Orange Book Blog

ACI "3rd Advanced Forum on Biosimilars," New York, May 22-23

It's been two years since Congress passed the Biologics Price Competition and Innovation Act, and FDA is still waiting to receive the first biosimilar application.  But that doesn't mean progress hasn't been made.  FDA issued three draft guidance documents in February, and various companies and industry groups have submitted comments on the guidance (see this GEN article for a summary of the comments).  On May 11, FDA will hold a public hearing to receive additional input on the draft guidance.

American Conference Institute's 3rd Advanced Forum on Biosimilars, taking place May 22-23 in New York City, will address these developments and more.  The agenda includes the following presentations:

• Implementing the Biosimilar Pathway: FDA Guidance and Planning for the U.S. Biosimilars Regime
• Answering the $100 Million Question: Evaluating the Commercial Viability and Opportunity of Biosimilars
• Defining Biosimilarity and Meeting the Additional Statutory Standards for Interchangeability
• Practical Implications of a 12-Year Exclusivity Period: Strategically Defining and Calculating Exclusivity
• The Biosimilars Experience: Providing an Optimal Patient Encounter
• Overcoming Biosimilars Regulatory, Marketing, and Commercialization Challenges
• In-Depth Breakdown of the Biosimilar Framework in the EU: Risk Management Strategies to Protect your Biologic on the International Stage
• The First Wave of Litigation: Proactive Procedures and Early Considerations for Innovators and Biosimilar Companies
• Timing is Everything: A Checklist to Ensure Preparedness for Litigation
• The Post-AIA World: Factoring the Impact of Patent Reform into Biosimilars Prosecution and Litigation Strategies
• Understanding FDA's Requirements for Biosimilars Clinical Trials
• Safeguarding Intellectual Property and Maximizing Biologic Patent Life Through a Robust Biosimilars Patent Portfolio Strategy
• BLAs, Biobetters and Beyond: Evaluating the Benefits and Risks of Alternative Routes to Market

In addition, ACI is offering a pre-conference primer on Monday, May 21:  "Biologics 101: Formulating a Biosimilars Patent Portfolio Development Plan Grounded in Complex Scientific Properties."   ACI is also offering a post-conference master class on Thursday, May 24:  "Maximizing Market Share in a Global Economy: Exploring Opportunities for Biosimilars Growth into Emerging Markets."

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

Federal Circuit Affirms Dismissal of Bayer's Inducement Claims in YASMIN Case

Bayer Schering Pharma et al. v. Lupin et al., Nos. 2011-1143, -1228 (Fed. Cir.)

by Malaika D. Tyson

In a 2-1 opinion this past Monday, the Federal Circuit affirmed a district court decision dismissing Bayer's patent infringement claims against Watson, Sandoz and Lupin because their ANDAs did not seek approval for the patented use.  At issue, according to the majority opinion, was whether the FDA approved certain uses of YASMIN (drospirenone/ethinyl estradiol) that were not mentioned in the "Indications and Usage" section of the drug label.

Bayer's U.S. Patent No. 5,569,652 is a method-of-use patent listed in the Orange Book for YASMIN, a product approved "for the prevention of pregnancy in women who alect to use an oral contraceptive" (according to the Indications and Usage section of the YASMIN label).  The '652 patent claims a method of simultaneously achieving a contraceptive effect, an anti-androgenic effect (which can be useful for treating acne), and an anti-mineralocorticoid effect (which can be useful for reducing excess water retention).  After Watson, Sandoz and Lupin submitted ANDAs with paragraph IV certifications to the '652 patent, Bayer filed suit against the ANDA applicants under 35 U.S.C. § 271(e)(2), alleging that their generic versions of YASMIN would induce infringement of the '652 patent.

In the district court, Watson and Sandoz moved for judgment of noninfringement on the pleadings under Fed. R. Civ. P. 12(c), arguing that their ANDAs related to the use of of generic YASMIN only for oral contraception and not for the combination of uses claimed in the '652 patent.  The district court granted their motions, holding that "because the FDA had not given approval for the use of the drug that was claimed in the '652 patent, Bayer could not state a claim for patent infringement."

