Plenary Highlights

The SuperFreakonomics of IP Licensing – Do Patents Slow Innovation? - Steven Levitt, co-author of the New York Times best-seller Freakonomics: A Rogue Economist Explores the Hidden Side of Everything and its recent follow-up SuperFreakonomics, will present a keynote address on the unintended impact of the patent system on innovation. He will also discuss his groundbreaking research on the effects of incentives on economics and market behavior as they relate to innovation. A book signing will follow Mr. Levitt’s presentation.  You can buy SuperFreakonomics: Global Cooling, Patriotic Prostitutes, and Why Suicide Bombers Should Buy Life Insurance by Steven D. Levitt and Stephen J. Dubner via Amazon.

Is the U.S. Patent System Under Siege: Congress, the PTO, the FTC and the Supreme Court -The Honorable Judge Paul Michel, retired Chief Judge of the United States Court of Appeals for the Federal Circuit will look at the many challenges facing the U.S. patent system including the reform legislation currently pending in Congress, the USPTO’s efforts to reduce backlogs and improve the quality of issued patents, and increased scrutiny by the Supreme Court and FTC.

IP as a National Responsibility: A Global Outlook for Strategies, Policies and Laws — Economist and Former Vice Presidential Candidate Pat Choate, will join John Whealan, Associate Dean of Intellectual Property Law at George Washington University Law School and Suzanne Michel, Deputy Director of FTC’s Office of Policy Planning to discuss how the United States, Europe, Asia and developing countries might leverage IP to secure future wealth and what this could mean for commercial collaboration across national boundaries.

IP100 Recap: IP Hot Topics 2010 — Over the course of 2010, LES has hosted innovative IP100 forums comprised of high-level IP leaders who have analyzed several hot IP topics. This panel will revisit the topics, review previous findings and discuss what we’ve learned from the world-class IP100 panels about best practices in licensing. Key ‘take-aways’ will be included in a white paper available after the meeting for attendees.

Register now here and save!  Rates increase $100 on September 1^st.

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Who is a Top Prosecutor?

A Top Patent Prosecutor is any patent attorney who has achieved a reputation among their peers for high quality work product and counseling skills in patent preparation and prosecution. In order to receive recognition, you must be a registered patent attorney who is actively engaged in the preparation and prosecution of U.S. Patent applications. No more than ten percent of all patent prosecution attorneys will be awarded this recognition.

What does it take to become a Top Prosecutor?

Patent Buddy believes that very few of America’s best patent prosecutors get the recognition they deserve. In order to provide recognition to these attorneys Patent Buddy has created the Top Prosecutor’s recognition program. To qualify for this recognition, a registered patent attorney must have obtained a high degree of accomplishment in patent prosecution.

Patent Buddy Nomination Process

How does the nomination process work? Any registered patent attorney with five or more years of experience can nominate a Top Prosecutor.  Just simply fill out an on-line ballot to nominate up to ten registered patent attorneys either within or outside your organization, either in private or corporate practice, and that you feel should be recognized for their distinguished abilities and achievements. You may designate any one of a variety different technology or legal specialties for your nominees.

Nominations are being received through September 15th, 2010.

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The 8th Annual Pharmaceutical-Biotech Partnering Conference

There are a lot of pharmaceutical and biotechnology investment conferences and Pharma-Biotech networking events in the market.  BioNetwork is offering a conference that offers you the chance to spend quality time with the right people.

With its intimate setting and extensive networking opportunities, you will meet executives from both the Pharmaceutical and Biotech companies who are actively looking for partners to fuel pipelines and find the next cure…and not just attending the event because they have to.

What Makes BioNetwork Different?

