing dates that predate 1995.  In fact, some of these applications have been pending for 20, 30, and even 40 years.

The 103rd Congress never intended for such applications to stay pending for half a century.  To remove such technology from the public domain in 2012, would bear no relation to the patent system's Constitutional purpose to promote the progress of science and the useful arts.

Now it is important for the 113th Congress and the Public to learn fully about these applications from the USPTO.  The Committee expects that the report will contribute to an understanding of whether these applications present special circumstances that require further action to protect the public's interests.

Those who may have concerns about this report must understand that there is no way to "target'' these submarine applications -- the targets are, in fact, the people who will be sued once these submarine patents surface.  The real targets are American job creators like small businesses, innovators and university researchers.  And the public has a right to know in advance if certain widely used and long known technology is about to be withdrawn from the public domain.

The patent system was never intended to be a playground for trial lawyers and frivolous lawsuits.  Sound patents should issue in a timely manner and should be used to create wealth and jobs.

(emphasis added).

Now let's be clear:  there is little evidence that applicants have "gamed" the system to delay grant and indeed there is ample evidence that applicant delay was not a factor.  (The strategic misuse of the term "submarine patent" might have appeared apt to Rep. Smith at the time, but that term was coined to characterize patent applicants who took advantage of the 17-year term by avoiding prosecution in a strategic manner.)  The majority of these applications have been involved in protracted interferences, appeals, or had examination suspended for Office consideration of third party interferences that would influence the patentability of pending claims.  This does not require Rep. Smith to believe that all patent applicants are on the side of the angels:  however, it would be good if the Congressman recognized that the implementing legislation and PTO rules concerning these patents were drafted expressly to prevent such shenanigans.  Examples include the "transitional" procedures adopted by the Office that permitted an applicant to petition for withdrawal of the finality of a rejection no more than twice, wherein thereafter the only recourse for pre-GATT applications was filing an appeal.  The current route for which applicants are accused of delaying, filing a continuation or Request for Continued Examination, strips these applications of their pre-GATT status (which in most cases would lead to the same loss-of-rights that the original version of the bill would cause).  The Office's carefully crafted rules were designed to minimize long pendencies for pre-GATT cases, and that  policy has been successful to the extent that the number of such cases has been limited to 200.

Puffery and bloviating are a politician's stock-in-trade and there was plenty of that in Rep. Smith's remarks (as with most remarks of the AIA's supporters).  But if Rep. Smith was honestly expressing his beliefs that motivated (or he believes motivated) the proposal to enact a statutory loss-of-rights for pre-GATT cases he is sadly mistaken.  And that degree of misunderstanding increases the size of the grain of salt with which we should take Rep. Smith's other pronouncements from the floor of the House:

Mr. SMITH of Texas.  . . .  Mr. Speaker, the Leahy-Smith America Invents Act, or AIA, was signed into law on September 16, 2011.  It was the first major patent reform bill in over 60 years and the most substantial reform of U.S. patent law since the 1836 Patent Act.  The Leahy-Smith AIA reestablishes the United States patent system as a global standard.

* * *

As the provisions of the Leahy-Smith AIA continue to take effect, our Nation's innovation infrastructure becomes much stronger, unleashing the full potential of American innovators and job creators.

If only thinking would make it so.

The Senate must take up the measure before this Congress adjourns, an eventuality that is not assured.

The Plot Thickens around H.R. 6621 -- Updated

By Kevin E. Noonan --

Rep. Lamar Smith's H.R. 6621 came up for a vote today on the House floor under a suspension of the rules permitting the House to consider and vote upon the measure without debate.  In contrast with Rep. Smith's (at right) earlier version of the bill (see "Pre-GATT Patent Applications Threatened by Lamar Smith's H.R. 6621"), this version substituted the requirement for a "report" to Congress on the status of so-called "pre-GATT" applications rather than inserting into a law a provision that would effectively eliminate patent rights.

The new provision, Section 1(m), reads as follows:

(m) REPORT ON PRE-GATT APPLICATIONS.-- Using existing resources, not later than four months after the date of the enactment of this Act, the Director of the United States Patent and Trademark Office shall submit a report to the Committees on the Judiciary of the United States House of Representatives and the Senate that describes--
    (1) the total number of pending United States applications for patent that--
        (A) are not subject to an order under section 181 of title 35, United States Code; and
        (B) were filed before the effective date of the amendments made by section 532 of the Uruguay Round Agreements Act (Public Law 103–465; 108 Stat. 4983);

    (2) the filing date of each such application;

    (3) the filing date of the earliest application for which each such application claims the benefit of or a right of priority to its filing date;
    (4) the inventor and assignee named on each such application;
    (5) the amount of time that examination of each such application has been delayed because of a proceeding under section 135(a) of title 35, United States Code, an appeal to the Patent Trial and Appeal Board under section 134(a) of such title, a civil action in a United States District Court under section 145 or 146 of such title, or an appeal to the United States Court of Appeals for the Federal Circuit under section 141 of such title; and
    (6) other information about such applications that the Director believes is relevant to their pendency.