On appeal, Bayer argued that the FDA did approve the use of the drug for all three effects because in the Clinical Pharmacology section of the drug label, which is identical to the proposed label in each ANDA, there was information regarding the use of the drug for all three effects.  While the Federal Circuit acknowledged that the description of the effects in the label demonstrated that the FDA was aware that YASMIN could cause those effects, the court did not agree that the presence of the information anywhere in the label was sufficient evidence to show that the FDA approved YASMIN to achieve the combination of the three effects claimed in the '652 patent.

According to the Federal Circuit, "The FDA labeling regulation, 21 C.F.R. § 201.57, makes clear that the FDA has not approved the use of Yasmin to produce the pharmacological effects that are listed in the Clinical Pharmacology section of the label."  The court stated that approved uses are listed in the Indications and Usage section of the label and indications or uses "must not be implied or suggested in other sections of the labeling if not included in [the Indications and Usage] section."  Moreover:

The reference in the Clinical Pharmacology section of the label to the anti-mineralocorticoid and anti-androgenic activity of drospirenone is certainly not a direct indication of an appropriate use for Yasmin, and even if it could be considered an "implied or suggested" indication of an appropriate use, the regulation expressly states that such implied or suggested uses do not constitute approved uses.

The Federal Circuit further remarked that the FDA regulation requires that "the label provide a summary of essential scientific information needed for the safe and effective use of the drug" and the Yasmin label does not provide this type of summary regarding the anti-androgenic and anti-mineralocorticoid effects.  The court found this to be further evidence that the FDA did not approve YASMIN to treat those effects.

The court continued:

the fact that certain of the effects of a drug are described in the Clinical Pharmacology section of the label does not mean that the FDA has approved the use of the drug to produce those effects; it only ensures that physicians are aware of the full range of the drug's pharmacological effects (especially those that might be considered adverse effects) when prescribing the drug for a purpose set forth in the Indications and Usage section and under the conditions described in other parts of the label.

The court concluded that the FDA did not approve the YASMIN for its anti-androgenic and anti-mineralocorticoid effects because the FDA did not find YASMIN to be safe and effective to cause those effects and the recognition of such safety and efficacy is absent from the YASMIN label.  The court held that since the FDA did not approve YASMIN for the method of use claimed in the '652 patent and the defendants' ANDAs sought to market the generic form solely for contraceptive use, the defendants could not induce infringement of the '652 patent.

In dissent, Judge Newman found the majority's ruling to be in error because "the portion of the FDA label in which a product's properties are described is irrelevant to whether the patent is infringed. . . ."  Instead, in her view, "[t]he infringement inquiry is whether the generic counterpart, when used in accordance with its proposed ANDA authorization, would infringe the patent."

Supreme Court Sides With Generic Pharmaceutical Companies in Dispute Over Orange Book "Use Codes"

Caraco Pharm. Labs. v. Novo Nordisk, 566 U.S. ___ (2012)

In a unanimous opinion today, the Supreme Court held that an ANDA applicant may employ the counterclaim provision of 21 U.S.C. § 355(j)(5)(C)(ii)(I) not only to seek the delisting of a patent from the Orange Book, but also to force amendment of an Orange Book "use code."  The Federal Circuit had held that the counterclaim provision was not available for the second purpose.  The Supreme Court reversed that decision and remanded the case for further proceedings.

Today's decision is notable for being the first ANDA case decided by the Supreme Court since the Hatch-Waxman Act was passed in 1984.  Moreover, the tone of the Court's opinion is very pro-generic.

21 U.S.C. § 355(j)(5)(C)(ii)(I) provides that if an ANDA applicant is sued for patent infringement,

the applicant may assert a counterclaim seeking an order requiring the [NDA] holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) of this section on the ground that the patent does not claim either--(aa) the drug for which the application was approved; or (bb) an approved method of using the drug.

In this case, Caraco filed an ANDA for a generic version of Novo's PRANDIN (repaglinide), which is FDA-approved for the treatment of diabetes in three different treatment regimens: (1) alone; (2) in combination with metformin; and (3) in combination with thiazolidinediones.  U.S. Patent No. 6,677,358, claiming the use of repaglinide in combination with metformin, was listed in the Orange Book at time Caraco filed its ANDA.  To avoid infringing the '358 patent, Caraco submitted its ANDA with proposed labeling omitting the patented regimen, seeking approval only for the use of repaglinide in the unpatented regimens.  Accordingly, Caraco's ANDA included a section viii statement, indicating that Caraco sought approval for only unpatented uses of the drug.

