11th Annual Patent Law Institute -...

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11th Annual Patent Law Institute

INTELLECTUAL PROPERTYCourse Handbook Series

Number G-1316

Co-ChairsScott M. Alter

Douglas R. NemecJohn M. White


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Outline: Trends and Trajectories in Life Sciences Litigation (January 13, 2017)

Douglas R. Nemec

Skadden, Arps, Slate, Meagher & Flom LLP

If you find this article helpful, you can learn more about the subject by going to www.pli.edu to view the on demand program or segment for which it was written.

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1. CAUTION: POTENTIAL CHANGES MAY MOOT THIS MATERIAL

(a) The Trump Administration’s push for repeal of the Affordable Care Act, which includes the Biologics Price Competition and Innovation Act (“BPCIA”), may upend the biosimilar approval and patent chal-lenge framework

(b) New administration may take more conservative approach to antitrust enforcement

(c) David Kappos recently called on Congress to abolish § 101 of the Patent Act1

2. RECENT KEY BIOSIMILAR LITIGATIONS

(a) The biosimilar market is expected to play an increasing role in the global economy. (i) Large projected market share. (ii) May alleviate impending small-molecule drug “patent cliff.” (iii) Cost of biologics can be enormous: SpinrazaTM, $375,000 per

patient for one year of treatment2; Humira®, $14B global sales in 20153; Enbrel®, $5B global sales in 20154

(b) Abbreviated Licensure for Biosimilar Biological Products (i) Licensure pathway laid out in § 351(k) of the Public Health Ser-

vice Act (“PHSA”), as amended by the BPCIA. (ii) Biological products may rely on the FDA determinations made

for similar, previously licensed biological products. (c) FDA shall license a biological product under § 351(k) if:

(i) The FDA determines that the information submitted in the appli-cation is sufficient to show that the biological product (1) is

1. See Ryan Davis, Kappos Calls For Abolition Of Section 101 Of Patent Act,

LAW360 (April 12, 2016), https://www.law360.com/articles/783604/kappos-calls-for-abolition-of-section-101-of-patent-act.

2. Doni Bloomfield, Biogen Prices Drug for Deadly Muscle Disease at $375,000 a Year, 15 PHARM. L. & INDUS. REP. 22-23 (Jan. 6, 2017).

3. AbbVie Form 10-K (fiscal year ended 2015). 4. Amgen Form 10-K (fiscal year ended 2015).

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biosimilar5 to the reference product; OR (2) is demonstrated to be interchangeable6 with the reference product by meeting the standards described in § 341(k)(4).

(ii) The applicant consents to inspection of the facility. (d) Exclusivity:

(i) No approval of biosimilar until 12 years after the licensing of the reference product. Biosimilar application may not be sub-mitted until 4 years after licensing of reference product.

(ii) Exclusivity granted for first interchangeable biosimilar.7 (e) Patent Dance Statutory Timeline8

5. Biosimilar Definition: Biosimilarity means that the biological project is (i) “highly

similar to the reference product notwithstanding minor difference in clinically inactive components” and (ii) does not contain any “clinically meaningful differ-ences between the biological product and the reference product in terms of safety, purity, and potency.” 42 U.S.C. § 262(i)(2) (2012). FDA guidance to industry on biosimilarity is available at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf.

6. Interchangeable Definition: (i) The biological product is biosimilar to the reference product; (ii) It can be expected to produce the same clinical result as the reference product in any given patient; and (iii) For a product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the produce and its reference product is not greater than the risk of using the reference product without such alternation or switch.

7. 42 U.S.C. § 262(k)(6). 8. (1) Within 20 days after the FDA has accepted its abbreviated application, the bio-

similar applicant must provide the reference product sponsor with confidential access to the biosimilar application and relevant manufacturing information for the proposed biologic.

(2) Within 60 days of receiving these materials, the reference product sponsor must provide to the biosimilar applicant: (1) a list of patents it believes are infringed, and (2) identify which, if any, of these patents it would be willing to license to the biosimilar applicant.

(3) Within 60 days of receipt of the patent list, the biosimilar applicant must pro-vide the reference product sponsor a statement describing, on a claim-by-claim basis, the factual and legal basis as to why each patent is invalid, unenforceable, and/or not infringed.

(4) Within this same 60 day period, the biosimilar applicant may provide to the reference product sponsor a counter list of patents that the biosimilar appli-cant believes could be subject to a claim of patent infringement.

