Archive for the ‘Supreme Court’ Category

Supreme Court Strikes Down Isolated DNA Claims; Permits cDNA Claims

June 17, 2013

USSupremeCourtWestFacadeLast week, the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc.  Justice Thomas, writing for a unanimous Court, ruled that isolated DNA sequences are not patent eligible.  The Court did permit the patent claims to isolated cDNA to stand.

The gene patent saga filed by the ACLU on behalf of a large number of plaintiffs has finally come to an end.  After 4 years of litigation and 2 trips to the Supreme Court, the law is that isolated DNA is no longer eligible for patent protection.  cDNA, however, remains patentable.

Given the recent Supreme Court decisions on patent eligibility under § 101, the only surprising thing about the opinion was that they did not strike down all of the claims.  Myriad retains its claims to methods of screening patients for the genetic mutation that indicates a higher propensity for breast and ovarian cancers, and it retains its claims to complementary DNA (cDNA).

The opinion did not seem to conflate patent eligibility with novelty or obviousness as in Mayo v. Prometheus.  The opinion in Myriad started with the statutory language and then turned to the judicial exceptions for “laws of nature, natural phenomena, and abstract ideas.”  The Court then quoted extensively from Mayo to expound on these exceptions:

without [these] exception[s], there would be considerable danger that the grant of patents would “tie up” the use of [basic tools of scientific and technological work] and thereby “inhibit future innovation premised upon them.”

This idea from Mayo is that patents inhibit research and development instead of encouraging it.  It has been thought for years that one of the purposes of patents is to provide an incentive to innovate.  These statements bring that premise into question.

And, of course, by definition a patent will “tie up” the claimed subject matter.  That’s the whole point:  to be able to exclude others from copying the claimed invention.

In the analysis of the isolated DNA, the Court held that Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes.  ”Myriad did not create anything,” according to the Court.  ”[S]eparating [the] gene[s] from [the] surrounding genetic material is not an act of invention.”  The PTO apparently thought otherwise for about 30 years.  The Supreme Court whisks it all away without providing support for the contention that is does not constitute an act of invention.

The Court did recognize that cDNA is not naturally occurring.  It may retain some characteristics of the isolated DNA, but it is generally created in the lab and does not exist in the human body.  Therefore, cDNA is still patent eligible.

Finally, the Court seemed to try to give some hope and encouragement to the biotechnology industry:

  1. The Court noted that no method claims were included in its opinion.  Innovative methods of manipulating the genes would still be patent eligible.
  2. The Court noted that new applications of knowledge about particular genes may still remain patent eligible.
  3. The Court noted that it provided no opinion on the patent eligibility of DNA in which the order of the naturally occurring nucleotide sequences has been altered.

On the third point, the Court did not provide guidance.  How much alteration is required for patent eligibility?

Justice Scalia wrote a rather bizarre opinion concurring in part and concurring in the judgment.

I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.

This is something to keep in mind regarding these cases.  The judges and juries who must ultimately rule on them will very rarely understand the science behind them.  They are usually not this candid in admitting their lack of understanding.

Implications

How will this opinion affect the biotechnology industry? Given this and other recent Supreme Court opinions on patentable subject matter, it seems that patents in the area of personalized medicine will be difficult to obtain and enforce. Many biotechnology companies are working on ways to grow organs that can be transplanted into the human body to replace defective organs. The goal is for these organs to be as similar to the natural organs as possible. This opinion seems to indicate that such organs could not be patented.  HT:  IPWatchdog.

Given the extensive costs of research in these areas, will companies continue to make large scale investments? The Supreme Court seems to be arguing, somewhat contrary to historical understandings, that patent inhibit rather than encourage research. Monopoly profits for the limited term of the patent are set to encourage companies to make large initial upfront investments.