The FDA, however, rejected Caraco's section viii statement because the use code that Novo provided in connection with the '358 patent overlapped with Caraco's proposed labeling.  Novo's use code was "A method of improving glycemic control in adults with type 2 diabetes"--in other words, the use code covered all three of the approved uses, not only the single patented use.  After its section viii statement was rejected, the only way for Caraco to seek approval of its ANDA prior to expiration of the '358 patent was to file a paragraph IV certification.  Caraco did so, which meant that Caraco was also required to amend its proposed labeling to be identical to the PRANDIN label.  Thus, Caraco was forced to pursue approval of repaglinide for all three approved uses, including the patented use.

After Novo sued Caraco for infringing the '358 patent, Caraco filed a counterclaim under § 355(j)(5)(C)(ii)(I), seeking to force Novo to narrow the PRANDIN use code such that it could pursue approval of repaglinide for only the unpatented uses.  The district court allowed the counterclaim, but the federal circuit reversed the district court, and Caraco appealed to the Supreme Court.

In today's opinion, the Supreme Court rejected each one of Novo's arguments.  First, the Court "dispose[d] of a recently raised jurisdictional argument."  Novo contended that the courts lost subject-matter jurisdiction over the case at the moment Caraco filed its section viii statement.  But, according to the Court, that "argument is wrong even assuming (as Novo contends) . . . that a section viii filing is not an act of infringement."  According to the Court, "[t]he want of an infringing act is a merits problem, not a jurisdictional one."

Proceeding to the merits, the Court addressed Novo's argument that an ANDA applicant may use the counterclaim provision only if the Orange Book-listed patent does not claim any approved method of using the drug, regardless of whether the ANDA applicant seeks approval for that use.  The Court agreed with Caraco:  the counterclaim provision is available "whenever the patent does not claim a method of use for which the ANDA applicant seeks to market the drug."  Here, the court read the counterclaim provision in the context of the Hatch-Waxman Act as a whole:

The Hatch-Waxman Amendments authorize the FDA to approve the marketing of a generic drug for particular unpatented uses; and section viii provides the mechanism for a generic company to identify those uses, so that a product with a label matching them can quickly come to market.  The statutory scheme, in other words, contemplates that one patented use will not foreclose marketing a generic drug for other unpatented ones.  Within that framework, the counterclaim naturally functions to challenge the brand's assertion of rights over whichever discrete use (or uses) the generic company wishes to pursue.  That assertion, after all, is the thing blocking the generic drug's entry on the market.  The availability of the counterclaim thus matches the availability of FDA approval under the statute:  A company may bring a counterclaim to show that a method of use is unpatented because establishing that fact allows the FDA to authorize a generic drug via section viii.

The Court then addressed Novo's argument that the "counterclaim does not provide a way to correct use codes because they are not 'patent information submitted by the [brand] under subsection (b) or (c)' of § 355."  Here, although subsections (b) and (c) refer expressly only to "the patent number and the expiration date of any patent" claiming the drug or a method of its use, the Court read "submitted under" broadly.  According to the Court, "use codes fall within the counterclaim's ambit if the phrase 'submitted under' reaches filings that not only subsections (b) or (c) themselves, but also their implementing regulations require."  The Court cited precedent in support of such a broad reading, stating that "'Patent information submitted . . . under subsection (b) or (c)' most naturally refers to patent information provided as part of the 'comprehensive scheme of regulation' premised on those subsections."

The Court concluded:

The statutory counterclaim we have considered enables courts to resolve patent disputes so that the FDA can fulfill its statutory duty to approve generic drugs that do not infringe patent rights.  The text and context of the provision demonstrate that a generic company can employ the counterclaim to challenge a brand's overbroad use code.  We accordingly hold that Caraco may bring a counterclaim seeking to "correct" Novo's use code "on the ground that" the '358 patent "does not claim . . . an approved method of using the drug"--indeed, does not claim two.

Federal Circuit Affirms Unenforceability of TAXOTERE Patents

Aventis Pharma S.A. et al. v. Hospira, Inc. et al., No. 2011-1018 (Fed. Cir.)