This is a vast improvement over the earlier provision:

(m) Effective Date of Uruguay Round Agreements Act--
    (1) CERTAIN PATENT APPLICATIONS-- Notwithstanding section 534(b)(1) of the Uruguay Round Agreements Act (35 U.S.C. 154 note), section 154(a) of title 35, United States Code, as amended by section 532 of the Uruguay Round Agreements Act (Public Law 103-465; 108 Stat. 4809), shall apply, and section 154(c)(1) of title 35, United States Code, shall not apply, to any application that is –
        (A) filed before the date that is 6 months after the date of the enactment of the Uruguay Round Agreements Act; and
        (B) pending on a date that is 1 year or more after the date of the enactment of this Act.
    (2) EFFECTIVE DATE-- This subsection shall take effect on the date that is 1 year after the date of the enactment of this Act and shall apply to any original plant or utility patent application that is pending on or after that effective date.

The revised bill also removes a provision that would have repealed 35 U.S.C. § 325(f) and thus subjected reissue patents to post-grant review.

The bill did not pass today, due in large measure to the objections of Rep. Dana Rohrabacher (R-CA) (at left).  Rep. Rohrabacher's objections were reportedly based on section 1(m)(4) of the bill, which would require the report to identify "the inventor and assignee named on each such application."  Although this information is routinely set forth in the PTO's PAIR database for applications filed after November 29, 2000 that are published (i.e., not subject to the non-publication provisions of the American Inventors Protection Act of 1999), Rep. Rohrabacher correctly notes that pre-GATT applications are entitled to non-disclosure of any part of their prosecution history until grant, being considered completely ex parte by the PTO.  It is unclear why Rep. Smith included this provision in the bill, unless he was persuaded that applicant delay (and thus culpability) was the source of the delay that has kept these applications pending and thus that there was a public interest justification in notifying competitors that such pre-GATT patents were pending.

This would not be surprising but it is wrong (and not the first time a misapprehension of the facts has motivated introduction of a provision in a patent reform bill; see "The (Un)Intended Consequences of the Law").  While these cases are somewhat of an embarrassment to the Office (insofar as their existence can be used to insinuate that the Office has been tardy in examining them), there is little evidence that applicants have "gamed" the system to delay grant.  The majority of these applications have been involved in protracted interferences, appeals, or had examination suspended for Office consideration of third party interferences that would influence the patentability of pending claims.  That applicants have not been responsible for the delay in prosecuting these applications is evidenced by the implementing legislation and PTO rules concerning these patents, which were drafted to prevent such shenanigans.  For example, "transitional" procedures adopted by the Office permitted an applicant to petition for withdrawal of the finality of a rejection but this opportunity could only be used twice; thereafter, the only recourse for pre-GATT applications was filing an appeal.  Filing a continuation or Request for Continued Examination in these applications strips such applications of their pre-GATT status and would result in the same loss-of-rights that the original version of the bill would cause.  The Office's carefully crafted rules were designed to minimize long pendencies for pre-GATT cases, a policy that undoubtedly is responsible for limiting the number of existing cases to 200.

The easiest path to passage would be for Rep. Smith to delete this requirement from the bill.  Whether he does so should shed some light on the motivations behind these provisions directed towards pre-GATT applications, although if the Office's performance regarding reports mandated by the Leahy-Smith America Invents Act are any guide, it may be a while before the Office can issue this latest report requested to satisfy the specific concerns of a Member of Congress (see "USPTO Report on Genetic Testing Delayed" and "USPTO to Hold Roundtable on Genetic Diagnostic Testing").

Update: Last night, the House passed an amended version of H.R 6621 by a 308-89 vote.  In the bill that was passed, § 1(m) was amended to only require a report on pre-GATT applications.

News from Abroad: Parliament Approves EU Unitary Patent Package

A unitary patent package covering 25 member states of the EU (Italy & Spain are not currently taking part) may finally be realised after approval of a new EU patent regime by the EU parliament.  In three separate voting sessions relating to a European unitary patent, a language regime and a unified patent court, Members of the European parliament (MEPs) approved the "EU patent package".

Long time in the making

Negotiations relating to agreement on a European unitary patent system have been on going for over 40 years with many false dawns including the rejection, by the ECJ, of a previous intergovernmental agreement proposal for a single European patent court.

The previous proposal was rejected by the ECJ who ruled that such a proposal was illegal under the EU Treaty and that only a unified patent system setup within the EU legislative framework would be legal.  The current package is by way of EU regulation for a unitary patent with the court system the result of intergovernmental agreement albeit with EU Commission support and blessing.  The package was achieved by way of the so-called "enhanced co-operation" procedure allowing a sub-set of member states to proceed with a project without the other member states under certain conditions.

On 29th June 2012 the European council agreed on the package but this was still to be approved by the European parliament.  The European parliament has now approved the unitary patent, the unitary patents court and an appropriate language regime.

