Patent Docs

IPO Releases List of Top 300 Patent Holders for 2010

June 30, 2011

"Biotech/Pharma Top 50 (plus 6)"

By Donald Zuhn —

The Intellectual Property Owners Association (IPO) released its 28th annual list of the top 300 organizations receiving U.S. patents. Patent Docs Readers may recall that the U.S. Patent and Trademark Office stopped releasing its annual list of top patent recipients in 2006 in order to "discourag[e] any perception that we believe more is better."

The IPO stated that while it does not intend for the report to "encourage or discourage patenting," it would continue to publish its annual list of top recipients because "the number of patents granted is one of the few objective measures of the patent system as a whole and the patenting activities of individual industries and companies." The IPO compiled its list by counting the number of utility patents granted during 2010 on which an organization or its subsidiary was listed as the owner on the face of the patent. However, the IPO attributed patents that were granted to two or more organizations jointly to the organization listed first on the patent. The IPO noted that 207,915 patents were issued in 2010, which was an increase from the 165,213 patents that issued in 2009. The top fifteen companies on the IPO Top 300 are listed below

As in past years, Patent Docs used the IPO's list of top patent holders to compile a list of the top "biotech and pharma" companies and organizations receiving U.S. patents in 2010. This year's list of 56 biotech and pharma companies and organizations continues to reverse a downward trend that saw the number of biotech and pharma companies and organizations drop from 51 in 2006 to 47 in 2007 to 43 in 2008 before rising to 47 last year. Each organization's IPO top 300 ranking for 2010 is indicated in the "'10 IPO Rank" column; the IPO top 300 ranking for 2009 (if available) is indicated in the "'09 IPO Rank" column. Biotech and pharma companies and organizations that failed to make the IPO top 300 in 2010 after making it in 2009 included Cardiac Pacemakers, Inc. (#121 on the IPO top 300 for 2009), Battelle Memorial Institute (157), Zymogenetics, Inc. (242), and Eli Lilly and Co. (258).

Please note that some of the companies and organizations listed below may be involved in non-biotech or non-pharma work, and therefore, a portion of the patents granted to these companies and organizations may be directed to other than biotech and pharma-related inventions. In addition, our list is a little inclusive in that we included medical device companies.

For additional information regarding this topic, please see:

• "IPO Releases List of Top 300 Patent Holders for 2009," May 26, 2010
• "IPO Releases List of Top 300 Patent Holders for 2008," May 14, 2009
• "IPO Releases List of Top 300 Patent Holders," May 22, 2008
• "IPO Posts List of Top 300 Patent Holders," April 20, 2007
Docs at BIO: Session on the Myriad Case

June 29, 2011

By Sherri Oslick —

On Tuesday morning, attendees at the BIO International Convention had the opportunity to attend a session entitled "The Myriad Case and the Patentability of Isolated DNA Molecules," presented by the team from Wilmer Hale that submitted a joint amicus curiae brief to the Federal Circuit on behalf of BIO and the Association of University Technology Managers (AUTM) (see "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO"). The presentation was well organized and well presented, and struck a balance so as to appeal to both those familiar with the case as well as those who may not have been. The slides from the presentation can be found here.

The session was introduced by Seth Waxman, former Solicitor General of the United States. Mr. Waxman noted that there is relatively little law with regard to the patentability of isolated and purified DNA molecules, and that while the USPTO struggled with the standards for examining applications claiming such molecules, ultimately the USPTO issued generally permissive guidelines. The Myriad case was described by Mr. Waxman as a "frontal challenge" to the patentability of isolated and purified DNA molecules.

Mark Fleming provided the historical context of the case, which involves fifteen claims in seven patents covering isolated DNA molecules linked to breast cancer (BRCA1/BRCA2), including methods for detecting mutations in these genes. The claims at issue were challenged on three grounds, two constitutional grounds and the primary ground of patentability under 35 U.S.C. § 101. As Mr. Fleming pointed out, the parties named as plaintiffs in the case were well thought out by the ACLU, the entity behind the suit. There were four medical associations (led by AMP), eight physicians, two advocacy groups, and six patients who claimed they were unable to access the test for BRCA1/BRCA2 mutations due to Myriad's patents. Defendants included the patent owner (University of Utah Research Foundation) and Myriad Genetics as the exclusive licensee, and the USPTO, whose involvement was limited to the constitutional issues.

