Intellectual Property Developments in the Chemical Industry

Over the last several years, the Federal Circuit has focused its lens on the chemical industry from a variety of angles. Though we have seen  a disproportionate number of cases pertaining to inventorship or priority of invention under 35 U.S.C. § 102(g)(2), there have also been significant cases related to written description, double patenting, and anticipation. The following discussion provides an overview of the most notable Federal Circuit cases since 2010  that could have a wide-reaching effect on Intellectual Property in the chemical industry.  Click the links below to jump to that section of the discussion.

When Claims Are Directed to a Genus of Chemical Compounds, a Written Description Failing to Disclose a Variety of Species is Insufficient

In Ariad Pharm. Inc. v. Eli Lilly and Co.1 the Federal Circuit granted Ariad’s petition for rehearing en banc in light of the controversy concerning (i) whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement, and (ii) if a separate written description requirement is set forth in the statute, what is the scope and purpose of that requirement.

The patent-in-suit relates to the regulation of gene expression and recites methods encompassing a genus of materials achieving a stated useful result (functional language),2 but the specification does not disclose a variety of species that accomplish the result.3

Ariad argued that because the original claims are part of the original specification, the original claim language discloses the subject matter that it claims and satisfies the written description requirement and that the only question left is whether the invention is enabled.4

The Federal Circuit held that, although many original claims will satisfy the written description requirement, certain claims may not.5 The court continued that a generic claim, for example, may define a vast genus of chemical compounds, and the question may remain whether the original specification (including the claims) demonstrates that the applicant has invented species sufficient to support a claim to a genus.6 The problem is exacerbated when the patentee claims a genus using functional language.7 In such a case, “the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”[8]

Sufficient written description of a genus requires “the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.”9 “[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and the complexity and predictability of the relevant technology.”10

The Federal Circuit recognized that, though in some fields there is little difference between describing an invention and enabling one to make and use it (and thus written description and enablement rise and fall together), this is not always the case, particularly in chemical inventions.11 Back to top.

An Individual Responsible for Developing a Method for Making a Genus of Compounds Is a Properly Named Inventor of Broadly Drafted Claims

In Falana v. Kent State Univ.12 the Federal Circuit held that for claims broadly drafted to cover an entire genus of compounds, the individual responsible for developing a synthesis protocol for making the genus is a properly named inventor.

Falana filed an action to correct inventorship of the patent-in-suit under 35 U.S.C. § 256 alleging that he was an omitted co-inventor of that patent, which relates to chiral additives used to improve the performance of liquid crystal displays (LCDs).13

Kent Displays, Inc. (“KDI”), a spinoff from Kent State, started a research program to develop chiral additives and hired Falana to synthesize and develop these additives.14 Falana developed a synthesis protocol for making a novel genus of compounds (napthyl substituted TADDOLs) and synthesized Compound 7 (a species within that genus) using that protocol.15 Although it represented great progress, Falana’s Compound 7 did not completely satisfy the temperature independence goals of the project.16 Falana subsequently resigned from KDI and another KDI employee synthesized Compound 9, which was also a napthyl substituted TADDOL synthesized using Falana’s synthesis protocol.17 Compound 9 exhibited substantial temperature independence and therefore satisfied the goals of the project.18

KDI filed a patent application (which led to the patent-in-suit) disclosing the synthesis protocol developed by Falana and did not list Falana as an inventor.19 The claims were drafted broadly to include the entire genus, as opposed to only the Compound 9 species.20

Based on the broad claims of the patent-in-suit, the Federal Circuit upheld the district court’s determination that Falana should be named as a joint inventor.21 This holding shows the importance of narrowly tailoring claims to what was actually conceived by the named inventors. Back to top.