Significant Case Studies Give You The Chance To Learn About New Partnerships and New Agreements In The Industry

* BMS and Allergan
* Merck and Schering-Plough
* Sanofi-Aventis and Intelliject
* J&J and Takeda
* Eli Lilly and Kowa Pharmaceuticals
* Eli Lilly and Incyte Corporation

The Perfect Pitch: Biotech Investment Challenge

In this groundbreaking session, Biotech companies will have the chance to present your new research and new therapies (either in early stages or mid-late stages) to a panel of big Pharma executives, VCs, and Investment Banks who are all willing to give their feedback about the strength of your pitch, highlighting portions of the presentations that piqued their interest. This gives the presenting companies, as well as the audience, important insights into what sparks the interest of potential partners and investors. Find out how you can participate.

Onsite Facebook and Onsite Message Board

Tired of sifting through a sea of name tags to find the person you want to meet? Upon check-in, the BioNetwork team will be taking photos of all speakers and attendees so that you can easily spot the person you wish to network with. Then placed in a central location by the registration area, the onsite message board allows you to leave notes for speakers or attendees that you are looking to connect with while at BioNetwork West.

Improved One-To-One Partnering Software

On this website you will find a list of registered attendees along with their contact details (viewable at their discretion), a brief description of their companies and partnership aspirations and a timetable of available meeting rooms. Upon receiving an accepted invitation from a potential partner, you will be able to schedule a private partnering room. It’s easy to use and our team is always available to help you maximize the tool to plan meetings before you even arrive at the event.

Who:  Speakers include:

• Robert Wills, Vice President Alliance Management, Pharmaceuticals Group. Johnson & Johnson
• Jack Tupman, VP Corporate Business Development, Eli Lilly and Company
• Laura Pierce, Vice President, Alliance Management, Bayer Healthcare Pharmaceuticals
• Martin Reeves, VP Business Development, Cephalon

When: 25-27 October, 2010

Where: The Ritz Carlton, Laguna Nigel, CA

Email: bionetwork@wbresearch.com

Visit: BioNetwork West

*Update!!!   BioNetwork has just offered a a 25% discount to PatentBaristas.com readers.  You can get the discount by registering using code 10386XZ299.  Below is the link to the registration page:

Discount code 10386XZ299

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Biothera sued Biotec alleging that Biotec for infringement of 14 of Biothera’s patents. Both parties filed summary judgment motions concerning one of the patents in suit, United States Patent No. 5,702,719, a patent related to the use of purified beta (1,3) yeast extract glucan particles, in particular finely ground, as nutritional supplements and as dermatological agents.  The district court granted Biotec’s motion for summary judgment that the ’719 patent was not infringed.

While the case was pending in the district court, the parties entered into a settlement agreement. Pursuant to the terms of the settlement agreement, the district court entered judgment of noninfringement, and Biothera appealed.

Biotec showed a letter indicating that, pursuant to the settlement agreement, it had agreed not to participate in this appeal. The court then directed Biothera to show cause why this case should not be dismissed as moot due to lack of a case or controversy.

Biothera said that this appeal is not moot because:

“[a] very real and current controversy exists as to whether defendants’ products infringe the ’719 patent.” Biothera states that this appeal “will directly decide the legal rights between Biothera and the defendants. If Biothera fails to prevail in its appeal, the judgment of non-infringement of all of Defendant’s accused products will become final. However, if Biothera prevails in its appeal, the judgment of non-infringement will be reversed or vacated.”

A settlement agreement does not necessarily result in mootness of an appeal. However, if by reason of settlement or other circumstance a court can no longer grant effectual relief, a case becomes moot and must be dismissed:

Based on Biothera’s response and the court’s review of the settlement agreement, that this court cannot grant any effectual relief to Biothera. Biothera has not shown that any claim for monetary or other relief is contingent on this court’s determination. Under these circumstances, this case does not present a “definite and concrete [case or controversy], touching the legal relations of parties having adverse legal interests.” Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 240-41 (1937). In this case, because the court cannot grant Biothera any effectual relief, there is no case or controversy and the appeal must be dismissed.

In addition, when a case becomes moot due to settlement, vacatur is not justified in the absence of exceptional circumstances. In this case, Biothera did not show that exceptional circumstances warrant vacatur.