The case was decided on summary judgment by Judge Sweet of the Southern District of New York with a 153 page opinion finding the claims unpatentable. Judge Sweet's opinion centered around two basic principles: 1) that purification of a naturally occurring substance is not patentable; 2) however, if the naturally occurring substance is transformed and has "markedly different characteristics" from a product of nature, it is patentable subject matter. DNA, according to Judge Sweet's opinion, "carries genetic information" and is "the physical embodiment of laws of nature." In other words, isolated DNA is not different from naturally occurring DNA, and it is the fact that isolated DNA (like natural DNA) is a carrier of information that makes it useful, not the fact that it is isolated. As to the remaining issues, the method claims were found invalid under Bilski, the constitutional claims were dismissed without prejudice, and the challenge to plaintiffs' standing was rejected.

On appeal to the Federal Circuit, Mr. Fleming noted that the U.S. government took a Solomonic approach in its position, splitting the baby as it were, such that some DNA (engineered, including cDNA) was patentable and some (isolated and unmodified) was not. This, as Mr. Fleming advised, marked a radical change in the government's position, and in fact the government, who co-owned four of the seven patents at issue, was arguing that its own patents were invalid.

Allen Nunnally followed Mr. Fleming and presented the position of BIO in its amicus brief on the issue on appeal of the patentability of composition claims to isolated DNA molecules. BIO argued that both isolated DNA as well as cDNA was patentable, noting that § 101 of the Patent Act is broad and is only meant to be a threshold test to exclude laws of nature, physical phenomena, and abstract ideas. Isolated DNA molecules, in BIO's view, represent new compositions of matter that do not exist in nature, are clearly transformed (separated from carrier proteins, covalent bonds broken, etc.), and which differ from their natural counterparts; cDNA represents an even greater difference from naturally occurring DNA. As to the District Court's interpretation of DNA as "information," BIO noted that such a characterization was mere metaphor, and that, simply put, isolated DNA molecules were chemical compositions of matter. Further discussion centered on BIO's position that isolated DNA patents would not discourage innovation, that invalidating isolated DNA patents would have far-reaching negative consequences, and that isolated DNA patents do not impede research or harm patients.

Following Mr. Nunnally, Tom Saunders offered a lively presentation on the oral arguments in the appeal, held on April 4, 2011 with Judges Lourie, Bryson, and Moore on the panel. On the issue of the plaintiffs' standing to sue, the panel focused its inquiries on the adequacy of the affidavits used to establish standing. Mr. Saunders indicated that there was little relationship between the focus in oral arguments at the Federal Circuit and the focus at the District Court level, including a minimal focus at the Federal Circuit on the idea of DNA as information. Oral argument was dominated by hypotheticals, including those trying to analogize the isolated aspect of the claimed DNA molecules. Questions from the panel revealed that the judges were struggling on where to draw the line, where their opinion might have very far reaching implications without knowing what those implications might be. Overall, it was Mr. Saunders' assessment that the panel was leaning toward keeping the USPTO's precedent in finding isolated DNA molecules to be patentable.

Looking forward, with almost certainty there will be a request for rehearing en banc, followed by a petition for certiorari to the Supreme Court (all panel members agreed that the plaintiffs structured the case with the ultimate goal of Supreme Court review), and the possibility of Congress taking up the issue.

Overall, this BIO International Convention breakout session provided a well organized and balanced summary of the Myriad case from start to today, as we await a decision from the Federal Circuit.

Finally, Patent Docs would like to thank Mr. Saunders for providing access to the presentation slides, for allowing them to be shared with our readers, and for mentioning Patent Docs during the presentation.