Supreme Court to Review Burden of Proof in Declaratory Judgment Actions

May 21, 2013

Yesterday, the Supreme Court agreed to hear the appeal of the declaratory judgment plaintiff in Medtronic Inc. v. Boston Scientific Corp.  The question presented in the case is as follows:

In MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 137 (2007), this Court ruled that a patent licensee that believes that its products do not infringe the patent and accordingly are not subject to royalty payments is “not required … to break or terminate its … license agreement before seeking a declaratory judgment in federal court that the underlying patent is … not infringed.”

The question presented is whether, in such a declaratory judgment action brought by a licensee under MedImmune, the licensee has the burden to prove that its products do not infringe the patent, or whether (as is the case in all other patent litigation, including other declaratory judgment actions), the patentee must prove infringement.

Federal Circuit Decision

Medtronic licensed patented technology related to cardiac resynchronization therapy (CST) from Mirowski Family Ventures (MFV).  Nearly from the start of the relationship, the parties disagreed as to which products were covered by the patents and whether the patents were valid.  In 2003, Medtronic challenged the validity of a licensed patent while paying royalties into an escrow account.  The parties ultimately settled the case.  The settlement agreement indicated that MFV would inform Medtronic as to which products were covered by the patents.  If Medtronic disagreed, it could retain the license while bringing a declaratory judgment action to have the court decide the issue.

In late 2007, Medtronic filed just such a declaratory judgment action of non-infringement and invalidity of the patents.  Because it continued in the license agreement, MFV could not counterclaim for infringement.  The parties disputed whether the burden to prove infringement rested on MFV, as is typically the case for the patent owner, or if, given the stature of the case, Medtronic bore the burden to prove non-infringement.  The district court sided with Medtronic and found the MFV did not meet its burden of proving infringement of the Medtronic products.

On appeal, the Federal Circuit recognized that the case is not the typical patent infringement situation where the patent owner files the initial complaint, nor is it the typical declaratory judgment case where the patent owner files the compulsory infringement counterclaim.  In those situations, the patent owner quite clearly bears the burden of proving infringement.

Now that the Supreme Court has indicated that counterclaims can be filed in the absence of ceasing royalty payments, patent owners cannot always file infringement counterclaims in the face of a declaratory judgment action.  Does the patent owner still bear the burden of proving infringement or has it shifted to the declaratory judgment plaintiff?

The Federal Circuit reversed the district court and allocated the burden of proof to the declaratory judgment plaintiff.  The court clearly struggled with how to handle the burden in light of MedImmune.  The court ultimately reasoned that MedImmune would become not simply a shield to keep licensees from large damage awards from non-payment of the license, but also a sword to haul the patent owner into court where the patent owner must prove infringement.  It is the licensee and not the patent owner who seeks relief from the court and a change in the status quo.  If neither party presented evidence, the court should not upset the status quo of the license agreement.  Thus, fairness requires them to bear the burden of proof.

The Supreme Court has now agreed to resolve this dilemma of its own making during its October 2013 term.

Supreme Court Affirms Federal Circuit in Seed Patent Exhaustion Case

May 13, 2013

In a rare affirmance of the Federal Circuit, the Supreme Court found no exhaustion in the seed patent case.  Bowman v. Monsanto Co.

Justice Kagan, writing for a unanimous Court, held that the doctrine of patent exhaustion only restricts a patent owner’s rights to a particular article sold.  It does not limit the patent owner’s right to keep others from making additional copies of the patented invention.

Exhaustion protected Bowman as to his ability to use the patented seeds as he saw fit.  It does not, however, protect him from charges of infringement should he decide to “make” new seeds.  This is what the Court said he did.  He planted the original seeds and harvested new ones from the resulting plants.  The act of making the new seeds was an act of infringement not protected by patent exhaustion.

More details are available in my preview post for the Supreme Court’s current term.

International IP Exhaustion Reprised

March 27, 2013

As an update to my earlier post on the case, the Supreme Court recently issued its decision on international copyright exhaustion.

Kirtsaeng v. John Wiley & Sons

The Supreme Court reversed the decision of the Second Circuit and held that John Wiley’s copyright was exhausted by the authorized sale of the textbooks in Thailand.  Kirtsaeng was free to do whatever he wanted with the books once he lawfully acquired them, including importing them into the United States and reselling them.