Protection conferred by Unitary Patent

The unitary patent will provide automatic unitary patent protection in all 25 participating member states (Spain and Italy are not included) in a move said to be directed at cutting costs for EU companies and, hence, boosting competitiveness.  Of course, unitary patents and their enforcement via the unified court is available for non-EU applicants as well and it remains to be seen whether or not competitiveness of EU companies is boosted by the new arrangements.

Court Structure

The court will comprise a court of first instance, which in turn comprises local or regional divisions and a central division, and a court of appeal.

Each contracting state will have a local division but there will be a regional division if a common division is preferred.  The central division of the court of first instance will be based in Paris but with sub-divisions in London (dealing with Pharmaceutical, Chemical and Human Necessities subject-matter, IPC A & C) and Munich (dealing with Mechanical subject-matter, IPC F).  Paris will conduct proceedings relating to all other subject-matter.  The central division will have exclusive jurisdiction over revocation actions which are brought separately from infringement actions.

The unified patents court will have jurisdiction over all unitary patents established under the regulation.  Following a transitional period of 7 years, the unified patents court will have jurisdiction over all EP patents designating an EU member state a part of the unitary package.  The transitional period may be extended following a review of the workings of the new arrangements.  During the transitional period it is possible for a European patent to be "opted out" of the unified system, and indeed "opted in" if previously opted out.  However, requests to exercise an option must be received by the registry of the unified court prior to expiry of the transitional period.  In due course, patentees should give consideration as to which of their European patents they wish to be in or out of the system and make arrangements accordingly.

Local and regional divisions can choose whether or not to hear infringement and validity actions together, or to adopt a so-called bifurcated system in which validity is heard separately from the infringement action.  In a bifurcated system, the validity issues will be heard by way of a revocation action brought separately in the relevant central division.  If an infringement action is started after a revocation action has been brought in the central division then the revocation action may be moved to the court having conduct of the infringement proceedings.

The unified patents court will not have jurisdiction over national patents or national utility models.

How to obtain a Unitary Patent

Any applicant will be able to apply to the EPO for an EU unitary patent valid in all of the 25 member states taking part.  Applications are to be filed in English, French or German but can be made in another language if a translation is provided.  Patents will be made available in English, French and German.

Disputes

In case of a dispute, the patentee will have to provide a full translation of the patent in question in an official language of the member state in which the alleged infringement took place or the alleged infringer is domiciled.  Damages are likely to take into account that prior to being provided with a translation the alleged infringer may have acted in good faith and did not have reasonable grounds to know they were infringing the patent.  Whilst the jurisdictional issues are complex, they generally follow the Brussels regulation, and a general rule of thumb is that an infringement action can be brought before the court (local, regional or central) of the member state in which the infringement took place or where the defendant has their place of business within the EU.  Apparently, at the option of the plaintiff, non-EU defendants may be sued in the relevant central division.

Cost

Within the language regime, provisions have been made for translation costs to be reimbursed for EU-based SMEs, non-profit organisations, universities and public research organisations.  Renewal fees are also to be set at a level which takes into account the special needs of smaller organisations.

The cost of filing a unitary patent is not yet clear but is likely to be the same as validating in five or six countries under the current EPO regime.

Comment

The unitary patent will provide protection in 25 member states for the cost of a single patent application and a translation into two other languages.  Whilst this is beneficial to those organisations that validate in many member states, the benefit to organisations that validate in only two or three is not clear and this may be the case for many SMEs.

However, the EU parliament does appear to be taking steps to reduce costs for smaller organisations such as SMEs and non-profit organisations.  That said, until the cost of renewal or other official fees are released for the unitary patent, it is still not clear how SMEs and non-profit organisations are going to benefit.

Applicants should be asking themselves if the unitary benefits of the system outweigh the risk throughout its life of losing single European patent coverage by central revocation compared to the flexibility and partitioned risk of revocation through seeking national patents.

This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK.  Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.

Court Report

By Sherri Oslick --

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

Astellas US LLC et al. v. Fresenius Kabi USA LLC
1:12-cv-01699; filed December 12, 2012 in the District Court of Delaware

• Plainitffs:  Astellas US LLC; Astellas Pharma US, Inc.; Item Development AB
• Defendant:  Fresenius Kabi USA LLC

Infringement of U.S. Patent No. 5,731,296 ("Selective Vasodilation by Continuous Adenosine Infusion," issued March 24, 1998), licensed to Astellas, following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Astellas' Adenoscan® product (adenosine injection, used as a diagnostic for myocardial reperfusion injury).  View the complaint here.

Endo Pharmaceuticals Inc. v. Actavis Inc. et al.
1:12-cv-08985; filed December 11, 2012 in the Southern District of New York

• Plaintiff:  Endo Pharmaceuticals Inc.
• Defendants:  Actavis Inc.; Actavis South Atlantic LLC

Infringement of U.S. Patent No. 7,851,482 ("Method for Making Analgesics," issued December 14, 2010), 8,309,122 ("Oxymorphone Controlled Release Formulations," issued November 13, 2012), and 8,329,216 (same title, issued December 11, 2012) based on Actavis' manufacture and sale of a generic version of Endo's Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time).  View the complaint here.

