Orange Book Blog

Bloomberg BNA "AIA Post-Grant Patent Practice Conference," Arlington, VA, February 19-20

Bloomberg BNA's upcoming "AIA Post-Grant Patent Practice Conference" presents a unique opportunity to hear from present and former PTAB judges--as well as keynote speakers Hon. Pauline Newman and Hon. Randall Rader.  This two-day conference is based on the Bloomberg BNA treatise Post-Grant Patent Practice, which was authored by four former Administrative Patent Judges and which will be distributed to each conference attendee as part of the materials.

The first day of the conference will provide an overview of the statutory and regulatory basis for post-grant practice and will discuss how post-grant practice has evolved over its first year.  The second day will feature mock demonstrations of the various hearings that occur during post-grant trials, including inter partes review, post-grant review, and covered business method patent review.  These demonstrations will feature prominent attorneys who have significant experience before the Patent Trial and Appeal Board.

Here's the complete agenda:

Day One:  The Law Governing Post-Grant Practice, Including the Fresenius USA v. Baxter Int'l case, and Real-World Experience Practicing Before the PTAB

• The Fundamentals of Post-AIA Post-Grant Patent Procedures--a panel discussion that includes McAndrews shareholder Herbert D. Hart III
• Luncheon Address by the Honorable Pauline Newman, Circuit Judge, Federal Circuit
• Inter Partes and Post-Grant Reviews (including CBM Patent Reviews)
• Derivation and Interference Procedures
• Fresenius USA v. Baxter Int'l and its Impact on Post-Grant Practice

Day Two:  Mock Hearings/Conferences with APJs and Insights from Lawyers "In the Trenches"

• Motions Based on Estoppel/Privity and Mock Conference
• Motions for Joinder and Mock Conference
• Discovery Motions and Mock Conference
• Luncheon Address by the Honorable Randall Rader, Chief Judge, Federal Circuit
• Motions to Amend Claims and Mock Hearing on Amendment
• Final Briefing and Mock Final Hearing

An advance registration discount is available until Friday, January 31 with the code EARLYBIRD.  For more information or to register, please visit the conference website.

CPhI "Pharma IPR India 2014" Conference, Mumbai, India, February 26-28

CPhI will be presenting its 3rd annual "Pharma IPR India" conference in Mumbai on February 26-28.  The conference features speakers from more than a dozen different countries across the world.  The complete agenda is as follows:

Day 1: USA, Canada, and Mexico

• Analysing the scope and implications of Inter Partes Review (IPR) in the United States after one year
• Evaluating reverse payment settlement cases and decisions after Actavis
• Determining patent eligibility for a US patent and ascertaining ways to use attorney fees/cost shifting for the benefit of pharmaceutical companies
• Formulating the best litigation strategies in the US to optimise costs for pharma and biopharma companies
• Biosimilars status in the USA
• Evaluating the current regime ofthe Canadian Patent Act
• Mapping the current patent regime and patent linkage by tracking recent patent infringement cases in Mexico

Day 2: Europe, South Africa, Brazil, GCC countries, and Australia/New Zealand

• Overview of current implementation of the Unitary Patent System in Europe, including its coming into force, structure, competence, language, and particularities
• Ascertaining data exclusivity in Europe and understanding implications of SPCs on pharma companies
• Formulating strategies to introduce generic products in the European market if there are unavoidable patents not yet invalidated
• Understanding application of the Doctrine of Equivalents in European patent cases
• Understanding recent changes in patent legislature in South Africa and analysing current IP infrastructure
• Understanding the scope of patent law in Brazil and determining reforms therein impacting pharma and biopharma companies
• Examining patent regimes in GCC countries and basic laws of the market and guidance on how to develop a product for these markets
• Defining devised changes affecting patentability in Australia/New Zealand by updating recent trends to standards of applications and litigation in the industry

Day 3: India, South Korea, Taiwan, China, and Japan

• Determining the current position of post-grant oppositions filed by pharmaceutical companies in India
• Determining grounds for invoking compulsory licenses in India, to determine new growth strategies for generic and multi-national companies
• Understanding patent law and the IP regime in South Korea as they apply to pharmaceuticals
• Highlighting amendments related to the dual invention/utility model system in Taiwan, and enforcement of patent rights and damages under the Taiwan Patent Act of 2013
• Understanding the revised version of "Measures for Compulsory Licensing for Patent Implementation" that came into effect in the Chinese patent law
• Understanding techno-legal aspects involved in the patent system of Japan to facilitate breaking the barriers for the entry of generic companies

The early bird discounted registration rate for the conference is still available, but only until January 31st.  For more information or to register, please visit the conference website.