In a precedential decision earlier this week, the Federal Circuit affirmed a district court decision holding two patents on TAXOTERE (docetaxel), U.S. Patent Nos. 5,750,561 and 5,714,512, unenforceable for inequitable conduct.  The Federal Circuit also affirmed findings that claim 5 of the '561 patent and claim 7 of the '512 patent are invalid for obviousness and that claim 7 of the '512 patent is not infringed.

The decision is notable as one of the few cases--and the first Hatch-Waxman case--involving inequitable conduct that the Federal Circuit has decided since Therasense, which raised the bar for proving inequitable conduct.  In addition, the decision illustrates how losing a claim construction argument can lead to losing on validity, which in turn can lead to losing on inequitable conduct.

Claim 5 of the '561 patent recites:

5.  A perfusion, which contains approximately 1 mg/ml or less of [docetaxel], and which contains less than 35 ml/l of ethanol and less than 35 ml/l of polysorbate, wherein said perfusion is capable of being injected without anaphylactic or alcohol intoxication manifestations being associated therewith.

Claim 7 of the '512 patent depends from claims 1 and 6.  When the claims are considered together, claim 7 effectively recites:

7.  A composition comprising docetaxel, said composition being dissolved in polysorbate, said composition being essentially free or free of ethanol.

On appeal, Sanofi argued that the term "perfusion" in claim 5 of the '561 patent should have been construed to mean that the composition is effective for treatment, safe, and stable for at least eight hours.  Citing its recent decision in Thorner v. Sony Computer, the Federal Circuit refused to read those limitations into the claim.  And, because Sanofi's counsel conceded at oral argument that under the district court's construction of "perfusion," claim 5 was obvious over the prior art (the "GV reference" and the "Vidal reference"), the Federal Circuit affirmed the district court's judgment that claim 5 is invalid as obvious.

With respect to claim 7 of the '512 patent, Sanofi disputed the district court's construction of "essentially free or free of ethanol."  But the Federal Circuit ignored that dispute because the parties agreed that the "composition" of claim 7 encompassed both stock solutions and perfusions and, according to the Federal Circuit, "Sanofi has not addressed the district court's obviousness finding with respect to stock solutions in its opening brief."  The Federal Circuit therefore held that Sanofi waived any argument that the claimed stock solutions were not obvious over the prior art.

Turning to inequitable conduct, the Federal Circuit described the issues as follows:

The district court found that the Vidal and GV references were material to patentability and that inventor Fabre intentionally withheld them with the intent to deceive the U.S. Patent and Trademark Office.  Based on these findings, the court concluded that the '512 patents were unenforceable for inequitable conduct.  Sanofi argues that we should reverse the court's inequitable conduct judgment because Fabre explained why he did not disclose these references to the PTO and, thus, the court's finding that he acted with the intent to deceive was not the single most reasonable inference that could be drawn from the evidence.  Additionally, Sanofi contends that these references were not material to patentability because they were duplicative of references that were before the PTO.

The Federal Circuit addressed materiality first, quoting from Therasense:  "when a 'claim is properly invalidated in district court based on the deliberately withheld reference, then that reference is necessarily material' for purposes of the inequitable conduct inquiry."  The court stated:

Here, we have affirmed the district court's finding that the '561 and '512 patents were invalid based on, inter alia, the withheld GV and Vidal references.  Because such references are necessarily material to patentiablity, the district court did not err in finding that the materiality requirement was established.

Thus, a claim-construction loss led to a validity loss, which led to an inequitable-conduct loss.

Of course, inequitable conduct also requires intent to deceive, which, according to the Federal Circuit (quoting Therasense again), is shown by proving "by clear and convincing evidence that the applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it."  Here, the court concluded that, even though the district court reached its decision before Therasense, "Based on the district court's thorough discussion of its factual findings and its well-reasoned analysis that is consistent with Therasense, this determination was not an abuse of discretion."