OSI Pharmaceuticals LLC et al. v. Roxane Laboratories Inc.
1:12-cv-01669; filed December 7, 2012 in the District Court of Delaware

• Plaintiffs:  OSI Pharmaceuticals LLC; Pfizer Inc.; Genentech Inc.
• Defendant:  Roxane Laboratories Inc.

Infringement of U.S. Patent Nos. RE41,065 ("Alkynyl and Azido-Substituted 4-Anilinoquinazoline," issued May 5, 1998), 6,900,221 ("Stable Polymorph on N-(3-Ethynylpheny1)-6, 7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride, Methods of Production, and Pharmaceutical Uses Thereof," issued May 31, 2005), and 7,087,613 ("Treating Abnormal Cell Growth With A Stable Polymorph on N-(3-Ethynylpheny1)-6,7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride," issued August 8, 2006) following a Paragraph IV certification as part of Roxane's amendment to its ANDA (to add additional dosage forms) to manufacture a generic version of OSI's Tarceva® (erlotinib, used to treat non-small cell lung cancer and advanced pancreatic cancer).  View the complaint here.

Alkermes Pharma Ireland Ltd. v. Mylan Pharmaceuticals Inc.
1:12-cv-01673; filed December 7, 2012 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Mylan's  filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Celgene Corp. et al. v. Mylan Pharamaceuticals, Inc.
2:12-cv-07590; filed December 7, 2012 in the District Court of New Jersey

• Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendant:  Mylan Pharamaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Regents of the University of California v. Kappos
1:12-cv-01410; filed December 7, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,197,872 ("Human Milk Oligosaccharides to Promote Growth of Beneficial Gut Bacteria," issued June 12, 2012).  View the complaint here.

Medicis Pharmaceutical Corp. v. Alkem Laboratories Ltd. et al.
3:12-cv-07493; filed December 6, 2012 in the District Court of New Jersey

• Plaintiff:  Medicis Pharmaceutical Corp.
• Defendants:  Alkem Laboratories Ltd.; The Pharma Network, LLC.; Ascend Laboratories, LLC

Infringement of U.S. Patent Nos. 5,908,838 ("Method for the Treatment of Acne," issued June 1, 1999), 7,790,705 ("Minocycline Oral Dosage Forms for the Treatment of Acne," issued September 7, 2010), and 8,268,804 ("Method for the Treatment of Acne," issued September 18, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Medics' Solodyn® (minocycline hydrochloride extended release tablets, used to treat acne).  View the complaint here.

Oncothyreon Inc. v. Kappos
1:12-cv-01404; filed December 6, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,198,400 ("Vaccine For Modulating Between Tl and T2 Immune Responses," issued June 12, 2012).  View the complaint here.

Eli Lilly and Company v. Kappos
1:12-cv-01396; filed December 6, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,114,901 ("Crystalline 2,5-dione-3-(1-methyl-1H-indol-3-yl)-4-[1-(pyridin-2-ylmethyl)piperidin-4-yl]-1H-indol-3-yl]-1H-pyrrole mono-hydrochloride," issued February 14, 2012).  View the complaint here.

Conference & CLE Calendar

January 2-5, 2013 - National CLE Conference (Law Education Institute, Inc.) - Snowmass, Colorado

January 10, 2013 - China's Patent Regime and its Quest to Become an Innovation Economy (The George Washington University Law School and Fordham University School of Law) - Washington, DC

January 22, 2013 - Top Patent Law Stories of 2012 (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

January 22, 2013 - Patent Term Adjustments and Extensions: Recent Developments -- Leveraging Exelixis, Other Court Decisions and Recent USPTO Rule Changes to Maximize PTAs and PTEs (Strafford) - 1:00 - 2:30 pm (EST)

January 23-24, 2013 - The Comprehensive Guide to Patent Reform*** (American Conference Institute) - New York, NY

January 29, 2013 - Combined Customer Partnership Meeting of TC3700 and TC1600 (U.S. Patent and Trademark Office) - Alexandria, VA

January 29-30, 2013 - Biotech & Pharma Patent Litigation*** (C5) - Amsterdam, Netherlands

February 20-22, 2013 - Intensive Patent Law Seminar (Chisum Patent Academy) - New York, NY

***Patent Docs is a media partner of this conference or CLE

Webinar on Top Patent Law Stories of 2012

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on the "Top Patent Law Stories of 2012" on January 22, 2013 from 10:00 am to 11:15 am (CT).  Patent Docs co-authors and MBHB attorneys Donald Zuhn and Kevin Noonan will take a look back at the top patent stories of 2012, many of which will likely impact patent applicants and practitioners in the coming year.  Topics to be covered include:

• Continued implementation of the Leahy-Smith America Invents Act
• The Supreme Court's grant of certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc.; Bowman v. Monsanto Co.; and Federal Trade Commission v. Watson Pharmaceuticals, Inc.
• The Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.

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, Georgia, Illinois, North Carolina, New Jersey, New York and Virginia.

