ANDA cases will hit decade low, suggests H1 2021 data

Despite US patent cases rising in the first half of 2021, it seems litigation over abbreviated new drug applications is set to hit a decade low.

Just under 100 (97) ANDA cases were filed in H1 2021, compared to 143 during the first six months of last year, representing a 47% drop. If matters are filed at the same rate for H2 2021, the courts will take in roughly 194 by the end of the year.

Docket Navigator, which provided this data to Managing IP, suggests that ANDA filings might rise slightly in the second half of this year, leading to a total of 214 cases filed by December 31.

Even if that more generous estimate turns out to be correct, it will be the smallest number of Hatch-Waxman cases filed in the past decade (since 242 were started in 2012).

Laura Masurovsky, partner at Finnegan in Washington DC, says this drop is likely a result of the COVID pandemic and its effect on the pharma industry, alongside regular business cycles of patents that cover pharmaceutical treatments available for generic challenge.

“We’re seeing a lifecycle of patents playing out in general,” she says. “This is creating a slowdown in ANDA filings by limiting the availability of products that can be challenged because of their patent expiration dates.”

Anthony Insogna, IP practice leader at Jones Day in San Diego, agrees, adding that ANDA cases are usually driven by the number of branded drugs available for challenge.

“It’s possible that the drop is just a result of fewer drugs coming off patent,” he says.

Under Hatch-Waxman (formally known as the Drug Price Competition and Patent Term Restoration Act), drugs companies can file ANDAs to use the safety and efficacy data of reference products for their own generic therapeutics.

In response to an ANDA filing, which is an artificial act of infringement, the reference product's patent owner (which is notified of the filing) can submit a suit to prevent the generic product from being commercialised.

Managing IP analysed data taken from the Docket Navigator database to determine the top plaintiffs, defendants and law firms at the district courts for ANDA cases in H1 2021. Readers should note that some of these law firms are also featured in our sister rankings publication, IP STARS.

Most of the ANDA cases for H1 2021 were filed in the District Court for the District of Delaware (59) and the District Court for the District of New Jersey (26). The two courts collectively took in 88% of all Hatch-Waxman matters filed as of July 1.

However, their share has so far decreased slightly compared to last year, when 99% of cases were filed in Delaware and New Jersey. The 12 cases that weren’t filed in those forums went to 10 other district courts, including the Western District of Texas (three), the District of Maryland (one) and the Northern District of West Virginia (one).

There hasn’t yet been a great migration of cases over to forums such as the District of Maryland as some predicted there might be earlier this year.

In November last year, the Court of Appeals for the Federal Circuit decided in Valeant v Mylan that acts of infringement pertaining to ANDA filings only occurred in districts where submission actions happened, not where generic therapeutics were likely to be distributed once launched.

The US Food and Drug Administration, to which ANDAs are submitted, is located in White Oak, Maryland.

Sarah Geers, partner at Jones Day in New York, says such a migration could still occur, but that pharma companies will probably wait to see how things play out in the courts before making the move.

“That’s still playing out in a few ongoing cases” she says. “Until litigants know exactly where that’s going to land, they’ll likely be conservative to preserve their 30-month stays – no one wants to stick their nose out on the issue yet.”

Masurovsky at Finnegan says she hasn’t changed her mind since Managing IP last wrote on this subject and still believes that litigants will keep going to Delaware and New Jersey because of the expertise those courts hold on ANDA matters.

Courtenay Brinckerhoff, partner at Foley & Lardner in Washington DC, adds that litigants' familiarity with these courts is probably also keeping them there. 

"Maryland would be a whole new ball park," she says. "Litigants wouldn't know the judges or the rules there anywhere near as well as they did in Delaware or New Jersey, so they wouldn't go there unless they had a substantive reason to do so."

Pfizer, which challenged the most ANDAs at the district courts in the first half of 2021, filed most of its cases in the District of Delaware. One matter was filed with the District of New Jersey against Aizant, and another was brought in the District Court for the Middle District of North Carolina against Synthon Pharmaceuticals.

