Tracking the landscape of patent remedies
 
Federal Circuit on Damages and other Remedies

Tracking Supreme Court Patent Decisions

Below are cases decided by the Supreme Court on patent law issues. This page will attempt to track all relevant Supreme Court decisions.

 

2020

Case Issue(s) Holding(s)
Thryv, Inc. v. Click-To-Call Techs., No. 18-916 (U.S. Apr. 20, 2020) Inter Partes Review “A party generally cannot contend on appeal that the agency should have refused to institute an inter partes review.”

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2019

Case Issue(s) Holding(s)
Peter v. NantKwest, Inc., No. 18-801 (U.S. Dec. 11, 2019) Section 145 Actions “The PTO cannot recover the salaries of its legal personnel under §145…. Section 145’s plain text does not overcome the American Rule’s presumption against fee shifting.”
Return Mail, Inc. v. Postal Service, 139 S. Ct. 1853 (2019) AIA Review Proceedings “The Government is not a ‘person’ capable of instituting the three AIA review proceedings.”
Helsinn Healthcare S. A. v. Teva Pharms. United States, Inc., 139 S. Ct. 628 (2019) On-Sale Bar “A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under §102(a)…. [A] sale or offer of sale need not make an invention available to the public to constitute invalidating prior art.”

 

2018

Case Issue(s) Holding(s)
Westerngeco LLC v. Ion Geophysical Corp., 138 S. Ct. 2129 (2018) Lost Profits

Section 271(f) Infringement

International Sales

“WesternGeco’s award for lost profits was a permissible domestic application of §284 of the Patent Act…. [T]he focus of §284 in a case involving infringement under §271(f)(2) is on the act of exporting components from the United States. So the conduct in this case that is relevant to the statutory focus clearly occurred in the United States.”
SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348 (2018) Inter Partes Review “When the Patent Office institutes an inter partes review, it must decide the patentability of all of the claims the petitioner has challenged…. [Section] 318(a) means that the Board must address every claim the petitioner has challenged. The Director’s partial institution power appears nowhere in the statutory text. And both text and context strongly counsel against inferring such a power.”
Oil States Energy Servs., LLC v. Greene’s Energy Grp., LLC, 138 S. Ct. 1365 (2018) Inter Partes Review “Inter partes review does not violate Article III…. The decision to grant a patent is a matter involving public rights. Inter partes review is simply a reconsideration of that grant, and Congress has permissibly reserved the PTO’s authority to con-duct that reconsideration.”

 

2017

Case Issue(s) Holding(s)
Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017) Biologics Price Competition and Innovation Act “Section 262(l)(2)(A)’s requirement that an applicant provide the sponsor with its application and manufacturing information is not enforceable by an injunction under federal law…. The Federal Circuit should determine on remand whether an injunction is available under state law to enforce §262(l)(2)(A)…. An applicant may provide notice of commercial marketing before obtaining a license.”
Impression Prods., Inc. v. Lexmark Int’l, Inc., 137 S. Ct. 1523 (2017) Patent Exhaustion

 

International Sales

“Lexmark exhausted its patent rights in the Return Program cartridges that it sold in the United States. A patentee’s decision to sell a product exhausts all of its patent rights in that item, regardless of any restrictions the patentee purports to impose. As a result, even if the restrictions in Lexmark’s contracts with its customers were clear and enforceable under contract law, they do not entitle Lexmark to retain patent rights in an item that it has elected to sell…. An authorized sale outside the United States, just as one within the United States, exhausts all rights under the Patent Act.”
TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514 (2017) Venue “As applied to domestic corporations, ‘residence’ in §1400(b) refers only to the State of incorporation…. [Section 1400(b)’s predecessor] permitted suit in the district of which the defendant was an ‘inhabitant’ or in which the defendant both maintained a ‘regular and established place of business’ and committed an act of infringement…. The amendments to §1391 did not modify the meaning of §1400(b).”
SCA Hygiene Prods. Aktiebolag v. First Quality Baby Prods., LLC, 137 S. Ct. 954 (2017) Laches “Laches cannot be invoked as a defense against a claim for damages brought within §286’s 6-year limitations period.”
Life Techs. Corp. v. Promega Corp., 137 S. Ct. 734 (2017) Section 271(f) Infringement The supply of a single component of a multicomponent invention for manufacture abroad does not give rise to §271(f)(1) liability…. Section 271(f)(1)’s phrase ‘substantial portion’ refers to a quantitative measurement…. Under a quantitative approach, a single component cannot constitute a ‘substantial portion’ triggering §271(f)(1) liability.”

