Orange Book Blog

Federal Trade Commission Issues Final Report on Authorized Generic Drugs

The Federal Trade Commission announced earlier today that it has completed its study into the competitive effects of authorized generic drugs.  The FTC's final report, entitled "Authorized Generic Drugs -- Short-Term Effects and Long-Term Impact," was unanimously approved by the five-member commission and follows up on a 2009 interim report.  The study was commenced upon requests in 2005 by Senators Grassley (R-IA), Leahy (D-VT) and Rockefeller (D-WV), and Representative Waxman (D-CA).

The final report contains four main findings:

1. Competition from authorized generics during the 180-day marketing exclusivity period has led to lower retail and wholesale drug prices.  Specifically, authorized generics are associated with retail prices that are 4-8% lower and wholesale prices that are 7-14% lower.
2. Authorized generics have a substantial effect on the revenues of competiting generic firms.  For instance, an authorized generic reduces the first filer's revenues by 40-52% during the 180-day exclusivity period and by 53-62% over the following 30 months.
3. Lower expected profits could affect a generic company's decision to challenge patents on products with low sales.  However, the reduced revenues resulting from authorized generic competition during the 180-day exclusivity period have not substantially reduced the number of challenges to branded drug patents by generic firms.
4. There is strong evidence that agreements not to compete using authorized generics have become a way that some branded firms compensate generic firms.  For example, in FY 2010, fifteen drug patent settlements combined an explicit agreement by the brand manufacturer not to launch an authorized generic competitor and a commitment by the first-filing generic to defer entry.

The report is 270 pages long, it contains dozens of tables and figures, and it includes a great deal of data about specific pharmaceutical companies.

The report concludes:

During the 180-day exclusivity period, competition from authorized generics lowers prices for consumers and lowers revenues for the independent generic competitor.  Over the longer term, lower expected profits could affect a generic company's decision to challenge a patent on products with low sales, and one company provided a few examples where it claimed the expectation of an authorized generic led it to reject or delay such a challenge.  Overall, however, patent challenges, even on drugs with low sales, remain robust and, by most measures, have increased despite the prevalence of authorized generic competition.  Moreover, as a consequence of an authorized generic's significant negative impact on a generic's revenues, some brand-name companies have used agreements not to launch an authorized generic as a way to compensate an independent generic in exchange for the generic's agreement to delay its entry.  The frequency of this practice and its profitability may make it an attractive way to structure a pay-for-delay settlement, a practice that causes substantial consumer harm.

FURTHER READING:

• GPhA statement
• PhRMA statement
• New York Times
• FDA Law Blog
• The Hill
• Pharmalot
• PharmPro

OBB News Briefs

• On June 25, the Congressional Budget Office released a cost estimate for the Biologics Price Competition and Innovation Act of 2007 (S. 1695), concluding that the biosimilars bill would save American consumers $25 billion on prescription drug costs over the next ten years.  For more: statements from BIO and PhRMA; FDA Legislative Watch; Pharmalot; The Hill's Congress Blog.
• Bayer and Barr announced on June 24 that they signed a deal licensing Barr to market authorized generic versions of Bayer's Yasmin and Yaz oral contraceptives.  Under the agreement, Bayer will continue to appeal the March 3rd district court decision on Yasmin and will receive higher royalties from Barr if it succeeds.  More: Reuters.
• On June 23, FDA Law Blog reported that Rep. William Delahunt (D-MA) introduced a bill specifically meant to allow The Medicines Company, a Massachusetts company, to obtain a patent term extension for its patent covering Angiomax (bivalirudin)--for $65 million.
• FDA Law Blog reported on June 19 that the House Commerce Committee posted the responses to its April 3rd letter soliciting feedback on how to establish a pathway for FDA approval of biosimilar products.
• On June 18, Pfizer and Ranbaxy announced a comprehensive settlement of patent litigation over generic Lipitor.  Under the agreement, Ranbaxy will have a license to sell generic versions of Lipitor (atorvastatin) and Caduet (atorvastatin/amlodipine) effective Nov. 30, 2011.  For more: NYT; Pharmalot; Reuters; WSJ; WSJ Health Blog.
• On June 17, the Federal Circuit affirmed the district court findings of inequitable conduct and exceptional case in Synthon IP v. Pfizer, in which Synthon unsuccessfully alleged that Pfizer infringed its patent on a process for making amlodipine, the active ingredient in Norvasc.
• The AP reported on June 5th that Abbott and Mylan settled their patent litigation over Mylan's generic version of Depakote ER, with the parties agreeing that Mylan may launch its generic no later than Jan. 1, 2009.
• The Lewis & Clark Law Review recently published a special issue devoted entirely to the patent law doctrine of obviousness.  One of the articles is of particular interest:  Pharma's Nonobvious Problem, by Prof. Rebecca S. Eisenberg.

