Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

  • FDA’s Request for Comments on Ramipril 180-day Exclusivity Draws Letters from Eight Generic Companies

    King Pharmaceuticals markets Altace (ramipril), a treatment for high blood pressure with nearly $1 billion in annual U.S. sales.  U.S. Patent No. 5,061,722, owned by Aventis and licensed to King, is listed in the Orange Book for Altace.

    Cobalt Pharmaceuticals submitted the first ANDA with a paragraph IV certification to the ‘722 patent in 2002, thereby earning 180-day exclusivity for ramipril (and thereby establishing this as a "pre-MMA" case).  In 2005, Lupin Pharmaceuticals submitted the second ANDA with a paragraph IV certification to the ‘722 patent.  Aventis and King sued both companies.  In 2006, Aventis and King settled with Cobalt.  On September 11, 2007, the Federal Circuit reversed a district court decision in the Lupin case and invalidated the claims of the ‘722 patent (see this post).

    According to the FDA website, five companies have received tentative approval to market generic ramipril: Dr. Reddy’s; Purepac; Roxane; Sandoz; and Teva (see this web page).  Shortly after the Federal Circuit decision, one of those five companies and Lupin submitted letters to FDA urging that final approval of their ANDAs should not be held up by Cobalt’s 180-day exclusivity (see this post).  In response, FDA requested comments from other interested parties.  To date, FDA has received comments from eight generic drug companies and three PBM companies (all may be found here).  The comments fall into three categories.

    Lupin (with support from the three PBMs)

    Besides accusing King of settling with the first ANDA filer to deliberately create a "bottleneck" to generic competition from subsequent ANDA filers, Lupin presents three main arguments : (1) Cobalt is no longer entitled to 180-day exclusivity because Cobalt stipulated to infringement of the ‘722 patent in its settlement with King, which caused Cobalt’s paragraph IV certification to be converted into a paragraph III certification; (2) Lupin should be permitted to amend its ANDA to remove its paragraph IV certification because the ‘722 patent was invalidated (such an amendment would mean Lupin’s approval would not be affected by any exclusivity Cobalt might have); and (3) Lupin is entitled to immediate approval of its ANDA–without waiting for the Federal Circuit to issue a mandate from its Sept. 11 decision (such immediate approval would give Lupin a head start in marketing ramipril before other generic competitors).

    Anonymous tentatively approved filer (with support from Sandoz and Apotex)

    The law firm of Hyman, Phelps & McNamara ("HPM") submitted a letter "on behalf of a company with a tentatively approved ANDA" for ramipril.  The letters from Sandoz and Apotex essentially mirror HPM’s letter.  The letters make two main arguments: (1) Cobalt is no longer eligible for 180-day exclusivity, for the same reasons as those put forward by Lupin; and (2) once the Federal Circuit issues its mandate, FDA should deem the ‘722 patent to be de-listed from the Orange Book, which will then free FDA to grant final approval to all tentatively approved ramipril ANDAs.  In support of the second argument, Sandoz cites FDA’s April 18, 2007 amlodipine decision.

    Cobalt (with support from Barr, Ranbaxy, and URL Mutual)

    Cobalt’s letter makes three main points: (1) contrary to the allegations of Lupin, HPM and others, this is not a case where 180-day exclusivity has been "parked" indefinitely–rather, Cobalt’s exclusivity period will be triggered when the Federal Circuit issues its mandate, and will terminate 180 days later; (2) the statute is unambiguous–no subsequent ANDA may be approved until the expiration of Cobalt’s 180-day exclusivity; (3) there is no statute, regulation or case under which Cobalt may be found to have forfeited its exclusivity.  Cobalt makes what seems to be a very important point in that last argument: the admission of infringement that Cobalt made in the settlement of its litigation with King was made "without prejudice to Cobalt’s allegations that the claims of the ‘722 patent are invalid and unenforceable."  Thus, Cobalt argues that it has not admitted the validity or enforceability of the ‘722 patent, and therefore its paragraph IV certification with respect to the ‘722 patent remains valid.  Barr and Ranbaxy echo this point in their letters.

    Finally, Cobalt correctly notes that the impact of FDA’s decision in this case will likely be limited, since there are only a handful of remaining cases governed by the pre-MMA version of the statute.  Nonetheless, it will be interesting to see how the FDA resolves this situation.