Webinar on Patent Term Adjustments and Extensions

Strafford will be offering a webinar/teleconference entitled "Patent Term Adjustments and Extensions: Recent Developments -- Leveraging Exelixis, Other Court Decisions and Recent USPTO Rule Changes to Maximize PTAs and PTEs" on January 22, 2013 from 1:00 - 2:30 pm (EST).  Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner; Donna M. Meuth, Senior Patent Counsel, Intellectual Property for Eisai; and Margaret J. Sampson of Vinson & Elkins will provide guidance to IP counsel for calculating patent term adjustments and extensions, examine recent court treatment and USPTO rule changes, and offer approaches for maximizing patent term adjustments and extensions.  The webinar will review the following questions:

• How will the recent rule changes by the USPTO change the landscape for PTA and PTE practice?
• What will be the impact of the recent decision by the federal district court in Exelixis Inc. v. Kappos?
• What steps should patent applicants take to maximize PTA and PTE?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by January 11, 2013 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

Joint GW-Fordham Program on China's Patent Regime

The George Washington University Law School and Fordham University School of Law will be holding a joint program entitled "China's Patent Regime and its Quest to Become an Innovation Economy" on January 10, 2013 at The George Washington University Law School in Washington, DC.  The program will offer presentations on the following topics:

• Keynote Speakers -- Chief Judge Randall R. Rader of the U.S. Court of Appeals for the Federal Circuit and U.S. Patent and Trademark Office Director David Kappos

• Challenges Facing China's New Leadership

• Overview of Patenting Trends and Enforcement Developments
• Innovation Policies from the Perspectives of the Current Change in Power/Policy in China
• Implementation of the 15 Year Science and Technology Plan and National IP Strategy
• US Government Engagement

• The Changing Legislative Scheme For Patents and Enforcement

• Patent Law Amendments
• Inventor Remuneration
• Standards and IP
• Antitrust and IP
• Corporate and Government Perspectives

• Developments At The Patent Office

• Patent Quality/Utility Model Patents and Designs
• Pharma Patent and High Tech Patent Challenges
• Chinese and Foreign Stakeholder Perspectives
• The Role of SIPO/USPTO Cooperation

A reception will take place following the roundtable.  Additional information about the program can be found here.  There is no registration fee for the program, but those interested in attending must register.  Those interested in registering, can do so here.

LEI National CLE Conference

Law Education Institute, Inc. (LEI) will be holding the 30th Annual National CLE Conference on January 2-5, 2013 in Snowmass, Colorado.  The Intellectual Property program of the conference will offer presentations on a number of topics, including:

• Keynote Address: Adjudicating Intellectual Property Disputes in the Digital Age -- Honorable Margaret McKeown, U.S. Court of Appeals for the Ninth Circuit
• The America Invents Act -- What You Need to Know Now
• Were you Willful? -- The Changing Landscape for Induced and Willful Infringement
• Patent-Eligible Subject Matter -- The State of the Union
• Hot Topics in Patent Licensing
• Objective Considerations of Non-Obviousness
• Damages and Remedies in Patent Litigation
• The Top Ten Patent Cases of 2012 Revealed (plus Predictions for 2013)
• What’s Keeping Corporate Counsel Awake at Night
• A Dialogue Between Bench and Bar -- panel to include the Honorable Kathleen M. O’Malley, U.S. Court of Appeals for the Federal Circuit, and the Honorable Ronald M. Whyte, U.S. District Court for the Northern District of California

An agenda and list of speakers for the Intellectual Property program of the conference can be found here.

The registration fee for the conference is $745.  Those interested in registering for the conference can do so by calling 888-860-2531, by faxing a registration form to 303-860-0624, or online here.  Information about lodging and skiing can be found here.

USPTO Seeks Public Feedback on RCE Practice

By Donald Zuhn --

Last week, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 72830) seeking public feedback on Request for Continued Examination (RCE) practice.  The notice indicates that the Office currently has a backlog of more than 90,000 applications that have not been examined since an RCE was filed, and states that this backlog diverts Office resources from the examination of new applications.  While the Office notes that several programs have been implemented to reduce the need to file an RCE, and thereby reduce the RCE backlog, the Office is now turning to its stakeholders "in an effort to better understand the full spectrum of factors that impact the decision to file an RCE."  The Office plans to use the information it gathers to design additional programs and initiatives aimed at reducing RCE filings and the RCE backlog.