Request denied.

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The petition for panel rehearing and for rehearing en banc was denied.

As part of the NDA process, the manufacturer must also identify all patents that claim the drug or a method of use. If the patent claims one or more methods of using the NDA drug, FDA forms require a description of each of those processes. This description is commonly known as the “use code narrative.” The FDA assigns a unique number, known as a “use code,” to each description. The FDA publishes a list of drugs, along with the applicable patents and their associated use codes, in the Orange Book.

A manufacturer that seeks to market a generic copy of these listed drugs may submit an abbreviated new drug application (ANDA) in which a generic manufacturer must make a certification that it would not infringe any patent identified in the Orange Book pertaining to its drug. Specifically, the generic manufacturer must select one of four alternatives permitting use of the patented product or process:  (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug. 21 U.S.C. § 355(j)(2)(A)(vii).

Often pharmaceutical formulations have multiple uses and applications. After expiration of the patent on the composition itself, only some of those uses may get continued protection as patented methods. If a generic manufacturer wants FDA approval for a use not covered by a method-of-use patent for a listed drug, the generic manufacturer must submit a proposed label to the FDA that does not contain the patented method of using the listed drug. When considering approval of these requests for a use not covered by a patent, the FDA relies on the applicable patent’s use code narrative to determine the scope of the patented method. The FDA approves the statement only where there is no overlap between the proposed carve-out label submitted by the generic manufacturer and the use code narrative submitted by the pioneering manufacturer.

The Hatch-Waxman Act enables a generic manufacturer in a Paragraph IV suit to assert a counterclaim challenging the accuracy of the “patent information” submitted to the FDA:

[The ANDA] applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) of this section on the ground that the patent does not claim either– (aa) the drug for which the application was approved; or (bb) an approved method of using the drug. 21 U.S.C. § 355(j)(5)(C)(ii

Congress enacted the counterclaim provision in order to prevent patent holders from making unwarranted or inaccurate claims of patent coverage in the Orange Book. Patent holders previously made such claims in order to delay the onset of competition from generic drug manufacturers, by preventing or delaying FDA approval of a generic manufacturer’s Abbreviated New Drug Application (ANDA).

Novo sells repaglinide under the brand name Prandin, approved for three uses: (1) repaglinide by itself (i.e., monotherapy); (2) repaglinide in combination with metformin; and (3) repaglinide in combination with thiazolidinediones (TZDs).

The Orange Book lists two patents for Prandin: U.S. Patent No. RE 37,035 (the “’035 patent”) for the chemical composition of repaglinide, which expired on March 14, 2009, and U.S. Patent No. 6,677,358 for repaglinide in combination with metformin, which expires on June 12, 2018.

The FDA initially assigned the ’358 patent the use code “U-546–Use of repaglinide in combination with metformin to lower blood glucose.”

Caraco filed an ANDA for the drug repaglinide with a Paragraph III certification for the ’035 patent and a Paragraph IV certification for the ’358 patent. Caraco stipulated that its ANDA would infringe the ’358 patent if it included a label that discussed the combination of repaglinide and metformin. Caraco submitted an amended ANDA declaring that Caraco was not seeking approval for the repaglinide-metformin combination therapy (a carve-out label). Novo got mad and said that the carve-out would render the drug less safe and effective.

Novo then updated its use code narrative for the ’358 patent where the FDA removed the use code U-546 from the Orange Book for Prandin and substituted the new use code “U-968–A method for improving glycemic control in adults with type 2 diabetes mellitus.” The FDA then disallowed Caraco’s section viii statement, because its proposed carve-out label overlapped with the use code U-968 for the ’358 patent. As a result, Caraco’s current label now includes the repaglinide-metformin combination therapy, which is stipulated to infringe claim 4 of the ’358 patent.

