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Amgen Inc Et Al v Sanofi Et Al

No. 21–757

Supreme Court of the United States

JG Roberts, SCJ and CJ; SA Alito, AC Barrett, N Gorsuch, KB Jackson, E Kagan, BM Kavanaugh, S Sotomayor, C Thomas, SCJJ

May 18, 2023

Reported by Faith Wanjiku and Bonface Nyamweya

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Intellectual Property Law- patents- scope of a patent claim- specification of the scope of a patent claim- where two pharmaceutical companies—the petitioner and the respondent—each developed in 2011, the petitioner obtained a patent for the antibody employed in its drug, and the respondent received one covering the antibody used in its drug- where each patent described the relevant antibody by its unique amino acid sequence- where the dispute in the case concerned two additional patents the applicant obtained in 2014 that relate back to the company’s 2011 patent- whether when a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification had to enable a person skilled in the art to make and use the entire class- Patent Act, 1790, section 112.

Brief facts

The case concerned patents covering antibodies engineered by scientists that helped reduce levels of low-density lipoprotein (LDL) cholesterol, sometimes called bad cholesterol because it could lead to cardiovascular disease, heart attacks, and strokes. To treat patients with high LDL cholesterol, scientists explored how antibodies might be used to inhibit PCSK9—a naturally occurring protein that bound to and degraded LDL receptors responsible for extracting LDL cholesterol from the bloodstream.

Two pharmaceutical companies—the petitioner and the respondent—each developed a PCSK9-inhibiting drug. In 2011, the petitioner obtained a patent for the antibody employed in its drug, and the respondent received one covering the antibody used in its drug. Each patent described the relevant antibody by its unique amino acid sequence. The dispute in the case concerned two additional patents the applicant obtained in 2014 that relate back to the company’s 2011 patent. Those later-issued patents purport to claim for the applicant the entire genus of antibodies that bound to specific amino acid residues on PCSK9, and block PCSK9 from binding to LDL receptors. As part of its submission to the patent office, the petitioner identified the amino acid sequences of 26 antibodies that performed those two functions. The petitioner then described two methods—one the petitioner called the roadmap and a second it called conservative substitution—that scientists could use to make other antibodies that performed the binding-and-blocking functions described in the claims.

After the petitioner obtained the 2014 patents, it sued the respondent for infringement. Sanofi replied that it was not liable to the petitioner for infringement because the petitioner’s relevant claims were invalid under the Patent Act’s enablement requirement. That provision required a patent petitioner to describe the invention in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the invention. The respondent characterized the methods the petitioner outlined for generating additional antibodies as amounting to little more than a trial-and-error process of discovery, and thus contended that the petitioner’s patents failed to meet the enablement requirement because they sought to claim for the petitioner’s exclusive use potentially millions more antibodies than the company had taught persons skilled in the art to make. Both the district court and the Federal Circuit sided with the respondent.

Issue

Whether a patent’s specification had to enable a person skilled in the art to make and use the entire class.

Relevant provisions of law

Patent Act, 1790

Section 112 – Specification

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form. Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed.

A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered. An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