The Office describes some of its efforts to reduce the RCE backlog in the notice, pointing to the Quick Path Information Disclosure Statement (QPIDS) pilot program and the After Final Consideration Pilot (AFCP) as two examples (see "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot Program"; "USPTO to Assess After Final Consideration Pilot Program"; and "USPTO News Briefs," June 21, 2012).  The notice does not, however, discuss the Office's efforts to decrease RCE filings by raising the cost of filing a first RCE to $1,200 (from the current fee of $930), and further raise the cost of filing subsequent RCEs to $1,700 (see "More on USPTO's Proposed New Fees - Part II"), a proposal that the Patent Public Advisory Committee (PPAC) has called "illogical" (see "PPAC Issues Report on USPTO Patent Fees Proposal").  On the topic of RCE filings, PPAC has previously explained that:

[A]pplicants rely on RCEs to continue the prosecution and eventually (and justly) receive a patent on their invention.  RCEs are mostly filed by applicants genuinely attempting to move prosecution forward and get a patent and not generally, it is believed, simply to delay the prosecution (applicants have the ability to file further continuation applications to proceed with other claim sets or to keep a particular patent family in prosecution in any case).  RCEs are a source of frustration for both the Office and the applicants, with both parties contributing to the problem.  However, from both casual conversation and also in public statements, the USPTO seems to place the blame for the rapid growth in RCE applications solely and squarely on applicants.  The change several years ago to move RCEs to the special new case docket (rather than an examiner’s amended docket) causes (as one would expect) significant delays in acting on RCEs.  That the Office has proposed significant increases in the RCE fees adds salt to an existing wound:  applicants must pay more for what most perceive as a reduction in service.  Thus, the proposed increase in fees for RCEs was not well received by the public.

Noting that "[t]he USPTO acknowledges that the cost of completing an RCE is less than that required for an original utility application," PPAC has also contended that "the increased costs to applicant being proposed to treat an RCE (and particularly a second and subsequent RCE) compared to the fees proposed for a utility or continuation application seems illogical."  Instead, PPAC has suggested that:

[A] small increase in the fee for an RCE might be appropriate but it should align more closely to the associated required work, and certainly be less than the fees for new or continuation applications.  The higher fee for second and subsequent RCEs should be eliminated because these become easier and cheaper to examine and any number of continuations may be filed at the same cost per continuation.  Rather than punishing applicants for pursuing their inventions by filing an RCE, it is suggested that the USPTO continue to find ways to reduce applicants' need for the RCEs in the first place.

The Office's request for comments on RCE practice also notes that a webpage devoted to its efforts to decrease the RCE backlog has been created on the USPTO website.  Data regarding RCE filings can be found at this webpage, including a chart showing the rise in the RCE backlog from just under 20,000 RCE filings awaiting an Office action in the fourth quarter of fiscal year (FY) 2009 to the current level of nearly 100,000.

The Office also provides data on RCE filings by technology, noting that the fraction of applications containing RCE filings is generally the same across technologies.

According to the notice, the public can provide feedback regarding RCE practice by submitting written comments by e-mail to [email protected]; by regular mail to the United States Patent and Trademark Office, Mail Stop Comments -- Patents, Office of Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Raul Tamayo; or using the web-based collaboration tool IdeaScale®, which allows users to post comments, view and respond to others' comments, and indicate agreement or disagreement with particular comments.  Comments must be submitted by February 4, 2013.  The Office also plant to hold a series of roundtables on RCE practice.

The notice provides a series of questions on which the Office is particularly seeking comment:

    (1) If within your practice you file a higher or lower number of RCEs for certain clients or areas of technology as compared to others, what factor(s) can you identify for the difference in filings?
    (2) What change(s), if any, in Office procedure(s) or regulation(s) would reduce your need to file RCEs?
    (3) What effect(s), if any, does the Office’s interview practice have on your decision to file an RCE?
    (4) If, on average, interviews with examiners lead you to file fewer RCEs, at what point during prosecution do interviews most regularly produce this effect?
    (5) What actions could be taken by either the Office or applicants to reduce the need to file evidence (not including an IDS) after a final rejection?
    (6) When considering how to respond to a final rejection, what factor(s) cause you to favor the filing of an RCE?
    (7) When considering how to respond to a final rejection, what factor(s) cause you to favor the filing of an amendment after final (37 CFR 1.116)?
    (8) Was your after final practice impacted by the Office’s change to the order of examination of RCEs in November 2009? If so, how?
    (9) How does client preference drive your decision to file an RCE or other response after final?
    (10) What strategy/strategies do you employ to avoid RCEs?
(11) Do you have other reasons for filing an RCE that you would like to share?

European Parliament Adopts Draft Regulations on Unitary Patent

By Donald Zuhn --

On Tuesday, the European Patent Office reported that the European Parliament in Strasbourg had adopted two draft regulations on the creation of the unitary patent.  The EPO hailed the adoption of the draft regulations as "a historic achievement."  EPO President Benoît Battistelli declared that "[t]he European Union is to be congratulated on this decision, which clears the way for the completion of the European patent system with a unitary patent and a Unified Patent Court, which we have been waiting for in Europe for 40 years."  President Battistelli added that the unitary patent would cut patenting costs in Europe and "strongly benefit European enterprises, especially research centres and SMEs," as well as "strengthen[] Europe's competitiveness."

