Entacapone, Levodopa, and Carbidopa – Belgium

On May 9, 2017, the Brussels court of commerce handed down its decision in the context of an infringement action initiated by Orion and its exclusive licensee Novartis against Belgian generic company Eurogenerics.

The proceedings relate to Orion’s European patent EP 1 189 608 (expiring on Jun 29, 2020), concerning an oral three-in-one solid composition of entacapone, levodopa and carbidopa, wherein a substantial portion of carbidopa is separated from entacapone and levodopa. On the basis of EP ‘608, Novartis commercializes the medicinal product Stalevo® used in the treatment of Parkinson’s disease. Eurogenerics obtained a marketing authorization for an alternative three-in-one formulation of entacapone/levodopa/carbidopa using Stalevo® as reference medicinal product. Novartis considers that the generic product of Eurogenerics falls under the scope of protection of EP ‘608 and therefore initiated an infringement action, based on either a literal infringement or an infringement by equivalence.

Although Eurogenerics contested the infringement of EP ‘608, it challenged its validity by way of a counterclaim. The Brussels court of commerce confirmed that EP ‘608 is invalid due to a lack of inventive step applying the problem-solution approach. As the combination of entacapone, levodopa and carbidopa was already disclosed in the prior art, in particular in one of Orion’s earlier patents, only the separation of carbidopa from the other two active substances claimed in EP ‘608 had to be assessed on its validity. The court noted in this regard that the separation of active substances was part of the prior art. The fact that such separation was only carried out when strictly necessary, does not imply that this process was exceptional, new or inventive. Considering the known chemical instability between levodopa, carbidopa and entacapone, a skilled person would have a clear incentive to separate one of the active substances in order to guarantee (and maintain) the chemical stability of the three-in-one formulation.

Finally court determined that, as a separation of carbidopa was an obvious choice any alleged unexpected therapeutic efficacy resulting from this separation could not render the invention inventive. Given the absence of a valid patent Eurogenerics could not infringe the invoked patent rights of Orion and Novartis.

Tadalafil – USA

On May 18, 2017 a Texas federal judge entered a $20 million judgment against Eli Lilly & Co. for infringing Germany-based company Erfindergemeinschaft UroPep’s patent. The ruling, which was handed down at the US District Court for the Eastern District of Texas Marshall Division, came after a jury verdict that Eli Lilly was liable for infringement.

The patent involved is US patent number 8,791,124 owned by UroPep. It covers treatment of prostatic disease and is titled “Use of phosphodiesterase inhibitors in the treatment of prostatic diseases.” UroPep sued Eli Lilly in July 2015, alleging infringement of patent ’124 based on marketing of Eli Lilly’s drug Cialis (Tadalafil) for benign prostatic hyperplasia (BPH). Asserted claim 1 of the '124 patent recites a method "for prophylaxis or treatment of benign prostatic hyperplasia comprising administering to a person in need thereof an effective amount of an inhibitor of phosphodiesterase (PDE) V," excluding certain specified compounds.

In a decision of Mar 03, 2017 Court denied all motions for summary judgment (invalidity based on anticipation, indefiniteness & non-infringement) requested by Eli Lilly. According to the ruling, the jury found that Eli Lilly failed to prove the patent invalid on grounds of anticipation, obviousness, lack of adequate written description, and lack of enablement.

Isosulfan blue - USA

On May 19, 2017 Federal Circuit upheld a preliminary injunction barring Aurobindo from selling a dye (isosulfan blue) used to map lymph nodes during a patent suit by Mylan, finding that while a lower court's decision was incorrect regarding two of the patents at issue, it was correct on one patent.