 

2016

Case Issue(s) Holding(s)
Samsung Elecs. Co. v. Apple Inc., 137 S. Ct. 429 (2016) Section 289 Total Profit “In the case of a multicomponent product, the relevant ‘article of manufacture’ for arriving at a §289 damages award need not be the end product sold to the consumer but may be only a component of that product.”
Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016) Inter Partes Review

 

Claim Construction

“The text of §314(d) expressly states that the Patent Office’s determinations whether to institute inter partes review ‘shall be final and nonappealable….’ The ‘strong presumption’ favoring judicial review… is overcome here by these ‘clear and convincing’ indications that Congress intended to bar review…. The Patent Office regulation requiring the Board to apply the broadest reasonable construction standard to interpret patent claims is a reasonable exercise of the rulemaking authority granted to the Patent Office by statute.”
Halo Elecs., Inc. v. Pulse Elecs., Inc., 136 S. Ct. 1923 (2016) Willfulness “A patent infringer’s subjective willfulness, whether intentional or knowing, may warrant enhanced damages, without regard to whether his infringement was objectively reckless…. Patent-infringement litigation has always been governed by a preponderance of the evidence standard. Enhanced damages are no exception…. Because §284 ‘commits the determination’ whether enhanced damages are appropriate to the district court’s discretion, ‘that decision is to be reviewed on appeal for abuse of discretion.”

 

2015

Case Issue(s) Holding(s)
Kimble v. Marvel Entm’t, LLC, 135 S. Ct. 2401 (2015) Reasonable Royalty “A patent typically expires 20 years from its application date. At that point, the unrestricted right to make or use the article passes to the public…. [T]he post-patent royalty provision was unlawful per se, because it continued the patent monopoly beyond the patent period, and, in so doing, conflicted with patent law’s policy of establishing a post-expiration public domain.”
Commil United States, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920 (2015) Induced Infringement “A defendant’s belief regarding patent validity is not a defense to an induced infringement claim…. Because induced infringement and validity are separate issues and have separate defenses under the Act, belief regarding validity cannot negate §271(b)’s scienter requirement of actively induced infringement.”
Teva Pharm. United States, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) Claim Construction “When reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a clear error, not a de novo, standard of review…. The ultimate construction of the claim is a legal conclusion that the appellate court can review de novo. But to overturn the judge’s resolution of an underlying factual dispute, the appellate court must find that the judge, in respect to those factual findings, has made a clear error.”

 

2014

Case Issue(s) Holding(s)
Alice Corp. v. CLS Bank International, 134 S. Ct. 2347 (2014) Subject Matter Eligibility “In applying the §101 exception,… the Court must first determine whether the claims at issue are directed to a patent-ineligible concept. If so, the Court then asks whether the claim’s elements, considered both individually and as an ordered combination, transform the nature of the claim into a patent-eligible application…. The claims at issue are directed to a patent-ineligible concept: the abstract idea of intermediated settlement…. The method claims, which merely require generic computer implementation, fail to transform that abstract idea into a patent-eligible invention.”
Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014) Indefiniteness “A patent is invalid for indefiniteness if its claims, read in light of the patent’s specification and prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention…. [A] patent must be precise enough to afford clear notice of what is claimed, thereby apprising the public of what is still open to them, in a manner that avoids a zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims.”
Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915 (2014) Induced Infringement “A defendant is not liable for inducing infringement under §271(b) when no one has directly infringed under §271(a) or any other statutory provision.”
Octane Fitness, LLC v. Icon Health & Fitness, Inc., 572 U.S. 545 (2014) Attorney Fees “Section 285 imposes one and only one constraint on district courts’ discretion to award attorney’s fees: The power is reserved for ‘exceptional’ cases…. An ‘exceptional’ case, then, is simply one that stands out from others with respect to the substantive strength of a party’s litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated. District courts may determine whether a case is ‘exceptional’ in the case-by-case exercise of their discretion, considering the totality of the circumstances…. Finally, we reject the Federal Circuit’s requirement that patent litigants establish their entitlement to fees under §285 by clear and convincing evidence.”
Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., 572 U.S. 559 (2014) Attorney Fees “All aspects of a district court’s exceptional-case determination under §285 should be reviewed for abuse of discretion.”
Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191 (2014) Declaratory Judgement “Here, if Medtronic had acted consistent with the understanding of its rights that it seeks to establish through the declaratory judgment suit (by ceasing to pay royalties), Mirowski could terminate the license and bring a suit for infringement. That suit would arise under federal patent law because patent law creates the cause of action. Thus, this declaratory judgment action, which avoids that hypothetical threatened action, also arises under federal patent law.… When a licensee seeks a declaratory judgment against a patentee that its products do not infringe the licensed patent, the patentee bears the burden of persuasion on the issue of infringement.”