(5) Within 60 days of receiving these materials, the reference product sponsor must provide a reciprocal statement describing, on a claim-by-claim basis, the

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(f) Key Cases Interpreting the BPCIA: (i) Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015)

(1) In Amgen, the Federal Circuit held that the patent dance was not necessary; instead, a patent infringement suit is the sole relief available where an applicant chooses not to dance.

(2) Under Amgen, an applicant may only give its 180-day notice of commercial marketing after the FDA has approved its product.

(3) In January 2017, the Supreme Court granted Sandoz’s petition for cert and Amgen’s cross-petition

(4) Sandoz’s petition asked the Supreme Court to review the Federal Circuit’s interpretation of the “notice of commer-cial marketing” provision

(5) Amgen’s cross-petition asked the Supreme Court to review the holding that the patent dance is optional

(6) The Solicitor General filed a brief before the Supreme Court granted cert, siding with Sandoz on the merits of both issues

(ii) Amgen v. Apotex, 827 F.3d 1052 (Fed. Cir. 2016) (1) Notice of commercial marketing effective only after FDA

licensing, even where applicant performed patent dance (2) Notice provision is enforceable by injunction

factual and legal basis that each patent will be infringed, as well as a response to any statement regarding validity and enforceability.

(6) The parties then have up to 15 days to negotiate in good faith to arrive at a list of patents, if any, that should be subject to a patent infringement action. (A) If the parties reach agreement, then the reference product sponsor must

bring an infringement action within 30 days for each patent on the nego-tiated list.

(B) If the parties do not reach agreement, the biosimilar applicant must notify the reference product sponsor of the number of patents it will provide in a second list, and the parties then simultaneously exchange within 5 days of this notice a list of patents that each party believes should be the subject of the infringement litigation. Within 30 days after this exchange, the reference product sponsor must bring an infringement action on all the patents on the simultaneously exchanged lists.

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(3) Supreme Court denied cert in December 2016, but it could address these issues in Amgen v. Sandoz—especially con-sidering that the Supreme Court granted Apotex’s motion for leave to file a brief as amici curiae in that case

(iii) Amgen v. Sandoz, No. 2:16-cv-01276 (D.N.J. 2016) (1) Amgen sought a declaratory judgment that Sandoz vio-

lated the BPCIA by refusing to participate in steps of the patent dance.

(2) Sandoz later reengaged in the patent dance, and the com-plaint was dismissed.

(iv) Amgen v. Hospira, No. 1:15-cv-00839 (D. Del. 2016) (1) The District Court held that specific manufacturing infor-

mation regarding Hospira’s proposed biosimilar need only be produced if it relates to claims already asserted

(2) An appeal is pending with the Federal Circuit, considering (1) whether the Federal Circuit has jurisdiction to review discovery orders; and (2) whether the ruling on discov-ery runs afoul of the Federal Circuit’s guidance in Amgen v. Sandoz that an RPS “can access the required infor-mation through discovery” in an infringement suit if appli-cants do not make disclosures under BPCIA

(g) Key Biosimilar Challenges: (i) Amgen v. Apotex, No. 15-cv-61631 (S.D. Fla.) (Neulasta® (peg-

filgrastim) and Neupogen® (filgrastim); decrease infection in patients receiving anti-cancer drugs) (1) First final judgment and trial under the BPCIA (2) After a bench trial in July 2016, the District Court found

all claims not infringed (3) Federal Circuit appeal pending on judgment of non-

infringement (4) The patent-at-issue is also the subject of a pending IPR

petition (ii) Janssen v. Celltrion, No. 1:15-cv-10698 (D. Mass.) (Remicade®

(infliximab); rheumatoid arthritis and other autoimmune disease) (1) First jury trial under the BPCIA set for February 2017

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(2) District Court entered partial final judgment of invalidity for double patenting on one of the two patents-in-suit

(3) Federal Circuit appeals pending on District Court judg-ment of double patenting and ex parte reexamination ruling finding patent invalid for double patenting

(4) Pfizer announced intention to launch its biosimilar Inflectra® at-risk by November 2016

(iii) Amgen v. Hospira, No. 1:15-cv-00839 (D. Del.) (Epogen®/ Procrit® (epoetin alfa); anemia) (1) Jury trial set for September 2017 (2) Hospira’s disclosure of manufacturing information during

patent dance at issue in pending Federal Circuit appeal, discussed above

(3) Court denied Hospira’s motion to dismiss Amgen’s request for declaratory judgment that Hospira’s pre-approval notice of commercial marketing is legally ineffective

(4) Hospira’s biosimilar is not yet approved (iv) Amgen v. Sandoz, Nos. 3:14-cv-04741, 3:16-cv-02581 (N.D.