Three of these cases concerned Pfizer’s rheumatoid arthritis therapy Xeljanz (tofacitinib), brought against Micro Labs, Zydus and Aurobindo. The rest involved the innovator company’s breast cancer treatment, called IBrance (palbociclib), against MSN Therapeutics, Synthon, Natco, Aizant and Sun Pharmaceutical.

The next most active Hatch-Waxman challenger was Warner-Lambert, a subsidiary of Pfizer, with nine cases, followed by Novartis (six) and Celgene (six).

Sunovion, Salix, Janssen, Bial and Bausch Health ranked joint fifth as plaintiffs in ANDA matters, all having filed five.

Aurobindo had more of its ANDAs challenged in the district than any other drugs company in H1 2021. Teva, Amgen, Astellas, Celgene, Pfizer, Covis, Hikman and Newron all brought cases against the India-based generics company in Delaware and New Jersey.

MSN and Lupin came joint runner up with seven cases filed against each of them, Dr Reddy’s was fourth (five), and Zydus, Teva, Mylan and Cadila all came in fifth (four).

Top 30 ANDA litigation plaintiffs and defendants in H1 2021
Rank	ANDA filer	Cases	Rank	Patent owner	Cases
1	Aurobindo Pharma	8	1	Pfizer	12
2	MSN Laboratories	7	2	Warner-Lambert	9
_	Lupin	7	3	Novartis	6
4	Dr Reddy's	5	_	Celgene	6
5	Zydus	4	5	Sunovion	5
_	Teva	4	_	Salix Pharmaceuticals	5
_	Mylan	4	_	Janssen	5
_	Cadila Healthcare	4	_	Bial	5
9	Sun Pharmaceutical	3	_	Bausch Health	5
_	Sandoz	3	10	Boehringer Ingelheim	4
_	Qilu Pharma	3	_	Azurity	4
_	Macleods	3	12	Vanda	3
_	Intas Pharmaceuticals	3	_	Supernus	3
_	Apotex	3	_	PBG Puerto Rico	3
_	Agila Specialties	3	_	Otsuka Pharmaceutical	3
_	Accord Healthcare	3	_	Merck	3
17	Torrent Pharma	2	_	CP Pharmaceuticals	3
_	Synthon Pharmaceuticals	2	_	Bayer	3
_	S&B Pharma	2	_	Astellas	3
_	Nexus Pharmaceuticals	2	_	Amgen	3
_	Micro Labs	2	21	Teva	2
_	Makro Technologies	2	_	Rempex Pharmaceuticals	2
_	Hikma Pharmaceuticals	2	_	Melinta	2
_	Handa Pharmaceuticals	2	_	KAI Pharmaceuticals	2
_	Fresenius Kabi	2	_	H Lundbeck	2
_	Eugia Pharma Specialities	2	_	Gilead	2
_	Aurolife Pharma	2	_	Eagle Pharmaceuticals	2
_	ANI Pharmaceuticals	2	_	Cephalon	2
_	Amneal	2	_	Auspex Pharmaceuticals	2
_	Alkem Laboratories	2	_	AstraZeneca	2
_	Alembic Pharmaceuticals	2	_	Astex Therapeutics	2
_	Aizant Drug Research Solutions	2

Williams & Connolly has so far taken the lead for the number of ANDA cases it filed on behalf of clients – both for patent owners and overall.

The Washington DC-based firm filed 21 matters in the first half of 2021, only seven fewer than for the whole of 2020, putting it on track to be the most active ANDA firm by the end of 2021 ahead of Finnegan, Saul Ewing, Jones Day and other active firms.

Finnegan was the runner up with 16 matters under its belt, followed by Saul Ewing with 14, McCarter & English with 14 and Quinn Emanuel with 10.

Winston & Strawn kept its position as the top national firm representing ANDA filers, having acted for clients in six matters. The firm has been involved in considerably fewer cases than last year, when it filed 21 matters for the whole of 2020.

The drop supports the idea that the decrease in ANDA filings has been driven by a fall in the number of challengeable patents.