  • Pharma News Briefs

    • FDA recently posted numerous comments from industry regarding Ramipril 180-day exclusivity issues on its website.  The comments come in response to FDA's request last month.  A summary of the new comments is in the works.
    • FDA also established a docket for comments on Granisetron HCl 180-day exclusivity issues.  This too follows an FDA request made last month.
    • Yesterday, the WSJ Health Blog had two pessimistic reports on the pharmaceutical industry: "Drug Drought Deepens as FDA Approvals Lag" and "Pharma Woes Won't Let Up Soon."
    • Also on Halloween, the New York Time published a spooky article entitled "Chinese Chemicals Flow Unchecked Onto World Drug Market."  Reuters published a similar article the next day.  This can't be good publicity for pharmaceutical companies–both innovators and generics alike–who are increasingly outsourcing production of key ingredients to China.
    • On Tuesday, the Federal Circuit denied rehearing of BIO and PhRMA v. District of Columbia, in which the court previously found Washington, D.C.'s drug price control law to be unconstitutional (see Patently-O).
    • Last week, Sen. Bernie Sanders (D-VT) introduced a new bill that would scrap patent and market exclusivity for drugs and replace it with a "medical innovation prize fund" (see FDA Law Blog and Pharmalot).  I suspect that this bill is DOA, and therefore nothing to fear.
    • Also last week, the WSJ Health Blog reported on Amgen's big win in its patent infringement suit against Roche's Mircera drug.
    • A couple weeks ago, BioPharma Reporter published an interesting article, "U.S. Dragging its Heels on Biosimilars, Report Says."

  • Bayer Prevails Over Dr. Reddy’s at Trial in Avelox Case

    Bayer AG v. Dr. Reddy’s Laboratories, Ltd., No. 04-179 (D. Del. 2007)

    Last Thursday, the U.S. District Court for the District of Delaware held that two Bayer patents on Avelox (moxifloxacin hydrochloride) are valid and enforceable, and infringed by Dr. Reddy’s ANDA for a generic version of Avelox.  The Opinion and Order follow a week-long bench trial held in August 2006.  Avelox is an antibiotic commonly used for the treatment of respiratory tract and other infections, with annual U.S. sales of $340 million.

    The first of the two patents-in-suit, U.S. Patent No. 4,990,517, generically claims millions of quinolone compounds.  Moxifloxacin is one of many compounds listed in the ‘517 specification; it had not yet been synthesized at the time the application was filed.  The second patent-in-suit, U.S. Patent No. 5,607,942, claims a specific quinolone and its four stereoisomers, one of which is moxifloxacin.

    Dr. Reddy’s asserted that the ‘517 and ‘942 patents are invalid for obviousness and unenforceable due to inequitable conduct, and that the ‘942 patent is invalid for double patenting over the ‘517 patent.  With respect to obviousness, Dr. Reddy’s asserted that one would have been motivated to modify a prior art compound at the 7-position; one would have been motivated to use a diazabicyclo octane (DBO) substituent at the 7-position; and through routine experimentation, one would have made compounds covered by the asserted claims.  Quoting KSR, the district court stated that “Reddy must identify some reason that would have prompted a person of ordinary skill in the relevant field to combine these elements to yield the claimed compounds.”  Moreover, according to the district court, “Reddy must demonstrate that such a person would have had a reasonable expectation of success in doing so.”

    The parties disputed whether Dr. Reddy’s was required to demonstrate why a person of ordinary skill in the art would have selected a particular lead compound to modify in the first place.  The district court sided with Bayer, citing the Federal Circuit’s recent decision in Takeda v. Alphapharm as “affirming the district court’s finding that defendant failed to prove a prima facie case of obviousness where the prior art disclosed a broad selection of compounds, any one of which could have been selected as a lead compound for further investigation, and defendant did not prove that the prior art would have led to the selection of the particular compound singled out by defendant.”  The district court further found that Dr. Reddy’s failed to demonstrate a motivation to modify a lead compound with DBO, or a reasonable expectation of success in making the proffered combination of prior art.

    According to Bayer’s press release announcing last Thursday’s court decision, Teva has also challenged the validity of the same Bayer patents at issue in the Dr. Reddy’s case.  Bayer’s case against Teva is also pending in the District of Delaware, with trial currently scheduled to begin on February 25, 2008.

