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ips signaled that collision was seeking a return to the federal circuit s pre ebay practice of near automatic injunctions once infringement is found his analysis suggested that collision was being disingenuous in arguing that public interest was the only barrier to an injunction and would also always favor injunctive relief as he put it collision s briefing seems to say heads i win tales you lose judge gilstrap s decision in collision communications v samsung shows just how difficult it is for a non practicing patentee to obtain injunctive relief even with the weight of the department of justice s thumb on the scale on two of the ebay factors all patentees must carefully now weight how their arguments on liability and damages will affect their chance for injunctive relief for a non practicing entity the scales are far more delicately balanced the opinion is carefully worded relying on factual showings rather than the legal absolutes proposed by the parties which makes it less susceptible to reversal on appeal all in all the decision will likely push other non practicing entities back toward putting their eggs in the liability and damages basket if collision cannot get a permanent injunction in this case it will be nearly impossible for a non practicing entity to obtain that relief without the government standing behind it 1 https patentdocs org 2026 03 05 uspto and doj statement of interest in collision communications another thumb on the scale in favor of npe patent plaintiffs united states files statement of interest in patent infringement proceedings may 28 2026 by kevin e noonan the united states recently filed a statement by the antitrust division of the department of justice under the provisions of 28 u s c 517 regarding the interests of united states in pending suits in corteva agriscience llc pioneer hi bred international and agrigenetics inc v inari agriculture inc and inari agriculture nv pending in the district of delaware the statement references the government s concerns with the agricultural sector of the economy citing department of justice competition and agriculture at 6 13 14 23 may 2012 and department of justice antitrust enforcement and agriculture aug 20 2002 the subject matter of this litigation is the seed industry which is highly concentrated with formidable market entry barriers as ongoing consolidation has resulted in a global seed industry dominated by just a few companies the government asserts citing u s department of agriculture more and better choices for farmers promoting fair competition and innovation in seeds and other agricultural inputs at 11 march 2023 usda report examples of this concentration cited in the statement are that according to usda estimates the top four firms bayer corteva chemchina and basf hold 84 of the corn market and 79 of the soybean market elsewhere estimated at 95 and 84 respectively citing usda economic research service concentration and competition in u s agribusiness economic information bulletin no 256 at 11 june 2023 concentration and competition report the issues provoking the government s interest involve corteva s ip rights and the extent of disclosure by patentee under ariad pharm inc v eli lilly and co 598 f 3d 1336 1353 54 fed cir 2010 en banc written description through deposits of its patented seeds with the american type culture collection atcc the statement asserts that t he boundaries of permissible conduct for the public to access and read claimed patented material must be carefully policed to prevent the ip laws from being misused to blunt rather than foster innovation for nascent companies there is a legitimate need for them to accurately identify the extant products and the parameters of the ip protection held by their larger competitors the statement asserts the nature of seeds and plant varieties prevents patents and patent applications to readily provide this information i e by simply reading a patent specification according to the statement leading to the filing of the statement the statement goes on to set forth the need for deposits to satisfy the written description and enablement provisions of 35 u s c 112 a under certain circumstances and for some inventions under the provisions of the budapest treaty on the international recognition of the deposit of microorganisms for the purposes of patent procedure these include biological materials such as seeds insofar as the material cannot reasonably be enabled by a description in written form and thus must instead be described in surrogate form by a deposit that is incorporated by reference into the specification citing enzo biochem inc v gen probe inc 323 f 3d 956 965 fed cir 2002 quoting 37 c f r 1 802 b this has become common practice for such inventions according to the statement citing ajinomoto co v archer daniels midland co 228 f 3d 1338 1345 46 fed cir 2000 this system has the added benefit in the government s view that u s companies can access biological material deposited in foreign depositories and vice versa to satisfy the requirements citing feldman v aunstrup 517 f 2d 1351 1355 56 c c p a 1975 under these circumstances the question arose can you infringe a patent merely by obtaining access to information in a biological deposit corteva sought on summary judgment to prevent disclosure of such biological deposit information by atcc the government s position is that the court should not deem any activity to constitute infringement if it is a means of accessing and reading biological material that the law requires be made publicly available in exchange for a valid patent or other ip protection in the context of atcc deposits corteva s objections run contrary to the provisions of 37 c f r 1 808 a 2 whereby all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent these provisions of the law and regulations rebut any allegations by corteva that access thereof by inari is without authorization and thus infringing under 271 the statement argues this is despite the reality that reading deposited biological materials requires something more specifically following the appropriate techniques to excise the patented material from the deposit s under 37 c f r 1 802 b as provided in enzo biochem inc v gen probe inc 323 f 3d 956 965 fed cir 2002 this is so because to do otherwise would prevent the public from receiving meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time emphasis in statement the statement faults corteva for recognizing the beneficial effects of depositing for protecting its patent rights but ignoring the concomitant public benefit from its disclosure to permit the scope of those rights to be appreciated and the statement notes that regulations require that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent the access inari demands are part of all those restrictions according to the government the statement also recognizes that there can be a requirement for a certain process be followed for public provision of the material emphasis in statement but these should not constitute contractual extra statutory encumbrances imposed by patent holders or the depository in a footnote the statement somewhat ironically says m ost of the filings in this case are under seal and the united states has no access to them supreme court oral argument in hikma v amarin may 26 2026 by kevin e noonan