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The ParagraphFour Report®

Overview ParagraphFour.com follows every Paragraph IV case, and it also includes 505(b)(2) cases, antibiotics, DESI designated products, BLA's (filed after 2012), and Inter Partes Reviews. The products are followed from PIV Certification through completion (from dismissal or settlement to Court of Appeals decision.) Our typical subscribers include generics and brand companies, formulation and discovery companies, API suppliers and brokers, law firms, and many from the investment community (research firms, investment banks, mutual funds, and hedge funds). ParagraphFour.com is not a "patent database." It includes patent data, but is comprehensive of the "Paragraph IV Market." As of January 2019, the database covers over 800 products and over 4,000 cases (and over 500 IPR proceedings), but, of course, these numbers are always growing.

Attached here is the Quarterly Note from January 2019, celebrating our 15 year anniversary. It provides a concise overview of the research philosophy and approach which you will find helpful as it provides context to the research and its real-world challenges. Quarterly Note 1Q19

Sample Information
To really see the depth and breadth of the databases contained in The Paragraph Four Report®, we strongly suggest that you contact us for a demonstration over the Web -- it takes about 20 minutes. No sales pitch involved, just the facts, answer a few questions, and you decide. The second best thing to see are samples of information. The following is just a SAMPLE of information that is provided by The Paragraph Four Report®. Note that the sample data is not necessarily kept up-to-date. The real data is updated weekly.

The contents of the Report break-down into two categories: (1) DATA and (2) ANALYSIS. In the future, as the issue matures, we will also be including a dedicated section to biogenerics.

CATEGORY 1: THE DATA
(A)PRODUCTS UNDER PIV CERTIFICATION All products listed that have PIV activity that is current, including all pending cases and generic applicants. New products added weekly. Here is a sample which provides the name of the product, annual sales, branded company, generic challenger (in this case one), case number and location, patents being challenged, judge, attorneys and update of what stage the litigation is in. It also includes any related PIV cases and Inter Partes Review petitions. Just about all of the cases include pleadings and opinions to download free. We also note when a product also has a pending citizen petition which are kept in our other publication FDAPetitions.com. When all activity is completed for a product, it is moved to the Old Cases section. Nothing leaves the database.

Aczone®(dapsone) Gel
Annual Sales $55M (as reported by Allergan)
Company ALLERGAN (ALMIRALL)
Date of First Filing February 13, 2017

Paragraph IV Applicant: Taro
Case Name: ALLERGAN INC. v. TARO PHARMACEUTICAL INDUSTRIES LTD
Court/Case #: Delaware District Court (dedc) 1:2017cv00663
Date Filed: 6/1/17
Judge: Bataillon
Product Strength: 7.50%
Litigated Patents (expiration): 9,517,219 (11/18/2033)
Non-Litigated Patents (expiration): 5,863,560 (9/11/2016); 6,060,085 (9/11/2016); 6,620,435 (9/11/2016); 9,161,926 (11/18/2033)
Plaintiff Lawyer/Firm: James Trainor/Fenwick West
Defendant Lawyer/Firm: Stephen Benson/Katten Muchin
Related Case: On 7/28/17, Allergan filed a second case against a different corporate entity Taro Pharmaceuticals (dedc 1:2017cv01048) (consolidated).
Status: The bench trial was scheduled 2/4/19 but was settled right before it began. Case dismissed 3/11/19.
Complaint Delaware ANDA Form Answer
'1048 Complaint Delaware ANDA Form Answer

Paragraph IV Applicant: Amneal
Case Name: ALMIRALL LLC v. AMNEAL PHARMACEUTICALS LLC
Court/Case #: Delaware District Court (dedc) 1:2019cv00658
Date Filed: 4/9/19
Judge: Stark
Product Strength: 7.50%
Litigated Patents (expiration): 9,517,219 (11/18/2033); 9,161,926 (11/18/2033)
Non-Litigated Patents (expiration): None
Plaintiff Lawyer/Firm: James Trainor/Fenwick West
Defendant Lawyer/Firm: Scott Bornstein/Greenberg Traurig
Related Case: None, but see the note below regarding IPR petitions Amneal had filed before this case was filed.
Status: Discovery; note the Answer added the '926 patent.
Complaint Delaware ANDA Form Answer

Special Notes: (1) On 2/12/18, Amneal filed a Petition for Inter Partes Review (18-00608) over the 9,161,926 patent. The Board instituted this IPR for review with oral argument scheduled 6/4/19. (2) On 11/6/18, Amneal filed a Petition for Inter Partes Review (19-00207) over the 9,517,219 patent.
Inter Partes Review Petition (18-00608) Preliminary Response (18-00608) Institution of Inter Partes Review (18-00608)
Inter Partes Review Petition (19-00207) Preliminary Response (19-00207)

Product Links from FDA and USPTO
Orange Book Patent & Exclusivity Data
'219 Patent
'560 Patent
'085 Patent
'435 Patent
'926 Patent

©2019 Parry Ashford Inc.