OBB News Briefs

• Apotex and an anonymous ANDA filer recently submitted new comments to FDA on ramipril 180-day exclusivity issues.  Earlier this month, we summarized previous comments on the ramipril docket.
• Roxane Labs recently submitted new comments to FDA on acarbose 180-day exclusivity, and Impax indicated that it intends to do the same.  Their submissions are available on FDA's acarbose docket.
• The FTC announced Thursday that it has settled its antitrust complaint against Barr Labs concerning Warner Chilcott's Ovcon birth control pill.  According to FTC's press release, the settlement provides that "Barr must refrain from entering into anticompetitive supply agreements with branded companies similar to Barr's agreement with Warner Chilcott regarding Ovcon."
• Via SpicyIP and Pharmalot, Sun Pharma has filed a paragraph IV challenge of Novartis's polymorph patent on Gleevec (imatinib mesylate), which expires in 2019.  The compound patent on imatinib expires in 2015.
• FDA Law Blog had an interesting post last week about a lawsuit by two pharmacy associations against the Center for Medicaid Services, charging that the new "AMP rule," which CMS uses to calculate how much it reimburses states for generic drugs, is unlawful.  Some believe that the new Medicaid reimbursement rules make it cost-prohibitive for brand name drug companies to sell authorized generics in many cases.
• Pharmalot reported recently that legislation that would have banned "reverse payment" settlements of Hatch-Waxman litigation has stalled in the Senate.  For background, see this OBB post from last February.

Pharma News Briefs

• The House of Representatives passed an omnibus FDA bill on Wednesday.  The Senate passed its own FDA bill in May.  Differences between the two bills will be hammered out in conference committee, where follow-on biologics provisions may be tacked on.  See coverage at: FDA Law Blog; Pharmalot;  PhRMA press release; WSJ Health Blog.
• Business Standard magazine had this story Monday on reaction by Indian generic drug companies to authorized generics.
• FDA Law Blog had an interesting post last week on a recent request for information on FDA's policy for Orange Book listings of patents that cover drug delivery systems but that do not recite an active ingredient or drug formulation.
• More generic Norvasc approvals: Lupin; Ranbaxy; Roxane.

Pharma News Briefs

• Barr Labs announced Monday that it has amended its paragraph IV certification with respect to Lilly's Zyprexa Zydis patent to a paragraph III certification, and that Lilly has dropped its related patent suit against Barr.  See also this AP article.
• FDA Law Blog had this post Tuesday about yet another new study on authorized generics.
• Patently-O reported today that the district court overseeing Abbott's Biaxin XL litigation against Sandoz has denied Sandoz's motion to stay a preliminary injunction pending appeal.  For background, see this April OBB post.
• The Patent Prospector recently posted Hal Wegner's new paper on post-KSR chemical obviousness.

Pharma News Briefs

• AP published this report on yesterday's House hearing on "reverse payment" settlements.
• AP also recently published this article on follow-on biologics legislation, entitled "Time is Running Out for Generic Biotech."
• Antitrust Review recently posted an update on the FTC's authorized generics study.
• FDA Law Blog has a new post today on the most recent developments in the generic Norvasc litigation.
• FDA Law Blog also posted last week on a Medicis challenge to FDA's policy regarding exclusivity for "old" antibiotics.
• Patent Docs has two interesting recent posts--here and here--on applying TRIPS to patented drugs in developing countries.
• Patently-O has a new post today by Cal Crary, a pharma litigation analyst: "Impact of KSR v. Teleflex on the Pharmaceutical Industry."
• PhRMA put out this press release on the U.S. Trade Representative's annual report on IP rights; see also this related post on Pharmalot.
• Pharmalot also recently had this interesting post on India's generic drug companies.