Aurobindo Pharma appeal from a decision of the United States District Court for the Eastern District of Texas granting Mylan and Apicore US LLC’s motion for a preliminary injunction precluding Aurobindo from making, using, selling, offering to sell, and importing the accused isosulfan blue (“ISB”) product that allegedly infringes three of Apicore’s patents—U.S. Patent 7,622,992 (“the ’992 patent”), U.S. Patent 8,969,616 (“the ’616 patent”), and U.S. Patent 9,353,050 (“the ’050 patent”). Apicore owns, and Mylan is the exclusive licensee of, the ’992, ’616, and ’050 patents. The ’992 and ’616 patents (together, “the process patents”) are directed to a process for preparing ISB. The ’050 patent (which the parties refer to as “the purity patent”) is directed to an ISB compound having a purity greater than 99.0%, as measured by HPLC.

Aurobindo sought FDA approval for a generic Lymphazurin®, informing the FDA that it had studied a “number of patents” describing ISB manufacture and selected, inter alia, Apicore’s ’992 patent, and that it “considered the process described [therein] for the initial sample preparation and further, the optimization of the process.” Aurobindo acknowledged to the FDA that it was looking for a reagent “other than silver oxide.” It eventually selected “manganese dioxide” and its process resulted in ISB with a 5–10% impurity which could not be removed by recrystallization. Instead, it used preparatory HPLC to achieve an ISB purity of greater than 99.5%. Mylan sued Aurobindo for infringement and sought a preliminary injunction, which the district court granted based on infringement under DOE & failed invalidity attack.

CAFC on appeal discussed each issue (DOE, Validity & Irreparable harm) in detail.

I. Process patents:

With respect to infringement of process patents under DOE court concluded that the district court’s analysis of equivalence in this case was flawed, no doubt because of the sparse and confusing case law concerning equivalents, particularly the paucity of chemical equivalence case law, and the difficulty of applying the legal concepts to the facts. Court said that this appeal is unusual in a first sense in that it arises from the grant of a preliminary injunction based on the doctrine of equivalents. Moreover, the law on the doctrine of equivalents as applied to chemical materials is not clear, and its misapplication can lead to unsound results. This appears to be such a case.

The district court here applied the “function-way-result” (FWR) test in evaluating the equivalence issue. CAFC concluded that district court’s analysis of the process claims under FWR was flawed by being unduly truncated and hence incomplete. The district court made a finding that silver oxide and manganese dioxide are “equivalent” in the context of the process patents, without considering the “way” prong of the FWR test without considering critical factors under that prong, namely, the relative oxidation strengths of silver oxide & manganese dioxide. The district court correctly evaluated the “function” aspect of the FWR test—deciding, in effect, that the function of the silver oxide was to oxidize the precursor isoleuco compound to ISB acid. But that is not considering the “way” the oxidation works. Manganese dioxide and silver oxide may have the same function, but the question is whether they operate in the same way. Critical facts that might be considered in an equivalents analysis include the relative oxidation strengths of the two oxidizing agents, as argued by Aurobindo, and the fact that manganese dioxide requires the use of an acid for oxidation, but silver dioxide does not, and results in a different yield. All of this in fact may at trial indicate a different “way.” Thus, there is room for sufficient doubt as to whether silver oxide and manganese dioxide oxidize isoleuco acid in the same way so as to satisfy the “way” prong of the FWR test. Accordingly, the district court erred in its equivalents analysis under FWR and we reverse its determination.

II.’050 Patent:

Federal circuit next considered whether the district court erred in finding that Aurobindo did not raise a substantial question as to validity of the ’050 patent. The preliminary injunction premised on the ’050 patent will stand unless Aurobindo raised a substantial question concerning the validity of the patent, or unless the court erroneously found irreparable harm. We find that the court did not err in either respect.

We have previously acknowledged that “a purified compound is not always prima facie obvious over the [prior art] mixture” if the process to arrive at the purified compound is itself of patentable weight (Aventis, 499 F.3d at 1301). Moreover, if the prior art teaches a mixture containing a compound but does not enable its purification, then the purified form of the compound may not have been obvious over the prior art mixture. See, e.g., Spectrum Pharm., Inc. v. Sandoz Inc., 802 F.3d 1326, 1335–36 (Fed. Cir. 2015).  It is clear from the record here that, although ISB was known in the prior art, the path to arrive at ISB with a purity of greater than 99.0% was not known before the relevant date of the ’050 patent. Thus, we see no error in the court’s legal analysis or its factual findings pertaining to validity of the ’050 patent, particularly at the preliminary injunction stage of the litigation.