U.S. Supreme Court Speaks on Patent-Eligibility of Diagnostic Method Claims

Mayo Collaborative Services v. Prometheus Labs., Inc., No. 10-1150 (U.S. 2012)

by Nabeela Rasheed

On Tuesday, in a unanimous opinion authored by Justice Breyer, the United States Supreme Court addressed the issue of patent eligibility of diagnostic method claims.  The issue was simple:  is a claim to a method of optimizing a particular therapy using specific diagnostic steps eligible for patent protection under 35 U.S.C. § 101?  The Supreme Court answered with a resounding "no."  The exemplary patent claim reviewed in the decision was as follows:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8x10⁸ red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Court's decision was that this claim was not eligible for patent protection because it merely recites laws of nature.  In arriving at this decision, the Court stated that a claim to "a process that focuses upon the use of a natural law [must] also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."

In addition to making an obviousness inquiry part of the patent-eligibility analysis, the Court also recognized that there may be an "overlap" between the § 101 patent-eligibility inquiry and the § 102 novelty inquiry.  The United States government filed an amicus brief in which it urged the Court to find the patent claim eligible for patent protection, but also unpatentable based on prior art grounds.  The Supreme Court declined to accept the government's position in preference of the "better established inquiry under §101," hence making the "law of nature" exception a strong defense against diagnostic method claims.  It appears that this decision subsumes the patentability requirements from §§ 102, 103 and possibly 112 as well into the initial patent-eligibility inquiry under § 101. 

While raising the patent-eligibility bar for diagnostic method claims by making it clear that additional steps are needed to render such claims patent-eligible, the decision includes very little guidance as to what type of steps would be "significant" enough to pass muster in converting a law of nature to a patent-eligible application.  The decision did categorically note that claims to "a new drug" or "a new way of using an existing drug" are patent-eligible.

This decision has significant ramifications for diagnostic companies and the field of personalized medicine.  The decision may push such companies towards trade secret protection for diagnostic methods.  The Court noted that "we must recognize the role of Congress in crafting more finely tailored rules where necessary . . . .  We need not determining here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable."

The decision decreases the protections available to the diagnostic methods industry as compared to all other industries and takes away rights that were previously available to a valuable economic sector of the biotechnology industry.  The decision also may influence the Supreme Court's decision whether to review AMP v. Myriad Genetics, which is pending the Court’s decision on petition for certiorari.

ACI "Paragraph IV Disputes" Conference, New York, April 24-25

I will have the honor of speaking at American Conference Institute's 6th annual Paragraph IV Disputes conference in New York next month.  I'll be part of a panel discussion entitled, "Of Labels, Patents and Use Codes: The Significance and Possible Repercussions of Novo Nordisk v. Caraco to Hatch-Waxman Challenges."

The remainder of the agenda includes the following presentations:

• Anticipating and reassessing Paragraph IV challenges in the era of the patent cliff
• Invalidity and non-infringement post-Microsoft: reaffirmation of the ANDA applicant's pre-litigation obligations and assertions
• Throwing down the guantlet: the Paragraph IV notice letter
• New claim construction considerations in Paragraph IV litigation
• Prior art obviousness and obviousness-type double patenting: legal analyses and practical applications for brand names and generics
• And they're off: the start of the Paragraph IV lawsuit--pleadings and other inital considerations
• A view from the bench (with the Honorable Garrett Brown, the Honorable Joel Pisano and the Honorable Tonianne Bongiovanni, all federal judges in the District of New Jersey)
• Reassessing Paragraph IV strategies for method-of-treatment patents in view of recent and pending decisions regarding inducement and divided infringement
• Exclusivities and forfeitures: new developments, controversies and concerns relative to Paragraph IV litigation
• Pay-for-delay update (with Markus Meier, Asst. Director of the Health Care Division, Bureau of Competition, Federal Trade Commission)
• New standards in inequitable conduct post-Therasense: ethical considerations for paragraph IV cases
• New controversies surrounding damages and injunctions relative to at-risk launches
• Parallel proceedings in Paragraph IV disputes: strategies for balancing and streamlining proceedings before the federal courts, PTO and ITC

Additionally, ACI is offering two pre-conference workshops on Monday, April 23rd: "Hatch-Waxman and BPCIA 101--A Primer on IP Basics and Regulatory Fundamentals" and "Working Group Session: The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation."  Finally, a post-conference session will be offered on Thursday, April 26th: "The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics."