The unitary patent, which will co-exist with national patents and the classical European patent, will provide protection for inventors in 25 EU member states through one single administrative step.  The unitary patent will differ from European patents with respect to the post-grant phase -- i.e., unitary patents will be treated as a single patent that does not require validation (including translation) and that does not need to be administered nationally in each and every state.  The unitary patent is based on two regulations, one creating the instrument, and one on the applicable language regime for the new patent.  According to the EPO release, the positive vote in the Parliament became possible after EU member states endorsed the regulations in their Competiveness Council meeting on Monday.  The unitary patent now has to be formally adopted by the EU Council and the European Parliament, which the EPO said is expected soon.  It has been noted, however, that the unitary patent could still face a legal challenge from Italy and Spain, two EU member states that have challenged the unitary patent at the Court of Justice of the European Union (CJEU) (see "Progress for Single European Patent and Litigation System").

The EPO will be responsible for delivering and administering unitary patents.  The Office said it expects to validate the first unitary patent in 2014.

According to the EPO release, an agreement establishing the Unified Patent Court (UPC), a specialized court having exclusive jurisdiction over infringement and validity questions related to unitary patents, is expected to be signed on February 18, 2013 and will enter into force once thirteen EU member states have ratified the package, including France, Germany and the United Kingdom.

For additional information regarding this topic please see:

• "Unitary Patent & Unified Patent Court," December 12, 2012
• "Progress for Single European Patent and Litigation System," November 12, 2012
• "EU Patent Is Finally Born," July 2, 2012
• "European Parliament Approves Enhanced Cooperation Procedure to Create Unified EP Patent System," March 1, 2011
• "Several EU Members Push for Unified Patent System," December 30, 2010
• "Europe Takes Step Closer to Single EU Patent and Patent Court," February 24, 2010

News from Abroad: Unitary Patent & Unified Patent Court

By Mark Richardson --

Last week the pan-European Intellectual Property Summit (IP Summit) was held in Brussels and the first morning of the summit saw a number of discussions regarding the unitary patent and unified patent court.  A common theme that seemed to crop up from anyone representing the official EU position was that the proposed unitary patent protection (UPP) package isn't perfect but it'll do!  Hmm.

The opening keynote introduction was from Kerstin Jorna from the European Commission (Director, Intellectual Property – Internal Market & Services DG) who likened the UPP package to a cake that doesn't look like the picture in the recipe book when you remove it from the oven.  According to Ms Jorna, in such circumstances we should ask ourselves whether the cake is fit to be served to our family!  Apparently the UPP cake is fit to be eaten.  Please insert your own joke here about too many cooks in the kitchen . . . .

One other point to come out of the keynote session was that the European Commission intends to do everything in its power to grant the first unitary patent in Spring 2014.  Selection of the unitary patent would be made at the validation stage which means that the first unitary patent is probably already in the system somewhere.

The main session on the unitary patent and court threw up two main issues:  forum shopping in the unified patent court and the cost of maintenance fees for the unitary patent.

The maintenance fee issue was raised by the representative from Proctor & Gamble Europe.  P&G currently have a validation programme of between four and six contracting states.  They generally welcome the unitary patent proposals as it provides the option of enforcing their IP over a wider geographic area.  However, they raised the concern that the maintenance fee levels are currently unknown and these could have a big impact on whether the system is seen as financially viable.  They made the point that once a unitary patent is chosen there is no going back if the maintenance fee burden becomes too high.  Currently of course they have the option of dropping some of the validated states if they desire to prune country coverage.

A Dutch attorney later suggested that the proposed maintenance fee amounts being discussed would add approximately 50% to P&G's post-grant costs.  No basis was given for these figures.

Forum shopping was also raised as a concern by a number of people in the audience with one audience member suggesting that there might be a danger of some local divisions promoting a pro-patentee stance to get more cases coming their way.  If such local divisions were also associated with referring validity back to the Central Division, then this would make them potentially very attractive to patent rights holders looking to get a geographically significant injunction.

It was at this point that a representative from (I believe) the EPO suggested in the space of two minutes that (i) forum shopping from the point of view of efficiency and costs was healthy; (ii) forum shopping (in the manner suggested by the concerned audience members) would not take place, and; (iii) even if forum shopping developed, the Appeal Court would overturn matters so that the system would be self correcting!

This point of view was quite worrying.  Even if the Appeal Court did eventually overturn infringement decisions from the local division, it doesn't change the fact that until the patent is either shown to be invalid or the decision is overturned, a valid injunction is in place.  The other issue here is one of cost.  If the alleged infringer is forced to appeal the decision then this will add to their costs.

A point was made later in the session that under the system being developed the Appeal Court would be able to intervene and suspend the effect of an injunction if they felt it was wrong or the local division was issuing "crazy" decisions.  However, whether the Appeal Court would want to get involved that often is unknown.

A question was asked during the session on "Rules of Procedure for the Unified Patent Court" as to when we might expect to see the draft rules (apparently we are up to the 12th draft).  The answer, eventually, came that there would be a public consultation at some point next year (February onwards).

Mr. Richardson is a Director at Keltie in London, UK.

This article was reprinted with permission from the IPCopy blog.