(B) REPORTS
All of the data is placed in easy-to-read Reports so that you can see which generic companies have filed against which products, which branded companies are defending which products, law firm representation list, and timing trend data. Of course, the Reports included every company, every product. These are just abbreviated samples

(1) Branded Companies Report All branded companies and their products under Paragraph IV challenge.
AstraZeneca -- 4...
Diprivan®(propofol) Injection
Entocort EC®(budesonide) Capsules
Farxiga®(dapagliflozin) Tablets
Faslodex®(fulvestrant) Injection

Bristol-Myers Squibb -- 3....
Monopril®(fosinopril)Tablets
Monopril HCT®(fosinopril and hydrochlorothiazide) Tablets
Plavix®(clopidogrel bisulfate) Tablets

(2) Generic Companies Report All generic companies and the products they have filed against.
Teva Pharmaceticals -- 8... (remember this is a sample; Teva, of course, has many more)
Aciphex®(rabeprazole sodium) Delayed Release Tablets
Allegra®(fexofenadine HCl) Tablets
Biaxin®(clarithromycin) Tablets
Effexor XR®(venlafaxine hydrochloride) ER Capsules
Lamictal CD®(lamotrigine) Chewable Tablets
Linzess®(linaclotide) Capsules
Suboxone®(buprenorphine and naloxone) Sublingual Film
Xeljanz XR®(tofacitinib) Extended-release Tablets

(3) Annual Trends A few trends are captured.

(4) Representation List All law firms of record listed.
Taft Stettinius Chicago
Alkem Laboratories
Apotex
Custopharm
Micro Labs
Qilu Pharmaceutical

(C ) MONTHLY UPDATES
Every month, we update the Monthly Update which includes (a) the new Paragraph IV certifications, (b) all of the new Paragraph IV cases filed, and (c ) Significant Case decisions. The Updates are archived. Every month, when the Update is posted, Subscribers receive an email with the highlights. Below is an excerpt from August 2017: (this is an excerpt, there were many other cases filed that month as well as court decisions.)

The Paragraph Four Report®
Paragraph IV Activity for August 2017

New Certifications as reported by FDA on August 7, 2017

1. Entereg®(alvimopan) Capsules 12mg on 6/16/2017
2. Absorica®(isotretinoin) Capsules 35mg on 11/25/2015
3. Absorica®(isotretinoin) Capsules 25mg on 5/16/2016
4. Namzaric®(memantine and donepezil) Extended Release Capsules 21mg/10mg on 9/23/2016
5. Namzaric®(memantine and donepezil) Extended Release Capsules 7mg/10mg on 9/26/2016
6. Byvalson®(nebivolol and valsartan) Tablets 5mg/80mg on 6/9/2017

Comments: While the Entereg®(alvimopan) product was the first time the molecule had received a PIV certification, the other products on the FDA PIV List have seen PIV activity in the past. The sole PIV case involving Absorica®(isotretinoin) resolved back in 2015, and PIV cases have already been filed over the dosage strengths of Namzaric®(memantine and donepezil).

New Cases Filed

1. Product: Humira®(adalimumab) Injection
Case: ABBVIE INC et al v. BOEHRINGER INGELHEIM INTERNATIONAL GMBH et al dedc 1:2017cv01065 08/02/2017
Comment: This BPCIA case is the second filed over Humira with the first against Amgen filed last year and which is in the discovery phase.

2. Product: Brilinta®(ticagrelor) Tablets
Case: ASTRAZENECA LP et al v. INVAGEN PHARMACEUTICALS INC dedc 1:2017cv01073 08/02/2017
Comment: This case adds a dosage strength to an existing dispute. There have been several cases filed over this product which are in the discovery phase.

3. Product: Syndros®(dronabinol) Oral Solution
Case: INSYS THERAPEUTICS INC et al v. ENDO GENERICS HOLDINGS INC et al dedc 1:2017cv01078 08/03/2017
Case: INSYS THERAPEUTICS INC et al v. ENDO GENERICS HOLDINGS INC et al nysdc 1:2017cv05955 08/07/2017
Comment: This case is the first filed in the defense of this product.

4. Product: Faslodex®(fulvestrant) Injection
Case: Fresenius Kabi USA LLC, Petitioner- Inter Partes Review 2017-01910 08/04/2017
Case: Fresenius Kabi USA LLC, Petitioner- Inter Partes Review 2017-01912 08/04/2017
Case: Fresenius Kabi USA LLC, Petitioner- Inter Partes Review 2017-01913 08/04/2017
Comment: These IPR filings follow several PIV cases and other IPR filings. Most of these have resolved by settlement.