Held

1. The development of antibody drugs had yielded life changing therapies. Individuals across the world relied on antibody drugs to treat conditions ranging from Crohn’s disease to cancer. The case concerned patents covering antibodies that helped reduce levels of low-density lipoprotein cholesterol, sometimes called LDL cholesterol (for the obvious reason) or bad cholesterol (because it could lead to cardiovascular disease, heart attacks, and strokes).
2. While the immune system naturally produced an army of antibodies to protect people from various harms, scientists were able to engineer antibodies to assist in treating diseases. Some of those lab-made antibodies targeted not foreign agents but the body’s own proteins, receptors, and ligands.
3. One part of that effort had focused on the creation of antibodies to treat patients with high LDL cholesterol. A silent killer, LDL cholesterol could contribute to the formation of plaque in the arteries that could lead to cardiovascular disease, heart attacks, and strokes. For many people with high LDL cholesterol, drugs called statins offered an effective treatment. For others, statins did not work well or come with unwelcome side effects. In those cases, a relatively new antibody-based treatment known as a PCSK9 inhibitor could be appropriate.
4. PCSK9 was a naturally occurring protein that bound to and degraded LDL receptors. That could pose a problem because the body produced LDL receptors to perform the beneficial function of extracting LDL cholesterol from the bloodstream. Scientists had understood that much for some time. But it was not until fairly recently that they began exploring how antibodies might be used to inhibit PCSK9 from binding to and degrading LDL receptors as a way to treat patients with high LDL cholesterol.
5. In the mid-2000s, a number of pharmaceutical companies began looking into the possibility of making antibodies to target PCSK9. They sought to create antibodies that could bind to a particular region of PCSK9 called the sweet spot. The sweet spot was a sequence of 15 amino acids out of PCSK9’s 692 total amino acids. Scientists found, an antibody could prevent PCSK9 from binding to and degrading LDL receptors.
6. The petitioner developed a PCSK9-inhibiting drug that it marketed under the name Repatha, and the respondent produced one it labelled Praluent. Each drug employed a distinct antibody with its own unique amino acid sequence. In 2011, the petitioner obtained a patent for the antibody employed in Repatha, and the respondent received one covering the antibody used in Praluent. Each patent described the relevant antibody by its amino acid sequence. Neither of those patents was at issue in that case.
7. Instead, the dispute focused on two additional patents the petitioner obtained in 2014 that related back to the company’s 2011 patent. The court referred to them as the ’165 and ’741 patents. In particular, the case revolved around claims 19 and 29 of the ’165 patent and claim 7 of the ’741 patent. In those claims, the petitioner did not seek protection for any particular antibody described by amino acid sequence. Instead, the petitioner purported to claim for itself the entire genus of antibodies that bound to specific amino acid residues on PCSK9, and blocked PCSK9 from binding to LDL receptors.
8. The petitioner identified the amino acid sequences of 26 antibodies that performed those two functions, and it depicted the three-dimensional structures of two of those 26 antibodies. But beyond that, the petitioner only offered scientists two methods to make other antibodies that performed the binding and blocking functions it described.
9. The first method was what the petitioner called the roadmap. At a high level, the roadmap directed scientists to:
   

   (a) generate a range of antibodies in the lab;

   (b) test those antibodies to determine whether any bound to PCSK9;

   (c) test those antibodies that bound to PCSK9 to determine whether any bind to the sweet spot as described in the claims; and

   (d) test those antibodies that bound to the sweet spot as described in the claims to determine whether any block PCSK9 from binding to LDL receptors.

10. The second method was what the petitioner called conservative substitution. That technique required scientists to:
    

    (a) start with an antibody known to perform the described functions;

    (b) replace select amino acids in the antibody with other amino acids known to have similar properties; and

    (c) test the resulting antibody to see if it also performs the described functions.