Cal.) (Neulasta® (pegfilgrastim) and Neupogen® (filgrastim)) (1) Jury trial set for December 2017. (2) Sandoz’s conduct during patent dance for biosimilars to

these RPs was at issue in the D.N.J. case and the pending Supreme Court case, discussed above.

(3) One of Sandoz’s biosimilars, Zarxio®, was the first bio-similar approved by the FDA and is on the market. The other biosimilar is not yet approved.

(v) Immunex v. Sandoz, No. 2:16-cv-1118 (D.N.J.) (Enbrel® (entanercept); rheumatoid arthritis and other autoimmune diseases) (1) Bench trial set for April 2018; Markman hearing set for

February 2017 (2) Sandoz agreed to Immunex’s patent list and waived its

right to receive statement on infringement/validity, alleg-edly asserting that the patent dance was complete and that Immunex must bring suit within 30 days

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(3) Sandoz’s biosimilar Erelzi® is approved, but Sandoz stip-ulated not to launch its product before a date that is not public

(vi) AbbVie v. Amgen, No. 1:16-cv-00666 (D. Del.) (Humira® (ada-limumab); rheumatoid arthritis and other autoimmune diseases) (1) Bench trial set for November 2019 (2) Amgen identified 61 patents infringed by AbbVie, which

the parties narrowed to 10 patents for this First Wave litigation

(3) Amgen’s biosimilar Amjevita® is approved, but Amgen asserted in its answer that it will not launch its products for 180 days after approval

(h) Potential New Biosimilar Litigation – FDA Filings (i) FDA accepted for review Samsung Bioepis/Merck’s aBLA

for biosimilar to Remicade® (ii) FDA accepted for review Coherus Biosciences’ aBLA for bio-

similar to Neulasta® (iii) Mylan/Biocon submitted aBLA for biosimilar to Herceptin® (iv) Amgen/Allergan submitted aBLA for biosimilar to Avastin®

(i) Conclusions: Bounds of BPCIA are Relatively Unsettled (i) Supreme Court could provide clarity in its first chance to review

BPCIA requirements (ii) Threat of repeal of the BPCIA by the new administration adds

more uncertainty

3. FUTURE OF REVERSE PAYMENT SETTLEMENTS IN ANDA CASES

(a) Reverse Payment Settlements Disfavored (i) Under Federal Trade Commission v. Actavis, reverse payment

pharmaceutical patent settlements are not categorically immune from antitrust laws even when within the scope of the patent. Instead, courts must apply the “rule of reason” to determine whether antitrust laws under the Sherman Act are violated.

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(b) Recent Circuit Case Law (i) In re: Nexium® (Esomeprazole) Antitrust Litigation (1st Cir.

2016) (1) Affirmed first jury verdict on pharmaceutical company

settlements since Actavis. (2) Found antitrust violation in reverse payment but no injury,

because the retailers had not shown that Ranbaxy could have launched its generic sooner.

(3) Petition for rehearing and rehearing en banc denied in January 2017.

(ii) In re Loestrin 24 Fe Antitrust Litigation (1st Cir. 2016) (1) Holding Actavis controls a settlement agreement which

allows delayed entry of a generic in return for favorable promotional deals and the brand maker’s promise not to introduce a generic.

(iii) King Drug Co. of Florence, Inc. v. SmithKline Beecham Corp. (3d Cir. 2015) (1) Holding consideration in the form of an agreement by

the brand not to launch an “authorized generic” during the generic’s 180-day exclusivity period can be a reverse pay-ment under Actavis

(2) Petition for cert denied in November 2016 (c) Statistics Following Actavis9

(i) 21 final settlements potentially involving pay for delay because they contain both (i) explicit compensation from a brand man-ufacturer to a generic manufacturer and (ii) a restriction on the generic manufacturer’s ability to market its product in compe-tition with the branded product.

9. Press Release, FTC Report on Drug Patent Settlements Shows Potential Pay-for-

Delay Deals Decreased Substantially in the First Year Since Supreme Court’s Actavis Decision (Jan. 13, 2016), https://www.ftc.gov/news-events/press-releases/ 2016/01/ftc-report-drug-patent-settlements-shows-potential-pay-delay (most recent report from FTC, covering settlements from FY 2014).