Caraco made a counterclaim requesting to change the use code for the ’358 patent in reference to Prandin from U-968 to U-546. Caraco claimed that the use code U-968 was overbroad because it incorrectly suggested that the ’358 patent covered all three approved methods of using repaglinide even though it claimed only one approved method. Caraco also added a patent misuse defense, asserting that Novo misrepresented the scope of the ’358 patent in its use code narrative.

The district court found that Novo had improperly filed an overbroad use code narrative for the ’358 patent and directed Novo Nordisk to correct the description of the ’358 patent by reinstating its former U-546 listing for Prandin and describes claim 4 of the ’358 patent in section 4.2b as covering the “use of repaglinide in combination with metformin to lower blood glucose.”

The ’358 patent claims only one of the three approved methods of using PRANDIN (i.e., repaglinide in combination with metformin). Novo argued that the counterclaim is available only if the ’358 patent does not claim any approved methods. Caraco countered that it is entitled to the counterclaim because the ’358 patent does not claim two of the approved methods of PRANDIN use. In other words, Novo reads “an approved method” in the counterclaim statute as “any approved method” while Caraco reads it as “all approved methods.”

The Federal Circuit shot down Caraco’s chances for a rehearing by extending the rights of the original patent holder:

This court detects no ambiguity in the statutory language. When an indefinite article is preceded and qualified by a negative, standard grammar generally provides that “a” means “any.”

The rest of the counterclaim provision also does not support Caraco’s interpretation. In the context of this case, the statutory language “an approved method of using the drug” refers to the approved methods of using the listed drug, PRANDIN. This language cannot refer to the methods of using Caraco’s generic drug, because the FDA has not yet approved Caraco’s ANDA. Therefore, the Hatch-Waxman Act authorizes a counterclaim only if the listed patent does not claim any approved methods of using the listed drug.

[Legislative] language selected for this Amendment supports this court’s interpretation that “an approved method” means “any approved method.” A patent listing that covers one amongst several approved methods of using a formulation protects that patented method and thus bears a direct relation to the purpose of Orange Book listings. This court does not detect a situation such as the one occurred in Mylan.

As Judge Clevenger points out, Caraco’s real complaint should lie with the FDA, not with Novo. Had it not been for the FDA’s regulatory action, Caraco could have asserted in a Paragraph IV lawsuit that its proposed labeling did not infringe the ’358 patent. It was the FDA, not Novo, that tipped the careful balance in the favor of pioneering manufacturers.

Denied.

Circuit Judges Gajarsa and Dyk dissented:

As the dissent explains, the majority’s opinion adopts an overly narrow construction of “patent information” and an overly broad construction of “an approved method of using the drug.” See id. at 1370-72, 1376-78. Both constructions are irreconcilable with pre-existing FDA regulations, the text of the HWA, and Congressional intent. See id. at 1370-78. I believe rehearing the case en banc is necessary to rectify these improper constructions.

Not only is the majority’s construction of the counterclaim provision erroneous, it also eliminates the careful balance Congress has struck between encouraging pharmaceutical discoveries and ensuring that the American people have access to low cost generic drugs. Specifically, the majority’s opinion seriously undermines Section viii, a critical provision of the HWA that facilitates the approval and marketing of lower-cost generic drugs for uses no longer protected by a patent.

To defeat this Section viii carve-out statement, Novo changed the Orange Book use code associated with the ’358 patent from “use of repaglinide in combination with metformin to lower blood glucose” to “a method for improving glycemic control in adults with type 2 diabetes mellitus.” See id. at 1362-63. The latter use code unmistakably covering both patented and unpatented uses. … This effectively allows a patent holder to extend its monopoly to unpatented uses.

The majority opinion thus eviscerates Section viii. A generic, like Caraco, cannot use Section viii if the pioneering manufacturer’s use code is erroneously broad. With the majority’s blessing, pioneering drug manufacturers now have every incentive to follow Novo’s lead and draft exceedingly broad use codes thereby insulating themselves from generic competition and rendering Section viii a dead letter.

See the original decision here: Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359, 1370-78 (Fed. Cir. 2010) (Dyk, J., dissenting).

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