Proposed Amendment Bans IPRs for Generics and Biosimilars

https://www.hatch.senate.gov/public/_cache/files/7fda71ea-a175-4a93-9d62-d3bf801a70e9/EHF18270.pdf

https://www.hatch.senate.gov/public/index.cfm/releases?ID=4D895DB2-0F0C-4023-A2AB-7771166AFF00

Senator Orrin Hatch (R-UT), the Chairman of the Senate Republican High-Tech Task Force and co-author of the Hatch-Waxman Act, delivered the following remarks at the Senate Judiciary Committee hearing.  

Thank you, Mr. Chairman. I appreciate your efforts on this bill. As the co-author of Hatch-Waxman, I have a keen interest in ensuring that we have a well-functioning generic drug industry. For that to happen, generics need to be able to obtain access to samples so they can conduct the tests and research necessary to achieve bioequivalency. 

The CREATES Act has a laudable goal. But I don’t believe it strikes the right balance as currently written, and so I will be voting no today. In particular, I believe the damages cap in the bill far exceeds what is necessary to ensure adequate deterrence and could incentivize non-meritorious litigation.

I’d also like to take a moment to discuss the amendment I circulated. I’ve titled this amendment the Hatch-Waxman Integrity Act. 

I mentioned earlier that as the co-author of Hatch-Waxman, I have a keen interest in ensuring we have a well-functioning generic drug industry. Well, there are two sides to that coin. One is ensuring that generic companies are able to develop drugs. The other is ensuring that brand companies have sufficient protections in place to recoup their investments. It won’t do to give generics the ability to develop and market low-cost medications if brand companies don’t have the incentive to create those medications in the first place. And so Hatch-Waxman struck a careful balance, one that has endured for decades.

But it’s recently come to my attention that the inter partes review, or IPR, process that this committee created in the America Invents Act, and which I strongly support, is producing unintended consequences in the Hatch-Waxman context.  

IPR is a critical tool for fighting patent trolls and is of particular importance to the tech community. But it also threatens to upend the careful Hatch-Waxman balance by enabling two separate paths to attack a brand patent.  

First is Hatch-Waxman litigation, which contains numerous carefully calibrated requirements affecting timing, market exclusivity, and FDA approval. Second is IPR, which is a much blunter instrument than Hatch-Waxman and which contains none of the important industry-specific balancing features that come into play in Hatch-Waxman litigation.

I want to be clear that I strongly support IPR. But I do not support its use in a way that upends or eviscerates Hatch-Waxman.

And so I’ve circulated an amendment that would force a party that wishes to challenge a brand patent to choose: the party can file a Hatch-Waxman suit, which carries the benefits of being able to rely on the brand company’s safety and efficacy studies for FDA approval, or it can file an IPR proceeding, which is cheaper, faster, and easier to win. But it can’t do both.

My amendment would preserve Hatch-Waxman as the standard path for generic companies to challenge brand patents, while keeping IPR as an option in situations where other interests come into play. But it would prevent companies from using IPR to put added litigation pressure on innovators above and beyond what Hatch-Waxman already provides. And it would prevent a company that rightfully loses a Hatch-Waxman suit from getting a second bite at the apple. 

I would note as well that for purposes of symmetry, the amendment also applies to post-grant review and to biologics. It will not have any impact on the use of IPR by the tech community.

I won’t be offering my amendment today because it goes beyond the scope of CREATES. But I wanted to discuss it today because it touches on issues that tie back directly to the purpose of CREATES and because it will be a top priority for me during my remaining months in office.

IMRALDI™, Biogen’s Adalimumab Biosimilar Referencing Humira®, Is Launched in the European Union

https://www.nasdaq.com/press-release/imraldi-biogens-adalimumab-biosimilar-referencing-humira-is-launched-in-the-european-union-20181017-00050

Gilead AIDS Patent Question Before the Supreme Court

In the context of patent cases involving pharmaceutical products, does the “actual controversy” requirement of the Declaratory Judgment Act, 28 U.S.C. § 2201(a), require a party seeking to introduce a generic drug product to file an application for FDA approval of that generic drug product before it can file suit for declaratory relief for patent invalidity?

https://www.aidshealth.org/wp-content/uploads/2018/08/36429-cert-petition.pdf

REMICADE CELL CULTURE PATENT NOT INFRINGED SINCE THE SCOPE OF EQUIVALENTS COVERS THE PRIOR ART

Janssen Biotech, Inc. ("Janssen") alleged that the  Defendants Celltrion Healthcare Co. and Celltrion, Inc. (collectively, "Celltrion") and Hospira, Inc. ("Hospira"),  infringed U.S. Patent No. 7,598,083 (the "'083 patent"), under the doctrine of equivalents, by producing a biosimilar infliximab drug (Remicade biosimilar).  The '083 patent claims "a soluble composition, suitable for producing a final volume of cell culture media" with the following ingredients:

anhydrous CaCl2, 5-200 mg;

anhydrous MgCl2, 15-50 mg;

anhydrous MgSO4, 20-80 mg;

FeSO4.7H2O, 0.05-0.50 mg;

Fe(NO3)3.9H2O, 0.01-0.08 mg;

ZnSO4.7H2O, 0.40-1.20 mg;

ferric ammonium citrate, 0.04-200 mg;

KCl, 280-500 mg;

NaCl, 5000-7500 mg;

NaH2PO4.H2O, 30-100 mg;

Na2HPO4, 30-100 mg;