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(1) These 21 potential pay-for-delay settlements involve 20 different branded pharmaceutical products with combined annual U.S. sales of approximately $6.2 billion.

(2) Ten include compensation solely in the form of cash (with nine purportedly covering litigation fees and one in the form of debt forgiveness) ranging from $35,000 to $5 million.

(3) Six include compensation in the form of a side business deal.

(4) Five include compensation in the form of a brand manu-facturer’s promise not to market an authorized generic in competition with the generic manufacturer’s product for some period of time.

(ii) 111 of the 160 final settlements restrict the generic manu-facturer’s ability to market its product but contain no explicit or possible compensation.

(d) Two Cases in the Third Circuit May Clarify Pleading Standards (i) In re: Wellbutrin XL Antitrust Litigation, Nos. 15-2875 15-3559,

15-3591, 15-3681, and 15-3682 (1) Deal allowed patent dispute to continue and generics mak-

ers to launch products either whenever the generics makers prevailed in the patent suit or by a set date

(ii) In re: Effexor XR Antitrust, No. 15-1342 (1) “No-authorized generic” deal

(e) President-elect Trump’s appointees may signal relief on pay-for-delay policy: (i) Selected former FTC commissioner Joshua Wright to lead the

transition on antitrust and the FTC (ii) Wright has criticized the FTC’s approach to pay-for-delay set-

tlements and suggested he would take a more conservative approach

(f) Conclusions: Available reverse payment settlements: (i) Payments for reimbursement of attorneys’ fees; and (ii) Settlement allowing early entry by the generic without any

payment.

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(iii) N.B. Variations of both of these scenarios may give rise to antitrust scrutiny

4. FACTS & STRATEGIES FOR LIFE SCIENCES IPRs

(a) Life Sciences IPRs Are Growing More Common (i) Over 530 life sciences IPRs have been filed in total since the

post-grant opposition procedures took effect.10 (ii) ~170 of these life sciences IPRs were filed in 2016, and ~190

were filed in 2015.11 (iii) 94% filed by pharmaceutical and biological companies (iv) 6% filed by hedge funds

(1) Nearly all filed by Coalition for Affordable Drugs (hedge fund created by Kyle Bass).

(2) Only three successful challenges from Bass: (A) Shire’s patent covering Gattex®; on appeal in the

Federal Circuit (B) Two Celgene patents covering three Orange Book

Drugs: Thalomid®, Pomalyst®, and Revlimid®; requests for rehearing pending

(3) Last IPR filed by Bass in Sept. 2015. (4) Federal Circuit precedent requiring standing for IPR

appeals may further discourage petitions from hedge funds. See Phigenix, Inc. v. Immunogen, Inc., No. 2016-1544 (Fed. Cir. Jan. 9, 2017).

(b) Conclusions (i) Life sciences IPRs are heating up. (ii) Hedge funds are not dominating life sciences IPRs in general;

Kyle Bass has been the prime driver behind hedge fund initiated life sciences IPR petitions.

10. Data on challenges to TC 1600 patents compiled by the USPTO, https://ptabtrials.

uspto.gov/prweb/PRWebLDAP2/HcI5xOSeX_yQRYZAnTXXCg%5B%5B*/!STANDARD?UserIdentifier=searchuser (last visited Dec. 21, 2016).

11. Id.

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(iii) Statistics show that life sciences IPRs are less likely to be instituted and claims, once instituted, are more likely to survive.

5. RECENT KEY LIFE SCIENCES CASES

(a) U.S. contributions to Global Life-Sciences Innovation.12 (i) Ranked first in contributions to global life-sciences innovation. (ii) Between 1997 and 2012, more than half of the intellectual prop-

erty related to the world’s new medicines was invented in America.

(iii) In the 2000s, U.S. biopharmaceutical companies introduced more new chemical entities than companies from the next five nations combined.

(b) Recent judicial decisions on § 101 may alter this trend (i) Mayo Collaborative Services v. Prometheus Laboratories, Inc.

(2011) (1) Prometheus Laboratories patented a method for optimiz-

ing treatment of certain gastrointestinal diseases by meas-uring the medicine’s effect on the body and adjusting the amount administered based on the medicine’s known interaction with the body.

(2) Under § 101, a process which merely applies a natural law without more is patent ineligible. If a patent is directed to an abstract idea, it must contain some inventive concept in the application of that idea to become patentable.