For additional information regarding the AMP v. USPTO ("Myriad") case, please see:

• "AMP v. USPTO: Oral Argument at the Federal Circuit," April 4, 2011
• "Federal Circuit to Hear Argument in AMP v. USPTO," April 3, 2011
• "Curiouser and Curiouser," February 16, 2011
• "AMP v. USPTO — Briefing Update III," February 8, 2011
• "Amicus Briefs in AMP v. USPTO: AARP," January 27, 2011
• "AMP v. USPTO: Appellees' Brief," January 12, 2011
• "AMP v. USPTO — Briefing Update II," December 16, 2010
• "Amicus Briefs in AMP v. USPTO: Alynylam Pharmaceuticals, Inc.," December 15, 2010
• "The Relevance of Patent Exhaustion in the Myriad Genetics Case," December 14, 2010
• "AMP v. USPTO — Briefing Update," December 14, 2010
• "Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law," December 12, 2010
• "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
• "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," November 3, 2010
• "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
• "AMP v. USPTO — Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
• "AMP v. USPTO — Briefing Schedule Update," August 22, 2010
• "FCBA Submits Amicus Brief on Motion for Recusal in AMP v. USPTO," August 9, 2010
• "Appellees Move for Recusal of Chief Judge Rader in AMP v. USPTO Appeal," July 19, 2010
• "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
• "Myriad Appeals AMP v. USPTO Decision," June 16, 2010
• "AMP v. USPTO: What Everyone Else Is Saying – Part II," June 8, 2010
• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
• "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th — Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
Patent Profile: Antisense Pharma Secures Patents for Convection Enhanced Delivery

June 28, 2011

By Kwame Mensah —

Earlier this month, Antisense Pharma, GmbH, a biopharmaceutical company located in Regensburg, Germany, announced the issuance of U.S. Patent No. 7,963,956, entitled "Portable equipment for administration of fluids into tissues and tumors by convection enhanced delivery technique," which is directed to Convection Enhanced Delivery (CED). CED is being touted as an application system for long-term and outpatient administration of therapeutic substances into brain tissue. The portable system was specially developed for the treatment of brain tumor patients using Antisense Pharma's drug Trabedersen. Patents in Europe, Canada, Japan, and India, with additional patents being pursed worldwide, also cover CED.

Dr. Karl-Hermann Schlingensiepen, Chief Executive Officer of Antisense Pharma, stated that CED provides a solution to "[t]he difficulty of administering a therapeutic dose of a pharmacologically effective substance into the brain tissue due to the very small number of substances capable to pass the blood-brain barrier." Dr. Schlingensiepen further stated that this difficulty "is one of the main reasons for the currently very few therapy options we can offer to brain tumor patients." Antisense Pharma explains that CED uses a special infusion technology that provides a high and uniform concentration of active substances in the brain tissue — even at a distance from the place of infusion. The company explains further, that the substance is administered directly into the tumor or the surrounding brain tissue using a permanent, pressure-supported infusion using a special catheter/pump system. It concludes that since CED builds up a pressure gradient, a clearly higher and more homogeneous penetration volume can be achieved compared to conventional diffusion.

Dr. Hubert Heinrichs, Chief Medical Officer at Antisense Pharma, explains that with the development of the first portable, and now patented CED application system, "[t]he option of a CED-based treatment using a portable application system over weeks and months could well stimulate the development of urgently required neurotherapeutics."

The CED consists of several harmonized components. After the catheter has been stereotactically placed in the tumor, the drug is administered via an infusion line using an external, programmable, portable pump. The implantation of the catheter is a neurosurgical intervention, which is geared to the placement of a shunt for hydrocephalus patients where excessive brain liquid is diverted into the blood circulation. The brain catheter is inserted through the skin to a port chamber, which is usually placed in the chest muscle. The chamber is then connected to an external infusion line, which in turn is connected to a small, portable infusion pump that can easily be attached to the belt. Dr. Schlingensiepen summarizes that:

Using this application system, we are able to administer highly effective drugs, by-passing the blood-brain barrier. At the same time, we allow patients to continue living their normal lives during the therapy: once the catheter system has been positioned, no extensive hospitalization is required. The total 5-month treatment using Trabedersen provides patients with maximum mobility and quality of life.