III. Irreparable Harm:

Finally, court considered whether the district court erred in finding likelihood that Apicore will sustain “substantial and immediate irreparable injury” without preliminary relief. Aurobindo argues that the district court erred in finding a causal nexus between Apicore’s alleged harm and the patented features of the process and ’050 patents. Mylan responds that Aurobindo’s causal nexus argument is flawed because it improperly focuses on a subset of the relevant customers (physicians) and ignores all others (active pharmaceutical ingredient (“API”) suppliers, pharma companies, hospitals, the FDA, etc.). Mylan maintains that Apicore’s harm is directly caused by Aurobindo’s infringement because ample evidence shows Sigma’s difficulty in finding an acceptable ISB supplier and that, by admittedly copying Apicore’s patented process, Aurobindo gained a competitive advantage.

We agree with Mylan that the district court’s determinations were not clearly erroneous. On the record evidence, the court found that: (1) due to Aurobindo’s infringement, Apicore has, and will continue to, suffer from lost sales, lost research and development, price erosion, and having to directly compete with an infringer (2) there was a causal nexus between Aurobindo’s infringement and Apicore’s harm because Aurobindo’s product “would not be on the market if [it] had not obtained [FDA] approval for a product that will likely be found to be covered by the patents.

Take-away: This decision highlights the use of FWR test in pharmaceutical/chemical field. By citing Supreme court‘s decision of Graver Tank, Federal circuit said that non-mechanical cases may not be well-suited to consideration under the FWR test. However, this test can be used depending on the circumstances of the case.  Thus, the Court seemingly blessed two equivalents tests (FWR & the substantial difference), leaving to the lower courts in future cases the choice of which to apply.

CAFC further said that when this case goes back to the district court for a full trial on the merits, the court may wish to consider whether the substantiality of the differences test may be more applicable in this chemical case. In this case, the district court conducted an incomplete FWR analysis while essentially bypassing the substantial differences test, in a situation where the latter test might seemingly be more appropriate.

Diclofenac – USA

On May 15, 2017 United States District Court for the District of New Jersey upheld the validity of Horizon Pharma's patent, US 9,066,913 (expiring on Oct 17, 2027) covering PENNSAID® (diclofenac sodium topical solution) 2% w/w, which Actavis Laboratories UT, Inc. (Actavis) has admitted that its proposed generic diclofenac sodium topical solution product would infringe. 

On July 6, 2015, Horizon filed a patent infringement lawsuit in District Court against Actavis related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration to market a generic version of PENNSAID 2%. Bench trial was completed in Mar 2017.  The District Court's decision was made based on the validity of Horizon Pharma's ‘913 patent for PENNSAID 2% and the Court's judgment will prevent Actavis from launching a generic version of PENNSAID 2% in the United States.

PENNSAID 2% has 19 Orange Book listed patents with terms that extend to 2030. Paddock Labs (Perrigo), Taro, Lupin, Amneal, IGI Labs (Teligent) are other Para IV filers.          

Mesalamine - USA

On May 09, 2017, Federal appeals court affirmed district court’s decision of non-infringement of US6773720 (expiring on Jun 8, 2020) and thus cleared the way for generic-drug maker Zydus to bring its version of Shire PLC’s gastrointestinal drug Lialda to market. Zydus was the first to file (FTF) an abbreviated new drug application (ANDA) for a generic version of Lialda. Shire has reported annual sales of $714 million for this product in 2016 in the United States.

In a separate case involving Watson, the Court of Appeals for the Federal Circuit on Feb 10, 2017 reversed district court’s decision & sent case back to the Florida Southern District Court. In this decision, the Court of Appeals noted that the first claim had “Markush” limitations. When analyzing the Watson ANDA, it concluded that its use of magnesium stearate in its formulation matrix was not part of the Markush group. As such, the Court of Appeals concluded that the Watson ANDA does not infringe.