 

2013

Case Issue(s) Holding(s)
Fed. Trade Comm’n v. Actavis, Inc., 570 U.S. 136 (2013) Antitrust “Although the anticompetitive effects of the reverse settlement agreement might fall within the scope of the exclusionary potential of Solvay’s patent, this does not immunize the agreement from antitrust attack…. This Court declines to hold that reverse payment settlement agreements are presumptively unlawful. Courts reviewing such agreements should proceed by applying the ‘rule of reason,’ rather than under a ‘quick look’ approach.”
Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) Subject Matter Eligibility “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring…. cDNA is not a ‘product of nature,’ so it is patent eligible under§101…. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.”
 Bowman v. Monsanto Co., 569 U.S. 278 (2013) Patent Exhaustion “Patent exhaustion does not permit a farmer to reproduce patent-ed seeds through planting and harvesting without the patent holder’s permission…. [T]he doctrine restricts the patentee’s rights only as to the particular article sold; it leaves untouched the patentee’s ability to prevent a buyer from making new copies of the patented item. By planting and harvesting Monsanto’s patented seeds, Bowman made additional copies of Monsanto’s patented invention, and his conduct thus falls outside the protections of patent exhaustion.”
 Gunn v. Minton, 133 S. Ct. 1059 (2013) Federal Question Jurisdiction “[I]t is clear that Minton’s legal malpractice claim does not arise under federal patent law. Resolution of a federal patent question is necessary to Minton’s case. To prevail on his claim, Minton must show that an experimental-use argument would have prevailed if only petitioners had timely made it in the earlier patent litigation. That hypothetical patent case within the malpractice case must be resolved to decide Minton’s malpractice claim. The federal issue is also actually disputed…. Here, the federal issue does not carry the necessary significance. No matter how the state courts resolve the hypothetical ‘case within a case,’ the real-world result of the prior federal patent litigation will not change. Nor will allowing state courts to resolve these cases undermine ‘the development of a uniform body of patent law.”

 

2012

Case Issue(s) Holding(s)
Kappos v. Hyatt, 132 S. Ct. 1690 (2012) Section 145 Actions “There are no limitations on a patent applicant’s ability to introduce new evidence in a §145 proceeding beyond those already present in the Federal Rules of Evidence and the Federal Rules of Civil Procedure. If new evidence is presented on a disputed question of fact, the district court must make de novo factual findings that take account of both the new evidence and the administrative record before the PTO…. The district court may, however, consider whether the applicant had an opportunity to present the newly proffered evidence before the PTO in deciding what weight to afford that evidence.”
Caraco Pharm. Labs., Ltd. v. Novo Nordisk, 566 U.S. 399 (2012) Hatch Waxman “A generic manufacturer may employ the counterclaim provision to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of using a drug…. The statute … contemplates that one patented use will not foreclose marketing a generic drug for other unpatented ones. Within this scheme, the counterclaim naturally functions to challenge the brand’s assertion of rights over whichever discrete uses the generic company wishes to pursue; the counterclaim’s availability matches the availability of FDA approval under the statute.”
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) Subject Matter Eligibility “Because the laws of nature recited by Prometheus’ patent claims—the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—are not themselves patentable, the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. The three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims.”

 

2011

Case Issue(s) Holding(s)
 Microsoft Corp. v. I4I Limited Partnership, 564 U.S. 91 (2011)  Invalidity Defenses “Section 282 requires an invalidity defense to be proved by clear and convincing evidence. Here, by stating that a patent is ’presumed valid,’ §282, Congress used a term with a settled common-law meaning…. [I]f the PTO did not have all material facts before it, its considered judgment may lose significant force. Consistent with that principle, a jury may be instructed to evaluate whether the evidence before it is materially new, and if so, to consider that fact when determining whether an invalidity defense has been proved by clear and convincing evidence.”
Bd. of Trust. of L.S.J.U. v. Roche Mol. Sys., 563 U.S. 776 (2011)  Bayh-Dole Act “The Bayh-Dole Act does not automatically vest title to federally funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions…. Absent an agreement to the contrary, an employer does not have rights in an invention which is the original conception of the employee alone; an inventor must expressly grant those rights to his employer.”
Global-Tech Appliances, Inc. v. Seb S. A., 563 U.S. 754 (2011) Induced Infringement “Induced infringement under §271(b) requires knowledge that the induced acts constitute patent infringement…. Deliberate indifference to a known risk that a patent exists does not satisfy the knowledge required by §271(b). Nevertheless, the Federal Circuit’s judgment must be affirmed because the evidence in this case was plainly sufficient to support a finding of Pentalpha’s knowledge under the doctrine of willful blindness.”