    In addition to the ‘517 and ‘942 patents, the Orange Book lists two other Bayer patents for Avelox: U.S. Patent No. 5,849,752, directed to a crystal form of moxifloxacin; and U.S. Patent No. 6,610,327, claiming pharmaceutical formulations of moxifloxacin.  It is unclear how Dr. Reddy’s and Teva intend to deal with those patents.

  • Federal Circuit Affirms Invalidity of Par Pharma’s Patents on Megestrol Acetate Formulations

    Par Pharmaceuticals v. Roxane Labs, No. 2007-1093 (Fed. Cir. 2007)

    In the early 1990s, Bristol-Myers Squibb developed and patented Megace, a liquid pharmaceutical composition of megestrol acetate indicated for the treatment of anorexia, cachexia, or an unexplained weight loss.  Par Pharmaceuticals sought to design around the claims of BMS’s patent and introduce a generic version of Megace.  In developing its product, Par discovered that flocculated suspensions of megestrol acetate could be formed using a much wider range of excipients and concentrations than those known to BMS.  Through those efforts, Par obtained a series of patents on its flocculated suspensions, including U.S. Patent Nos. 6,593,318 and 6,593,320, the two patents-in-suit in this case.

    Par won its paragraph IV challenge of BMS’s patent in 2001 and, as the first ANDA applicant to file a paragraph IV certification, earned 180 days of market exclusivity for megestrol acetate oral suspension.  In 2003, Par brought suit against Roxane Laboratories, a subsequent ANDA filer for megestrol acetate oral suspension, asserting that Roxane’s formulation infringes the ‘318 and ‘320 patents.  The district court granted Roxane’s motion for summary judgment of invalidity for lack of enablement under section 112, paragraph 1.  Last Friday, the Court of Appeals for the Federal Circuit affirmed that decision.

    The test of enablement is whether one of ordinary skill in the art can make and use the claimed invention without undue experimentation.  Furthermore, under In re Wands (Fed. Cir. 1988), eight factors are relevant to the enablement analysis: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.

    The Federal Circuit cited two factors that were particularly relevant to the enablement analysis in this case: the unpredictability of the art and the breadth of the claims.  According to the court, “all the record evidence establishes that the art of making stable flocculated suspensions of megestrol acetate is highly unpredictable.”  Moreover, the court concluded that the claims at issue “have an extraordinarily broad scope,” allowing, for example, “the choice of any surfactant in any concentration.”  The court observed: “In this case, Par sought extremely broad claims in a field of art that it acknowledged was highly unpredictable, therefore, Par has set a high burden that its patent disclosure must meet to satisfy the requisite quid pro quo of patent enablement.”

    In reviewing Par’s evidence of enablement, the Federal Circuit noted that the specification of Par’s patents discloses only three working examples, utilizing only one new surfactant.  Moreover, the court found the two declarations submitted by Par’s expert witness to be conclusory and lacking “specifics as to the experimentation that would be needed to practice the entire scope of the claims.”  Additionally, the court characterized Par’s evidence that Par’s inventor was able to formulate the claimed composition with seven different surfactants as “merely colorable” evidence, failing to create a genuine issue of material fact as to enablement of the full scope of the claims.

    Thus, the Federal Circuit concluded that each of the asserted claims of Par’s patents is invalid for lack of enablement, and therefore affirmed the district court’s grant of summary judgment.

  • Pharma News Briefs

    • Last Friday, FDA Law Blog wrote about yet another 180-day exclusivity letter from the FDA, this one requesting comment on the "failure to market" forfeiture provisions of the MMA.
    • FDA Law Blog also posted a very nice summary of the FDA Amendments Act, which, among other changes, revises the citizen petition process.
    • GSK sued the U.S. Patent & Trademark Office last Tuesday to block implementation of the PTO’s new rules restricting patent claims and continuation applications.  Read more here: Patent Docs; Patently-O; Pharmalot; WSJ Health Blog.
    • The Wall St. Journal had an interesting article last week on China’s generic drug industry.  In case you’re not a subscriber to the Journal, you can read the WSJ Health Blog’s summary here or Pharmalot’s here.
    • On October 4, the FDA announced an initiative to streamline the generic drug approval process.  GPhA reacted with skepticism.