Suprep® - USA

On May 05, 2017, The Federal Circuit ruled that Breckenridge Pharmaceutical Inc.’s planned generic version of the laxative drug SUPREP® infringes a patent owned by Braintree Laboratories Inc., reversing a New York federal judge’s 2016 ruling.

U.S. Patent No. 6,946,149 is directed to compositions and methods for purging a patient’s colon, as is routinely performed prior to a colonoscopy. Braintree markets a bowel prep kit named SUPREP, which is listed in orange book. SUPREP is sold as a kit consisting of two six-ounce bottles of an aqueous hypertonic solution of potassium sulfate, magnesium sulfate, and sodium sulfate. Its FDA-approved label instructs patients to fill each bottle with water to the sixteen-ounce line (473 mL) prior to consumption and directs that the first bottle be taken the evening before and the second bottle the morning of the colonoscopy. According to SUPREP’s label, “[t]he dose for colon cleansing requires administration of two bottles of SUPREP.

On March 15, 2012, Breckenridge submitted an Abbreviated New Drug Application (“ANDA”) to the FDA, seeking approval to market a generic version of SUPREP. Braintree filed the instant action accusing Breckenridge of infringement. The parties’ dispute centers on the relationship between the “purgation” and “from about 100 ml to about 500 ml” limitations. Court previously construed the “purgation” limitation of the ’149 patent in Braintree Laboratories, Inc. v. Novel Laboratories, Inc., 749 F.3d 1349 (Fed. Cir. 2014). While the Novel appeal was pending, Breckenridge stipulated that the district court’s Novel construction of “purgation” would apply in this case. Breckenridge further stipulated to “be bound by a final decision in the Novel Case . . . on any issues having to do with patent invalidity . . . and non-infringement” other than the “from about 100 ml to about 500 ml” limitation.

Breckenridge subsequently moved for summary judgment of noninfringement based on this limitation, arguing its proposed generic does not infringe the claims of the ’149 patent “because it is administered as 946 ml of aqueous solution, and thus falls outside the recited volume range.” It argued that based both on the claim construction of the term and the infringement inquiry under § 271(e), “from about 100 ml to about 500 ml” must refer to the total volume of solution administered. It argued its proposed label could not induce infringement of method claims 19, 20, and 23 under § 271(e) because its ANDA label instructs patients to consume the “entire amount” of solution (946 mL) for the sole indication of “preparation for colonoscopy”—not only one bottle to “induce colonic purgation.”

The district court granted Breckenridge’s motion for summary judgment of noninfringement. It held that Novel did not preclude Breckenridge’s noninfringement theory because that opinion did not address the separate volume limitation. It construed “from about 100 ml to about 500 ml” to mean “the entire volume of solution administered to a patient over a treatment period rather than the volume of a single bottle, or half-dose.” Because every asserted claim requires “from about 100 ml to about 500 ml,” the district court found that Breckenridge’s proposed product, with a total volume of 946 mL, does not infringe any of the asserted claims. The district court also agreed that Breckenridge’s ANDA label could not induce infringement under § 271(e), finding inducing purgation without “achieving a fully cleansed colon” is not an FDA-approved use of Breckenridge’s product.

During appeal  Breckenridge argues the district court’s summary judgment of noninfringement should be affirmed notwithstanding its construction of the volume limitation because Braintree’s infringement theory is contrary to 35 U.S.C. § 271(e). Court disagreed. This case is distinguishable from the cases in which we have held an ANDA applicant’s proposed label would not induce infringement [Warner-Lambert Co v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003); Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003); Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1321 (Fed. Cir. 2012)].