Claims to a Narrow Species May Be Anticipated by the Disclosure of the Broad Genus

Despite the Federal Circuit having previously held that the prior art’s teaching of a broad genus does not anticipate every species within that genus, the court held that claims to a more narrow species are anticipated by disclosure of a broader genus when the patentee fails to establish the different portions of the broad range would work differently.22 In other words, the patentee failed to establish that its narrower range or species was critical to invention or to provide any evidence demonstrating any difference across the broad range.23

The claims of the patent-in-suit relate to process for clarifying water with alkalinity of 50 ppm or less and the prior art patent to Hassick disclosed clarifying water with alkalinity of 150 ppm or less.24 Plaintiff relied upon Atofina v. Great Lakes Chem. Corp.25 to argue that the 150 ppm disclosed in Hassick was too broad to anticipate the 50 ppm limitation of the claims at issue.26

The patent in Atofina claimed a method for synthesizing dithoromethane at a temperature between 330-450°C and the prior art taught a broad temperature range of 100-500°C.27 The Federal Circuit distinguished Atofina on the facts:  the patent in Atofina claimed a method for synthesizing dithoromethane at a temperature between 330-450°C and stated that only that narrow temperature range enables the process to operate as claimed, and that problems occur outside that temperature range.28 Also, during the prosecution of the Atofina patent, Atofina described the temperature range as “critical.”29 The Atofina court explained that the prior art’s teaching of a broad genus (100-500°C) does not disclose every species within that genus.30

After distinguishing Atofina, the Federal Circuit found anticipation of the ClearValue patent because ClearValue did not argue that the 50 ppm limitation was “critical” or that the claimed method works differently within the prior art range of 150 ppm or less.31 Back to top.

Prior Inventor Under § 102(g) Must Prove that it Appreciated What it had Made, But Did Not Have to Understand Everything About How or Why the Invention Worked

In Teva Pham. Indus. v. AstraZeneca Pharm. LP,32 the Federal Circuit held that, while a party must prove that it appreciated what it had made in order to establish prior invention under 35 U.S.C. § 102(g), it did not have to understand everything about how or why its invention worked.

Teva’s patent-in-suit claimed statin formulations (useful in treating dyslipidemia, or high cholesterol) stabilized exclusively by an AGCP compound (amino-group containing polymeric compound).33 AstraZeneca asserted invalidity based on its prior invention under § 102(g).34 AstraZeneca’s prior invention consisted of a stabilized statin (rosuvastatin calcium) designed with tribasic calcium phosphate (not an AGCP compound) as a stabilizer.35 AstraZeneca’s prior invention also contained crospovidone, which is an AGCP compound, as a disintegrant.36 However, AstraZeneca did not understand crospovidone to have a stabilizing effect.37

Astrazeneca conceded infringement for the limited purpose of advancing the summary judgment motion and there were no issues of fact, only an issue of law:  “whether AstraZeneca had to understand that crospovidone stabilized its drug in order to win a priority dispute under § 102(g)(2).”38 Teva argues that district court misapplied § 102(g)(2) by failing to require AstraZeneca to prove that it appreciated the stabilizing effect of crospovidone in its formulation.39

The Federal Circuit held that to establish prior invention, a party must prove that it appreciated what it had made.40 It does not need to know everything about how or why its invention worked nor must it conceive of its invention using the same words as the patentee.41 Therefore, the court held that, despite AstraZeneca not understanding the stabilizing effect of crospovidone and despite the claim language “stabilizing effective amount,” AstraZeneca had established prior invention under § 102(g)(2). Back to top.

A Double Patenting Inquiry Looks to the Disclosure As Well As to What Is Claimed

In Sun Pharm. Indus. V. Eli Lilly and Co.,42 the Federal Circuit held that a claim to a method of using a composition (for the treatment of cancer) is invalid for obviousness-type double patenting over an earlier claim to the identical composition in a patent disclosing (but not claiming) that use (treatment of cancer). However, in a dissent to a decision denying a Petition for Rehearing en banc, Justices Newman, Rader, Laurie and Linn argued that this opinion violates a vast body of precedent that the issue of obviousness-type double patenting is directed to whether the invention claimed (and not disclosed) in a later patent is an obvious variant of the invention claimed in an earlier patent.43

Eli Lilly’s patents-in-suit relate to gemcitabine, a pharmaceutical composition used for treating cancer. The ’614 patent claims gemcitabine and the method of using gemcitabine for treating viral infections, and the later-issued ’826 patent claims a method of using gemcitabine for treating cancer.

In support of its invalidity finding, the court held that for “a claim directed to a compound, a court must consider the specification because the disclosed uses of the compound affect the scope of the claim for obviousness-type double patenting purposes.”44

The dissent to the court’s denial of the Petition for Rehearing en banc opined that “until recently it was beyond dispute that the law of double patenting is concerned only with what is patented—that is, what is claimed.”45 The dissent argued that the double patenting analysis occurs only when the earlier patent is not prior art against the later patent and that “[t]he specifications of the patents are irrelevant to the double patenting analysis, other than to guide in construing the claims.”46

The applications that led to the patents-in-suit were filed on the same day, but the ’826 patent expired 2 ½ years after the ’614 patent. The result, the dissent argued, is that “Lilly would be entitled to a separate patent on the anticancer use if” it had not included the disclosure of anticancer use in the specification filed on the same day.47 Dissenters claim that such disclosure does not “improperly extend” any patent.48 Back to top.

§ 102(g) Prior Invention Not Established by Reduction to Practice Prior to Priority Date

In Solvay S.A. v. Honeywell Int’l, Inc.,49 the Federal Circuit held that an invention reduced to practice by another in the United States before the priority date of the patent-in-suit is insufficient to establish a prior invention defense under 35 U.S.C. § 102(g)(2). 

The Federal Circuit reversed the district court’s finding of invalidity holding that Honeywell was a prior inventor of the claimed process.50 The Federal Circuit held that under the rules governing the determination of priority of invention, which are often applied to prior invention under § 102(g)(2), Honeywell must prove that it conceived of the invention and reduced it to practice in the U.S.51

The patent-in-suit is directed to methods for making HFC-245fa, which is advantageous as a blowing and insulation agent in the preparation of expanded polymeric materials, of the type commonly used in refrigeration and heat storage systems.52 Honeywell entered into a research contract with RSCAC (Russian Scientific Center for Applied Chemistry) pursuant to which (i) RSCAC performed in Russia a process that corresponds to patent claims at issue; (ii) RSCAC transmitted to Honeywell in the United States complete instructions for the process; (iii) Honeywell replicated the Russian process by following the information provided by RSCAC, thereby practicing the invention in the United States before the priority date.53

Based on these facts, Honeywell argues that it qualifies as “another inventor” under § 102(g)(2) and the fact that the claimed invention was previously reduced to practice in the United States by someone other than the patentee is sufficient to establish a prior invention defense under § 102(g)(2).54 § 102(g)(2) states that a person is not entitled to a patent if, before the applicant’s invention thereof, “the invention was made in this country by another inventor who had not abandoned, suppressed or concealed it.”

Honeywell argued that “as a matter of policy, it would contradict the purpose of § 102(g)(2) to allow Solvay to have a patent covering subject matter that Solvay was not the first to invent.”55 In rejecting this argument, the Federal Circuit reasoned that “[w]hether the holding ignores the realities of globalization and outsourcing by modern-day research companies . . . is not the question before us” but whether Honeywell qualifies as “another inventor” under § 102(g)(2).56 The Federal Circuit found that Honeywell did not conceive of the invention but merely followed another inventor’s instructions and therefore, was not “another inventor” under § 102(g)(2).57 Back to top.

Burden of Proof for Invalidity Based on Priority of Invention

Creative Compounds, LLC v. Starmark Labs58 presented several interesting issues including whether the burden of proof is lowered for invalidity when the issue is priority of invention, whether the accused infringer has the burden to establish that its product is not made pursuant to the patented method, and whether declaratory judgment jurisdiction exists when accusatory communications were only sent to customers as opposed to directly to the declaratory judgment plaintiff. 

Creative sued Starmark seeking declaratory judgment that Starmark’s ’373 patent was invalid and not infringed.59 Starmark alleged infringement of the ’373 patent and sought a declaration that Creative’s ’273 patent was invalid.60 Both patents relate to formulations of the dietary supplement creatine that increases bioavailability.61

Invalidity – Burden of Proof

 

Creative argued that the correct burden of proof on invalidity is the preponderance of the evidence as opposed to clear and convincing evidence, because preponderance is the standard for priority of invention as between co-pending interfering patents.62

The Federal Circuit distinguished two other Federal Circuit cases that applied the preponderance of the evidence standard to priority determinations.63 The Environ case was distinguishable because the parties stipulated that the same invention was common to the co-pending patent applications and agreed on the description of the common subject matter that would serve as the basis for determining who the original inventor was.64 The Slip Track case was distinguishable because it was a § 291 action (civil patent interference), in which common claimed subject matter must be identified.65

Therefore, in Creative Compounds the Federal Circuit held that an accused infringer cannot obtain the benefit of the lower burden of proof applied in interference proceedings (preponderance of the evidence) simply by alleging that the asserted patent is invalid based upon a co-pending patent (§ 102(g)(2)) unless common claimed subject matter is first identified.66

Infringement

 

As to infringement of the method claims of the ’373 patent (Creative conceded infringement of compound claims), the court affirmed the district court’s infringement finding.67 Starmark submitted expert testimony that the process most likely used to manufacture the claimed compound is the method claimed in the claims at issue.68 Starmark also sought discovery on the manufacturing process but Creative failed to produce documentation.69 The court held that the burden of establishing that the product was not made by the method claims at issue was properly on Creative, which offered no evidence as to how or why the process did not infringe the ’373 patent.70

Jurisdiction

 

The court reversed the district court’s determination that declaratory judgment jurisdiction existed as to the invalidity of the ’273 patent.71 Despite letters from Creative’s patent counsel opining that the ’373 patent was invalid in light of the ’273 patent and letters from Creative to purchasers of dicreatine malate alleging infringement of the ’273 patent, the court held there was no jurisdiction because Creative had never accused Starmark directly of infringement of the ’273 patent.72 The court noted that Starmark had no indemnity obligation to its customers, so Starmark had only an economic interest in clarifying its customers’ rights, which alone is not enough to form the basis of an actual controversy.73 Back to top.

Contact Information

If you have any questions regarding this alert, please contact—

Steven M. Zager
szager@akingump.com
212.872.1037
New York
Sarah J. Ring
sring@akingump.com
713.250.2123
Houston

1 598 F.3d 1336, 1342 (Fed. Cir. 2010) (en banc).

2 Id. at 1340-1341.  Specifically, the patent-in-suit relates to a genus encompassing the use of all substances that achieve the desired result of reducing the binding of NF-êB to NF-êB recognition sites.  Id.

3 Id. at 1350.

4 Id. at 1349. 

5 Id.

6 Id.

7 Id.

8 Id.

9 Id. at 1350.

10 Id. at 1351.

11 Id. at 1352. 

12 No. 2011-1198, 2012 WL 171550 (Fed. Cir. Jan. 23, 2012).

13 Id. at *1. 

14 Id.

15 Id. at *2. 

16 Id.

17 Id.

18 Id.

19 Id.

20 Id. at *9. 

21 Id.

22 ClearValue, Inc. v. Pearl River Polymers, Inc., __F.3d __, 2012 WL 517488, *3-4 (Fed. Cir. Feb. 17, 2012).

23 Id. at *4. 

24 Id. at *1, 3. 

25 441 F.3d 991 (Fed. Cir. 2006).

26 ClearValue, 2012 WL 517488 at *3.

27 Id.

28 Id.

29 Id.

30 Id.

31 Id. at *4.

32 661 F.3d 1378 (Fed. Cir. 2011).

33 Id. at 1380. 

34 Id. at 1381.

35 Id. at 1380-1381. 

36 Id.

37 Id.

38 Id. at 1382.

39 Id. at 1381-1382.

40 Id. at 1384.

41 Id.

42 611 F.3d 1381 (Fed. Cir. 2010).

43 625 F.3d 719 (Fed. Cir. 2010).

44 611 F.3d at 1387. 

45 625 F.3d at 721. 

46 Id.  

47 Id. at 723. 

48 Id.

49 622 F.3d 1367 (Fed. Cir. 2010).

50 Id. at 1379. 

51 Id.

52 Id. at 1370. 

53 Id. at 1371, 1374-75. 

54 Id. at 1374. 

55 Id. at 1379. 

56 Id.

57 Id.

58 651 F.3d 1303 (Fed. Cir. 2011).

59 Id. at 1306. 

60 Id.

61 Id.

62 Id.at 1309.

63 Id. at 1310-1311 (distinguishing Environ Prod., Inc. v. Furon Co., 215 F.3d 1261 (Fed. Cir. 2000) and Slip Track Sys., Inc. v. Metal-Lite, Inc., 304 F.3d 1256 (Fed. Cir. 2002).).

64 Id. at 1310-1311.

65 Id.

66 Id. at 1311. 

67 Id. at 1315. 

68 Id.

69 Id.

70 Id.

71 Id. at 1317. 

72 Id. at 1315-1317.

73 Id.