Key claims encompass the CED apparatus itself and a method of use for the apparatus to treat a number of cancer tumors.
Docs at BIO: Session on Patent Litigation Tactics and Strategies for Biosimilars

June 27, 2011

By James DeGiulio —

One of the highlights of the afternoon sessions at the BIO International Convention was a seminar appropriately entitled "A Brave New World: Patent Litigation Tactics and Strategies for Biosimilars," where an experienced panel of patent attorneys presented their interpretation of the new biosimilars pathway of the Biologics Price Competition and Innovation Act and speculated on some of the potential issues that will arise once the statute is put into practice. The panel consisted of patent counsel from both brand and generic industries, including Mark Bowditch (Sandoz, Inc.), Edward Murray (Merck & Co., Inc.), and Bart Newland (Biogen Idec Inc.), while moderator Eric Marandett of Choate Hall & Stewart LLP supplied the perspective of outside counsel. The panel outlined the various litigation phases of the framework, with each panelist discussing a specific aspect of the statute, often returning to a big-picture view of the timeline of the procedural provisions of the statute. After this thorough discussion of the provisions of the statute (which will not be covered here), the panel described several issues that the statute as written will present in the near future.

The first strategic decision that the biosimilar applicant must make is to decide which pathway it wishes to take toward FDA approval of the biologic. The statute provides two pathways for a biosimilar applicant: the interchangeable pathway, and the biosimilar pathway. Interchangeable biologics are awarded their own exclusivity term, but biologics classified as merely "biosimilar" do not enjoy any exclusivity. However, the standard for interchangeability with the BLA reference product will presumably be much higher, and likely more expensive to achieve, though the FDA has yet to issue its guidelines on these standards. The decision will ultimately come down to the business strategy of the particular product. Interestingly, the panel noted that many of the biosimilar products on the horizon are focused on being "biobetters," in that they wish to distinguish themselves as a better, and thereby different, product than the BLA reference product. How this emphasis will impact FDA approval on particular biosimilars remains to be seen.

The various periods of exclusivity are well known under the new scheme, for they were intensely debated prior to passage of the statute. In light of these various periods of exclusivity, the question arises: when should a biosimilar applicant file their application? On one hand, it may be of interest to file the application as early as possible after the 4-year data exclusivity period. This will provide ample time to resolve any patent disputes before FDA approval. However, unlike the 180-day exclusivity under Hatch-Waxman, the biosimilar scheme lacks a reward for a first-to-file biosimilar application. On the other hand, it may be beneficial for the applicant to wait until the 12-year market exclusivity is set to expire, using more time to perfect the biosimilar application. Since the biosimilar scheme also lacks a 30-month stay, the biosimilar applicant could then launch its product after providing the required 180-day notice to the BLA holder. However, since the patent litigation would still be unresolved, this would be equivalent to launching "at risk," which can have serious financial consequences if the litigation does not go as planned for the biosimilar applicant.

Access of confidential information by the BLA holder was a major point of concern at the session. Under the statute, within 20 days after the FDA has accepted its application, a biosimilar applicant must provide the BLA holder a copy of the full application, including a description of the process for manufacturing the biosimilar product. The BLA holder must keep the application and information confidential, and the use of such information is restricted. From the side of the biosimilar applicant, it is extremely unsettling to have to provide the entire application to the BLA holder. Essentially, the biosimilar applicant must hand over all of the most important information pertaining to the biosimilar to its fiercest competitor, including manufacturing processes which may apply to future pipeline biologic products. The panelists noted that this disclosure seems excessive, particularly when the applicant has no intention to challenge the patents covering the BLA reference product.

One of the hallmarks of the new biosimilar scheme is the complex exchange of patent lists and detailed statements of infringement/validity/enforceability between the BLA holder and the biosimilar applicant. The question was raised — how does one decide which patents to list? The panel was nearly unanimous in their assessment that every patent that can plausibly be asserted should be listed at least on the original exchange list. There is simply much more risk in not listing a patent, for the BLA holder is forever barred from bringing an infringement action relating to that patent, even in the later pre-commercial marketing stage where litigation can arise. These patent lists are likely to be extensive, for the BLA holder will likely have in patents not only on the composition itself, but it will also have patents on the platform technology used to make the biologic. All of these patents conceivably can be asserted under the biologics scheme, which is in contrast to the Orange Book, which has restrictions on which patents can be listed.