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

District of Delaware: Paragraph IV Certification Not Required for Jurisdiction Under Section 271(e)(2) or Declaratory Judgment Act

Cephalon v. Sandoz, No. 11-821-SLR (D. Del.)

In January 2010, Sandoz sent a Paragraph IV notice letter to Cephalon in connection with its ANDA for a generic version of Cephalon's FENTORA (fentanyl citrate) buccal tablets.  Cephalon responded by filing suit against Sandoz under 35 USC § 271(e)(2), alleging infringement of U.S. Patent Nos. 6,200,604 and 6,974,590 based on Sandoz's Paragraph IV certifications on the two patents.

On January 4, 2011, U.S. Patent Nos. 7,862,832 and 7,862,833 were issued.  On April 25, 2011, Cephalon submitted the '832 and '833 patents for listing in the Orange Book with respect to FENTORA.  But because Cephalon did not submit the '832 and '833 patents for listing within 30 days of issuance, Sandoz was not required to (and did not) file an amended patent certification with respect to the two patents in its ANDA.  See 21 CFR § 314.94(a)(12)(vi):

(vi)Late submission of patent information. If a patent on the listed drug is issued and the holder of the approved application for the listed drug does not submit the required information on the patent within 30 days of issuance of the patent, an applicant who submitted an abbreviated new drug application for that drug that contained an appropriate patent certification before the submission of the patent information is not required to submit an amended certification.

Notwithstanding that Sandoz did not file a Paragraph IV (or any) certification with respect to the '832 and '833 patents, on September 15, 2011, Cephalon filed suit against Sandoz alleging infringement of the patents under § 271(e)(2).  Cephalon also included claims under the Declaratory Judgment Act in its complaint.  Sandoz responded by filing a motion to dismiss the complaint for lack of subject matter jursidiction and failure to state a claim.

In an Order today, the district court denied Sandoz's motion.  According to the court, "Sandoz, relying primarily on the opinion issued in Eisai v. Mutual (D.N.J. 2007), argues that the court's authority to exert subject matter jurisdiction over the instant dispute is narrowly limited . . . put more simply, no Paragraph IV certification, no jurisdiction."  The Delaware court distinguished Eisai, stating that in that case, "the patent holder's conduct was so egregious that its ability to take advantage of § 271(e)(2) was forfeited."  Further, the Eisai court "went on to hold that the patentee could not maintain an infringement action pursuant to the Declaratory Judgment Act because '§ 271(e)(2) provides the jurisdictional peg for infringement actions brought prior to ANDA approval and, in the absence of the jurisdictional hook, jurisdiction is lacking.'"

The Delaware court stated:

I respectfully disagree with the sweeping conclusion that the absence of a Paragraph IV certification limits, as a matter of law, the court's subject matter jurisdiction under both 35 USC § 271(e)(2) and [the Declaratory Judgment Act].  With respect to § 271(e)(2), the sole purpose of the Paragraph IV certification in the artificial world of the Hatch-Waxman Act is to provide notice of what patents may be implicated by the ANDA, in order to trigger suit.  In reality, however, the inquiry truly begins because the ANDA filer seeks approval to market a patented drug prior to the expiration of the relevant patent.

The court held:

Where, as here, the jurisdictional trigger was properly pulled by the filing of an ANDA and the initial Paragraph IV certification by Sandoz, the court's jurisdiction should not be confined simply because Sandoz was not required to file an amended Paragraph IV certification.  Clearly, Sandoz was put on notice of the '832 and '833 patents.  It would be ironic, indeed, if the absence of an amended Paragraph IV certification precluded suit, when the certification provisions exist for the benefit of the patentee.

Finally, the court concluded that there is no connection between § 271(e)(2) and the Declaratory Judgment Act:  "so long as there is an actual controversy, that is, there is a 'sufficient allegation of immediacy and reality,' 'the exercise of jurisdiction over such an action is within the discretion of the district court.'"

ACI "Life Sciences Collaborative Agreements and M&A" Conference, New York, February 27-28

American Conference Institute will be holding its 16th Advanced Forum on Life Sciences Collaborative Agreements and M&A in New York on February 27th and 28th.