(ii) Association for Molecular Pathology v. Myriad Genetics (2013) (1) Myriad patented isolated forms of the BRCA1 and BRCA2

genes and certain mutations that indicate a high risk of developing breast cancer. Association for Molecular Pathology along with several other medical associations sued arguing these genes were unpatentable under § 101 as products of nature.

12. J. John Wu & Stephen J. Ezell, How National Policies Impact Global Biopharma

Innovation: A Worldwide Ranking, INTF (April 2016), http://www2.itif.org/2016-national-policies-global-biopharma.pdf?_ga=1.38927467.953023900.1461265513.

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(2) Under § 101, naturally occurring gene sequences and their natural derivative products are not patent eligible. Gene sequences refined by synthetic processes to create mole-cules that do not occur naturally, however, are patent eligible.

(iii) Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015) (en banc) (1) Sequenom patented methods of making a prenatal diag-

nosis based on non-invasive testing using cell free fetal DNA. The method of DNA testing was well known in the art; however, the discovery that cell free fetal DNA could be tested was not.

(2) The Federal Circuit held that under § 101, the application of a well-known method for a new purpose was insuffi-cient to supply the inventive concept required under the Mayo-Alice framework.

(3) In his concurrence, Judge Lourie warned that “a crisis of patent law and medical innovation may be upon us.”

(4) Supreme Court denied cert in June 2016. (iv) Genetic Technologies Ltd. v. Merial LLC (Fed. Cir. 2016)

(1) Genetic Technologies patented a method of analyzing sequences of genomic DNA by amplifying the exon DNA and then analyzing the linked intron region. The methods of analysis and amplification were well known in the prior art; the linkage between the exon and intron regions was not.

(2) The Federal Circuit held that under Mayo, Alice, and Ariosa, this using a well-known method in a new context based on a recent scientific discovery was insufficient to add the inventive concept required to satisfy § 101 patent eligibility.

(v) Rapid Litigation Management LTD v. Cellzdirect, Inc. (Fed. Cir. 2016) (1) The patents covered a method of an improved process of

preserving hepatocytes (liver cells). (2) The Federal Circuit reversed the district court’s finding

of patent ineligibility in the first eligibility finding since

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Alice on claims relating to a “law of nature” or “natural phenomenon.”

(3) The Federal Circuit held that claims were not directed to ineligible law of nature, but rather “a new and useful laboratory technique.” Further, the claims reflected a “sig-nificant” improvement that was not routine or conven-tional given unpredictability in field.

(c) Recent judicial opinions at the district level signal the situation Judge Lourie warned might ensue—but Cellzdirect and computer-based § 101 precedent suggest courts are tapping the brakes. (i) Bristol-Myers Squibb Co. v. Merck & Co., Inc., No. CV 15-560-

GMS, 2016 WL 1072841 (D. Del. Mar. 17, 2016) (Keytruda® (pembrolizumab)) (1) Bristol-Myers owns a patent directed to a method of treat-

ment using the body’s immune system via the PD-1 pathway.

(2) According to Merck, this is unpatentable because it claims the natural operation of the body’s immune system. Bristol-Myers responds that the patent adds the inventive step of administering a composition of anti-PD-1 anti-bodies to induce the immune response.

(3) The court denied the 12(b)(6) motion to dismiss upon find-ing that “[w]hen the factual allegations . . . [are] read in the light most favorable to [the plaintiff], there are . . . material factual disputes . . . .”

(4) Nonetheless, the court held that the patent failed step one of the Alice test “conclud[ing] that . . . the [patent] touches upon a natural phenomenon by using T cells to activate the immune system.”

(ii) Vanda Pharms., Inc. v. Roxane Labs., Inc. (D. Del. Aug. 26, 2016) (Sleet, J.) (FANAPT® (iloperidone)) (1) Patents include personalized medicine method claims

directed to diagnosing certain genetic polymorphisms and treating those with particular polymorphisms with spe-cific dosages of iloperidone

(2) The court entered judgment for the patentee after a bench trial, including a finding of patent eligibility

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(3) The court found that method of treatment claims were directed to laws of nature.

(4) However, drawing on Cellzdirect, the court held that “using this genetic test to inform the dosage adjustment recited in the claims was not routine or conventional” and passed step 2

(iii) Oxford Immunotec Ltd. v. Qiagen NV (D. Mass. Sept. 30, 2016) (Gorton, J.) (1) Patents include “kit” and “method” claims relating to

tuberculosis tests. “Kit” claims cover kits for diagnosing tuberculosis infection comprised of a specific panel of peptides, and “method” claims cover methods of using these kits in vitro.