The listing of newly acquired patents during an active litigation may present serious logistical problems. Under the statute, the BLA holder has 30 days to supplement its patent listing with newly granted or newly licensed patents. The biosimilar applicant then has 30 days to put forth its detailed statement. However, depending on the stage of litigation and proximity to trial, it may be practically impossible to add the new patent to the litigation. It is unclear how a judge would handle such a case — it is possible that the new patent would have to be litigated separately at a future date. One panelist suggested that, if possible, a BLA holder should expedite the prosecution or licensing of any applications or patents that could potentially be listed in the litigation immediately upon the filing of a biosimilar application against their biologic product.

Finally, of particular interest to the session audience, half of which were IP counsel, the new biologics pathway will have a major impact on the roles of outside counsel. With small molecules, most pharma companies are classified generally as "brand" or "generic," and these companies retain their outside counsel allegiance on their respective sides of the Hatch-Waxman scheme. However, under the new biosimilar pathway, many companies will step out of their traditional roles, where "brand" companies may be filing biosimilar applications, essentially becoming a "generic" and reversing roles. For biosimilars, the line is not as clear as "brand" and "generic," which has the potential to cause major conflict problems for outside counsel. The panelists recommend planning far ahead to line up counsel with specific roles. In-house counsel will not have time to shop firms and clear conflicts since the timeframes for the patent exchanges and the detailed statements are extremely short.

It is unclear exactly how, or if, the new biosimilar framework will work in practice. Even if it does work, will anyone even bother to file a biosimilar application over a traditional BLA? The panelists at today's session were of the opinion that we will see a biosimilar application sometime in the near future. The first biosimilar application filed under the new framework is certain to generate major interest within the biotech sector, and will undoubtedly be the subject of several future BIO sessions.

If any Patent Docs readers who may be attending BIO this week are interested in discussing today's session further, you are encouraged to stop by the MBHB booth #4723 – Hall C, or send me an e-mail. I will be at the booth from 3:00 – 5:00 pm on Wednesday, June 29, and from 11:30 am – 1:00 pm on Thursday, June 30. Enjoy the rest of the BIO conference.
Meet the Docs at BIO 2011

June 27, 2011

The Biotechnology Industry Organization (BIO) is holding its annual BIO International Convention this week in Washington, DC. Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of more than 1,100 biotechnology companies, state and international affiliates, and related organizations, as well as providing business development services for many emerging biotech companies.

As part of the Convention, more than 2,000 biotech companies, organizations, and institutions are expected to participate in the BIO Exhibition. Patent Docs Donald Zuhn, Kevin Noonan, Sherri Oslick, James DeGiulio, Andrew Williams, Bradley Crawford, and Kwame Mensah will also be attending BIO as part of the MBHB contingent, and will be participating in BIO's blogger network throughout the week. Patent Docs readers who may be attending BIO this week are encouraged to stop by booth #4723 – Hall C to meet the Docs, at the times indicated below, and talk a little biotech patent law.

Tuesday, June 28

9:45 am – 1:00 pm — Bradley Crawford
1:00 – 3:00 pm — Sherri Oslick
3:00 – 5:00 pm — Kevin Noonan
5:00 – 6:30 pm — Sherri Oslick & Andrew Williams

Wednesday, June 29

9:45 am – 11:00 am — Andrew Williams
11:00 am – 1:00 pm — Donald Zuhn & Kwame Mensah
1:00 – 3:00 pm — Bradley Crawford
3:00 – 5:00 pm — James DeGiulio & Kwame Mensah

Thursday, June 30

11:30 am – 2:00 pm — Donald Zuhn & James DeGiulio

In addition, most of the Docs will be attending the MBHB reception at Fado Irish Pub, 808 7th St. NW, from 9:00 to 12:00 pm on Tuesday, June 28. There will Irish whiskey tastings at 9:30 and 10:30 pm and live music (sponsored by Patent Docs). Additional information about the reception, including an RSVP for the event, can be found here.
Court Report

June 26, 2011

By Sherri Oslick —

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

Novozymes A/S et al. v. Central Trading Enterprises, Inc.
1:11-cv-04276; filed June 23, 2011 in the Northern District of Illinois

• Plaintiffs: Novozymes A/S; Novozymes North America, Inc.
• Defendant: Central Trading Enterprises, Inc.