The agenda includes the following presentations:

• What the America Invents Act means for deal makers and business development strategies
• Identifying IP red flags that impact the value and success of a life sciences transaction
• Deciphering alternative business models to select the best deal structure in a time of changing industry dynamics
• Preparing your IP for M&A or product license: what savvy buyers look for
• Partner selection for facilitating product development and maximizing commercial returns
• Opening doors to new markets and products with strategic alliances
• Bayh-Dole after Stanford: revisiting research agreements with academic institutions
• Exploring perspectives of innovative small companies on the industry's prospects for 2012 and beyond
• Bridging gaps between buyers and sellers: finding the right valuation and closing the deal
• Overcoming negotiating hurdles in developing profitable public-private deals
• "No regrets" drafting: terms to include at the outset that facilitate product commercialization and profitable cooperation between partners
• Building strategic end value into your agreement

In addition, ACI is offering a post-conference Life Sciences M&A/Strategic Alliances Due Diligence Master Class on February 29th.

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: Section viii Statement Avoids Infringement Under § 271(e)(2)

AstraZeneca Pharms. v. Apotex et al., No. 11-1182 (Fed. Cir.)

In a precedential decision today, the Federal Circuit held for the first time that an ANDA applicant who files a Section viii statement with respect to a method-of-use patent and, accordingly, does not seek approval of its ANDA product for the patented use, cannot be found liable for infringement of the patent under 35 U.S.C. § 271(e)(2).  Thus, the Federal Circuit dismissed AstraZeneca's § 271(e)(2) infringement claims against ANDA applicants for generic versions of CRESTOR (rosuvastatin calcium) pursuant to Fed. R. Civ. P. 12(b)(6).

As explained more fully in our post on the district court decision in this case, AstraZeneca sued numerous generic companies who filed ANDAs for generic CRESTOR, alleging infringement of U.S. Patent Nos. 6,858,618 (claiming a method of treating heterozygous familial hypercholesterolemia ("HeFH")) and 7,030,152 (claiming a method of lowering the cardiovascular disease risk for individuals with elevated C-reactive protein).  The ANDA applicants, however, had filed Section viii statements with respect to both patents, seeking approval of their ANDA products for only unpatented uses (namely, the treatment of homozygous familial hypercholesterolemia ("HoFH") and hypertriglyceridemia).

The Federal Circuit began its analysis with the text of § 271(e)(2):

It shall be an act of infringement to submit--(A) an application [i.e., an ANDA] under section 505(j) of the Federal Food, Drug, and Cosmetic Act [codified at 21 U.S.C. § 355(j)] for a drug claimed in a patent or the use of which is claimed in a patent . . . if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

The court explained that in Warner-Lambert v. Apotex, 316 F.3d 1348 (Fed. Cir. 2003), it construed the term "the use" as used in § 271(e)(2) to mean "the use listed in the ANDA."  Accordingly, the court held "that it is not necessarily an act of infringement under § 271(e)(2) to submit an ANDA for a drug if just any use of that drug is claimed in a patent; rather, infringement of method claims under § 271(e)(2) requires filing an ANDA wherein at least one 'use' listed in the ANDA is claimed in a patent."  The court found that Warner-Lambert was directly applicable to this case, stating:

[W]e again reject the contention that filing an ANDA for a drug having any patented use automatically constitutes infringement under § 271(e)(2).  As we held in Warner-Lambert, a patented method of using a drug can only be infringed under § 271(e)(2) by filing an ANDA that seeks approval to market the drug for that use.

AstraZeneca attempted to distinguish Warner-Lambert from this case on the basis that in Warner-Lambert the patent-in-suit claimed an off-label use, but the court found that distinction "irrelevant for purposes of § 271(e)(2)."  What matters instead is "the scope of approval sought in the ANDA."

Today's decision preserves the labeling carve-out and Section viii statement as a viable route to FDA approval of generic drugs.  A contrary decision would have dramatically limited the utility of the Section viii route.

FDA Issues Draft Guidance on Biosimilars

In a press release today, the FDA announced the publication of three draft guidance documents on biosimilar product development "to assist industry in developing such products in the United States."  FDA is seeking public comment on the draft guidance documents.

The three guidance documents are:

1. Scientific Considerations in Demonstrating Biosimilarity to a Referenced Product--intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product.
2. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product--provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product.
3. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009--provides answers to common questions that may arise in the early stages of product development.