(2) The court denied the 12(b)(6) motion to dismiss for both “kit” claims and “method” claims (overruling magistrate’s recommendation to grant motion as to “kit” claims)

(3) It distinguished “kit” claims from Myriad because “they are alleged to be chemically different than the naturally occurring amino acids.” “Method” claims survived as they “improve on the current testing methods for tuberculosis.”

(d) Recent Federal Circuit § 101 Precedent on Computer-Based Claims May Protect Life Sciences Patents (i) Cleveland Clinic Foundation v. True Health Diagnostics

LLC, No. 1-15-cv-02331 (N.D. Ohio Feb. 23, 2016) (1) Patented test for assessing cardiovascular disease risk by

analyzing inflammation of the blood vessels (2) The district court found three of four patents invalid under

§ 101 at motion to dismiss stage (and pleadings insuffi-cient for fourth patent)

(3) Appeal pending in the Federal Circuit (No. 16-1766), with the patentee drawing from arguments in McRO and BASCOM in addition to analogizing patent claims to Cellzdirect

(e) Takeaways on Subject Matter Eligibility (i) The weakened § 101 framework has deep effects on the life

sciences industry.

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(ii) Life sciences are particularly reliant on patent protection due to enormous innovation costs, long R&D timescale, relatively low cost of copying and, unlike most industries, the presence of both statutory and market incentives to copy.

(iii) Life sciences patents are more likely to resemble naked appli-cations of scientific discoveries.

(iv) Though the most recent cases suggest the trend is slowing, § 101 may still hinder U.S. contributions to medical innovations, and therefore global medical innovation.

(f) Recent Jurisdiction & Venue Caselaw (i) The Supreme Court declined to review the Federal Circuit’s

holding that a generic’s plan to nationally market a proposed drug is sufficient for personal jurisdiction in Acorda Thera-peutics, Inc. v. Mylan Pharms., Inc., 817 F.3d 755 (Fed. Cir. 2016).

(ii) In TC Heartland the Supreme Court may change the long-standing test that cases can be brought anywhere a defendant is subject to personal jurisdiction. TC Heartland LLC v. Kraft Food Brands Grp. LLC, No. 16-341.

6. RECENT CHANGES TO HATCH-WAXMAN ACT REGULATIONS

(a) The FDA issued new regulations, effective December 5, 2016: (i) New regulations apply to new NDAs, ANDAs, and 505(b)(2)

applications, and to existing submissions in certain circum-stances

(ii) NDA holders must provide specific use codes for their drugs that describe only the specific method of use claimed by the patent in the Orange Book

(iii) Third parties can challenge patent information in the Orange Book by submitting a written request to the FDA to dispute the accuracy or relevancy of patent information

(iv) Marketing notice requirement: First applicant is required to notify the FDA within 30 days of first commercial marketing, or risk losing some of the 180-day exclusivity

(v) NDA holders must submit “amendment to the description of the approved method(s) of use claimed by the patent [] within

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30 days of a decisions by the USPTO, or by a Federal District Court, the . . . Federal Circuit, or the U.S. Supreme Court that is specific to the patent and alters the construction of a method-of-use claim(s)” to avoid being considered late-listed

(b) Clarification on Availability of 30-Month Stay (i) Intention is to encourage NDA holders to move for preliminary

injunctions (“PI”) in advance of expiration of 30-month stay (ii) If a PI entered prior to expiration, the FDA will extend the stay

until the court decides infringement and validity (iii) If a court order requires termination of 30-month stay, the appli-

cation may be approved (iv) Voluntary agreement not to market will not have same effect

as a PI and will not require a stay beyond 30 months (v) Voluntary agreement consenting to approval will terminate

30-month stay (c) Paragraph IV Notice Letters

(i) A paragraph IV notice letter must be sent no later than twenty days after the defined postmarked date of a “paragraph IV acknowledgment letter” (as defined in regulations)

(ii) Paragraph IV recertifications are required after certain amend-ments, such as to indications or conditions of use or adding new strengths—and recertifications do not forfeit 180-day exclusivity

(d) Takeaways (i) Long due updates change responsibilities for both brand and

generic companies (ii) New regulations on specific use codes provide opportunities

for ANDA and 505(b)(2) applicants to target indications that do not infringe

(iii) Companies with pending submissions must carefully review new obligations

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