PTAB Institutes Inter Partes Review of Oracea (doxycycline) Formulation Patents

Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc., IPR2013-00368, IPR2013-00371, IPR2013-00372 (PTAB)

    by Robert F. Kappers

The U.S. Patent Trial and Appeal Board issued a trio of related decisions on December 17, 2013, each instituting inter partes review of one of three related patents on once-daily formulations of tetracycline. 

On June 20, 2013, Amneal Pharmaceuticals filed three petitions for inter partes review, seeking to invalidate a family of patents owned by Supernus Pharmaceuticals.  Each of the challenged patents--U.S. Patent Nos. 8,206,740; 8,394,405; and 8,394,406--relates to once-daily, sub-antimicrobial formulations of doxycycline used to inhibit collagen destruction enzymes without provoking undesired side effects attendant to an antibacterial dose.

Claim 1 of the '740 patent is illustrative of the claimed subject matter: 

1. An oral pharmaceutical composition of doxycycline, which at a once-daily dosage will give steady state blood levels of doxycycline of a minimum of 0.1 μg/ml and a maximum of 1.0 μg/ml, the composition consisting of

(i) an immediate release (IR) portion comprising 30 mg doxycycline;

(ii) a delayed release (DR) portion comprising 10 mg doxycycline; and optionally,

(iii) one or more pharmaceutically acceptable excipients.

Amneal asserted the same four grounds of unpatentability in each petition, but the Board accepted only two.  Amneal first asserted that the challenged claims were unpatentable for obviousness over WO 02/080932 A1 ("Ashley '932") as it incorporates Ser. No. 60/281,854 ("Ashley '854").  Amneal also asserted that the challenged claims were unpatentable for obviousness over Ashley '932 as it incorporates Ashley '854 in combination with U.S. 5,348,748 ("Sheth").  According to the petitions, Ashley '932 discloses administering a tetracycline compound in sub-antibacterial doses to treat acne, and further cites and incorporates Ashley '894 for disclosure of administering by sustained release, while Sheth discloses a once-daily formulation of minocycline with varying proportions of quick-release and delayed release dosage forms.

In each decision (-00368; -00371; -00372), the Board determined that Amneal had failed to demonstrate a reasonable likelihood of unpatentability for obviousness over Ashley '932 alone.  The Board rejected Amneal's argument that a person of ordinary skill would have envisaged the claimed ratios of immediate-release to delayed-release portions from the disclosure in Ashley '854 that at least half of the doxycycline dose be released in the upper GI tract.

The Board was more receptive to Amneal's second proffered ground of unpatentability; namely, that the subject matter of the challenged claims is obvious over the combination of Ashley '932 and Sheth.  Specifically, Amneal argued that Ashley '932 discloses all limitations of the illustrative claims except for the particular ratios of immediate-release and delayed-release portions of the formulation.  Rejecting Supernus’s counterarguments, the Board agreed that Sheth disclosed formulations of minocycline having a range of immediate-release to delayed-release ratios from which a person of ordinary skill could have envisaged the claimed ratios.

In the end, the Board instituted inter partes review of each of the three challenged patents, finding that Amneal had demonstrated a reasonable likelihood that the challenged claims in each patent were unpatentable over the combination of Ashley '932 and Sheth.

The petitions are related to ongoing litigation between the parties (currently stayed by joint stipulation), in which Galderma and Supernus alleged infringement of the '740 patent (the parent of the '405 and '406 patents) by Amneal's ANDA No. 203-278 and proposed generic version of Oracea.  See Galderma Labs. Inc., et al. v. Amneal Pharms., LLC, et al., C.A. No. 11-1106-LPS (D. Del.).