Infringement of U.S. Patent Nos. 6,255,084 ("Thermostable Glucoamylase," issued July 3, 2001) and 7,060,468 (same title, issued June 13, 2006) based on CTE's manufacture and sale of its GLUCOAMYL L 706+ and GLUCOAMYL LG20 products. View the complaint here.

Teva Neuroscience, Inc. et al. v. Apotex Inc. et al.
0:11-cv-61402; filed June 22, 2011 in the Southern District of Florida

• Plaintiffs: Teva Neuroscience, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.
• Defendants: Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 5,453,446 ("Use of the R-Enantiomers of N-Propargyl 1-Aminoindan Compounds for Treating Parkinson's Disease," issued September 26, 1995) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Teva's Azilect® (rasagiline mesylate, used to treat idiopathic Parkinson's disease). View the complaint here.

Astellas US LLC et al. v. Sagent Pharmaceuticals, Inc. et al.
3:11-cv-03533; filed June 20, 2011 in the District Court of New Jersey

• Plaintiffs: Astellas US LLC; Astellas Pharma US, Inc.; Item Development AB
• Defendants: Sagent Pharmaceuticals, Inc.; Strides Arcolab Ltd.; Strides Inc.; Sagent Strides 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 Sagent's 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.

Depomed, Inc. et al. v. Sun Pharma Global FZE et al.
3:11-cv-03553; filed June 20, 2011 in the District Court of New Jersey

• Plaintiffs: Depomed, Inc.; Valeant International (Barbados) SRL
• Defendants: Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.

Infringement of U.S. Patent Nos. 6,723,340 ("Optimal Polymer Mixtures for Gastric Retentive Tablets," issued April 20, 2004), 6,635,280 ("Extending the Duration of Drug Release Within the Stomach During the Fed Mode," issued October 21, 2003), 6,488,962 ("Tablet Shapes to Enhance Gastric Retention of Swellable Controlled-Release Oral Dosage Forms, issued December 3, 2002), 6,340,475 ("Extending the Duration of Drug Release Within the Stomach During the Fed Mode," issued January 22, 2002), 7,736,667 ("Shell-and-Core Dosage Form Approaching Zero-Order Drug Release," issued June 15, 2010), 7,780,987 ("Controlled Release Dosage Forms," issued August 24, 2010) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Depomed's Glumetza® (metformin hydrochloride extended release tablets, used to improve glycemic control in adults with type 2 diabetes mellitus). View the complaint here.

GlaxoSmithKline LLC v. Roxane Laboratories Inc. et al.
1:11-cv-00542; filed June 17, 2011 in the District Court of Delaware

• Plaintiff: GlaxoSmithKline LLC
• Defendants: Roxane Laboratories Inc.; Watson Pharma Inc.; Watson Pharmaceuticals Inc.; Watson Laboratories Inc. – Florida

Infringement of U.S. Patent Nos. 5,565,467 ("Androstenone Derivative," issued October 15, 1996), 5,846,976 (same title, issued December 8, 1998), and 5,998,427 ("Androstenones," issued December 7, 1999) following a paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of GSK's Avodart® (dutasteride, used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate). View the complaint here.

Sanofi-Aventis U.S. LLC et al. v. Sun Pharma Global FZE et al.
3:11-cv-03532; filed June 17, 2011 in the District Court of New Jersey

• Plaintiffs: Sanofi-Aventis U.S. LLC; Sanofi-Aventis; Debiopharm S.A.
• Defendants: Sun Pharma Global FZE; Sun Pharmaceutical Industries, Inc.; Sun Pharmaceutical Industries Ltd.; Caraco Pharmaceutical Laboratories, Ltd.