CuSO4.5H2O, 0.001-0.005 mg;

CoCl2.6H2O, 0.001-0.10 mg;

(NH4)6Mo7O24 4H2O, 0.001-0.005 mg;

MnSO4.H2O, 0.000070-0.0080 mg;

NiSO4.6H2O, 0.000025-0.0005 mg;

Na2SeO3, 0.004-0.07 mg;

Na2SiO3.9H2O, 0.02-0.4 mg;

SnCl2.2H2O, 0.000025-0.0005 mg;

NH4VO3, 0.0001-0.0025 mg;

D-Glucose, 500-8000 mg;

sodium pyruvate, 0.0-1000 mg;

sodium hypoxanthine, 0.0-20.0 mg;

glycine, 0.0-150 mg;

L-alanine, 0.0-150 mg;

L-arginine.HCl, 200-5000 mg;

L-asparagine.H2O, 40-250 mg;

L-aspartic acid, 20-1000 mg;

L-cysteine.HCl H2O, 25.0-250 mg;

L-cystine.2HCl, 15-150 mg;

L-glutamic acid, 0-1000 mg;

L-histidine.HCl.H2O, 100-500 mg;

L-isoleucine, 50-1000 mg;

L-leucine, 50-1000 mg;

L-lysine.HCl, 100-1000 mg;

L-methionine, 50-500 mg;

L-ornithine.HCl, 0-100 mg;

L-phenylalanine, 25-1000 mg;

L-proline, 0-1000 mg;

L-serine, 50-500 mg;

L-taurine, 0-1000 mg;

L-threonine, 50-600 mg;

L-tryptophan, 2-500 mg;

L-tyrosine.2Na.2H2O, 25-250 mg;

L-valine, 100-1000 mg;

d-biotin, 0.04-1.0 mg;

D-calcium pantothenate, 0.1-5.0 mg;

choline chloride, 1-100 mg;

folic acid, 1-10 mg;

i-Inositol, 10-1000 mg;

nicotinamide, 0.5-30 mg;

p-aminobenzoic acid, 0.1-20 mg;

riboflavin, 0.05-5.0 mg;

thiamine.HCl, 0.5-20 mg;

thymidine, 0-3.0 mg;

vitamin B12, 0.05-5.0 mg;

linoleic acid, 0.01-2.0 mg;

DL-α-lipoic acid, 0.03-1.0 mg;

pyridoxine.HCl, 0.5-30 mg;

putrescine.2HCl, 0.025-0.25 mg; and

ethanolamine.HCl, 2-100 mg.

The defendants moved for summary judgment of non-infringement on the grounds that Janssen's asserted scope of equivalents would ensnare the prior art. The ensnarement defense prevents the patentee from obtaining, under the doctrine of equivalents, coverage which he could not lawfully have obtained from the PTO by literal claims.

The court conducted a "hypothetical claim" analysis. The hypothetical claim analysis is a two-step process. First, the patentee must "construct a hypothetical claim that literally covers the accused device," which involves expanding the claim limitations to encompass the features of the

accused product.  Second, "prior art introduced by the accused infringer is assessed to determine whether the patentee has carried its burden of persuading the court that the hypothetical claim is patentable over the prior art."

Celltrion did not assert that the hypothetical claims would have been anticipated, but only that they would have been obvious.  In performing an obviousness analysis, the court refused to do a lead compound analysis: “The Federal Circuit's statement that ‘[a] lead compound analysis is not required in analyzing obviousness of a chemical compound when, in the inventing process, there was no lead compound’ does not mean that the lead compound analysis is required whenever evidence shows an inventor or POSA would begin development with a particular composition or product.”

The first prior art relied on by the defendants disclosed a medium with 50 of 52 ingredients required by the hypothetical claims, and for those 50 shared ingredients, the concentration ranges disclosed in the reference partially overlap with the concentration ranges in the hypothetical claims. Similarly, the second reference relied on by the defendants combined 47 of 52 ingredients required by the hypothetical claims, and for those 47 shared ingredients, 46 had partially overlapping concentration ranges.

The two claimed ingredients missing from the first prior art reference that are required by the hypothetical media are ferric ammonium citrate ("FAC") and ammonium metavanadate.  The five claimed ingredients missing from the second prior art reference were: FAC, ammonium metavanadate, manganese (II) sulfate monohydrate, sodium selenite, and tin(II) chloride dehydrate. With respect to the ingredients required by the hypothetical claims that are not disclosed in the references, it was undisputed that the media disclosed in these references contained alternative, previously-known ingredients that were known to provide the same active components as the claimed ingredients, For example, the first reference did not contain Ferric Ammonium Citrate, but had the alternatives ferric fructose and ferric citrate.

Furthermore, “For those 50 ingredients required in the hypothetical media that were previously disclosed in the first reference medium, all of the concentration ranges of the hypothetical claims overlap at least partially with the concentration ranges listed in the reference.”

Janssen argued that because the prior art discloses amounts of each ingredient that overlap only partially with the claimed concentration ranges, the non-overlapping portions constitute differences between the prior art and the hypothetical media that make the latter nonobvious. The court disagreed, stating that “the Federal Circuit has held in a series of cases that partially overlapping concentration ranges establish a prima facie case of obviousness.”

The court held that the "defendants are entitled to summary judgment of non-infringement of

the '083 patent because Janssen has not produced sufficient evidence to prove that the scope of equivalents would not ensnare the prior art."

 1:17-cv-11008 Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. et al.