Pharma News Briefs

• Pharmalot had a post today, "Kennedy Circulates Biogenerics Bill," regarding a new draft of a bill that would establish an abbreviated pathway for FDA approval of follow-on biologics.
• Rep. Jay Inslee (D-WA) and two co-sponsors introduced a new follow-on biologics bill in the House last week, H.R. 1956.  See also Press Release; Bill Summary.
• In "Abbott Blinks, Big Pharma Cringes," the Wall St. Journal Health Blog reported Monday about new developments in Abbott's battle over patent rights with the Thai government.
• Recent comments by FTC and DOJ officials on reverse payment agreements were quoted by AP in "FTC Head Defiant Over Drug Co. Payments."
• Last week, a new PhRMA-sponsored study concluded that authorized generics do not deter paragraph IV filings.  These two blogs recently had excellent posts on the study: Antitrust Review and FDA Law Blog.
• A new paper on authorized generics, written by Tom Chen, appears in this month's Virginia Law Review.  The paper approaches the authorized generics issue from an antitrust law perspective.

Mylan Launches Generic Norvasc; Other Generics to Follow Soon?

Mylan announced in a press release today that it has launched its generic Norvasc (amlodipine besylate).  Mylan's generic launch follows the Federal Circuit's decision yesterday, invalidating Pfizer's patent on Norvasc.  The case presents some very interesting issues involving the interaction between patent rights, pediatric exclusivity, and 180-day exclusivity.

Last month, Mylan lost its patent challenge when Judge Terrence F. McVerry of the U.S. District Court for the Western District of Pennsylvania found that Pfizer's patent is valid, enforceable and infringed by Mylan.  At the time, the district court enjoined Mylan from marketing its generic Norvasc "until after the expiration of Pfizer's '303 patent term, as extended by the pediatric exclusivity period."  Pfizer's patent expires this Sunday, March 25; Pfizer's pediatric exclusivity expires six months later, on September 25.  Since then, Pfizer and Mylan have been busy filing motions to amend the district court's injunction and Mylan has appealed the decision to the Federal Circuit.

On March 8, Pfizer asked the district court to modify its injunction to include a "section 271(e)(4)(A) order" stating that the effective date of approval of Mylan's ANDA shall not be earlier "than the date of expiration of the '303 patent (March 25, 2007, with attached six months of pediatric exclusivity ending on September 25, 2007, to which Pfizer is entitled)."  The FDA had already granted final approval to Mylan's ANDA and, according to Pfizer, "in a telephone conversation on March 7, 2007, the FDA advised Pfizer that the FDA will not reset Mylan's effective approval date without a judgment including a section 271(e)(4)(A) order."

Mylan opposed Pfizer's motion and filed its own motion to amend the district court's order, asking the district court to enjoin Mylan only until Pfizer's patent expires on March 25.  According to Mylan's motion:

Pediatric exclusivity does not grant a drug maker a six month patent extension, but acts [only] to prohibit FDA from granting final approval.  Here Mylan has already received final approval and is the only ANDA filer with final approval.  In effect, then, the pediatric exclusivity period applies to all generic competitors except Mylan, thus giving Mylan a six-month head start over generic competitors.

In response, Pfizer filed a combined opposition and reply.  Pfizer argued that its proposed amended judgment was "purely formal, incorporating the precise words of the statue.  Mylan's proposed amended judgment, on the other hand, seeks to . . . deny Pfizer its right of pediatric exclusivity without any basis whatsoever."

On March 16, the district court reached a sort of compromise, ordering that Mylan's ANDA shall not be approved until Pfizer's patent expires and enjoining Mylan until then.  Mylan then filed an emergency motion to stay the court's new order, arguing that "there is a real danger that the Court's order will prompt the FDA to revoke [Mylan's] approval, keeping Mylan off the market even after the patent has expired."  Mylan worried that it would lose its 180-day exclusivity rights if the FDA revoked its approval.  Three days later, Pfizer opposed the motion.  Later that same day, the court denied it.