Stamoulis & Weinblatt, which is generally better known for representing non-practising entities in tech patent cases, came in second with five cases. Withers Bergman, Taft Stettinius & Hollister, Stone Conroy, Sterne Kessler, Schiff Hardin and Katten Muchin were joint third, each with three cases.  

Top 30 law firms for ANDA plaintiffs and defendants in H1 2021
Rank	ANDA filer law firm	Cases	Rank	Patent owner law firm	Cases
1	Winston & Strawn	6	1	Williams & Connolly	21
2	Stamoulis & Weinblatt	5	2	Finnegan	16
3	Withers Bergman	3	3	Saul Ewing Arnstein & Lehr	14
_	Taft Stettinius & Hollister	3	_	McCarter & English	14
_	Stone Conroy	3	5	Quinn Emanuel	10
_	Sterne Kessler	3	6	Gibbons	8
_	Schiff Hardin	3	7	Jones Day	7
_	Katten Muchin	3	8	Venable	5
9	Robins Kaplan	2	_	Latham & Watkins	5
_	Perkins Coie	2	10	Wilson Sonsini	4
_	Midlige Richter	2	_	Wilmer Cutler	4
_	Maddox Edwards	2	12	Sidley Austin	3
_	Locke Lord	2	_	Paul Weiss	3
_	Cozen O'Connor	2	_	Haug Partners	3
_	Cosner Youngelson	2	_	Covington & Burling	3
_	Carlson Caspers Vandenburgh & Lindquist	2	_	Arnold & Porter	3
17	Windels Marx Lane & Mittendorf	1	17	Mayer Brown	2
_	Upadhye Tang	1	_	Kirkland & Ellis	2
_	Steptoe & Johnson	1	_	Hogan Lovells	2
_	Smith Anderson Blount Dorsett Mitchell & Jernigan	1	_	Gibson Dunn	2
_	Sills Cummis & Gross	1	_	Fish & Richardson	2
_	Rothwell Figg Ernst & Manbeck	1	_	DLA Piper	2
_	Rivkin Radler	1	23	Winston & Strawn	1
_	Merchant & Gould	1	_	Thomas Combs & Spann	1
_	McNeeley Hare & War	1	_	Potomac Law Group	1
_	McAndrews Held & Malloy	1	_	Polsinelli	1
_	Leydig Voit & Mayer	1	_	O'Melveny	1
_	Kratz & Barry	1	_	Mullins Duncan Harrell & Russell	1
_	Husch Blackwell	1	_	Milbank	1
_	Hahn Loeser & Parks	1	_	Merchant & Gould	1
_	Greenberg Traurig	1	_	McDermott Will & Emery	1
_	Fox Rothschild	1	_	K&L Gates	1
_	Flaster Greenberg	1	_	Hahn Loeser & Parks	1
_	FisherBroyles	1	_	Goodwin Procter	1
_	Daignault Iyer	1	_	Frost Brown Todd	1
_	Connor Kudlac Lee	1	_	Foley & Lardner	1
_	Colella Zefutie	1	_	Fenwick & West	1
_	Capuano IP	1	_	Eversheds Sutherland	1
_	Bevelock & Fisher	1	_	Dorsey & Whitney	1
			_	Dechert	1
			_	Buchanan Ingersoll & Rooney	1
			_	Boies Schiller Flexner	1

Six attorneys from Saul Ewing, Williams & Connolly and McCarter & English came in joint first in the list of counsel representing patent owners in the most Hatch-Waxman cases: William Baton, Charles Lizza and Sarah Sullivan from Saul Ewing, Daniel Silver and Alexandra Joyce from McCarter & English, and David Berl from Williams & Connolly.

Williams & Connolly attorneys featured the most in the top 30, however, appearing 13 times.

Stamatios Stamoulis, a founding attorney of Stamoulis & Weinblatt in Delaware, took the top spot for the attorney representing the most ANDA filers, having managed all five of his firm’s cases.