In contrast, inducing purgation is not a distinct use of Breckenridge’s proposed product; inducing purgation is the means by which the approved indication achieves its result. Breckenridge concedes that its proposed product “cleanses the colon of a patient by inducing purgation” when taken as directed by its label. J.A. 1780–81 ¶¶ 25, 37–38 (emphasis added). Its stipulations make clear that inducing purgation is not supplemental or ancillary to its proposed indication of colon cleansing—it is plainly within the scope of Breckenridge’s proposed indication. Therefore We hold that Breckenridge’s labeled indication for colon cleansing “recommends or suggests to physicians that the drug is safe and effective for administration to patients for the purposes of inducing [purgation].” There can be no dispute that, given SUPREP’s sole approved use, the FDA has approved SUPREP as safe and effective for the indication of colon cleansing. Because Breckenridge’s labeled indication of colon cleansing requires performing the claimed steps in order to achieve colon cleansing, it follows that a physician would understand Breckenridge’s ANDA label to recommend or suggest that “inducing purgation” is safe and effective.

Finally Federal Circuit said that we have considered all of Breckenridge’s arguments on appeal and find them to be without merit. For the foregoing reasons, we reverse the district court’s grant of summary judgment of noninfringement and remand for entry of judgment for Braintree.

Darunavir - UK

On May 03, 2017, Mr Justice Arnod of England and Wales High Court found SPC based on a Markush formula valid in Sandoz v Searle case.

In these proceedings the Claimant (Sandoz) challenge the validity of supplementary protection certificate SPC/GB07/038 ("the SPC") under Article 3(a) for a product described in the SPC as "Darunavir or the pharmaceutically acceptable salt, ester or prodrug thereof". The proprietor of the SPC is the First Defendant ("Searle") and the exclusive licensee is the Second Defendant ("JSI"). The SPC covers a product which is marketed in Europe by companies related to JSI under the trade mark Prezista. Prezista®is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV). The Claimants seek to revoke the SPC, which expires on 23 February 2019 (including a paediatric extension of six months), in order to clear the way for the marketing of a generic darunavir product. The Claimants have admitted for the purpose of these proceedings only that, if the SPC is valid, then the marketing of their product prior to the expiry of the SPC would infringe it.

Article 3 of SPC regulation which relates to conditions for obtaining a certificate state that a certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a) the product is protected by a basic patent in force. The interpretation of Article 3(a) has been the subject of a number of references to the CJEU from the English courts, the most recent of which arose in the case of Teva UK Ltd v Gilead Sciences Inc [2017] EWHC 13 (Pat) that is currently pending before the CJEU. 

The Patent, EP0810209 is entitled "Alpha- and beta-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors". The application was filed on 24 August 1993 with a claimed priority date of 25 August 1992. The Patent expired on 23 August 2013. Claim 1 is to a compound presented by Formula I. The claimants argued that darunavir was not "protected" by the claims of the patent because darunavir was not specifically identified by name or structure in the claims or in the specification, and because of the lack of any teaching in the patent pointing to darunavir. Claimants' objection is that claim 1 is of excessive breadth because it encompasses a vast number of compounds which the skilled person could not make even a tiny fraction of and which it is not plausible would all be efficacious as protease inhibitors (and the same goes for claims 2, 5, 10 and 11). This was despite the fact that it was agreed that darunavir fell within the Markush formulae of the claims. For the purposes of determining whether Markush claims complied with Article 3(a), the claimants had proposed a test which required determining whether the skilled person would consider the product to be part of the subject-matter of the patent based on their reading of the specification and their common general knowledge as at the priority date without undue burden or further invention.

Arnold J dismissed the claimants' test as unworkable and not in keeping with the "simple and transparent" system that had been envisaged by the European Commission before the SPC Regulation came into force. It is clear from this that the identification of the active ingredient in the claim by means of a structural formula is permissible, but not essential; that it is not necessary for the claim individually to name or depict the active ingredient; and that it is not necessarily an objection that the claim in question covers a large number of other compounds in addition to the active ingredient in question (since, if that was so, it would have provided a simple answer to the Lilly case)." I cannot see that there is any tenable interpretation of Article 3(a) which leads to the conclusion that darunavir is not "protected" by the Patent. 

For the reasons given above, Arnold J concluded that the SPC complies with Article 3(a) of the SPC Regulation. Accordingly, the Claimants' claim is dismissed.