 

2010

Case Issue(s) Holding(s)
Bilski v. Kappos, 561 U.S. 593 (2010) Subject Matter Eligibility “Petitioners seek to patent both the concept of hedging risk and the application of that concept to energy markets. Under Benson, Flook, and Diehr, however, these are not patentable processes but attempts to patent abstract ideas…. Claims 1 and 4 explain the basic concept of hedging and reduce that concept to a mathematical formula. This is an unpatentable abstract idea…. Petitioners’ remaining claims, broad examples of how hedging can be used in commodities and energy markets, attempt to patent the use of the abstract hedging idea, then instruct the use of well-known random analysis techniques to help establish some of the in-puts into the equation.”

 

2008

Case Issue(s) Holding(s)
Quanta Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617 (2008) Patent Exhaustion “Nothing in this Court’s approach to patent exhaustion supports LGE’s  argument  that  method  claims,  as  a  category,  are  never  exhaustible.  A patented method may not be sold in the same way as an article  or  device,  but  methods  nonetheless  may  be  “embodied”  in  a product, the sale of which exhausts patent rights.” “Because the doctrine of patent exhaustion applies to method patents, and because the License Agreement authorizes the sale of components  that  substantially  embody  the  patents  in  suit,  the  exhaustion  doctrine  prevents  LGE  from  further  asserting  its  patent  rights with respect to the patents substantially embodied by those products.”

 

2007

Case Issue(s) Holding(s)
Microsoft Corp. v. AT&T Corp., 550 U.S. 437 (2007) Section 271(f) Infringement

 

International Sale

Section 271(f) attaches liability to the supply abroad of the ‘components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components.” “A copy of Windows, not Windows in the abstract, qualifies as a ‘component’ under §271(f).” “Because Microsoft does not export from the United States the copies of Windows installed on the foreign-made computers in question, Microsoft does not ‘suppl[y] . . . from the United States’ ‘components’ of those computers, and therefore is not liable under §271(f) as currently written.”
KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) Obviousness “When  a  work  is  available  in  one  field,  design  incentives  and  other  market  forces  can prompt  variations  of  it,  either  in  the  same  field  or  in  another.    If  a  person of ordinary skill in the art can implement a predictable variation,  and  would  see  the  benefit  of  doing  so,  §103  likely  bars  its  patentability.  Moreover,  if  a  technique  has  been  used  to  improve  one  device, and a person of ordinary skill in the art would recognize that it  would  improve  similar  devices  in  the  same  way,  using  the  technique is obvious unless its actual application is beyond that person’s skill.  A  court  must  ask  whether  the  improvement  is  more  than  the predictable  use  of  prior-art  elements  according  to  their  established functions….  To determine whether  there  was  an  apparent  reason  to  combine  the  known  elements in the way a patent claims, it will often be necessary to look to interrelated  teachings  of  multiple  patents;  to  the  effects  of  demands  known to the design community or present in the marketplace; and to the  background  knowledge  possessed  by  a  person  having  ordinary skill in the art.  To facilitate review, this analysis should be made explicit. But it need not seek out precise teachings directed to the challenged claim’s specific subject matter, for a court can consider the inferences and creative steps a person of ordinary skill in the art would employ… The  flaws  in  the  Federal  Circuit’s  analysis  relate  mostly  to  its  narrow conception of the obviousness inquiry consequent in its appli-cation of the TSM test.  The Circuit first erred in holding that courts and  patent  examiners  should  look  only  to  the  problem  the  patentee was trying to solve. …    Second,  the  appeals  court  erred  in  assuming  that  a  person  of  ordinary  skill  in  the art  attempting  to  solve  a  problem  will  be  led  only  to  those  prior  art elements  designed  to  solve  the  same  problem….   Third,  the court erred in concluding that a patent claim cannot be proved obvious merely by showing that the combination of elements was obvious to  try.…  Finally,  the  court  drew  the wrong conclusion from the risk of courts and patent examiners falling prey to hindsight bias.”
Medimmune, Inc. v. GenenTech, Inc., 549 U.S. 118 (2007) Declaratory Judgment The Federal Circuit erred in affirming the dismissal of this action for lack of subject-matter jurisdiction. The standards for determining whether a particular declaratory-judgment action satisfies the case-or-controversy requirement—i.e., whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant relief—are satisfied here even though petitioner did not refuse to make royalty payments under the license agreement.” “Contrary to respondents’ assertion that only a freestanding patent-invalidity claim is at issue, the record establishes that petitioner has  raised  and  preserved  the  contract  claim  that,  because  of  patent invalidity,  unenforceability,  and  noninfringement,  no  royalties  are owing.”