Infringement of U.S. Patent Nos. 5,338,874 ("Cis oxalato (trans 1-1,2-cyclohexanediamine) PT(II) Having Optically High Purity," issued August 16, 1994), 5,716,988 ("Pharmaceutically Stable Preparation of Oxaliplatinum," issued February 10, 1998), and 5,959,133 ("Process for the Preparation of Platinum Compounds," issued September 28, 1999) following a paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of plaintiffs' Eloxatin® (oxaliplatin for injection, used to treat colorectal cancer). View the complaint here.
Conference & CLE Calendar

June 26, 2011

June 27-30, 2011 – BIO International Convention (Biotechnology Industry Organization) – Washington, DC

June 29-30, 2011 – Pharmaceutical Portfolio & Product Life Cycle Management (SMi Group) – London, UK

July 8, 2011 – Stanford v. Roche: The Impact on Management of University IP (Technology Transfer Tactics) – 1:00 – 2:00 PM (Eastern)

July 16-19, 2011 – 2011 Annual Meeting; The Nuts & Bolts of Patent Prosecution Practice; and 2011 Patent Practice Update (National Association of Patent Practitioners) – Las Vegas, NV

July 18-19, 2011 – Hatch-Waxman Boot Camp*** (American Conference Institute) – San Diego, CA

July 20-21, 2011 – Advanced Forum on Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – San Francisco, CA

July 25-27, 2011 – Intensive Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

July 26, 2011 – The New Inequitable Conduct Standard in Patent Litigation: Asserting and Defending Inequitable Conduct Challenges After the Landmark Therasense Decision (Strafford) – 1:00 – 2:30 PM (EDT)

August 4-7, 2011 – 2011 Annual Meeting (American Bar Association) – Toronto, Ontario

August 15-19, 2011 – Intellectual Property Law Summer School 2011 (IBC Legal) – Cambridge, UK

August 16-18, 2011 – The Bilski Impact: Procuring & Enforcing Software, Business Methods & Bioinformatics Patents (Patent Resources Group) – Alexandria, VA and Southfield, MI

September 11-13, 2011 – 2011 Annual Meeting (Intellectual Property Owners Association) – Los Angeles, CA

September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa (South African Department of Science and Technology) – Cape Town, South Africa

***Patent Docs is a media partner of this conference or CLE
IPO 2011 Annual Meeting

June 24, 2011

The Intellectual Property Owners Association (IPO) will be holding its 2011 Annual Meeting on September 11-13, 2011 in Los Angeles, CA. Among the presentations being offered at the annual meeting are:

• Recent case law developments;
• A look at patent landscaping and analysis;
• Legal issues surrounding genetic information research and development;
• Damages;
• Current state of the ITC;
• Patentability issues;
• Recent developments in patent offices around the world; and
• Ethical questions arising from en banc review of Therasense v. Becton Dickinson.

In addition, James Pooley, Deputy Director General for Patents for the World Intellectual Property Organization, will present the luncheon keynote on September 13.

A draft program for the meeting, including an agenda, descriptions of the scheduled sessions, and list of speakers, can be obtained here. The brochure for the meeting is not yet available.

The registration fee for the meeting is $950 for IPO members or $1,450 for attendees who are not IPO members (attendees registering by July 29 will receive a $100 discount). Those interested in registering for the meeting can do so here.
Intellectual Property Law Summer School 2011

June 24, 2011

IBC Legal Conferences will be holding its 11th Annual Intellectual Property Law Summer School 2011 on August 15-19, 2011 in Cambridge, UK. The five-day conference devotes one day each to the IP law basics, patents, transactions and enforcement, trademark and designs, and copyrights. During the patent and transactions and enforcement days, IBC faculty will offer presentations on the following topics:

• Future trends in patents;
• Cross border patent strategy;
• Freedom to operate: What are the risks of infringement?
• Patent law in China;
• Patent validity;
• Biotech and pharmaceutical developments;
• IP portfolio management;
• Trade secrets and breach of confidence;
• Intellectual property licensing;
• IP due diligence: Maximising the benefits;
• IP enforcement; and
• IP rights and competition law within the pharmaceutical and TMT sectors.

A complete brochure for this conference, including an agenda for all five days of the conference, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee is £2998 (all five days), £2599 (days 2-5), or £799 (day 1). Attendees registering by July 15, 2011 will receive a £200 discount off the five day or days 2-5 packages. Those interested in registering for the conference can do so here.
House Passes H.R. 1249

June 23, 2011

By Donald Zuhn —

The House of Representatives earlier today passed H.R. 1249, the America Invents Act, by a 304-117 vote. All told, 168 Republicans and 136 Democrats voted in favor of the bill and 67 Republicans and 50 Democrats voted against the legislation (ten members did not vote; the final vote results can be viewed here). While H.R. 1249 garnered more than 70% of the House vote, the victory for proponents of the House bill was not nearly as decisive as that for the Senate version of the bill, which was passed in March by a 95-5 margin (see "Senate Passes S. 23"). The House bill will now be reconciled with the Senate bill before being sent to the President.