Professor Kristen Osenga of the University of Richmond Law School (my wife) provided a podcast for the Federalist Society about the Supreme Court’s decision.  http://www.fed-soc.org/publications/detail/kirtsaeng-v-john-wiley-sons-inc-post-decision-scotuscast.

The question of what, if any, impact this decision will have on patent law remains unanswered.  The Supreme Court refused to consider an appeal in a patent case on this same issue and left the Federal Circuit’s patent exhaustion opinion in place, even though the decision is contrary to the decision in Kirtsaeng.  Ninestar v. ITC.

Patent Malpractice Cases Belong in State Court

February 21, 2013

Yesterday, a unanimous Supreme Court has overturned the Federal Circuit practice of keeping malpractice cases against patent attorneys in Federal court with appeals to the Federal Circuit.  Gunn v. Minton.

In this case, the Texas Supreme Court had followed the Federal Circuit’s rule and dismissed the case for lack of subject matter jurisdiction.  The Federal Circuit’s rule was that such cases required resolution of significant issues of patent law, including whether the complainant would have prevailed if not for the alleged malpractice.  Would the complainant have received its patent in prosecution or prevailed on infringement claims in litigation?  The Federal Circuit was concerned that state courts are not adequately experienced in deciding patent cases which have exclusive Federal jurisdiction.  There could also be cases with conflicting results.

Judge O’Malley had recently been dissenting from the court’s prevailing view on this issue.

The Supreme Court held that although the state courts must answer questions of patent law to resolve the malpractice claims, the answer has no broader effects.  It is not binding precedent on future patent claims and will not effect the validity of the patent.  Therefore, state courts may retain jurisdiction over such malpractice claims.

The question next becomes whether the resolution of this case will effect other cases.  For example, is a dispute over a license or other contract whose subject matter is a patent belong exclusively in Federal court?  Contract disputes are typically decided under state law.  This question is presented in another case where a petition is pending before the Supreme Court.  Regents of Univ. of California v. Caldera Pharm., Inc.

As noted by Patently-O, however, the AIA changed the jurisdictional requirement from whether the dispute “arises under” the patent laws to whether it involves “any claim for relief arising under any Act of Congress relating to patents.”

Supreme Court Won’t Review Claim Construction

January 8, 2013

The Supreme Court has denied the request to hear Retractable Techs., Inc. v. Becton, Dickinson & Co.  The case involves claim construction and whether deference should be given to the district court’s interpretation on appeal.

In 1998, the Federal Circuit issued its decision in Cybor Corp. v. FAS Techs., Inc.  The en banc court ruled that district court claim construction rulings should be reviewed de novo on appeal.  This means that the court held that claim construction was purely a matter of law.  Traditionally, factual issues are reviewed by appellate courts under a different standard of review than legal issues.  The district court actually heard the witnesses and reviewed the evidence and is thus entitled to deference when reviewing factual issues on appeal.  Not so with legal issues.

That decision has led to extremely high reversal rates on appeal at the Federal Circuit.  A district court will issue and claim construction order, conduct an infringement trial and then be reversed on appeal.  The court would then have to try the case all over again.  This procedure is highly inefficient given the high costs of patent litigation.

Sometimes, parties would stipulate to infringement or non-infringement if they lost the claim construction battle at the district court.  This would tee the case up for appeal without the need for multiple trials.  If the case was affirmed, there was no need for trial; if it was reversed, the final word on claim construction permitted a single trial on infringement.

Since Cybor Corp., there have been a number of calls for the Federal Circuit to reconsider the standard of review.  Claim construction should not be viewed as a purely legal matter.  There are always underlying issues of fact that the district court reviews.  During hearings on claim construction, the court may review evidence of the invention, hear witness testimony, and review expert reports.  The Federal Circuit does not provide any deference to the district court’s review of this evidence as it does most other factual issues.