  • Paddock Labs Prevails Over Schwarz Pharma in Univasc Case at Federal Circuit

    Schwarz Pharma v. Paddock Labs, No. 2007-1074 (Fed. Cir. 2007)

    In a decision released this morning, the Federal Circuit affirmed a 2006 district court decision granting summary judgment of noninfringement of U.S. Patent No. 4,743,450 in favor of Paddock Labs.  The ‘450 patent, owned by Warner-Lambert and exclusively licensed by Schwarz Pharma, covers pharmaceutical compositions containing Angiotensin Converting Enzyme ("ACE") inhibitors, including Schwarz Pharma’s Univasc (moexipril hydrochloride).  ACE inhibitors are popular drugs for the treatment of hypertension and congestive heart failure.  The Federal Circuit affirmed the district court decision "because the district court did not err in its conclusion that prosecution history estoppel bars resort to the doctrine of equivalents in this case."

    Claim 1 of the ‘450 patent is directed to a pharmaceutical composition comprising an ACE inhibitor; "an alkali or alkaline earth metal carbonate"; and a saccharide.  Claim 16, the only other independent claim of the ‘450 patent, is directed to a process for stabilizing an ACE inhibitor comprising contacting the drug with "an alkali or alkaline earth metal carbonate"; and a saccharide.  Originally, the independent claims recited a "metal containing stabilizer" and "an alkali or alkaline earth-metal salt," respectively.  However, following an obviousness rejection during prosecution, each was amended to recite "an alkali or alkaline earth metal salt carbonate."  Paddock’s ANDA products comprise an ACE inhibitor (moexipril chloride) and magnesium oxide (MgO).

    As a preliminary matter, the Federal Circuit decided an issue concerning jurisdiction: whether Schwarz Pharma lacked standing to bring the appeal because Warner-Lambert, the patent owner, did not appeal the district court’s judgment.  Paddock argued that Schwarz was "merely an exclusive licensee of the ‘450 patent who does not possess ‘all substantial rights’ in the patent."  While it is well established that a patent owner must be joined in an action for infringement brought by an exclusive licensee, the issue concerning appeals was one of first impression for the Federal Circuit.  The court determined that "when a patentee joins an exclusive licensee in bringing a patent infringement suit in a district court, the licensee does not lose standing to appeal even though the patentee does not join in the appeal," explaining that the reason for requiring joinder in the district court (to avoid subjecting the alleged infringer to multiple actions) does not exist on appeal.

    With regard to the patent issues, the Federal Circuit agreed with the district court that amendment-based prosecution history estoppel precluded Schwarz Pharma from resorting to the doctrine of equivalents to prove infringement.  The court noted that the original claims recited a metal containing stabilizer and an alkaline earth metal salt, and therefore the subject matter encompassed by those terms was presumptively surrendered when the claims were amended.  Schwarz Pharma argued, however, that the term "stabilizer" was defined in the specification more narrowly, to exclude MgO.  But the Federal Circuit didn’t buy it, since the "definition" in the specification wasn’t so clear, and the ordinary meaning of "alkaline earth metal salt" encompasses MgO.  The Federal Circuit further found that Schwarz failed to rebut the presumption of surrender because MgO was not an unforseeable equivalent and the narrowing amendment was not merely tangentially related to the use of MgO.

    Paddock (and Teva, incidentally) is already on the market with its generic Univasc products, so as a practical matter, today’s decision simply means that Paddock won’t have to pay damages for past infringement and may continue to sell its products.

  • Federal Circuit Affirms Injunction Against Apotex in Depakote Case, But Finds Apotex Was Not in Contempt

    Abbott Labs v. Torpharm and Apotex, No. 2007-1019 (Fed. Cir. 2007)

    In 1997, Apotex filed an ANDA for generic Depakote (divalproex sodium), Abbott’s blockbuster treatment for bipolar disorder, migraine headaches, and epilepsy.  Abbott responded by filing suit against Apotex for infringement of U.S. Patent Nos. 4,988,731 and 5,212,326, which claim an oligomer containing about 4 to 6 repeating units of divalproex sodium.  In 2001, the district court granted summary judgment of validity and infringement.  However, in 2002, the Federal Circuit remanded for a trial on infringement.  On remand in 2004, Judge Posner, sitting by designation in the Northern District of Illinois, found that Apotex infringed Abbott’s patents and enjoined Apotex from making, using or selling "divalproex sodium which the Court has found to be infringing" until Abbott’s patents expire (January 29, 2008).

    Not content to sit around and wait four years, Apotex attempted to design around Abbott’s patents, and allegedly developed divalproex sodium in the form of a polymer that is composed of much more than about 4 to 6 repeating units of divalproex sodium.  Rather than file a new ANDA, however, Apotex struck a deal with Nu-Pharm, Inc. (a former sister company of Apotex) whereby Apotex would pay for the costs of preparing the ANDA and Nu-Pharm would take on the "litigation risks" arising from the filing.

    Nu-Pharm filed the ANDA in 2005 and Abbott responded by filing suit against Nu-Pharm.  In March 2006, Nu-Pharm filed an amended ANDA, seeking approval for additional dosage strengths of the product, and Apotex filed a second lawsuit–this time naming both Nu-Pharm and Apotex as defendants.  The two cases were consolidated before Judge Pallmeyer in the Northern District of Illinois.  On August 15, 2006, Abbott filed a "Motion to Enforce Its Injunction Order" before Judge Posner and a motion to stay the proceedings before Judge Pallmeyer.

    On October 6, 2006, Judge Posner found Apotex in contempt for violating the injunction he issued two years earlier.  He characterized the injunction as extending to "any generic divalproex sodium manufactured by Apotex that has been found to be infringing."  He then found that there was no difference between Apotex’s old product and its new product, and that, based upon the evidence presented by the parties, Apotex’s new product would infringe Abbott’s patents.  Accordingly, Judge Posner extended the injunction to cover Nu-Pharm’s ANDA.  Apotex then appealed to the Federal Circuit.

    Apotex raised two issues on appeal: (1) whether the contempt proceeding was beyond the district court’s statutory authority because the Hatch-Waxman Act does not itself grant a district court subject matter jurisdiction to conduct such contempt proceedings; and (2) whether the contempt proceeding was improper in any event because the infringement inquiry was amenable only to trial under the Federal Rules of Civil Procedure.

    In a decision released today, the Federal Circuit upheld the district court’s decision to hold a contempt proceeding as well within its discretionary authority, notwithstanding any provisions in (or not in) the Hatch-Waxman Act, and affirmed the revised injunction against Apotex.  The Federal Circuit observed that "Apotex has failed to provide any authority, be it statute, case law, or legislative history of the Hatch-Waxman Act, suggesting that suits commenced under the provisions of the Act are to be treated any differently than patent infringement suits under 35 U.S.C. 271(a)."  Moreover, the Federal Circuit affirmed Judge Posner’s finding that clear and convincing evidence proved that the Nu-Pharm drug would infringe the claims of Abbott’s patents.  Such evidence was found in documents showing no difference between the new drug and the old, and expert testimony showing the Nu-Pharm drug is in fact an oligomer.  Accordingly, the Federal Circuit affirmed that Judge Posner acted entirely within his authority to extend the injunction to prohibit the FDA from approving the Nu-Pharm ANDA, and refused to vacate the revised injunction.  Thus, it appears that Apotex will have to wait until 2008, after all, before it can market its generic version of Depakote.

    As minor consolation to Apotex, the Federal Circuit also held that the district court erred in finding Apotex in contempt.  Here, the Federal Circuit held that the district court made an error of law in interpreting its original injunction to preclude the filing of the Nu-Pharm ANDA.  It was undisputed that Apotex’s actions in attempting to design around Abbott’s patents occurred outside the United States.  Thus, since Apotex did not make, use, sell, offer to sell in the U.S. or import into the U.S. generic divalproex sodium, the Federal Circuit found that Apotex did not violate the original injunction.

  • iiBIG “New Directions for Drug Delivery” Conference, Las Vegas, October 29-30

    The International Institute for Business Information & Growth will hold a conference entitled “New Directions for Drug Delivery,” October 29-30 in Las Vegas, Nevada.  The conference is designed for pharmaceutical scientists and specialty pharma, biopharmaceutical, and nanotechnology licensing and business development team leaders.  According to iiBIG, attendees will learn “how new scientific technologies are driving investments, alliances and clinical trials to bring novel drug delivery technologies to market.”

    The agenda includes several interesting sessions, including:

    • “Rapid Evaluation of Drug Delivery Technologies”
    • “FDA & Patents — Case Study of Transdermal Patches”
    • “Innovations and Success Strategies: Learning and Un-learning from Key Players” (a panel on which I’ll be speaking)
    • “Eye on the Future — Breakthrough Scientific and Partnership Strategies”
    • “Converting from Drug Delivery to Specialty Pharma — The Road More Traveled”

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

    Orange Book Blog is a media partner of this conference.

  • FDA Requests Comments on 180-Day Exclusivity for Generic Altace (Ramipril)

    For the second time in as many weeks, FDA has asked interested parties to submit comments regarding 180-day generic drug exclusivity issues.  On September 26, as FDA Law Blog reported, FDA requested comments on exclusivity for generic Precose (acarbose) tablets; last week, FDA asked for comments
    on exclusivity for generic Altace (ramipril) capsules.  Two letters have been submitted so far.

    Hyman, Phelps & McNamara, P.C. submitted a letter on behalf of an unnamed company that has a tentatively approved ANDA for ramipril capsules.  Their letter explains: Cobalt Pharmaceuticals was the first ANDA filer and, as such, was eligible for 180-day exclusivity; Cobalt’s ANDA was submitted prior to enactment of the 2003 Medicare Modernization Act, and therefore pre-MMA exclusivity provisions apply; Cobalt’s ANDA contained a paragraph IV certification with respect to U.S. Patent No. 5,061,722, a composition of matter patent set to expire in 2008; King and Aventis sued Cobalt for infringing the ‘722 patent, and later settled the litigation, with Cobalt stipulating to infringement; then, on September 11, 2007, the Federal Circuit invalidated the ‘722 patent.  According to Hyman, Phelps’ letter, "Thus, Cobalt’s 180-day exclusivity is ‘parked’ to the detriment of subsequent ANDA applicants with tentative approval (unless and until a court decision triggers exclusivity)."

    Hyman, Phelps argues that FDA should determine that Cobalt’s ANDA no longer contains a paragraph IV certification, but contains a paragraph III certification instead (based on the fact that Cobalt has stipulated to infringement and therefore is no longer challenging the ‘722 patent), and so is ineligible for 180-day exclusivity.  Moreover, they argue that as soon as the Federal Circuit issues the mandate from its September 11 decision, FDA should remove the ‘722 patent from the Orange Book (because it will have been formally declared invalid) and grant final approval to any tentatively approved ANDAs for ramipril capsules.

    In the other letter, Buc & Beardsley wrote to FDA on behalf of its client, Lupin Pharmaceuticals, to request immediate approval of Lupin’s ANDA for ramipril capsules.  Lupin is the party that prevailed over King and Aventis in the Federal Circuit on September 11.  Like Hyman, Phelps’ letter, Buc & Beardsley’s letter argues that Cobalt’s ANDA no longer contains a valid paragraph IV certification, because Cobalt stipulated to infringement.  But unlike Hyman, Phelps’, Buc & Beardsley argues that final approval of other ANDAs need not await issuance of a mandate.  Instead, based on a fine distinction from the amlodipine case, Buc & Beardsley argues that Lupin’s ANDA must be finally approved immediately.

    The last point may become moot, since the Federal Circuit may in fact issue a mandate from its September 11 decision before FDA decides all the exclusivity issues raised in these letters.

  • ACI “Maximizing Pharmaceutical Patent Life Cycles” Conference, New York, October 24-25

    American Conference Institute will hold its eighth annual "Maximizing Pharmaceutical Patent Life Cycles" conference October 24-25 in New York.  According to ACI, this is the "one and only event that has consistently allowed brand name and generic drug makers to benchmark their companies’ current strategies and tactics against competitors in both camps."

    The agenda includes many topics covered on Orange Book Blog.  Specific talks include:

    • "KSR and the New Standard for Obviousness: Exploring Its Impact on Primary and Secondary Pharmaceutical Patents"
    • "Brand Name and Generic Pharmaceutical Patent Settlements: Pending Legislation, Key Cases and Strategies to Employ"
    • "Patent and Non-Patent Exclusivity–New Developments Affecting the Basics and Beyond"
    • "Orange Book Listings and Delistings: New Controversies, Concerns and Considerations" (I’ll be speaking on this panel)
    • "Update on FDA Activities Relative to Pharmaceutical Patent Life Cycles" (by Elizabeth Dickinson, Assoc. Chief Counsel for Drugs, FDA)

    In addition, two optional post-conference workshops are offered on October 26: a brand name master class entitled "New Strategies for Obtaining Pharmaceutical Patent Extensions Post-KSR" and a generics master class entitled "Updated Drafting Guidelines for Paragraph IV Certifications and Notice Letters."

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

    Orange Book Blog is a media partner of this conference.