Before voting on the bill, the House spent almost four hours debating and voting on a number of amendments. The House voted 283-140 in favor of the Manager's Amendment offered by House Judiciary Chairman Lamar Smith (R-TX), and 223-198 in favor of an amendment offered by Rep. John Conyers, Jr. (D-MI) that would restore language concerning the calculation of the 60-day period for applying for patent term extension that was stricken from H.R. 1249 by the Manager's Amendment. Amendments that would direct the USPTO to develop methods for studying the diversity of patent applicants (offered by Rep. Gwen Moore (D-WI)), add a sense of Congress that it is important to protect the rights of small businesses and inventors (offered by Rep. Sheila Jackson Lee (D-TX)), add requirements to the satellite office location selection process (offered by Rep. Ben Ray Lujan (D-NM)), mandate a USPTO-led study on what the USPTO, SBA, and other agencies can do to help small businesses obtain, maintain, and enforce foreign patents (offered by Rep. Gary Peters (D-MI)), and prescribe a requirement that parties provide sufficient evidence to prove and rebut a claim of derivation (offered by Rep. Jackie Speier (D-CA)) were agreed to by voice vote.

Among the amendments that failed to secure enough votes for passage were those that would condition the U.S. move to a first-to-file system only upon a Presidential finding that other major patent authorities had adopted a one-year grace period (offered by Rep. Conyers; rejected 316-105), strike Section 5 on prior user rights (offered by Rep. Tammy Baldwin (D-WI); rejected 342-81), strike Section 3 of the bill, which would convert the U.S. patent system from "first-to-invent" to "first-to-file" (offered by Rep. James Sensenbrenner, Jr. (R-WI); rejected 295-129), eliminate the ability of the USPTO Director to set fees, retaining that authority for Congress (offered by Rep. Donald Manzullo (R-IL); rejected 329-92), eliminate the burden of post-grant reviews and reexaminations on individual inventors and small businesses with 100 or fewer employees (offered by Rep. Dana Rohrabacher (R-CA); rejected 342-81), and strike section 18, which concerns the transitional program for covered business method patents (offered by Rep. Aaron Schock (R-IL); rejected 262-158).

Reaction to the House's passage of H.R. 1249 was (not surprisingly) swift. In a statement posted on the House Committee on the Judiciary website, Chairman Smith (at left) called H.R 1249 "the most significant jobs creation bill passed by Congress this year." Asserting that "the [current patent] system intended to protect and promote new inventions has become a barrier to innovation and job creation," Chairman Smith said that the legislation "represents a fair compromise and creates a better patent system for inventors and innovative industries."

Rep. Manzullo, who was unsuccessful in his bid to amend the bill to take fee-setting authority away from the USPTO Director, posted a statement on his website in which he explained that he "voted against a so-called 'patent reform' bill that will dramatically alter America's 220-year-old patent law, giving large corporations advantages over small inventors and sending more American jobs overseas." Rep. Manzullo called the move from a first-to-invent to a first-to-file system a "fatal flaw" of the legislation that "would put America's small inventors at a huge disadvantage against their larger, foreign competitors with resources to more quickly patent their products."

In an e-mail distributed by the Biotechnology Industry Organization (BIO), the industry group "praised" the House's passage of the bill, stating that "[s]mall biotechnology companies rely heavily on their patents to attract investment to fund the lengthy and expensive research and development process necessary to bring breakthrough medical therapies and other products to patients and consumers," and that the bill "will bring our patent system into the 21st century . . . by enhancing patent quality and the efficiency, objectivity, predictability and transparency of the U.S. patent system."

In a statement posted on its website, the Innovation Alliance noted that it was "disappointed that the House of Representatives has approved legislation that will not end permanently the diversion of user fees from the U.S. Patent and Trademark Office." The group promised to "continue to work with lawmakers and other stakeholders to ensure that any patent bill that becomes law ends fee diversion permanently."

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