In re Ditto (Fed. Cir. 2012)

Cats and the Federal Circuit

By Kevin E. Noonan --

Unlike dog breeds that tend to be of ancient vintage (Labra-doodles and Yorkie-poos to the contrary), many cat breeds are of relatively recent parentage.  While there are many naturally occurring breeds (such as Maine Coons and Norwegian Forest Cats), a surprising number of cat breeds were developed in the last 50 years or so.  The most recent (and perhaps most extreme) are Savannahs, that are the result of breeding between a domestic short-haired cat and a serval, a wild, undomesticated African cat.  The Federal Circuit had the opportunity to opine on whether another (relatively) recent cat breed, the Pixie-Bob (at right), was patent-eligible subject matter or novel in an appeal from rejection on both these grounds before the Patent Office.  While the Court avoided the statutory subject matter question, it affirmed rejection for lack of novelty for the remarkably named applicant, Frank Robert Ditto.

Mr. Ditto claimed a breed of cats produced by mating a bobcat, lynx or bobcat-lynx mix with a domestic cat.  The sole independent claim is directed to "[a] domestic cat breed produced by breeding a purebred cat produced by mating a Bobcat, Lynx, or Bobcat Lynx species with a domestic cat," with dependent claims reciting various phenotypic characteristics of the cats (in most part relating to the cats' propensity to vocalize).  As explained in the specification, the breed has a unique combination of domesticated behaviors and "the spirit and disposition of the wild" cat as well as other specific traits (including "a variety of colors, have hind legs that are larger than their front legs, may have spotted fur or a stump tail, and have 'sturdy muscular bodies.'"

The Board affirmed the Examiner's rejection of §§ 101 and 102 grounds.  The basis for the § 101 rejection was that the breed was a "product of nature" that resulted from breedings that occurred in the wild.  The Board affirmed this rejection insofar as the claims did not require any particular degree of interbreeding and that naturally occurring cats could satisfy the limitations recited in claim 1.  With regard to the § 102 rejections, the Examiner cited two prior art references:  a 1994 Seattle Times article by Green relating to a Pixie-Bob produced by mating of a wild bobcat and a domestic cat (in a family barn without human intervention); and a 1995 Bellingham Herald article by Porter describing the Pixie-Bob breed and its introduction to The International Cat Association (TICA) as an "official" cat breed.  These references also satisfied the limitations recited in claim 1 on similar grounds, i.e., that there was no limitation as to the degree of breeding required and that "there was no evidence . . . suggest[ing] any difference between the Pixie-Bob cat [described in the cited prior art] and the claimed cats."

The Federal Circuit affirmed in a per curiam opinion before Judges Dyk, Prost, and Reyna.  Their opinion did not address the § 101 rejection, finding sufficient evidence that the claims were anticipated under § 102.  According to the panel, the term "purebred" was properly given its "broadest reasonable interpretation," particularly in view of the lack of any particular definition in Inventor Ditto's specification.  And the panel apparently relied on a dictionary definition of "breed" as meaning "a distinctive group of domestic animals differentiated from the wild type under the influence of man and usu[ally] incapable of maintaining its distinctive qualities in nature," citing Webster's Third New International Dictionary of the English Language 274 (1993).  Like the Board, the panel rejected Inventor Ditto's argument that the Green and Porter references did not describe a breeding that had achieved the desired level of domesticity (particularly with reference to the TICA "SBT" breeding standards).  Tellingly, Inventor Ditto's filing date (March 25, 1999) was after the date (May 1, 1998) when TICA accepted the Pixie-Bob as a recognized breed.  According to the panel, both the Green and Porter references disclosed characteristics and features of the Pixie-Bob cats that are distinctive and comprise the "desired effects" recited as a limitation in Inventor Ditto's claims.

The panel's decision finishes the patenting process for Inventor Ditto.  However, the "product of nature" rejection before the Office remains unscrutinized and intriguing (and, truthfully and in full compliance with the Supreme Court's analytical protocol, is based in part on the prior existence -- i.e., on § 102 grounds -- of the breeding in nature).  But the question can be presented more starkly with the Savannah cat mentioned above.  This cat is bred solely with human intervention (there is no evidence that the African serval ever mated in the wild with a domestic cat and certainly not with an American domestic cat).  In addition, males in the F1 generation are sterile; indeed, it is not until the F4 generation that fertile males are produced.  This required backcrossing into the domesticated cat stock in order to produce cats that breed "true," i.e., that have both parents of the Savannah breed.  All of these aspects evince the "hand of man" and represent something that is the "product of human ingenuity 'having a distinctive name, character [and] use,'" Chakrabarty at 310, citing Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615 (1887).  Thus it is clear under prevailing precedent that the Savannah cat should comprise patent-eligible subject matter.  Although this question is beyond the scope of the question presented to the Supreme Court in the Myriad case or in Mayo v. Prometheus, the question remains whether this Court would find these "routine" and "conventional" breeding methods to provide "enough" for the Savannah cat to be "more than" a product of nature and become a patent-eligible product of man.

In re Ditto (Fed. Cir. 2012)
Panel: Circuit Judges Dyk, Prost, and Reyna
Opinion per curiam

Image of Pixie-bobs (above) by Angie 1900, from the Wikipedia Commons under the Creative Commons Attribution 3.0 Unported license.