11. Soon after receiving the ’165 and ’741 patents, the petitioner sued the respondent for infringing them. The respondent replied that it was not liable to the petitioner because the relevant claims were invalid as a matter of law. Invalid, the respondent said, because the petitioner had not enabled a person skilled in the art to make and use all of the antibodies that perform the two functions the petitioner described in its claims. While the petitioner had identified the amino acid sequences of 26 antibodies that bound to PCSK9 and blocked it from binding to LDL receptors, the respondent observed that the petitioner’s claims covered potentially millions more undisclosed antibodies that performed those same functions. And neither of the two methods the petitioner had outlined for generating additional antibodies with the same functions enable a person skilled in the art to do so reliably. Instead, those methods required scientists to engage in little more than a trial-and-error process of discovery.
12. After lengthy proceedings, the district court granted the respondent judgment as a matter of law, concluding that the claims at issue were not enabled. The Federal Circuit was affirmed. It determined that no reasonable factfinder could conclude that the petitioner had provided adequate guidance to make and use the claimed antibodies beyond the narrow scope of the working examples it had identified by their amino acid sequences. In response to the petitioner’s petition for certiorari, the court agreed to take up the case.
13. The Constitution vested Congress with the power to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries. In exchange for bringing new designs and technologies into the public domain through disclosure, so they could benefit all, an inventor received a limited term of protection from competitive exploitation.
14. Congress had exercised that authority from the start. The Patent Act of 1790 promised up to a 14-year monopoly to any applicant who invented or discovered any useful art, manufacture or device, or any improvement therein not before known or used. Reflecting the quid-pro-quo premise of patent law, the statute required the applicant to deposit with the Secretary of State a specification so particular as not only to distinguish the invention or discovery from other things before known and used, but also to enable a workman or other person skilled in the art or manufacture to make, construct, or use the same. The statute made clear that that disclosure would ensure the public could have the full benefit of the invention or discovery, after the expiration of the patent term.
15. Even as Congress had revised the patent laws over time, it had left that enablement obligation largely intact. Section 111 of the Patent Act provided that a patent application should include a specification as prescribed by section 112. Section 112, in turn, required a specification to include a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same. Just as in 1790, the law secured for the public its benefit of the patent bargain by ensuring that, upon the expiration of the patent, the knowledge of the invention inured to the people, who were thus enabled without restriction to practice it.
16. If a patent claimed an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification had to enable a person skilled in the art to make and use the entire class. In other words, the specification had to enable the full scope of the invention as defined by its claims. The more one claimed, the more one had to enable.
17. That was not to say a specification always had to describe with particularity how to make and use every single embodiment within a claimed class. For instance, it could suffice to give an example (or a few examples) if the specification also disclosed some general quality running through the class that gave it a peculiar fitness for the particular purpose. In some cases, disclosing that general quality could reliably enable a person skilled in the art to make and use all of what was claimed, not merely a subset.
18. A specification was not necessarily inadequate just because it left the skilled artist to engage in some measure of adaptation or testing. For example, a patent that claimed a process for making bricks by mixing coal dust into clay could include a general rule about the proportion of dust and clay to use and offered two alternative proportions where the clay had some peculiarity. Some small difference in the proportions had to occasionally be required given the varieties of clay. The record showed that preliminary tests were required to adapt the process to any particular ore. Certainty which the law required in patents was not greater than was reasonable. And because the composition of ores varied infinitely, it was impossible to specify in a patent the precise treatment which would be most successful and economical in each case.
19. What was reasonable in any case would depend on the nature of the invention and the underlying art. But in allowing that much tolerance, courts could not detract from the basic statutory requirement that a patent’s specification described the invention in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the invention. The court could no more subtract from the requirements for obtaining a patent that Congress had prescribed than it could add to them.
20. With those principles in mind, the court returned to claims 19 and 29 of the ’165 patent and claim 7 of the ’741 patent. In doing so, the court did not doubt that the petitioner’s specification enabled the 26 exemplary antibodies it identified by their amino acid sequences. Even the respondent conceded that description was enough to allow a person skilled in the art to make and use those embodiments. But the claims before the court swept much broader than those 26 antibodies. And the court agreed with the lower courts that the petitioner had failed to enable all that it had claimed, even allowing for a reasonable degree of experimentation.
21. The petitioner sought to monopolize an entire class of things defined by their function—every antibody that both bound to particular areas of the sweet spot of PCSK9 and blocks PCSK9 from binding to LDL receptors. The record reflected that that class of antibodies did not include just the 26 that the petitioner had described by their amino acid sequences, but a vast number of additional antibodies that it had not.
22. The petitioner freely admitted that it sought to claim for itself an entire universe of antibodies. Still, it said, its broad claims were enabled because scientists could make and use every undisclosed but functional antibody if they simply followed the company’s roadmap or its proposal for conservative substitution.
23. Those two approaches amounted to little more than two research assignments. The first merely described step-by-step the petitioner’s own trial-and-error method for finding functional antibodies—calling on scientists to create a wide range of candidate antibodies and then screen each to see which happened to bind to PCSK9 in the right place and block it from binding to LDL receptors. The second was not much different. It required scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they did too—an uncertain prospect given the state of the art. Whether methods like a roadmap or conservative substitution might suffice to enable other claims in other patents—perhaps because the inventor identified a quality common to every functional embodiment—they did not.
24. One could imagine a combination lock with 100 tumblers, each of which could be set to 20 different positions. Through trial and error, one could imagine that an inventor found and disclosed 26 different successful lock combinations. But one could imagine, too, that the inventor tried to claim much more, namely all successful combinations, while instructing others to randomly try a large set of combinations and then record the successful ones. Sure enough, that kind of roadmap would produce functional combinations. But it would not enable others to make and use functional combinations; it would instead leave them to random trial-and-error discovery. Like many analogies, that one could oversimplify a bit, but it captured the gist of the problem.
25. Failing in its primary argument that it had enabled all of the antibodies it claimed, the petitioner tried a few alternative lines of attack. First, it suggested that the Federal Circuit erred by applying an enablement test unmoored from the statutory text. As the petitioner saw it, that court conflated the question whether an invention was enabled with the question how long could it take a person skilled in the art to make every embodiment within a broad claim. The court did not see it that way. While the court agreed with the petitioner that enablement was not measured against the cumulative time and effort it took to make every embodiment within a claim, the court was not so sure the Federal Circuit thought otherwise. That court went out of its way to say that it did not hold that the effort required to exhaust a genus was dispositive. Instead, the court stressed, the problem it saw was the same problem as in the case at hand: Amgen offered persons skilled in the art little more than advice to engage in trial and error. The court viewed judgments of the lower courts, not statements in their opinions.
26. There was one statutory enablement standard. But, once more, the court did not understand the Federal Circuit to have thought differently. Instead, it understood that court to have recognized only that the more a party claimed for itself the more it had to enable. That much was entirely consistent with Congress’s directive and the court’s precedents.
27. The petitioner warned that an affirmance risked destroying incentives for breakthrough inventions. But striking the proper balance between incentivizing inventors and ensuring the public received the full benefit of their innovations was a policy judgment that belonged to Congress. Since 1790, Congress had included an enablement mandate as one feature among many designed to achieve the balance it wished. The court’s only duty in the case lay in applying that mandate faithfully.
28. Section 112 of the Patent Act reflected Congress’s judgment that if an inventor claimed a lot, but enabled only a little, the public did not receive its benefit of the bargain. For more than 150 years, the court had enforced the statutory enablement requirement according to its terms. The case could involve a new technology, but the legal principle was the same.