Yesterday, of course, the big news hit: the Federal Circuit invalidated Pfizer's patent in a separate case against Apotex, who had filed its own ANDA to market generic Norvasc (albeit later than Mylan).  Mylan's lawyers immediately picked up the phone, called Judge McVerry, and made "an emergency oral telephonic motion for a stay of the injunctive relief."  Recognizing that Mylan's lawyers presented the same emergency motion to the Federal Circuit, Judge McVerry denied Mylan's motion.

At the same time, Mylan filed this complaint against the FDA today in the District of Columbia district court, asking the court to enjoin FDA from taking any action that would "disturb the final approval granted to Mylan's ANDA."  Mylan indicated that in a phone call with Mylan's counsel, "FDA counsel stated that FDA would revoke Mylan's final approval and convert it to a tentative approval," if the Federal Circuit did not stay the March 16 order "by mid-day on March 23, 2007."  Mylan also filed this emergency TRO motion.

Apparently the Federal Circuit granted Mylan's motion for a stay of the March 16 order--otherwise Mylan could not have launched its generic Norvasc.  The Federal Circuit's action seems to moot the lawsuit Mylan filed today in the D.C. district court.

Now that Mylan has launched, the interesting question is whether the FDA will approve any other generics when Pfizer's patent expires on Sunday.  In its press release today, Mylan states that its generic launch triggered its 180-day exclusivity period, precluding the FDA from approving any other generics.  This AP story published today, however, suggests that Apotex has a different understanding, and expects to launch its own generic Norvasc "in the very near future."

Meanwhile, Pfizer announced late today that in response to Mylan's generic launch, it has launched an authorized generic Norvasc through its Greenstone subsidiary.  Pfizer added that it "will continue to pursue all available legal remedies to protect the market for Norvasc through a six-month pediatric exclusivity period that expires in September, 2007."

Stay tuned . . . this story is developing quickly.

RELATED READING:

• March 23 Bloomberg article

UPDATES:

• Mylan brief in support of its motion for a stay, pending appeal, of the district court's March 16 Order
• Pfizer brief in support of its motion to lift the Federal Circuit's temporary stay of the March 16 Order
• Fed. Cir. March 26 Order granting Mylan's motion and denying Pfizer's

Senators Reintroduce Bill to Ban Authorized Generics

Senator Jay Rockefeller (D-WV) has introduced S. 438, "The Fair Prescription Drug Act of 2007," which would ban the sale of authorized generic drugs during an ANDA applicant's 180-day exclusivity period.  The bill is cosponsored by Senators Kohl (D-WI), Leahy, (D-VT), and Schumer (D-NY).  The same bill was proposed last year as S. 3695.  Senator Kohl expressed optimism that the bill would have better prospects this time around--and it just might, given that the Democrats now control Congress.

RELATED READING:

• Jan. 31, 2007 UPI article
• Jan. 31, 2007 Mylan Labs press release
• July 24, 2006 OBB post on last year's bill

Savient Loses Motion for Preliminary Injunction in Oxandrin Case, Launches Authorized Generic, and Halts Promotion of Branded Oxandrin

Savient Pharms. v. Sandoz, No. 07-1081 (Fed. Cir.)

On December 28, 2006, the Federal Circuit Court of Appeals denied Savient Pharmaceuticals' motion for a preliminary injunction, pending appeal, to prevent Sandoz and Upsher-Smith from marketing their generic Oxandrin (Oxandrolone) products.  Oxandrin, with annual sales of $60 million, is indicated for the promotion of weight gain following extensive surgery, chronic infection, or severe trauma.

Savient appealed an earlier district court decision and had moved the Federal Circuit for a preliminary injunction, pending that appeal.  Although Savient may still pursue its appeal if it so chooses, the December 28th Order left Sandoz and Upsher-Smith free to launch their generic Oxandrin products.

In response to the Federal Circuit's decision, Savient announced in a December 29 press release that Watson Pharmaceuticals has launched an A-B rated authorized generic of oxandrolone tablets.  Additionally, Savient announced in a press release today that it "will discontinue its 19 person Oxandrin field sales force."  It appears that Savient is content to profit from its authorized generic deal with Watson, and will cease promotion of the branded product.

RELATED READING:

• December 12, 2006 post