Orange Book Blog

ACI "Patent Reform for Life Sciences Companies" Conference, New York, Jan. 31 - Feb. 1

American Conference Institute will be holding a conference on "Patent Reform for Life Sciences Companies" in New York, NY, January 31st to February 1st, 2012.  According to ACI, this is "the critical industry forum on the Leahy-Smith America Invents Act."

The agenda features the following presentations:

• A keynote address by Robert Stoll, Commissioner for Patents, USPTO
• "The Timeline of Enactment: Identifying What Needs to be Done Now and Planning for Future Changes"
• "First to File: Developing an Updated and Comprehensive Intellectual Property Strategy in the New Race to the Patent Office Regime"
• "Examining the Consequences of Changes to Inventorship Provisions"
• "Prior Art and Public Disclosure: Identifying What Constitutes Prior Art Under the Revised Section 102"
• "Expediting the Examination Process by Strategically Using the Different Examination Tracks, Including the New Prioritized Examination Option"
• "The Ghost of Best Mode: Balancing the Seemingly Contradictory Provisions to Maximize IP Protection"
• "Preparing for Emerging Patent Challenges Under the New Post-Grant Review System"
• "The Different World of Inter Partes Review"
• "Examining the Potential Ramifications of Patent Reform on Hatch-Waxman Litigation and the Brand/Generic Wars"
• "Specific Considerations for Universities, Non-Profit Institutions and Micro-Entitites"
• "Analyzing the Potential Impact of the 'Miscellaneous Provisions' on Life Sciences Companies"

In addition, ACI is offering an optional pre-conference primer on January 30th:  "Patent Reform 101: Overview of the Fundamental Provisions in the America Invents Act."

For more information or to register, please visit the conference website.  To receive a $200 discount on registration fees, use discount code OBB 200.

Federal Circuit Vacates Preliminary Injunction Entered Against Mylan in Doxycycline Case

Warner Chilcott Labs. v. Mylan Pharms. Inc., No. 2011-1611 (Fed. Cir.)

An interesting development in ANDA litigation this year has been the increasing frequency with which district courts have granted preliminary injunctions or temporary restraining orders against ANDA filers--even, in some cases, after the district court has found after a full trial that the patents in suit are invalid.  In a decision Monday, the Federal Circuit vacated a preliminary injunction against Mylan because the district court "relied on disputed facts in granting the preliminary injunction without holding an evidentiary hearing, and failed to make any findings as to Mylan's invalidity defense."

In this case, involving Mylan's ANDA for a generic version of DORYX (doxycycline hyclate), Warner Chilcott sued Mylan for infringement of U.S. Patent No. 6,958,161, directed to a tablet formulation of doxycycline.  In August 2011, just one month before the 30-month stay would expire, Warner Chilcott filed a motion for a temporary restraining order and preliminary injunction against Mylan.  The district court heard arguments from counsel, but did not conduct an evidentiary hearing and did not hear live testimony from any of the witnesses.  The district court granted the preliminary injunction, but "did not address Mylan's arguments that the '161 Patent is invalid because of anticipation or obviousness, though it did acknowledge that those claims had been asserted."  The Federal Circuit granted Mylan's request for expedited briefing and heard oral arguments on November 22, 2011.

At the outset of its analysis, the Federal Circuit cited the four well-known requirements for a preliminary injunction, as established by the Supreme Court, and noted that a preliminary injunction "is an extraordinary remedy never awarded as of right."  The court then cited its own precedent as establishing that when an accused infringer has challenged the validity of a patent in response to a motion for a preliminary injunction, "the trial court first must weigh the evidence both for and against validity that is available at this preliminary stage in the proceedings."  The Federal Circuit found:

In this case, the district court abused its discretion in two ways.  The court: (1) failed to hold an evidentiary hearing despite acknowledging that the decision turned on disputed factual issues; and (2) did not weigh the evidence or make any findings as to Mylan's invalidity challenge.

Interestingly, while the Federal Circuit vacated the preliminary injunction, it suggested that a temporary restraining order might be appropriate:

Although the district court's entry of the preliminary injunction in this case is contrary to controlling authority, we are mindful of the court's demanding schedule and desire to avoid duplicating its efforts with a soon-to-be-scheduled bench trial in this case.  If doing so serves judicial efficiency, the district court may consider entering a temporary restraining order after this court's mandate issues, then consolidating the preliminary injunction hearing with the bench trial on the merits, assuming that can occur within the timeframes mandated by the Federal Rules of Civil Procedure.

Discounted Registration for "Pharma IPR India 2012" Ending Soon

As we previously announced, CPhI will be holding a three-day conference on pharmaceutical intellectual property rights in Mumbai, India from January 31 through February 2, 2012.  Day 1 of the conference will focus on pharma IPR in India; Day 2 will focus on pharma IPR in the United States; and Day 3 will focus on pharma IPR in Europe, Japan, Brazil and China.  Click here for the complete agenda, which was recently updated.

Sign up now to take advantage of discounted registration fees.  Register by Friday, December 9, 2011 to receive a discount of INR 13,000 / US $300; register by Friday, January 13, 2012 to receive a discount of INR 7,000 / US $150.  For more information, please visit the conference website.

Federal Circuit Affirms Invalidity of Teva's Patent on Rosuvastatin Formulation

Teva Pharm. Indus. Ltd. v. AstraZeneca Pharms. LP, No. 2011-1091 (Fed. Cir.)

In a precedential opinion filed today, the Federal Circuit affirmed the invalidity of Teva's U.S. Patent No. RE39,502 under 35 U.S.C. § 102(g)(2).  Teva's '502 patent claims a rosuvastatin formulation comprising "a stabilizing effective amount" of crospovidone.  This post describes the district court decision and provides background on the case.

There was no dispute in this case that AstraZeneca manufactured rosuvastatin tablets falling within the scope of the '502 patent claims before Teva conceived and reduced to practice its claimed invention.  Instead, the principal dispute was whether, to prove prior invention under § 102(g)(2), AstraZeneca was required to prove that it "appreciated the stabilizing effect of crospovidone in its drug formulation."

In affirming the district court's answer to that question in the negative, the Federal Circuit traced a line of cases that it said demonstrate "consistent applications of the same rule."  According to the court, "[t]o establish prior invention, the party asserting it must prove that it appreciated what it had made."  In other words, an "unrecognized, accidental duplication" is not a prior invention.  But, the court continued, "[t]he prior inventor does not need know everything about how or why its invention worked.  Nor must it conceive of its invention using the same words as the patentee would later use to claim it."

Applying the rule to this case, the court explained:

AstraZeneca had to appreciate that the [formulation] it asserted as its invention was stable and what the components of this formulation were.  There is no question that AstraZeneca had this appreciation.  However, AstraZeneca did not need to appreciate which component was responsible for the stabilization.

Teva made other arguments as well, but the Federal Circuit summarily disposed of them.