5. Product: Ravicti®(glycerol phenylbutyrate) Oral Liquid
Case: HORIZON THERAPEUTICS LLC v. LUPIN LTD et al njdc 2:2017cv05900 08/08/2017
Case: HORIZON THERAPEUTICS LLC v. PAR PHARMACEUTICAL, INC 2:2017cv05901 08/08/2017
Comment: These cases add a recently issued patent to existing disputes which have been stayed for IPR proceedings.

6. Product: Lantus®(insulin glargine) Injection
Case: SANOFI-AVENTIS US LLC et al v. MERCK SHARP & DOHME CORP njdc 2:2017cv05914 08/08/2017
Comment: This case involves a second 505(b)(2) NDA Merck filed over this product. This NDA and PIV case involves a vial product while the prior NDA involves a cartridge product. This second case joins the first case which is in the discovery phase.

Significant Case Decisions and Activity

USPTO Board Finds Onglyza®(saxagliptin) Patent Valid On August 18, 2017, the Patent Trial and Appeal Board issued its Final Written Decision in an Inter Partes Review proceeding which hearing ended in January. Several ANDA filers had challenged the patentability of dozens of claims in the reissued patent RE44,186, and back in February, the Delaware District Court had concluded that the same patent was valid, overcoming claims of obviousness which ruling is currently on appeal. The patent also covers the combination with metformin Kombiglyze XR®. In this IPR proceeding, the petitioners similarly argued the claims were obvious considering the prior art. The Board disagreed, finding that the cited art did not render the claims obvious and that the results of the modification of the compound were unexpected. As such, the Baord concluded that the claims were patentable.

New Jersey District Court Finds Non-Infringement in Mucinex®(guaifenesin) Cases On August 22, 2017, the New Jersey District Court issued its Opinion in a case involving Amneal and Dr. Reddy’s and their formulations involving Mucinex®(guaifenesin) (Amneal) and Mucinex D®(guaifenesin and pseudoephedrine) ER Tablets (Dr. Reddy’s). The trial had ended in May, and essentially, the two patents (6,955,821 and 7,838,032) covered the product’s two-release formulation. In concluding neither ANDA filer infringed these patents, Judge Bumb found that each of their formulations are single formulation matrices. This ruling follows similar rulings made over the years in different jurisdictions over the Mucinex® family of products. The Court entered a Final Judgment.

Delaware District Court Finds Opana ER®(oxymorphone) Patent Valid On August 30, 2017, the Delaware District Court issued its Opinion after a trial ended in February against Actavis. This product has many PIV cases in two jurisdictions and prior rulings involving sevral patents. In this case, Judge Andrews found that several claims of patent 8,871,779 were valid, overcoming defenses of obviousness, anticipation and lack of written description. This ruling is consistent with a prior ruling. No Final Judgment was entered, and Endo had issued a press release in July regarding of the removal of the product from the market. However, several PIV cases and appeals still linger.


(D) NON-PARAGRAPH IV CASES
This is a List of patent cases filed between pharmaceutical companies that are filed under 505(b)(2) or otherwise a pharmaceutical patent cases. We add these as we run accross them, and they are not updated. Most of the Complaints are included.

(E) OLD CASES
When a Paragraph IV case is terminated (after November 1, 2003), it is moved to this section. It includes identical information as (A) above.

CATEGORY 2: THE ANALYSIS
As you can see, we provide context to the data. While that is a good thing, we have also added a great deal of analysis around the data which provides management tools. Analysis content makes up about 50% of the content in The Paragraph Four Report (data being the other half.) Below are samples of this. Of course, we cannot make this too revealing here...

(A) STATISTICS AND GRAPHS We have done extensive statistical analysis of the data which is updated quarterly. These are data analysis and tools that manage life-cycle decisiong. The statistics answer the following questions:
(1) How long do Pargraph IV cases typically last? Do some jurisdictions take longer than others?
(2) How soon after a product is approved will it receive a Paragraph IV certification? Is there a difference for novel compounds and follow-on compounds?
(3) What are the ranges of time for these events?

(B) PRODUCT WATCH
We have also analyzed the question of "What products are likely to receive a Paragraph IV filing in the next 6-9 months?" We have created a working model. An excerpt is included (without the actual rating.)

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(C ) CONTINUING EDUCATION
Confused about Paragraph IV issues or would you like in-depth analysis of current Paragraph IV issues? These modules include backround and analysis of the following issues. They also include down-loadable reference materials such as Citizen Petitions and Regulatory Documents. Topics currently covered:
(1) Authorized Generics
(2) The 180-day exclusivity
(3) Waiving the 180-day exclusivity
(4) The FTC Study
(5) Technical PIV Case Study
(6) Biosimilars
(7) Antibiotics Products
(8) Inter Partes Reviews

The Paragraph Four Report, ParagraphFour.com, and the PFOUR logo are registered trademarks of Parry Ashford Inc.

©2019 Parry Ashford Inc.
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The Paragraph Four Report®, ParagraphFour.com® and the PFOUR logo are registered trademarks of Parry Ashford Inc. • © Parry Ashford Inc. 2019