on april 27 the supreme court heard oral argument in hikma v amarin with charles klein representing hikma michael huston representing amarin and malcolm stewart addressing the court on behalf of the government first some statistics charles klein was questioned by the fewest justices justices thomas sotomayor and jackson while malcolm stewart and michael huston were each questioned by seven of the justices justices thomas alito sotomayor kagan kavanaugh jackson and chief justice roberts questioning stewart and justices thomas alito kagan gorsuch kavanaugh barrett and jackson questioning huston in his argument to the court mr klein emphasized that hikma s public statements entirely consistent with selling skinny label generic drug products under section viii cannot actively induce infringement which requires a clear message that necessarily promotes infringement moreover a ctive inducement cannot depend on whether doctors might read infringing instructions into product descriptions that on their face are entirely consistent with non infringing use he concluded these remarks by warning that under the decision below patent lawsuits filed after skinny label product launches will routinely survive a pleading challenge justice thomas began by asking whether it would have been safe for hikma to have said that its generic version of vascepa was approved solely for the severe hypertriglyceridemia sh indication while responding to the question mr klein stated that the earliest press releases did make such statements but that they were not required under the law the justice then asked whether hikma would have been baiting people into inducement had they merely quoted amarin s comments regarding its indications for the drug which mr klein conceded could support a claim if it s a clear message that necessarily promotes infringement the justice concluded his questioning by asking whether the only way to actively induce infringement is overstating or your own statements sound as though the patented use is covered by your product to which mr klein responded by saying that if the generic basically adopts by reference statements by the brand that would encourage the infringing use then that could plausibly state a claim justice sotomayor asked whether hikma was advocating any special rules for section viii cases mr klein responded that the complaint does not pass the standard for plausibility under twombly and iqbal and thus special rules are not necessary the justice noted that such rules are almost impossible in this area because determining whether or not there s active inducement is always contextual the justice further noted that it seems hikma wants the court to change the words the court has used in earlier cases but asks whether hikma wants the court to change the standards for finding inducement mr klein responded that there are obvious alternative explanations in view of the anodyne statements made by hikma and thus there is no need for a change in standards justice jackson the last justice to question hikma s counsel asked for clarification that generics have to have a label that essentially in all relevant circumstances mirrors the brand label except for just admitting the patented indication is that correct and that even if amarin is right that it thinks hikma could have or should have excluded a certain study or included some other information if those aren t on the original label hikma can t do that mr klein assured the justice that a generic can t add new disclaimers or new labeling in her follow up the justice asked it can t be accused of inducing infringement by refusing to put things on the label that the brand didn t have right to which mr klein answered the statute doesn t require active discouragement of infringement expounding on his answer mr klein stated that under the decision below you can get fda approval of your skinny product label but as soon as you put that product into commerce and you say anything about that product anything you call it a generic version even if you have disclaimers you can be sued as a consequence o nce a generic launches its product its profits will be much much lower than the brand s profits and so if the generic gets hit for a lost profits damages award it s devastating something that has already happened in the gsk litigation against teva wherein teva got hit for hundreds of millions of dollars that dwarfed its actual profits mr stewart for the government first stated that while the label itself was not sufficient to get amarin past 12 b 6 in this case we think the court of appeals erred in giving any weight at all to the label he mentioned that t he contents of a hatch waxman skinny label are largely dictated by federal law and to treat the generic manufacturers compliance with those requirements as any evidence of intentional inducement to infringe would be wrong with regard to amarin s explanation regarding the other generic manufacturers included in press releases that amarin has not sued because they had expressed disclaimers that their product is not authorized for use to treat the cardiovascular cv indication mr stewart stated that it s a bedrock principle of inducement law that active inducement to infringe is required and t he question is not whether the defendant has adequately warned people away from infringement justice thomas again posed the first questions to counsel whether in our world not the federal circuit s world w hat would respondent have to have alleged to survive a motion to dismiss mr stewart responded that to identify statements or actions that had the clear purpose of causing others to infringe as something that the brand wanted to bring about and under grokster by clear expression or other affirmative steps taken to foster infringement is liable for the resulting acts of infringement by third parties the justice next asked about the effect of state mandatory substitution laws and mr stewart said that the difficulty of going after the direct infringer or getting the direct infringement to stop is not a justification for watering down inducement principles he suggested that amarin and similarly situated companies could urge state legislatures to take measures to prevent this from happening and that while branded drugmakers would not want to sue the doctors they could attempt informational campaigns to doctors and tell the doctors our product is the only one that is authorized to be used for the cv indication justice alito asked about the effects on hikma if they had not just said its drug is generic vascepa but went on to say that vascepa is approved to treat cardiovascular risks and the government s counsel responded that if it had said those two things in the same breath that you would have a pretty strong case of active inducement whereas responding to justice alito s follow up regarding statements that studies have shown that icosapent ethyl the active ingredient in our drug reduces cardiovascular risks mr steward said although probably closer to the line when hikma prepared its skinny label in conformity with the rules kind of the most obvious thing it took off of amarin s label was the indication at the beginning regarding the cv indication justice sotomayor asked the same question of you that i asked of petitioners counsel regarding whether the court need ed...
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