In Retractable Techs., the district court construed the term “body” to include multi-piece and one-piece bodies.  On appeal, a divided panel of the Federal Circuit held that the specification limited the term to one-piece bodies.  When the court declined to rehear the case en banc and reconsider the standard of review, Judge O’Malley wrote a vigorous dissent that was joined by Chief Judge Rader and Judge Moore.  Judge O’Malley is a former district court judge and is thus familiar with the other side of the issue.

It was thought that this dissent might lead the Supreme Court to hear the case.  Alas, yesterday, they declined to do so.  One would surmise that this issue will not go away and will continue to be raised in future cases.

Supreme Court to Review Myriad Case Again

December 3, 2012

USSupremeCourtWestFacadeThe Supreme Court has again granted certiorari in the Myriad gene patent case.  Specifically, the Court agreed to decide the following question presented:

Are human genes patentable?

The Court declined to address the method claims or the standing issue in the case.

The ACLU and other plaintiffs sued Myriad and the USPTO in 2009 claiming that Myriad’s patents to isolated genes are invalid as directed to non-statutory subject matter and in violation of the First Amendment to the Constitution.  In early 2010, the district court agreed that the gene patent claims were invalid under § 101 of the Patent Act, but not under the First Amendment.

In 2011, the Federal Circuit reversed, holding that isolated DNA have a markedly different chemical identity and nature from DNA found in the human body.  After the Supreme Court issued its decision in Prometheus where it confused obviousness with patentable subject matter, the Court sent the Myriad case back to the Federal Circuit for reconsideration in light of that decision.  After reviewing the case again, the Federal Circuit reached the same conclusion that the isolated DNA claims are patentable.

The Supreme Court has now agreed to consider this case again.  Given its propensity for confusing patentability with patentable subject matter, the outcome is completely uncertain.

The case will be briefed in the coming months and should be argued before the Court in March or April.  A decision is expected by the end of the Court’s current term in June.

International IP Exhaustion

November 8, 2012

In the US, once a patented product has been lawfully sold, the patent rights are “exhausted.” This means that subsequent purchasers can obtain the product free of patent rights. The theory behind exhaustion is that a patent owner should be able to recover or obtain royalties only once for a given product.

A product covered by a US patent that is lawfully sold outside the US (by virtue of not being patented in the country of sale or by permission of the patent owner in the country of sale) and then imported into the US may still be liable for infringement. A foreign sale would not exhaust US patent rights. Other countries may take a different approach to this issue.

Kirtsaeng v. John Wiley & Sons

The Supreme Court recently heard arguments in a copyright exhaustion case from the Second Circuit.  Although the case involves copyrighted works, it will have implications for patent law.

Kirtsaeng lawfully acquired copyrighted textbooks in Thailand.  He imported them into the US and resold them.  The publisher sued him for copyright infringement.  He argued that the first sale or exhaustion defense shielded him from liability.  The Second Circuit held that the defense does not apply to works that were acquired outside the US.

Professor Kristen Osenga of the University of Richmond Law School (my wife) provided a podcast for the Federalist Society about the argument of the case at the Supreme Court.  http://www.fed-soc.org/publications/detail/kirtsaeng-v-john-wiley-and-sons-post-argument-scotuscast.

Supreme Court to Review Patent Cases

October 9, 2012

The Supreme Court has agreed to hear appeals in two patent cases during the October 2012 term.

Bowman v. Monsanto Co.

This case concerns the doctrine of patent exhaustion where a patent owner is only entitled to compensation from the first sale of a patented invention and not from subsequent authorized sales. 

Monsanto has engineered genetically modified seeds that are resistant to herbicides.  When purchasing the seeds, Monsanto requires farmers to agree that they won’t use the seeds for the next year’s planting.  In this way, Monsanto seeks to ensure that farmers must buy the patented seeds from them each year.

Bowman purchased Monsanto’s patented seeds for the purpose of growing new plants and harvesting the seeds from those plants to use in the following year’s planting.  He argues that the original sale exhausted Monsanto’s patent rights.  Monsanto has rights in the first generation of seeds and not in subsequent generations. 