Palonosetron - USA

On May 01, 2017, Federal appeals court invalidated Helsinn Healthcare SA's patents on its anti-nausea treatment Aloxi, clearing the way for Teva Pharmaceuticals Industries Ltd to launch a generic version of the drug. The U.S. Court of Appeals for the Federal Circuit said that four Helsinn patents [U.S. Patent Nos. 7,947,724; 7,947,725; 7,960,424 and 8,598,219] relating to palonosetron, Aloxi's active ingredient, are invalid under the so-called on-sale bar, a statutory provision holding that inventions sold for more than a year before a patent application is filed are not patentable.

Helsinn Healthcare S.A. (“Helsinn”) is the owner of the four patents-in-suit directed to intravenous formulations of palonosetron for reducing or reducing the likelihood of chemotherapy-induced nausea and vomiting (“CINV”). Helsinn brought suit against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. (collectively, “Teva”) alleging that the filing of Teva’s Abbreviated New Drug Application (“ANDA”) constituted an infringement of various claims of those patents. Teva defended, inter alia, on the ground that the asserted claims were invalid under the on-sale bar provision of 35 U.S.C. § 102. The district court found that the patents-in suit were not invalid. With respect to three of the patents, which are governed by the pre-Leahy-Smith America Invents Act (“pre-AIA”) version of § 102, the district court concluded that there was a commercial offer for sale before the critical date, but that the invention was not ready for patenting before the critical date. With respect to the fourth patent, which is governed by the AIA version of § 102, the district court concluded that there was no commercial offer for sale because the AIA changed the relevant standard and that, in any event, the invention was not ready for patenting before the critical date.

Facts & analysis:

On April 6, 2001, almost two years before applying for a patent, Helsinn and MGI Pharma, Inc. (“MGI”), an oncology-focused pharmaceutical company that markets and distributes in the United States, entered into two agreements: (1) a License Agreement and (2) a Supply and Purchase Agreement. Under the terms of the License Agreement, MGI agreed to pay $11 million in initial payments to Helsinn, plus additional future royalties on distribution of “products” in the United States. The parties agree that the “products” covered by the License Agreement were 0.25 mg and 0.75 mg doses of palonosetron. The License Agreement made reference to the ongoing clinical trials and stated that in the event that the results were unfavorable and FDA did not approve the sale of either dosage of the product, Helsinn could terminate the agreement. If the License Agreement were terminated, the Supply and Purchase Agreement would “terminate automatically.”

All of the above information about the transaction was publicly disclosed with two exceptions. The two features of the agreements that were not publicly disclosed were the price terms and the specific dosage formulations covered by the agreements—that is the 0.25 and 0.75 mg doses. After the signing of the agreements, and still before the critical date, Helsinn prepared preliminary statistical analysis of the earliest Phase III trial on January 7, 2002. The data showed that 81% of patients who received the 0.25 mg dose of palonosetron experienced relief from CINV for 24 hours. In September 2002, after the successful completion of all Phase III trials, Helsinn filed its New Drug Application for the 0.25 mg dose, but did not seek FDA approval of the 0.75 mg dose. On January 30, 2003, Helsinn filed a provisional patent application covering the 0.25 mg dose (and also the 0.75 mg dose).

The district court held a bench trial. The district court held that Teva’s 0.25 mg dose infringed all of the patentsin-suit. In addressing the on-sale issue, the court applied the two-step framework of Pfaff v. Wells Electronics, Inc., 525 U.S. 55 (1998), which requires that there was a sale or offer for sale and that the claimed invention was ready for patenting for the on-sale bar under 35 U.S.C. § 102 to apply. The court found that pre-AIA law applied under § 102(b) and that the MGI Supply and Purchase Agreement was a contract for a future sale of a commercial product embodying the 0.25 mg dose and therefore constituted a sale under § 102(b). But, the court found that the claimed invention was not reduced to practice before the critical date of January 30, 2002, and therefore was not ready for patenting under the second prong of Pfaff. The district court did not address whether the invention was ready for patenting on the alternative theory that Teva had shown that the inventor had created enabling descriptions before the critical date.