 

2006

Case Issue(s) Holding(s)
Ebay Inc. v. Mercexchange, L. L. C., 547 U.S. 388 (2006) Injunctions “The traditional four-factor test applied by courts of equity when considering whether to award permanent  injunctive  relief  to  a  pre-vailing  plaintiff  applies  to  disputes  arising  under  the  Patent  Act. That test requires a plaintiff to demonstrate: (1) that it has suffered an  irreparable  injury;  (2)  that  remedies  available  at  law  are  inadequate to compensate for that injury; (3) that considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.  The decision to grant or deny such relief is an act of equitable discretion by the district court, reviewable on appeal for abuse of discretion.”
Illinois Tool Works Inc. v. Independent Ink, Inc., 547 U.S. 28 (2006) Antitrust “Because a patent does not necessarily confer market power upon the patentee, in all cases involving a tying arrangement, the plaintiff must prove that the defendant has market power in the tying product…. [T]ying arrangements involving patented products should be evaluated under the standards of cases like FortnerII and Jefferson Parish rather than the per se rule in Morton Salt and Loew’s.”

 

2005

Case Issue(s) Holding(s)
Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) FDA Safe Harbor “[T]he use of a patented compound in experiments that are not themselves included in a ‘submission of information’ to the FDA does not, standing alone, render the use infringing. The relationship of the use of a patented compound in a particular experiment to the ‘development and submission of information’ to the FDA does not become more attenuated (or less reasonable) simply because the data from that experiment are left out of the submission that is ultimately passed along to the FDA. Moreover, many of the uncertainties that exist with respect to the selection of a specific drug exist as well with respect to the decision of what research to include in an IND or NDA….This is especially true at the preclinical stage of drug approval…We thus agree with the Government that the use of patented compounds in preclinical studies is protected under § 271(e)(1) as long as there is a reasonable basis for believing that the experiments will produce “the types of information that are relevant to an IND or NDA.”

 

2002

Case Issue(s) Holding(s)
Holmes Group, v. Vornado Air Circulation Systems, Inc., 535 U.S. 826 (2002) Federal Question Jurisdiction “The Federal Circuit cannot assert jurisdiction over a case in which the  complaint  does  not  allege  a  patent-law  claim,  but  the  answer  contains a patent-law counterclaim.… Because petitioner’s well-pleaded complaint asserted no claim arising under patent law, the Federal Circuit erred in asserting jurisdiction over this appeal….  The  well-pleaded complaint  rule  does  not  allow  a  counterclaim to  serve  as  the  basis  for  a  district  court’s  “arising  under”  jurisdiction.”
Festo Corp. v. Shoketsu Kinzoku Kogyokabushiki Co., 535 U.S. 722 (2002) Prosecution History Estoppel “When the patentee originally claimed the subject matter alleged to infringe but then narrowed the claim in response to a rejection,  he  may  not  argue  that  the  surrendered  territory  comprised  an unforeseen  equivalent.  The  rejection  indicates  that  the  patent  examiner  does  not  believe  the  original  claim  could  be  patented. While the patentee  has  the  right  to  appeal,  his  decision  to  forgo  an  appeal  and submit an amended claim is taken as a concession that the invention as patented  does  not  reach  as  far  as  the  original  claim…. Prosecution  history  estoppel  is  not  limited  to  amendments  in-tended to narrow the patented invention’s subject matter, e. g., to avoid prior art, but may apply to a narrowing amendment made to satisfy any Patent  Act  requirement,  including  § 112’s  requirements  concerning  the patent application’s form…. Prosecution  history  estoppel  does  not  bar  the  inventor  from  asserting infringement against every equivalent to the narrowed element. Though  estoppel  can  bar  challenges  to  a  wide  range  of  equivalents,  its reach  requires  an  examination  of  the  subject  matter  surrendered  by the narrowing amendment.”

 

2001

Case Issue(s) Holding(s)
J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001) Subject Matter Eligibility “Newly  developed  plant  breeds  fall  within  the  subject  matter  of § 101, and neither the PPA nor the PVPA limits the scope of § 101’s coverage….   The  PTO  has  assigned  utility  patents  for  plants  for  at  least  16years, and there has been no indication from either Congress or agencies with expertise that such coverage is inconsistent with the PVPA or the PPA.”