The Federal Circuit agreed with Monsanto that Bowman had created a newly infringing article.  The opinion seemed to rely in part on the conditional sale doctrine that allows patent owners to continue to assert rights in patented articles even after a sale.  Some argue that this is contrary to the Supreme Court’s 2008 decision in Quanta v. LG Electronics.

The Supreme Court often decides to hear cases based on a split between the lower courts of appeals on particular issues.  Given that all patent appeals are heard by the Federal Circuit, there aren’t really such splits.  Instead, the Court sometimes requests the views of the Administration on whether to hear a particular patent case.  Interestingly, the Court agreed to review this case against the advise of the Administration.

Question presented:

Patent exhaustion delimits rights of patent holders by eliminating the right to control or prohibit use of the invention after an authorized sale. In this case, the

Federal Circuit refused to find exhaustion where a farmer used seeds purchased in an authorized sale for their natural and foreseeable purpose-namely, for planting.

The question presented is:

Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?

Gunn v. Minton

The issue in this case is whether patent malpractice claims should be heard exclusively by Federal Courts and the Federal Circuit or whether they can be decided by state courts.

Attorneys are licensed on a state-by-state basis and malpractice cases against attorneys are generally filed in state court.  The Federal Circuit has held that patent law is an exception to this rule because the issues in such cases involve substantial questions related to patent law.  In particular, the court must decide whether the complainant would have won his infringement case or would have acquired a patent if not for the complained malpractice.

In this case, Minton sued his patent litigation counsel in Texas state court.  The trial court and court of appeals ruled for the attorneys based on lack of proof of the claims.  The Texas supreme court, however, dismissed the case because it lacked subject matter jurisdiction.  The court agreed with the Federal Circuit that the case should have been filed in Federal court.  The attorneys appealed to the Supreme Court.

In recent Federal Circuit cases on this issue, Judge O’Malley has been dissenting from the standard Federal Circuit view.  She has managed to get Judges Wallach and Mayer to join her.

The Supreme Court has finally agreed to determine this issue.  Question presented:

Did the Federal Circuit depart from the standard this Court articulated in Grable & Sons Metal Products, Inc. u. Darue Eng’g & Mfg., 545 U.S. 308 (2005 ), for “arising under” jurisdiction of the federal courts under 28 U.S.C. § 1338, when it held that state law legal malpractice claims against trial lawyers for their handling of underlying patent matters come within the exclusive jurisdiction of the federal courts? Because the Federal Circuit has exclusive jurisdiction over appeals involving patents, are state courts and federal courts strictly following the Federal Circuit’s mistaken standard, thereby magnifying its jurisdictional error and sweeping broad swaths of state law claims – which involve no actual patents and have no impact on actual patent rights – into the federal courts?

These cases will be briefed and argued in the coming months.  Decisions for each are expected by June.

Gene Patent Fight Continues

September 28, 2012

The ACLU filed another cert. petition where it asks the Supreme Court to overturn the Federal Circuit’s opinion that isolated human genes are patentable.  The questions presented in the petition include:

1. Are human genes patentable?

2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court’s ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?

3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad’s “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?

The first and third questions are the same ones that it presented in its December 2011 petition to the Supreme Court.  Question 3 is difficult to understand because the plaintiffs continue to win on this question despite not really have a single person or entity that does have standing.  Why continue to raise the question that it won but shouldn’t have?

The second question is new to this petition.  The Supreme Court issued a GVR order on this case in light of its Prometheus opinion and asked the Federal Circuit to reconsider the issues in light of Prometheus.  The Federal Circuit did so, but reached the same conclusion that the claims to isolated genes are patentable, claims to methods of screening cancer patients are patentable, and claims to methods of comparing and analyzing gene sequences to be ineligible.

We now await Myriad’s response.  The consensus seems to be that the Supreme Court will take this case again.  After Prometheus, it is completely unknown what the Court will do.


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