Appeal dismissed; judgment of the trial court affirmed.

Relevance to the Kenyan jurisprudence

The Constitution of Kenya, 2010, in article 260 (c) defines the term property to include intellectual property. Moreover, in articles 11 (2)(c), 40 (5) and 69 (1)(c) it stresses that the state shall support, promote and protect the intellectual property rights of the people of Kenya.

Kenya ratified and signed at Washington the Patent Co-operation Treaty on the June 19, 1970; as evidenced under the provisions of section 2 of part 1 of the Industrial Property Act, 2001 Cap 509 laws of Kenya.  Section 21 (1) of the Industrial Property Act, 2001, Cap 509 of the laws of Kenya provides that the term invention means a solution to a specific problem in the field of technology.

According to Mary Kiveu: A patent is an exclusive right granted for an invention that provides a new way of doing something or offers a new technical solution to a problem for a period of time (mostly 20 years) in exchange for knowledge disclosure to the public. Patents, in essence, give legal recognition to the owners of new inventions, providing them with authority to stop others from exploiting their invention and financial investment. Patent rights are granted for an invention that is new, has an inventive step and is industrially applicable.[1]

In John Kamonjo Mwaura v Kenya Industrial Property Institute & another; National Commercial Bank of Africa (NCBA) & another (Interested Party) [2020] eKLR, the court dismissed the petition holding that: