Orange Book Blog

"5th Product and Pipeline Enhancement for Generics" Conference, Washington, DC, July 18-19

Marcus Evans Conferences will be holding its "5th Product and Pipeline Enhancement for Generics" conference in Washington, DC, on July 18-19.  According to the producer, the conference will help attendees "adopt innovative approaches to strengthen the product pipeline and prepare for regulatory changes to emerge as a global player."  The conference chair is Richard Dicicco, Chairman of Harvest Moon Pharmaceuticals.

The full agenda is as follows:

• Implementing Strategies to Meet Current and Heightened Abbreviated New Drug Application (ANDA) Standards to Gain Product Approval
• Understanding Key Techniques to Ensure Regulatory Compliance
• America Invents Act: Assessing the Impact on Generics
• Understanding Antitrust Concerns When Settling Paragraph IV Litigation and the Analysis of Pay-for-Delay Settlements, by Markus H. Meier, Asst. Director of the Health Care Division, Bureau of Competition
• Analyzing Recent Updates to the Hatch-Waxman Act to Grasp Future Impacts and Challenges
• Developing Key Patent Strategies to Protect Intellectual Property and Ensure Market Sustainability
• Identifying Strategies to Strengthen Paragraph IV Patent Filings and Litigation to Maintain Exclusivity
• Exploring U.S. Healthcare Changes and the Effect on Patent Litigation for Generic Companies
• Adopting Key Techniques to Select, Prioritize and Manage a Generics Portfolio
• Examining Trends in Market Opportunities and Partnerships to Diversify the Company's Portfolio
• Implementing Successful Resource Management Techniques with Limited Resources
• Understanding How At-Risk Product Launches Factor into Portfolio Development
• Identifying Tactics to Improve Strategic API Sourcing
• How Generic User Fees (GDUFA) are Likely to Impact the API Industry
• Studying the Impact of the FDA's Guidance on Biosimilars for the Generics Industry to Ensure Regulatory Compliance
• Global Biosimilars: Differentiating Between the Draft U.S. Biosimilars Guidance and Existing EMA and Japanese Biosimilars Regulations
• Leveraging Novel Drug Delivery Technologies to Drive Innovation and Differentiation
• Understanding the Role and Challenges of a Small Startup Generics Company
• Generics in Emerging Markets: Analyzing the Benefits and Risks of Expanding to New Markets
• Assessing Global Manufacturing Possibilities to Increase Efficiency and Explore Business Opportunities

There will also be a pre-conference workshop on July 17, "Overcoming the Challenges of Global Portfolio Management to Improve Decision-Making."

For more information or to register, please visit the conference website.

ACI "Hatch-Waxman Boot Camp," San Diego, June 25-26

American Conference Institute will be holding a "Hatch-Waxman Boot Camp" conference in San Diego on June 25-26.  McAndrews partner Herb Hart will be speaking at the conference on post-grant proceedings under the America Invents Act, and particularly how such proceedings might impact ANDA litigation.

The full agenda is as follows:

• Key Agencies Overview: Understanding the Jurisdication and Interplay of the FDA and PTO in the Patenting of Drugs and Biologics
• Identifing and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics
• Exploring the Link Between the FDA Approval Process and the Patenting of Drugs and Biologics
• IP Overview for Drugs and Biologics:  Hatch-Waxman, BPCIA, Trade Dress, and More
• Paragraph IV Disputes and Litigation:  Federal Court, PTO Proceedings and ITC Actions
• How the Dynamics of Biosimilars are Changing the Hatch-Waxman Landscape
• Orange Book Listings, De-Listings and Related Challenges
• Bioequivalence and the "Same Active Ingredient" vis-a-vis Patentability
• An In-Depth Look at 180-Day Exclusivity
• Comprehending the Intracacies of Non-Patent/Regulatory Exclusivity
• Assessing Patent Protections Afforded Under the Safe Harbor of Section 271(e)(1)
• Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration

In addition, ACI is offering two post-conference workshops on June 27th:  "Biosimilars: An In-Depth Look at the Law, Interpreting Guidance, and Anticipated Litigation" and "Patent Reform 101: Overview of the Fundamental Provisions in the America Invents Act and the Impact on Hatch-Waxman Litigation."

For more information or to register, please visit the conference website.  Use registration code OBB 200 to save $200 on fees.

District Court Finds Inducement of Infringement in Doxercalciferol Case

Bone Care Int'l v. Roxane Labs., No. 09-cv-285 (GMS) (D. Del.)

In an opinion this past Monday, the U.S. District Court for the District of Delaware found in favor of Genzyme and against ANDA applicants Roxane, Sandoz, and Anchen in the paragraph IV litigation concerning HECTOROL (doxercalciferol), Genzyme's drug for the treatment of secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease (ESRD).  The court ruled that defendants' ANDA products would induce infringement of claim 7 of U.S. Patent No. 5,602,116; that claim 7 is entitled to a 1988 priority date; and that claim 7 is not invalid as "inoperative" or obvious.  This post focuses on the inducement issue.

Claim 7 of the '116 patent is directed to:

A method for lowering or maintaining lowered serum parathyroid hormone [PTH] in patients suffering from hyperparathyroidism secondary to end stage renal disease, comprising: administering to said patients an effective amount of [doxercalciferol] to lower and maintain lowered serum parathyroid hormone levels.

After a Markman hearing, the court construed the term "effective amount of doxercalciferol to lower and maintain lowered serum parathyroid hormone levels" to mean "an amount of doxercalciferol sufficient to lower and maintain lowered blood concentrations of PTH with a lower incidence of hypercalcemia than would result from using calcitriol or alfacalcidol to achieve the same level of PTH suppression."

After concluding that claim 7 would be directly infringed by the defendants' ANDA products (a predicate to finding inducement of infringement), the court addressed whether the defendants have the required intent to induce infringement.  The key issue here was whether the defendants intend to induce infringement of claim 7 notwithstanding that their proposed labeling says nothing about the incidence of hypercalcemia resulting from doxercalciferol relative to the incidence resulting from calcitriol or alfacalcidol.

The court began its analysis by stating:

As noted, the "pertinent question" in ANDA cases, with respect to induced infringement, is "whether the proposed label instructs users to perform the patented method," and "promotes" or "encourages" others to practice that method.  Here, the court has found, for the reasons stated above, that the defendants' proposed product labels would instruct users to perform each element of the patented method detailed in claim 7.  The Federal Circuit has clarified, however, that satisfaction of this element, without more, is insufficient to prove inducement.  Instead, the patentee must also present evidence that the defendant "knew or should have known that his actions would induce actual infringement" and "that the induced acts constitute patent infringement."

The court continued:

As noted, in the Hatch-Waxman context, "statements in a package insert that encourage infringing use of drug product are alone sufficient to establish intent to encourage direct infringement" for purposes of induced infringement under 35 USC 271(b).  The Federal Circuit has stated, however, that inducement in the ANDA context should not be decided according to the tenets of strict liability action.  Instead, a court assessing an inducement claim should determine whether the proposed label "instructs users to perform the patented method" and "teaches an infringing use . . . such that we are willing to infer from those instructions an affirmative intent to infringe the patent."  Here, each of these requirements is met.

For these statements of law, the court cited AstraZeneca v. Apotex (Fed. Cir. 2010), DSU Medical v. JMS (Fed. Cir. 2006), and Vita-Mix v. Basic Holdings (Fed. Cir. 2009).

The court thus concluded:

With respect to the specific intent element of inducement, the court concludes that the plaintiffs have sufficiently shown that the defendants "knew or should have known their actions would induce actual infringements."  In this case, all defendants filed ANDAs with the FDA seeking approval to market a doxercalciferol product that would be sold accompanied by information instructing physicians and medical professionals to administer doxercalciferol according to the method explained in claim 7 for treating SHPT in patients with ESRD.  This FDA-approved indication is the same use set forth in claim 7 of the patent-in-suit . . . .

The court concludes that, based on the clinical trials and literature available, the defendants knew or should have known that doxercalciferol has been shown to lower and maintain lowered PTH levels with a lower incidence of hypercalcemia than would result from using calcitriol or alfacalcidol at the same level of PTH suppression.  Thus, the court concludes that the defendants, in submitting their ANDAs, knew or should have known that their proposed products would induce actual infringement of claim 7.  The court finds this level of intent sufficient for inducement purposes.

The defendants are certain to appeal the decision to the Federal Circuit.