CAFC review-

There was a sale or offer for sale?

A primary rationale of the on-sale bar is that publicly offering a product for sale that embodies the claimed invention places it in the public domain, regardless of when or whether actual delivery occurs. The patented product need not be on-hand or even delivered prior to the critical date to trigger the on-sale bar. we have never required that a sale be consummated or an offer accepted for the invention to be in the public domain and the on-sale bar to apply, nor have we distinguished sales from mere offers for sale. We have also not required that members of the public be aware that the product sold actually embodies the claimed invention. For instance, in Abbott Laboratories v. Geneva Pharmaceuticals, Inc., 182 F.3d 1315 (Fed. Cir. 1999). Thus, our prior cases have applied the on-sale bar even when there is no delivery, when delivery is set after the critical date, or, even when, upon delivery, members of the public could not ascertain the claimed invention.

It is clear that the Supply and Purchase Agreement constituted a commercial sale or offer for sale for purposes of § 102(b) as to the asserted claims of the ’724, ’725, and ’424 patents. As the Supply and Purchase Agreement between Helsinn and MGI—was publicly announced in MGI’s 8-K filing with the SEC. An invention is made available to the public when there is a commercial offer or contract to sell a product embodying the invention and that sale is made public. Our cases explicitly rejected a requirement that the details of the invention be disclosed in the terms of sale. We conclude that, after the AIA, if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale.

Invention was ready for patenting?

An invention is reduced to practice when “the inventor (1) constructed an embodiment . . . that met all the limitations and (2) determined that the invention would work for its intended purpose.” In re Omeprazole Patent Litig., 536 F.3d 1361, 1373 (Fed. Cir. 2008). Thus, for instance, it is uncontested that the formulation had been made and was stable prior to the critical date. Accordingly, the only issue with respect to ready for patenting before the district court and on appeal is whether Helsinn had determined that the invention would work for its intended purpose, which, according to the claims, is “reducing the likelihood” of emesis and CINV.

Here, the district court based its finding that the invention was not reduced to practice before the critical date on insufficient testing for Helsinn to have “determined that the invention would work for its intended purpose.”  The district court appeared to believe that Teva needed to meet the FDA standard, which requires finalized reports with fully analyzed results from successful Phase III trials. The district court was influenced particularly by the fact that FDA found the so called Study 2330 insufficient to demonstrate efficacy. The district court clearly erred by applying too demanding a standard. The completion of Phase III studies and final FDA approval are not pre-requisites for the invention here to be ready for patenting. The evidence is overwhelming that before the critical date of January 30, 2002, it was established that the patented invention would work for its intended purpose of reducing the likelihood of emesis.

Indeed, the Study 2330 final report concluded that the relevant dose of palonosetron “was effective in suppressing” CINV. Under our cases this is sufficient to establish that the invention here would work for its intended purpose of reducing the likelihood of CINV. These results consistently showed that the invention worked for its intended purpose, from the final report for the 1995 Phase II trial to the preliminary results in January 2002 from a Phase III trial. There is simply no tenable argument that, before the critical date, Helsinn was unable to file a patent application that met the requirements of 35 U.S.C. § 112. We conclude that the invention was reduced to practice and therefore was ready for patenting before the critical date.

CONCLUSION: CAFC reversed. The asserted claims of the patents-in-suit were subject to an invalidating contract for sale prior to the critical date of January 30, 2002, and the AIA did not change the statutory meaning of “on sale” in the circumstances involved here. The asserted claims were also ready for patenting prior to the critical date. We hold that the asserted claims, claims 2 and 9 of the ’724 patent, claim 2 of the ’725 patent, claim 6 of the ’424 patent, and claims 1, 2, and 6 of the ’219 patent, are invalid under the on-sale bar. 

Take-away:  This is an important case for parties who have disclosed agreements and licensing deals prior to filing patent application describing subjects of those agreements/deals, even where that subject matter of the invention is referred to in the agreements/deals in only vague terms.