Seven attorneys tied for runner up, including Steven Moore at Withers Bergman, Sharon Lin, Jovial Wong and Bryce Cooper at Winston & Strawn, Rebekah Conroy at Stone Conroy, and Lance Soderstrom and Deepro Mukerjee at Katten Muchin.

Top 30 attorneys for ANDA plaintiffs and defendants in H1 2021
Rank	ANDA filer attorney	Cases	Rank	Patent owner attorney	Cases
1	Stamatios Stamoulis, Stamoulis & Weinblatt	5	1	William Baton, Saul Ewing Arnstein & Lehr	13
2	Steven Moore, Withers Bergman	3	_	Sarah Sullivan, Saul Ewing Arnstein & Lehr	13
_	Sharon Lin, Winston & Strawn	3	_	David Berl, Williams & Connolly	13
_	Rebekah Conroy, Stone Conroy	3	_	Daniel Silver, McCarter & English	13
_	Lance Soderstrom, Katten Muchin	3	_	Charles Lizza, Saul Ewing Arnstein & Lehr	13
_	Jovial Wong, Winston & Strawn	3	_	Alexandra Joyce, McCarter & English	13
_	Deepro Mukerjee, Katten Muchin	3	7	Michael Xun Liu, Williams & Connolly	10
_	Bryce Cooper, Winston & Strawn	3	_	Kevin Hoagland-Hanson, Williams & Connolly	10
9	Todd Werner, Carlson Caspers	2	_	Christopher Mandernach, Williams & Connolly	10
_	Steven Maddox, Maddox Edwards	2	10	Seth Bowers, Williams & Connolly	9
_	Stephen Auten, Taft Stettinius & Hollister	2	_	Andrew Hoffman, Williams & Connolly	9
_	Richard Weinblatt, Stamoulis & Weinblatt	2	12	F Dominic Cerrito, Quinn Emanuel	8
_	Oren Langer, Robins Kaplan	2	13	Shaun Mahaffy, Williams & Connolly	7
_	Michael Gaertner, Locke Lord	2	_	James Monroe, Finnegan	7
_	Michael Meneghini, Winston & Strawn	2	_	Bruce Genderson, Williams & Connolly	7
_	Maureen Rurka, Winston & Strawn	2	16	Matthew Hertko, Jones Day	6
_	Maria Stubbings, Perkins Coie	2	_	Lauren Dowty, Finnegan	6
_	Marc Youngelson, Cosner Youngelson	2	_	Eric Stops, Quinn Emanuel	6
_	Kevin Warner, Winston & Strawn	2	_	Anthony Insogna, Jones Day	6
_	Jitendra Malik, Katten Muchin	2	_	Andrew Chalson, Quinn Emanuel	6
_	Jillian Schurr, Katten Muchin	2	_	Alexander Zolan, Williams & Connolly	6
_	Jeremy Edwards, Maddox Edwards	2	22	Ryan McDonnell, Finnegan	5
_	James Richter, Midlige Richter	2	_	Michael Kelly, McCarter & English	5
_	James Nealon, Withers Bergman	2	_	Meredith Boerschlein, Finnegan	5
_	Imron Aly, Schiff Hardin	2	_	Justin Hasford, Finnegan	5
_	Grace Tuyiringire, Sterne Kessler	2	_	Julie Tavares, Williams & Connolly	5
_	George Lombardi, Winston & Strawn	2	_	Jessamyn Berniker, Williams & Connolly	5
_	Dennies Varughese, Sterne Kessler	2	_	Jennifer Roscetti, Finnegan	5
_	Christopher Jones, Perkins Coie	2	_	Elise Baumgarten, Williams & Connolly	5
_	Charles Klein, Winston & Strawn	2	_	Dov Grossman, Williams & Connolly	5
_	Brandon White, Perkins Coie	2	_	Danielle Pfifferling, Greenblum & Bernstein	5
_	Autumn Nero, Perkins Coie	2	_	Charles Collins-Chase, Finnegan	5
			_	Bryan Diner, Finnegan	5

Managing IP will publish a full-year analysis of district court ANDA litigation data for this year in early 2022.